[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"depression---major-depressive-disorder\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:depression---major-depressive-disorder":27},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,116,0,25,[9,53,78,116,137,154,183,217,247,275,302,334,362,392,416,443,470,498,524,547,572,592,617,640,670],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100607443","virtual-reality-enhanced-behavioral-activation-for-older-adults-with-depression-100607443",false,"NCT07188623","Virtual Reality-Enhanced Behavioral Activation for Older Adults With Depression","VR-Enhanced BA for Older Adults With Major Depressive Disorder","Inclusion Criteria:\n\n* Patient must meet DSM V criteria for MDD\n* Patient must be at least 65 years of age\n* Patient must be English speaking\n* Without cognitive impairment\n\nExclusion Criteria:\n\n* Substance Use Disorders in past year\n* Any psychosis or bipolar I disorder\n* Any seizure in the last 6 months or untreated epilepsy\n* Current nonsuicidal self-injury or parasuicidal behavior\n* Current suicidal urges and intent\n* Changing psychotherapy treatment within three months of study entry\n* Changing psychotropic medication(s) within two months of study entry","ALL","65 Years",{"count":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24],"NA","The primary aims of this study are to assess the feasibility, acceptability, and tolerability of using an immersive virtual reality (VR) headset to engage in behavioral activation (BA) for older adults diagnosed with major depressive disorder (MDD). The secondary aim of this study is to explore the efficacy of using VR to enhance BA therapy in a clinical MDD older adult population.",[27,28,29,30],"Depression - Major Depressive Disorder","Older Adults (65 Years and Older)","Behavioral Activation Treatment","Virtual Reality Therapy",[32,33,34,35,36,37,38,39],"Depression","Older adult","major depressive disorder","MDD","behavioral activation","VR","virtual reality","older adults","RECRUITING","2026-08-19",{"date":43,"type":44},"2026-08-21","ACTUAL",{"date":46,"type":44},"2025-09-30",{"date":48,"type":21},"2026-12",{"name":50,"class":51},"Stanford University","OTHER",1,{"id":54,"slug":55,"hasResults":12,"nctId":56,"briefTitle":57,"officialTitle":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":12,"sex":17,"minAge":59,"maxAge":18,"enrollmentInfo":60,"targetDuration":4,"studyType":22,"phases":62,"briefSummary":63,"conditions":64,"keywords":65,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":77},"100629888","efficacy-and-mechanisms-of-escitalopram-in-drug-nave-first-episode-major-depressive-disorder-100629888","NCT07480525","Efficacy and Mechanisms of Escitalopram in Drug-Naïve First-Episode Major Depressive Disorder","Inclusion Criteria:\n\n1. Aged 18-65 years (including 18 and 65), no gender restriction, Han Chinese ethnicity.\n2. Meets the diagnostic criteria for depressive disorders according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV), confirmed by the Mini-International Neuropsychiatric Interview, version 5.0 (MINI).\n3. Outpatients or inpatients; Hamilton Depression Rating Scale-17 items (HAMD-17) score ≥17; Hypomania Checklist-32 (HCL-32) score ≤13; and Clinical Global Impressions-Severity (CGI-S) score ≥4.\n4. First depressive episode (duration ≤3 months), with no use of antidepressants or other psychotropic medications in the past 3 months.\n5. Written informed consent obtained from the patient.\n\nExclusion Criteria:\n\n1. Meet DSM-IV diagnostic criteria other mental disorders, including schizophrenia spectrum and other psychotic disorders, bipolar and related disorders, obsessive-compulsive disorder, etc..\n2. Individuals with intellectual disabilities or who are unable to cooperate for other reasons, or those lacking or having incomplete civil capacity during the onset of illness;\n3. Suffering from neurological or organic brain diseases (such as stroke, cerebral hemorrhage, brain tumors, Parkinson's disease, epilepsy, etc.) and a history of severe traumatic brain injury;\n4. Have attempted suicide within the past 3 months, or currently present a high suicide risk, defined as a Montgomery-Åsberg Depression Rating Scale (MADRS) item 10 score ≥5.\n5. Are pregnant or breastfeeding, cannot use reliable contraception during the study, or plan to conceive (or impregnate a partner) within 3 months after study initiation.\n6. Have known allergies to escitalopram oxalate or its excipients.\n7. Are currently taking medications that may interfere with the evaluation of escitalopram efficacy.\n8. Have participated in another drug clinical trial within the past 3 months.\n9. Have contraindications to MRI scanning, such as metal implants or claustrophobia.\n10. Considered unsuitable for study participation by the investigators for any other reason.","18 Years",{"count":61,"type":21},200,[24],"The goal of this project is to quantify the effectiveness and safety of escitalopram oxalate oral solution in the treatment of first-episode, drug-naïve patients with major depressive disorder, and to explore the mechanisms underlying its antidepressant effects using multi-omics approaches. By integrating clinical, cognitive, laboratory, imaging, genetic, and environmental data, the study aims to identify patient subgroups who are most likely to benefit from escitalopram, thereby promoting individualized and precision treatment for depression.\n\nThis multicenter, prospective, single-arm intervention study will enroll 200 adults aged 18-65 years with major depressive disorder, who will receive escitalopram oxalate oral solution for 8 weeks. Depressive symptoms, cognitive function, and adverse events will be assessed at baseline, during treatment, and after 8 weeks of treatment to evaluate efficacy and safety. Escitalopram blood concentrations will be measured at week 4 to monitor treatment adherence and support safety evaluation. Through comprehensive data collection and multimodal analysis, this project seeks to clarify the biological mechanisms of escitalopram and provide evidence to guide more precise clinical use of antidepressant therapy.",[27],[66,67],"depression","antidepressant","2026-08-18",{"date":70,"type":44},"2026-08-20",{"date":72,"type":44},"2026-03-20",{"date":74,"type":21},"2026-12-31",{"name":76,"class":51},"Peking University",5,{"id":79,"slug":80,"hasResults":12,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":12,"sex":17,"minAge":59,"maxAge":86,"enrollmentInfo":87,"targetDuration":4,"studyType":22,"phases":89,"briefSummary":91,"conditions":92,"keywords":97,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":115},"100577061","phase-3-a-study-of-a-deuterated-psilocin-analog-cyb003-in-humans-with-major-depressive-disorder-100577061","NCT06793397","A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder","An Efficacy and Safety, Phase III, Multi-center, Double-Blind, Randomized Controlled Study Comparing 2 Active Doses of CYB003 and Placebo in Eligible Participants With Major Depressive Disorder","EMBRACE","Inclusion Criteria:\n\nParticipants must meet all the following criteria to be included in the trial:\n\n* Age18 to 85 years.\n* Participant has a diagnosis of MDD (single or recurrent episode as defined by DSM-5 TR \\[if single episode, duration of ≥4 weeks and ≤24 months\\] and established as per evaluation by the Investigator. The first MDD episode must have occurred prior to age 60.\n* Moderate to severe depression at Screening and Baseline, independently confirmed.\n* Participants have been on a stable dose of antidepressant medication (label specified) at an adequate dose in the last 4 weeks prior to Screening and has had an inadequate response (less than 50% improvement), as judged by the Investigator.\n* Participant has a body mass index (BMI) of 40 kg\u002Fm2 or less (BMI ≤40 kg\u002Fm2), inclusive, at Screening.\n* Participant is able to refrain from nicotine use during the dosing session (up to 8 hours).\n* Participants capable of producing sperm must use a condom plus spermicide during the trial and for 12 weeks after their final dose of trial medication, if their partner is a person of childbearing potential.\n* Participants of childbearing potential who have a partner capable of producing sperm must agree to use a highly effective method of contraception in combination with the use of a condom plus spermicide during the trial and for 12 weeks after their final dose of trial medication. Such participants must have a negative pregnancy test at Screening and Day 1 prior to dosing.\n* Participants of non-childbearing potential who are or were capable of producing eggs (ova) must have been postmenopausal or permanently sterile following hysterectomy, bilateral salpingectomy, or bilateral oophorectomy.\n* Participants have provided written informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form.\n\nExclusion Criteria\n\nParticipants with any of the following characteristics\u002Fconditions will be excluded from trial participation:\n\n* Current or previously diagnosed schizophrenia spectrum or other psychotic disorders, including schizophrenia, schizoaffective disorder, schizotypal disorder, schizophreniform disorder, brief psychotic disorder, current or previous history of bipolar disorder, or current borderline personality disorder.\n* Participants with a medical diagnosis of attention deficit hyperactivity disorder (ADHD) will be excluded if currently taking medication for ADHD.\n* Family history of schizophrenia, schizoaffective disorder, or bipolar disorder type 1 (first-degree relatives).\n* Significant suicide risk within the past 6 months, during the Screening Period, or at Baseline; or (b) suicidal behaviors within 12 months of Screening; or (c) clinical assessment of significant suicidal risk during clinical interview; or (d) non-suicidal self-injury within 12 months of Screening.\n* Current or previous diagnosis of treatment-resistant MDD, defined as failure to respond to 2 or more antidepressant treatments of 2 different classes given at an adequate dose (label specified) for an adequate duration as judged by the Investigator and clinical interview.\n* Has had electroconvulsive treatment, transcranial magnetic stimulation, deep brain stimulation, or vagal nerve stimulation for any episode of MDD in the last 6 months.\n* Currently receiving a monoamine oxidase inhibitor, tricyclic antidepressants, mirtazapine, trazodone, moclobemide, buspirone, or an antipsychotic or mood stabilizer. Note: if receiving these medications are for another indication, they must be discontinued ≥ 14 days or 5 half-lives, whichever is longer, prior to Day 1.\n* Participant report of (or if available in medical record) exposure to psilocin, or 5-HT2a receptor agonists, or any other psychedelics, such as ayahuasca, mescaline, lysergic acid diethylamide, peyote, or 3,4-methylenedioxymethamphetamine, more than 10 times over the participant's lifetime or any psychedelic use within 12 months prior to Screening.\n* Participant report of (or if available in medical record) treatment with ketamine or S-ketamine use within 6 months prior to Screening.\n* Clinically relevant history of abnormal physical health interfering with the trial (including but not limited to, neurological, cardiovascular, respiratory, gastrointestinal \\[including dyspepsia or gastroesophageal reflux disease\\], hepatic, or renal disorder).\n* Has hypothyroidism or hyperthyroidism, unless controlled on appropriate medication.\n* Current diagnosis of uncontrolled hypertension or an arrhythmia, or clinically relevant abnormal results for heart rate.\n* Participants have a presence or relevant history of organic brain disorders.\n* Participant is taking or has taken OTC doses of 5-HTP or St John's Wort within prior to trial medication administration.\n* Donation of blood or plasma within 4 weeks prior to first dosing and until 4 weeks after final dosing.\n* Participants capable of producing sperm who will not abstain from sperm donation between first dosing and 12 weeks after final dosing.\n* Participants of childbearing potential who are pregnant, breastfeeding, planning to conceive or unwilling to abstain from egg (ova) donation between first dosing and 12 weeks after final dosing.\n* History of serotonin syndrome.\n* Unwilling to consent to audio and video recording of psychological support and dosing sessions.","85 Years",{"count":88,"type":21},330,[90],"PHASE3","The purpose of this study is to determine the efficacy, safety and tolerability of CYB003 compared to matching placebo as adjunctive treatment in patients with MDD.\n\nFor more information about the EMBRACE study, including participating study locations, and to register your interest in learning more about participation, please visit the study website: https:\u002F\u002Fembrace-mdd-trial.com\u002F",[93,94,27,95,96,32],"Major Depressive Disorder (MDD)","Depression in Adults","Depression Disorders","Depression Disorder",[35,98,32,99,100,101,102,103,104],"Psychedelic","Major Depressive Disorder","CYB003","CYB003-001","CYB003-002","Psilocybin","psilocin-7438","2026-08-14",{"date":107,"type":44},"2026-08-17",{"date":109,"type":44},"2025-12-10",{"date":111,"type":21},"2027-05-08",{"name":113,"class":114},"Cybin IRL Limited","INDUSTRY",68,{"id":117,"slug":118,"hasResults":12,"nctId":119,"briefTitle":120,"officialTitle":120,"acronym":4,"eligibilityCriteria":121,"healthyVolunteers":12,"sex":17,"minAge":122,"maxAge":59,"enrollmentInfo":123,"targetDuration":4,"studyType":22,"phases":125,"briefSummary":127,"conditions":128,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":52},"100608560","phase-2-selenium-supplementation-for-improving-depression-in-children-and-adolescents-efficacy-and-mechanistic-study-100608560","NCT07203144","Selenium Supplementation for Improving Depression in Children and Adolescents: Efficacy and Mechanistic Study","Inclusion Criteria:\n\n* Aged 12-18 years;\n* Diagnosed with major depressive disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), using the K-SADS-PL diagnostic tool;\n* A score of ≥40 on the Children's Depression Rating Scale-Revised (CDRS-R);\n* Adequate visual and auditory abilities to complete the study;\n* Willingness to participate in the study with informed consent signed by both the participant and a legal guardian.\n\nExclusion Criteria:\n\n* Patients with severe psychiatric disorders such as bipolar disorder, schizophrenia, bulimia nervosa, anorexia nervosa, or primary obsessive-compulsive disorder;\n* Those with severe physical illnesses or other life-threatening conditions; patients in a current depressive episode with a clear suicidal plan or history of suicide attempt;\n* Individuals with a history of substance or drug abuse;\n* Those requiring immediate hospitalization for psychiatric disorders;\n* Patients currently taking medications contraindicated with the investigational drug or that may interfere with its efficacy;\n* Those who have received modified electroconvulsive therapy (MECT) within the past 12 months;\n* Individuals allergic to selenium yeast protein, including those with allergic rhinitis, gastrointestinal sensitivity, allergic constitution, or autoimmune diseases such as Graves' disease or Hashimoto's thyroiditis;\n* Patients with contraindications to magnetic resonance imaging (MRI);\n* Left-handed individuals.","12 Years",{"count":124,"type":21},172,[126],"PHASE2","The purpose of this study is to investigate the role and mechanisms of selenium in depression among children and adolescents, aiming to provide new insights for understanding the pathogenesis and treatment of depression in this population.",[27],"2026-08-13",{"date":107,"type":44},{"date":132,"type":44},"2025-12-31",{"date":134,"type":21},"2027-04-01",{"name":136,"class":51},"First Affiliated Hospital of Chongqing Medical University",{"id":138,"slug":139,"hasResults":12,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":4,"eligibilityCriteria":143,"healthyVolunteers":12,"sex":17,"minAge":122,"maxAge":59,"enrollmentInfo":144,"targetDuration":4,"studyType":22,"phases":145,"briefSummary":146,"conditions":147,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":148,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":52},"100607199","efficacy-and-safety-of-transcranial-alternating-current-stimulation-tacs-combined-with-stable-medication-in-adolescents-with-depression-a-randomized-double-blind-controlled-pilot-study-100607199","NCT07185451","Efficacy and Safety of Transcranial Alternating Current Stimulation (tACS) Combined With Stable Medication in Adolescents With Depression","Efficacy and Safety of Transcranial Alternating Current Stimulation (tACS) Combined With Stable Medication in Adolescents With Depression: A Randomized, Double-Blind, Controlled Pilot Study","Inclusion Criteria:\n\n1. Age 12-18 years.\n2. Meet DSM-5 diagnostic criteria for a current depressive episode, as confirmed by the K-SADS-PL.\n3. Children's Depression Rating Scale-Revised (CDRS-R) score ≥40 at baseline.\n4. Stable psychotropic medication treatment for at least 4 weeks prior to enrollment and willingness to continue the same regimen throughout the study.\n\nExclusion Criteria:\n\n1. Psychiatric comorbidities other than anxiety disorders.\n2. Depression with psychotic features.\n3. Young Mania Rating Scale (YMRS) score \\>13.\n4. History of neurological disorders (e.g., epilepsy, traumatic brain injury) or severe physical illnesses (e.g., thyroid disease, lupus, diabetes, significant liver, kidney, or lung impairment, major trauma).\n5. Previous treatment with electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), transcranial direct current stimulation (tDCS), tACS, or other neurostimulation therapies.\n6. Current use of antiepileptic drugs or high-dose benzodiazepines.\n7. History of alcohol or substance abuse or dependence.\n8. Pregnant or breastfeeding females.\n9. Contraindications to MRI.\n10. Current high suicide risk.",{"count":20,"type":21},[24],"This randomized, double-blind, sham-controlled pilot study will evaluate the feasibility, acceptability, safety, and preliminary clinical effects of transcranial alternating current stimulation as an adjunctive treatment for adolescents with major depressive disorder. It will also examine changes in depressive symptoms and related clinical outcomes, while exploring potential effects on emotional regulation, cognitive function, and brain function following the intervention.",[27],{"date":107,"type":44},{"date":150,"type":44},"2025-10-01",{"date":152,"type":21},"2027-10-01",{"name":136,"class":51},{"id":155,"slug":156,"hasResults":12,"nctId":157,"briefTitle":158,"officialTitle":158,"acronym":4,"eligibilityCriteria":159,"healthyVolunteers":12,"sex":17,"minAge":59,"maxAge":160,"enrollmentInfo":161,"targetDuration":4,"studyType":163,"phases":4,"briefSummary":164,"conditions":165,"keywords":168,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":174,"lastUpdatePostDateStruct":175,"startDateStruct":177,"completionDateStruct":179,"leadSponsor":180,"locationsCount":182},"100651145","health-and-work-ability-following-inpatient-treatment-for-stress-related-disorders---follow-up-study-of-the-harmodi-cohort-100651145","NCT07757997","Health and Work Ability Following Inpatient Treatment for Stress-related Disorders - Follow-up Study of the HARMODI Cohort","Inclusion Criteria:\n\n* Previously participatiom in the HARMODI study (No. 2022-01871)\n* Completion of inpatient treatment at the Clinica Holistica Engiadina\n\nExclusion Criteria:\n\n* Withdraw of consent for participation in the HARMODI study.\n* Participants who cannot be reached despite predefined contact attempts (e.g., invalid email or postal address or telephone number)","80 Years",{"count":162,"type":21},143,"OBSERVATIONAL","When treating stress-related conditions, it is important to understand how health and work ability develop over the long term. In our research project, we aim, firstly, to investigate how health and work ability develop over the three years following inpatient treatment, and, secondly, to identify the factors that influence a return to work and work ability. Former inpatients undergoing treatment for stress-related disorders who took part in the HARMODI-study will be invited to complete online questionnaires up to three years after their discharge from the clinic. The online questionnaires contain questions regarding current work ability, mental and physical health as well as the process of return to work after discharge.",[27,166,167],"Adjustment Disorder","Burnout Syndrome",[32,169,170,171,172,173],"Burnout","Return to Work","long-term treatment effects","work ability","mental health","2026-08-06",{"date":176,"type":44},"2026-08-11",{"date":178,"type":21},"2026-08",{"date":48,"type":21},{"name":181,"class":51},"Clinica Holistica Engiadina",2,{"id":184,"slug":185,"hasResults":12,"nctId":186,"briefTitle":187,"officialTitle":188,"acronym":189,"eligibilityCriteria":190,"healthyVolunteers":12,"sex":17,"minAge":59,"maxAge":4,"enrollmentInfo":191,"targetDuration":4,"studyType":22,"phases":193,"briefSummary":194,"conditions":195,"keywords":199,"overallStatus":210,"whyStopped":4,"lastUpdateSubmitDate":174,"lastUpdatePostDateStruct":211,"startDateStruct":213,"completionDateStruct":214,"leadSponsor":215,"locationsCount":52},"100621657","an-evaluation-of-the-impact-of-pharmacist-comprehensive-medication-management-with-pharmacogenomic-results-to-improve-depression-outcomes-in-community-pharmacies-100621657","NCT07373470","An Evaluation of the Impact of Pharmacist Comprehensive Medication Management With Pharmacogenomic Results to Improve Depression Outcomes in Community Pharmacies.","Genotype-guided Comprehensive Medication Management to Improve Depression Outcomes in Pennsylvania","COMPASS-PGx","INCLUSION CRITERIA:\n\n* At targeted community pharmacy for:\n\n  * New prescription or change in dose\u002Fschedule of SSRI (citalopram, escitalopram, sertraline, paroxetine), OR\n  * Concurrent SSRI (citalopram, escitalopram, sertraline, paroxetine) and new prescription\u002Fchange in SNRI (desvenlafaxine, duloxetine, and venlafaxine) \u002F bupropion.\n* Depressive symptoms confirmed by PHQ8 assessment (\\>5 indicating at least mild depressive symptoms)\n* UPMC patient (or able\u002Fwilling to become one) and has UPMC provider (or able\u002Fwilling to obtain one)\n* Signed consent to join Pitt+Me Discovery biobanking research study.\n* English-speaking\n\nEXCLUSION CRITERIA:\n\n* Inability to receive CMM at specific pharmacy\u002Fpharmacist\n* Comorbid diagnosis of schizophrenia (patient-reported)\n* Untreated sleep disorder (patient-reported)\n* Pitt+Me Discovery participant who has elected to not receive return of results, or who has already received results previously",{"count":192,"type":21},220,[24],"The goal of this prospective, randomized clinical trial is to learn whether pharmacogenomic (PGx)-guided comprehensive medication management delivered by pharmacists in community pharmacies will improve antidepressant treatment outcomes.\n\nThe primary aim is to determine whether comprehensive medication management with review of PGx testing results improves depression symptoms, compared with usual care.\n\nParticipants 18 years of age or older who have undergone PGx testing (e.g. through an independent biobanking study (Pitt+Me Discovery) who require initiation or adjustment of antidepressant therapy will be randomly assigned to receive either PGx-guided comprehensive medication management or usual care. Those who receive usual care will receive their PGx results at the end of the study. Researchers will compare the groups to assess whether PGx-guided care provided in partnership with community pharmacists and prescribers results in better depression and medication outcomes.",[196,27,197,198],"Pharmacogenetics","Pharmacogenomic Drug Interaction","Community Pharmacy Services",[200,201,202,203,204,205,206,207,208,209],"precision medicine","pharmacogenomics","PGx","Comprehensive medication management","pharmacist","community pharmacy","medication review","antidepressants","pharmacogenomic testing","management of depression","NOT_YET_RECRUITING",{"date":212,"type":44},"2026-08-07",{"date":178,"type":21},{"date":74,"type":21},{"name":216,"class":51},"University of Pittsburgh",{"id":218,"slug":219,"hasResults":12,"nctId":220,"briefTitle":221,"officialTitle":222,"acronym":223,"eligibilityCriteria":224,"healthyVolunteers":12,"sex":17,"minAge":225,"maxAge":4,"enrollmentInfo":226,"targetDuration":4,"studyType":22,"phases":227,"briefSummary":229,"conditions":230,"keywords":233,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":174,"lastUpdatePostDateStruct":239,"startDateStruct":241,"completionDateStruct":242,"leadSponsor":244,"locationsCount":52},"100612277","psilocybin-to-treat-depression-in-spinal-cord-injury-100612277","NCT07251491","Psilocybin to Treat Depression in Spinal Cord Injury","Safety, Tolerability, Outcomes of Psilocybin for Depression (STOP Depression) in Veterans With Spinal Cord Injury","STOP","Inclusion Criteria:\n\n* Able and willing to provide informed consent\n* Spinal cord injury for at least 1 year\n* Confirmed diagnosis of depression\n* At least 22 years of age at time of consent\n* At least 50 kg (110 lbs.) body weight\n* Fully independent from ventilatory support (ventilator or diaphragm pacer)\n* Fluent in speaking and reading English\n* Able to swallow pills\n* Agree to have study visits recorded with audio and video\n* Agree to release outside medical and psychiatric records\n* Able and willing to taper off antidepressant, under clinician supervision\n* Agree to use adequate contraceptive methods\n\nExclusion Criteria:\n\n* Are not able to give adequate informed consent\n* Have used psilocybin or another psychedelic within 6 months\n* Have received Electroconvulsive Therapy (ECT) within 12 weeks\n* Have used ketamine within 12 weeks\n* Have a history of Bipolar I Disorder\n* Have a current eating disorder\n* Have a current severe alcohol or cannabis use disorder within the 6 months\n* Have an illicit drug or prescription drug substance use disorder within 12 months\n* Current serious suicide risk\n* History of heart attack, aneurysm, or stroke\n* Uncontrolled hypertension\n* Are pregnant or nursing","22 Years",{"count":20,"type":21},[228,126],"PHASE1","The main goal of this study is to determine if psilocybin is safe for use in people with SCI. The study will measure how people with SCI respond to three psilocybin doses: low (5mg), medium (10mg), and high (25mg).\n\nThe main question the study aims to answer is: does psilocybin increase the number and severity of adverse (bad) events reported by people with SCI? These may include pain, muscle spasms, symptoms of depression, and symptoms of low or high blood pressure. The investigators will also measure how well people with SCI tolerate the psychedelic experience, and compare responses between the low (5mg), medium (10mg), and high (25mg) doses.\n\nParticipants will:\n\n* Agree to be enrolled in the study for up to 13 months.\n* Agree to complete the seven (7) visits that are included in the psilocybin-assisted therapy.\n* Agree to complete follow-up study visits, including in-person visits to the James J Peters VA Medical Center, located in the Bronx, New York and remote visits.\n* Agree to keep a log of how they are feeling and any change in the frequency or severity of adverse events.",[231,27,232],"Spinal Cord Injury","Veteran",[234,235,236,32,237,238],"Tetraplegia","Paraplegia","Psychosocial Wellbeing","Neuropathic Pain","Psychedelics",{"date":240,"type":44},"2026-08-10",{"date":174,"type":44},{"date":243,"type":21},"2028-03-01",{"name":245,"class":246},"James J. Peters Veterans Affairs Medical Center","FED",{"id":248,"slug":249,"hasResults":12,"nctId":250,"briefTitle":251,"officialTitle":252,"acronym":4,"eligibilityCriteria":253,"healthyVolunteers":12,"sex":17,"minAge":59,"maxAge":254,"enrollmentInfo":255,"targetDuration":4,"studyType":22,"phases":257,"briefSummary":258,"conditions":259,"keywords":262,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":174,"lastUpdatePostDateStruct":268,"startDateStruct":269,"completionDateStruct":271,"leadSponsor":273,"locationsCount":52},"100596679","brief-trial-of-act-i-for-adults-with-chronic-insomnia-100596679","NCT07048600","Brief Trial of ACT-i for Adults With Chronic Insomnia","Brief Group Acceptance and Commitment Therapy for Insomnia: Study Protocol for a Randomized Controlled Trial","Inclusion Criteria:\n\n* clinical\u002F subclinical diagnosis of chronic insomnia either already diagnosed by a professional, or identified with SCISD-R by our team of clinicians\n* age over 18 and older, but not over 59 years old;\n* minimal\u002F mild symptomatology of depression (scores ≤ 9 on PHQ-9) and\u002F or anxiety (scores ≤ 9 on GAD-7) or as diagnosed with SCID-5-CV;\n\nExclusion Criteria:\n\n* diagnosed with a neurological degenerative disorder, or any moderate\u002F severe psychiatric disorder;\n* diagnosed with other sleep disorder (e.g., sleep apnea, restless legs\u002F periodic limb movements, circadian-based sleep disorder);\n* diagnosed with cognitive impairments;\n* unable to understand Romanian;\n* unable to attend to online-sessions (e.g., no laptop, microphone, camera);","59 Years",{"count":256,"type":21},76,[24],"This is a prospective, randomized-controlled trial that assesses the efficacy of a brief Acceptance and Commitment Therapy (ACT-i), compared to an attentional control group, in adults with chronic insomnia. The interventions will be evaluated for their impact on insomnia severity, cognitive function, depression, anxiety, psychological flexibility, and sleep beliefs - measured before treatment, two weeks after and at a three-month follow-up.",[260,27,261],"Chronic Insomnia","Anxiety",[263,264,265,66,266,267],"acceptance and commitment therapy","chronic insomnia","cognitive functions","anxiety","randomized controlled trial",{"date":212,"type":44},{"date":270,"type":44},"2025-05-23",{"date":272,"type":21},"2026-08-30",{"name":274,"class":51},"Babes-Bolyai University",{"id":276,"slug":277,"hasResults":12,"nctId":278,"briefTitle":279,"officialTitle":280,"acronym":281,"eligibilityCriteria":282,"healthyVolunteers":12,"sex":17,"minAge":59,"maxAge":18,"enrollmentInfo":283,"targetDuration":4,"studyType":22,"phases":285,"briefSummary":286,"conditions":287,"keywords":289,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":294,"lastUpdatePostDateStruct":295,"startDateStruct":296,"completionDateStruct":298,"leadSponsor":300,"locationsCount":52},"100629461","iprgc-as-a-potential-biomarker-for-predicting-transcranial-magnetic-stimulation-treatment-response-in-major-depressive-disorder-100629461","NCT07474974","ipRGC as a Potential Biomarker for Predicting Transcranial Magnetic Stimulation Treatment Response in Major Depressive Disorder","Illuminating Depression: ipRGC as a Potential Biomarker for Predicting Transcranial Magnetic Stimulation Treatment Response in Major Depressive Disorder","BRIGHT","Inclusion Criteria:\n\n* Diagnosis of MDD, confirmed via the structured clinical interview;\n* TRD type;\n* Age between 18-65 years;\n* Visual acuity of 20\u002F32 or better.\n\nExclusion Criteria:\n\n* Prior rTMS treatment;\n* Contraindications for TMS;\n* Psychiatric disorders other than MDD;\n* Systemic diseases affecting the eyes (e.g., diabetes mellitus);\n* Ocular conditions;\n* Head injuries causing loss of consciousness;\n* Current or past alcohol\u002Fsubstance dependence within 6 months;\n* Neurodegenerative diseases;\n* Major neurological illnesses;\n* Use of medications affecting iris mechanics or the autonomic nervous system.",{"count":284,"type":21},44,[24],"This research explores the potential of retinal ganglion cells (RGCs), particularly intrinsically photosensitive RGCs (ipRGCs), as biomarkers for predicting response to transcranial magnetic stimulation (TMS) in treatment-resistant depression (TRD). We also aim to assess the impact of TMS treatment on RGCs and ipRGCs in TRD patients, investigating associations with clinical improvements and cognitive status. A clinical trial involving 44 patients with treatment-resistant depression (TRD) will be conducted. All participants will receive rTMS targeting the dorsolateral prefrontal cortex (DLPFC). Data will be collected pre- and post-intervention, as well as at a 2-month follow-up, using multiple outcome measures, including the post-illumination pupil response (PIPR). The project seeks to confirm the effectiveness of TMS and the potential of RGCs\u002FipRGCs as predictors of treatment response, thereby facilitating the development of personalized treatment strategies for TRD patients undergoing rTMS therapy.",[27,288],"Treatment Resistant Depression",[99,290,291,292,293],"Repetitive Transcranial Magnetic Stimulation","Retinal Ganglion Cells","ipRGCs","Treatment-resistant depression","2026-08-03",{"date":174,"type":44},{"date":297,"type":44},"2026-03-15",{"date":299,"type":21},"2027-07-31",{"name":301,"class":51},"Polytechnic Institute of Porto",{"id":303,"slug":304,"hasResults":12,"nctId":305,"briefTitle":306,"officialTitle":307,"acronym":308,"eligibilityCriteria":309,"healthyVolunteers":12,"sex":17,"minAge":310,"maxAge":4,"enrollmentInfo":311,"targetDuration":4,"studyType":22,"phases":313,"briefSummary":314,"conditions":315,"keywords":318,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":325,"lastUpdatePostDateStruct":326,"startDateStruct":328,"completionDateStruct":330,"leadSponsor":332,"locationsCount":182},"100596813","combining-rtms--aerobic-exercise-to-treat-depression-and-improve-post-stroke-walking-100596813","NCT07050355","Combining rTMS & Aerobic Exercise to Treat Depression and Improve Post-Stroke Walking","Combining rTMS & Aerobic Exercise to Treat Depression and Improve Post-Stroke Walking (RESTORATION)","RESTORATION","Inclusion criteria:\n\n* age \\>21\n* stroke at least 12 months prior\n* screen positive for depressive symptoms (PHQ-9 \\> 5) and HAM-D17 ≥ 12\n* residual paresis in the lower extremity (Fugl-Meyer LE motor score \\\u003C34)\n* ability to walk without assistance and without an AFO at speeds ranging from 0.2-1.0 m\u002Fs\n* not currently on antidepressant medications or no changes in antidepressant dosage in the last 4 weeks and clinically stable\n* HAM-D17 question #9 regarding suicide \\\u003C2\n* provision of informed consent. I\n* All subjects who screen for major depressive disorder will be formally diagnosed by the project psychiatrist at each site using the Structured Clinical Interview for DSM5 (SCID-5).\n* All subjects who meet criteria for the training portion must complete an exercise tolerance test and be cleared for participation by the study physician.\n\nExclusion criteria:\n\n* unable to ambulate at least 150 feet prior to stroke, or experienced intermittent claudication while walking\n* history of congestive heart failure, unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during ADL's\n* history of COPD or oxygen dependence\n* history of traumatic brain injury\n* blindness or severe visual impairment\n* history of psychosis or other Axis I disorder that is primary\n* life expectancy \\\u003C1 yr.\n* severe arthritis or problems that limit participation in testing or training\n* history of DVT or pulmonary embolism within 6 months\n* uncontrolled diabetes with recent weight loss, diabetic coma, or frequent insulin reactions\n* severe hypertension with systolic \\>200 mmHg and diastolic \\>110 mmHg at rest\n* attempt of suicide in the last 2 years or suicidal risk assessed by SCID\n* history of seizures or currently prescribed anti-seizure medications\n* current enrollment in a trial to enhance motor recovery\n* currently participating in behavioral treatment for depression\n* currently exercising ≥ 2 times per week (≥20 minutes)\n* contraindications to TMS\n* pregnancy or other contraindications to MRI.","21 Years",{"count":312,"type":21},96,[24],"Investigators primary aim is to carry out a two-site, randomized, double-blind, sham-controlled, phase II trial to systematically examine the potential for aerobic exercise (AEx) to enhance the anti-depressant benefits of rTMS in individuals with post-stroke depression (PSD).\n\nInvestigators propose to determine the efficacy of combining two known anti-depressant treatments shown to be effective in non-stroke depression, aerobic exercise (AEx) and repetitive transcranial magnetic stimulation (rTMS), on post-stroke depressive symptoms. This project is based on the idea that depression negatively affects the potential for the brain to adapt in response to treatment such that rehabilitation may not produce the same changes that it does in non-depressed individuals. Investigators believe that effective treatment for PSD will result in a virtuous cycle whereby reducing depression enhances response to rehabilitation, thereby facilitating functional gains. That is, effectively treating depression will enable individuals to better recover from stroke.",[316,27,317],"Stroke","Walking Impairment",[319,320,321,322,323,324],"stroke","rehabilitation","neuromodulation","TMS","walking","exercise","2026-08-01",{"date":327,"type":44},"2026-08-04",{"date":329,"type":44},"2024-11-01",{"date":331,"type":21},"2029-08-31",{"name":333,"class":51},"Medical University of South Carolina",{"id":335,"slug":336,"hasResults":12,"nctId":337,"briefTitle":338,"officialTitle":338,"acronym":339,"eligibilityCriteria":340,"healthyVolunteers":12,"sex":17,"minAge":59,"maxAge":341,"enrollmentInfo":342,"targetDuration":4,"studyType":22,"phases":344,"briefSummary":345,"conditions":346,"keywords":347,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":354,"lastUpdatePostDateStruct":355,"startDateStruct":356,"completionDateStruct":358,"leadSponsor":360,"locationsCount":52},"100577219","phase-1-modulating-spinal-interoceptive-pathways-to-evaluate-their-role-and-therapeutic-potential-in-mdd-symptomatic-domains-100577219","NCT06795451","Modulating Spinal Interoceptive Pathways to Evaluate Their Role and Therapeutic Potential in MDD Symptomatic Domains","MOSPID","Inclusion Criteria:\n\n* 18 to 60 yrs., inclusive,\n* Female or Male,\n* With current MDD episode according to MINI 7.0.2. duration (≥4 weeks and\n\n  ≤ 2 yrs.),\n* Current BMI ≥18.5 and ≤ 35.99 kg\u002Fmts2\n* MADRS score at screening ≥18\n* Currently on an FDA- approved antidepressant medication at a stable therapeutic dose for ≥ 8 weeks,\n* Psychotherapeutic interventions are allowed if dose\u002Ffrequency stable for ≥4 weeks,\n* Anxiety disorders allowed if no more than moderate in severity and are not the main diagnosis,\n* Using an effective contraceptive method (participants with childbearing potential), and 10)Able to complete study related tasks.\n\nExclusion Criteria:\n\n* Treatment resistance during current depressive episode (\\>2 treatment trials at adequate doses\u002Fduration), including medication and neuromodulation treatments.\n* Current\u002Flifetime diagnosis of bipolar disorder or schizophrenia spectrum disorders.\n* Significant risk of suicide according to CSSRS or clinical judgment, or suicidal behavior in the past year.\n* Psychotic symptoms during the current MDD episode or in the past 6 months.\n* Current (past month) substance use disorder (nicotine, caffeine allowed).\n* Current unstable neurological conditions including seizure disorders (infantile seizures are not exclusionary), neurodegenerative disorders, or stroke.\n* Evidence of severe peripheral neuropathy.\n* History of moderate to severe traumatic brain injury (e.g., skull fracture or loss of consciousness \\>10 minutes) or spinal cord injury.\n* Unstable clinically significant medical conditions (e.g., uncontrolled hypertension as indicated by a systolic \\>150 mmHg or diastolic \\>95mmHg).\n* History of cancer allowed if remitted for the past 5 years.\n* Use of anticonvulsant medications and calcium channel blockers at screening.\n* Current severe pain conditions or need for chronic use of pain medication including NSAIDs and opiates.\n* Implanted electronic medical devices.\n* Neuromodulation interventions in the past month.\n* Active skin lesions on electrode placement sites.\n* pregnant or breastfeeding.\n* Suspected IQ \\\u003C80.\n* Any other relevant clinical reason as judged by the clinician.","60 Years",{"count":343,"type":21},67,[228,126],"Spinal interoceptive pathways (SIPs) convey bodily signals to an interoceptive system in the brain and their dysregulation is linked to major depressive disorder (MDD). Current treatments are partially effective and the role of SIPs in MDD is vastly unexplored. Preliminary data suggests that SIPs are feasible therapeutic targets in MDD. The central hypothesis is that non-invasive spinal cord stimulation will modulate SIPs to elucidate their role and therapeutic potential in MDD using an R61\u002F33 phased innovation approach.\n\nR61 phase specific aims (SA). The specific goal will be to evaluate spinal and brain-based SIPs target engagement markers of transcutaneous spinal direct current stimulation (tsDCS) in MDD with two SAs: SA1) To determine tsDCS SIPs modulation using laser-evoked potentials (LEPs) as electroencephalography (EEG)- based neural measures of target engagement. SA2) To evaluate optimal tsDCS dose based upon tolerability and SIPs target engagement markers. Anodal tsDCS will be evaluated as a tool to modulate SIPs in MDD. SIPs (Aδ and C fibers) can be evaluated via LEPs as neural measures (EEG) elicited in MDD-relevant brain regions within an interoceptive system. Prior data shows anodal tsDCS inhibits SIPs and LEPs N2 component will be assessed as tsDCS engagement markers. Adults with MDD (n=67) will participate in a double-blind, crossover, sham-controlled study to evaluate tsDCS at 0,2.5,3, and 3.5 mA. The working hypothesis is that tsDCS will induce a change in LEPs (SA1) in a dose-dependent and tolerable manner (SA2), supporting their use as SIPs engagement markers. Go\u002FNo-Go milestones: Compared to sham, the active tsDCS dose that induces a change in LEPs at a preestablished threshold will be evidence of SIPs engagement and \"Go\" criteria for the R33 phase.",[27],[66,348,321,349,350,34,351,352,353],"non-invasive","spinal stimulation","transcutaneous spinal direct current stimulation","interoception","spinal interoceptive pathways","laser-evoked potentials","2026-07-30",{"date":294,"type":44},{"date":357,"type":44},"2025-02-25",{"date":359,"type":21},"2027-03-31",{"name":361,"class":51},"University of Cincinnati",{"id":363,"slug":364,"hasResults":12,"nctId":365,"briefTitle":366,"officialTitle":367,"acronym":368,"eligibilityCriteria":369,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":370,"targetDuration":4,"studyType":22,"phases":372,"briefSummary":373,"conditions":374,"keywords":375,"overallStatus":210,"whyStopped":4,"lastUpdateSubmitDate":383,"lastUpdatePostDateStruct":384,"startDateStruct":386,"completionDateStruct":388,"leadSponsor":390,"locationsCount":52},"100649854","painhunting-therapy-versus-cognitive-behavioural-therapy-for-event-related-depression-100649854","NCT07738146","Painhunting Therapy Versus Cognitive Behavioural Therapy for Event-Related Depression","Painhunting Therapy Versus Cognitive Behavioural Therapy for Event-Related Depression: Active-Comparator Randomized Pilot Trial With Adaptive Sample-Size Re-Estimation","PH-CBT","Inclusion Criteria:\n\n* Age 18 years or older.\n* PHQ-9 score of 9 or greater at screening.\n* At least one adverse life event within the prior 24 months, documented using the Life Events Threshold (LTE) instrument.\n* Resident of Kazakhstan.\n* Fluent in Russian.\n* Capacity to provide written informed consent.\n* Willing to attend at least six sessions within the protocol treatment schedule.\n\nExclusion Criteria:\n\n* Active suicidal ideation requiring immediate referral, defined as PHQ-9 item 9 score of 3 or clinical judgment of imminent risk.\n* Active psychosis or mania.\n* Active substance use disorder meeting DSM criteria.\n* Current psychotherapy with another provider.\n* Initiation of pharmacotherapy within the prior four weeks.\n* Pre-existing stable antidepressant monotherapy unchanged for eight weeks or longer is permitted.\n* Inability to provide informed consent in Russian.",{"count":371,"type":21},60,[24],"This randomized, active-comparator pilot trial will compare Painhunting Therapy with manualized Cognitive Behavioural Therapy (CBT) in adults with event-related depressive symptoms. Participants will be randomly assigned in a 1:1 ratio to receive either Painhunting Therapy or CBT. The primary outcome is depressive symptom severity measured by the Patient Health Questionnaire-9 (PHQ-9) at six weeks after randomization. Secondary outcomes include anxiety symptoms, event-related distress, functional impairment, treatment response and remission, treatment retention, and durability of outcomes at 10 to 12 weeks. The study will also assess treatment fidelity, therapeutic alliance, and selected potential moderators of treatment response. The trial uses a randomized, rater-blinded, parallel-group design with an adaptive sample-size approach.",[27],[376,377,378,379,66,380,381,382],"painhunting","painhunting therapy","CBT","event-related depression","psychotherapy","Cognitive Behavioral Therapy","Depressive Symptoms","2026-07-28",{"date":385,"type":44},"2026-07-31",{"date":387,"type":21},"2026-09-01",{"date":389,"type":21},"2027-04-30",{"name":391,"class":51},"Painhunting LLP",{"id":393,"slug":394,"hasResults":12,"nctId":395,"briefTitle":396,"officialTitle":397,"acronym":4,"eligibilityCriteria":398,"healthyVolunteers":12,"sex":17,"minAge":399,"maxAge":400,"enrollmentInfo":401,"targetDuration":4,"studyType":22,"phases":402,"briefSummary":403,"conditions":404,"keywords":406,"overallStatus":210,"whyStopped":4,"lastUpdateSubmitDate":408,"lastUpdatePostDateStruct":409,"startDateStruct":411,"completionDateStruct":412,"leadSponsor":414,"locationsCount":52},"100635490","auditory-stimulation-for-insomnia-and-depression-100635490","NCT07553364","Auditory Stimulation for Insomnia and Depression","Feasibility of Using Alpha Phase-Locked Auditory Stimulation for Insomnia Symptoms in People With Depression","Inclusion Criteria:\n\n* Ability to complete overnight EEG study including placement of EEG leads\n* Ability to read and understand English\n* Presence of Insomnia\n* Moderate Depression\n* Home internet and smartphone (Android or Apple) device access\n\nExclusion Criteria:\n\n* Presence of severe, untreated sleep apnea\n* Presence of restless leg syndrome\n* Significant neurological disease (e.g. Parkinson's disease, epilepsy)\n* Diagnosed with schizophrenia, bipolar disorder, substance use disorder, or presence of current suicidal ideation\n* Has active implanted device ( e.g. intracranial device, cochlear implant)\n* Currently deaf or experiencing hearing loss or using hearing aids\n* Currently taking medications that could alter EEG\n* Currently pregnant","20 Years","50 Years",{"count":7,"type":21},[24],"The goal of this clinical trial is to determine if alpha phase-locked auditory stimulation can improve sleep in people with insomnia and depression. The main goals of the pilot study are the following:\n\nDetermine whether alpha phase-locked auditory stimulation (active stimulation) improves objective and subjective sleep in individuals with insomnia and depression.\n\nThe study team hypothesizes that active auditory stimulation will reduce objective and subjective sleep onset latency (SL) and wake after sleep onset (WASO) compared to a sham stimulation.\n\nParticipants will:\n\n* Wear Elemind Neuromod headband nightly for 4 weeks (1 week baseline, 1 week active\u002Fsham stimulation, 1 week washout, and 1 week opposite condition - active\u002Fsham stimulation)\n* Wear actigraphy watch for duration of the study\n* Complete questionnaires regarding their sleep, mood, and satisfaction with the device",[27,405],"Insomnia",[407,32,405],"sleep","2026-07-23",{"date":410,"type":44},"2026-07-24",{"date":178,"type":21},{"date":413,"type":21},"2027-12-01",{"name":415,"class":51},"Wake Forest University Health Sciences",{"id":417,"slug":418,"hasResults":12,"nctId":419,"briefTitle":420,"officialTitle":420,"acronym":421,"eligibilityCriteria":422,"healthyVolunteers":12,"sex":423,"minAge":59,"maxAge":18,"enrollmentInfo":424,"targetDuration":4,"studyType":22,"phases":426,"briefSummary":427,"conditions":428,"keywords":430,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":434,"lastUpdatePostDateStruct":435,"startDateStruct":437,"completionDateStruct":439,"leadSponsor":441,"locationsCount":52},"100612231","resolving-early-life-stress-psychotherapy-outcomes-and-neurobiology-in-complex-depression-100612231","NCT07250893","Resolving Early Life Stress: Psychotherapy Outcomes and Neurobiology in Complex Depression","RESPOND","Inclusion Criteria:\n\n* Adults 18 years old or older\n* At or above 18 on HAM-D, indicative of moderate-severe depressive symptoms\n* Any childhood (before 18 years old) adversity as indicated by scores on the CECA q and ACES q\n\nExclusion Criteria:\n\n* Individuals who meet for PTSD diagnosis from a criterion A trauma occurring in adulthood without a history of ELA\n* Individuals experiencing active mania or psychosis\n* Individuals with an active substance use disorder\n* Individuals presenting with active suicide risk (plan, intention, means) indicative of a need for higher level care\n* Individuals in current psychotherapeutic treatment (defined as having engaged in consistent psychotherapy within the last 3 months)","FEMALE",{"count":425,"type":21},50,[24],"The RESPOND trial explores the link between early life adversity and later life depressive symptoms. The investigators have designed a new psychological therapy tailored to address the symptoms that can be caused by difficult experiences in early life. These symptoms include low mood, emotional dysregulation, and distressing thoughts and beliefs related to difficult or traumatic experiences. The investigators would like to see if this new therapy helps people feel better. The investigators are also studying the biological changes that can occur as a result of early life adversity, and how this therapy may influence those changes. To do this, the investigators ask questions about participants' physical and mental health and take blood samples.",[27,429],"Childhood Traumas",[431,32,432,433],"Early life adversity","Emotional dysregulation","Childhood trauma","2026-07-13",{"date":436,"type":44},"2026-07-14",{"date":438,"type":44},"2025-10-25",{"date":440,"type":21},"2028-08-15",{"name":442,"class":51},"St. Joseph's Healthcare Hamilton",{"id":444,"slug":445,"hasResults":12,"nctId":446,"briefTitle":447,"officialTitle":448,"acronym":449,"eligibilityCriteria":450,"healthyVolunteers":12,"sex":17,"minAge":59,"maxAge":4,"enrollmentInfo":451,"targetDuration":4,"studyType":22,"phases":453,"briefSummary":454,"conditions":455,"keywords":456,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":461,"lastUpdatePostDateStruct":462,"startDateStruct":464,"completionDateStruct":466,"leadSponsor":468,"locationsCount":52},"100639942","eeg-prediction-and-clinical-efficacy-of-tdcs-in-major-depression-100639942","NCT07611773","EEG Prediction and Clinical Efficacy of tDCS in Major Depression","Clinical Efficacy of tDCS in Major Depression: A Controlled Clinical Trial and Analysis of Electrophysiological Biomarker Predictors","DM-TDCS-PREDIC","Inclusion Criteria:\n\n* Patients aged 18 years or over.\n* Patients diagnosed with Major Depressive Disorder with a current depressive episode, based on the criteria of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (American Psychiatric Association, 2013).\n* Score on the Hamilton Depression Rating Scale (HDRS-17) ≥16 (Hamilton et al., 1960).\n* Patients on a stable prescription of antidepressants\u002Fpharmacological medication and who agree to continue this throughout the study; and\u002For, if undergoing psychotherapy, who have maintained this treatment consistently for at least 6 weeks.\n* Demonstrate the ability to apply home-based tDCS appropriately, either independently or with the help of a carer.\n* Have access to an electronic device with a camera to enable monitoring of the intervention, as well as to contact the participant.\n* Have the ability and willingness to commit to the study team to complete all phases of the study.\n* Volunteer to participate and sign the specific informed consent form for this study.\n\nExclusion Criteria:\n\n* Patients with a current manic episode as determined by the Young Mania Rating Scale (YMRS), or a psychotic episode as defined by the MINI scale.\n* Patients who answer 'yes' to questions 4, 5 or 6 of the Columbia Suicide Severity Rating Scale (C-SSRS), a risk assessment and identification tool.\n* Patients with treatment-resistant depression, defined as an inadequate clinical response to two or more courses of antidepressant treatment at appropriate doses and duration.\n* Any previous hospitalisation for suicidal behaviour.\n* Presenting with current chronic or severe insomnia (\\\u003C 4 hours' sleep per night) or sleep apnoea.\n* Presence of any structural lesion (e.g., any structural neurological condition or more subcortical lesions than would be expected for their age, or having suffered a stroke affecting the stimulated area or connected areas) or any other clinically significant abnormality that may affect safety, participation in the study, or confound the interpretation of study results, as determined by the investigator.\n* History or presence of any other condition or comorbidity associated with TDM: cardiac or neurological conditions, cognitive impairment.\n* History of or current diagnosis of any other mental disorder: obsessive-compulsive disorder, bipolar disorder (type 1 or 2), anxiety disorder, agoraphobia, eating disorders, personality disorders.\n* Any exclusion criteria other than those established by clinical guidelines on non-invasive brain stimulation (Woods et al., 2016):\n* Metal implants or head injuries, any electronic devices such as cochlear implants or cardiac pacemakers\n* Brain stimulation within the last 6 months.\n* Clinical or family history of epilepsy or seizure episodes.\n* Presence of dermatological problems (allergic skin reaction at the electrode site, psoriasis, etc.)\n* History of drug or alcohol abuse during the study or in the 3 months prior (with the exception of nicotine).\n* Pending trial or litigation during the course of the trial.\n* Pregnancy.",{"count":452,"type":21},270,[24],"The purpose of this randomized controlled trial is to investigate the non-inferiority, and possible superiority, of a high-dose home-based tDCS protocol compared with a conventional home-based protocol, and to assess its cost-effectiveness, in patients with major depression.\n\nAs a secondary aim, we aim to assess the predictive value of baseline EEG for clinical response to high-dose home-based tDCS treatment in patients with major depression.",[27],[457,458,459,460],"tDCS","Major depression","EEG","Cost-effectiveness","2026-07-03",{"date":463,"type":44},"2026-07-07",{"date":465,"type":44},"2026-06-14",{"date":467,"type":21},"2028-12-31",{"name":469,"class":114},"Ionclinics & Deionic SL",{"id":471,"slug":472,"hasResults":12,"nctId":473,"briefTitle":474,"officialTitle":474,"acronym":475,"eligibilityCriteria":476,"healthyVolunteers":12,"sex":17,"minAge":59,"maxAge":18,"enrollmentInfo":477,"targetDuration":4,"studyType":22,"phases":479,"briefSummary":480,"conditions":481,"keywords":483,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":490,"lastUpdatePostDateStruct":491,"startDateStruct":493,"completionDateStruct":495,"leadSponsor":496,"locationsCount":52},"100599323","comparing-the-efficacy-of-heated-yoga-and-sauna-as-a-treatment-for-depression-100599323","NCT07082998","Comparing the Efficacy of Heated Yoga and Sauna as a Treatment for Depression","SHINE","Subject Characteristics\n\nInclusion Criteria:\n\n1. adults (18-65 years old)\n2. Ability to provide informed consent\n3. English language proficiency\n4. PHQ-9 score \\> 10, indicating at least moderate depressive symptoms 21\n5. Must have filled out the waiver for the community-based partners prior to enrolling in the study\\*\n6. Individuals of childbearing potential must use an acceptable form of birth control\n7. (if applicable) willingness to keep psychiatric medications and psychotherapy stable throughout the course of the study\n8. Must be able to access mindfulness app on a device (i.e., smartphone, iPad, etc.)\n9. Can travel to Breathe in Harvard Square and at least one Restore location (i.e., Hingham, Somerville, Dedham, Newton, Lynnfield)\n\nExclusion Criteria:\n\n1. Pregnant or planning to become pregnant\n2. Breast feeding\n3. Active suicidal thinking (i.e., PHQ-9 item 9 ≥1 and a positive response to C-SSRS screener items 3, 4, 5, or 6)\n4. Active eating disorders or substance use disorders within the past 12 months, as per the MINI\n5. Primary OCD or PTSD, as per the MINI\n6. History of bipolar disorder, psychotic disorders, as per the MINI\n7. ≥25% drop in PHQ-9 score from screen to baseline\n8. Under the influence or withdrawal of drugs or alcohol\n9. Positive urine toxicology screen due to illicit drug use or other exclusionary medications. (Potential false positives will be addressed on a case-by-case basis at the discretion of the PI or designee)\n10. have had a bone fracture or joint surgery in the past 6 months\n11. not able to walk freely or without difficulty\n12. any serious, unstable medical condition as determined by the revised Physical Activity Readiness Questionnaire (PAR-Q+) and do not have approval from their treating physician (we will check in with treating physician in the event that participants endorse any item on the PAR-Q+)\n13. participants must have a healthcare provider who they could contact if they needed medical care, such as a primary care doctor, a counselor, a psychiatrist, a nurse practitioner, or a clinic that you go to.\n14. Significant exposure to heated yoga classes in the past 3 months (i.e., more than 6 classes)\n15. Significant exposure to sauna sessions in the past 3 months (i.e., more than 6 sessions)\n16. Significant exposure to mindfulness app in the past 3 months (i.e., more than 6 uses of the app)\n17. are on medications that make dehydration more likely (e.g., lithium, antipsychotics, insulin-dependent) diuretics, barbiturates, b-blockers, anticholinergics, current ETOH acute intoxication, reduced ability to sweat, hemophilia, pacemaker (magnets used to assemble saunas can interrupt the pacer)\n18. antidepressant or psychiatric medications that are initiated less than 8 weeks or a dose change less than 4 weeks prior to screening visit\n19. psychotherapy that has been initiated within the past 3 months\n20. psychiatric hospitalization within the past year\n21. diagnosed with any neurological disorders that would impact participation or make participation unsafe\n22. are currently in active ketamine, Electroconvulsive therapy, or Transcranial Magnetic Stimulation treatments\n23. are unable to follow the study procedures (e.g., not able to travel to the heated yoga or sauna studios)\n24. A subject who in the opinion of the Principal Investigator would not be able to safely complete the study or would jeopardize study integrity",{"count":478,"type":21},120,[24],"This project explores whether heated yoga, sauna, and a mindfulness app reduce depressive symptoms",[95,27,96,482,32,94],"Depression Chronic",[66,484,485,486,487,488,489],"heated yoga","yoga","sauna","mindfulness","mindfulness app","clinical trial","2026-07-01",{"date":492,"type":44},"2026-07-06",{"date":494,"type":44},"2025-09-12",{"date":299,"type":21},{"name":497,"class":51},"Massachusetts General Hospital",{"id":499,"slug":500,"hasResults":12,"nctId":501,"briefTitle":502,"officialTitle":502,"acronym":503,"eligibilityCriteria":504,"healthyVolunteers":12,"sex":17,"minAge":59,"maxAge":4,"enrollmentInfo":505,"targetDuration":4,"studyType":163,"phases":4,"briefSummary":506,"conditions":507,"keywords":510,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":516,"lastUpdatePostDateStruct":517,"startDateStruct":518,"completionDateStruct":520,"leadSponsor":522,"locationsCount":52},"100646932","longitudinal-study-on-the-sustainability-of-transcranial-magnetic-stimulation-protocols---biomarkers-100646932","NCT07684911","Longitudinal Study on the Sustainability of Transcranial Magnetic Stimulation Protocols - Biomarkers","LONGISTIM-BIO","Inclusion Criteria:\n\n* Patients aged 18 or older.\n* Patients who have experienced treatment-resistant unipolar or bipolar depression and responded to a previous TMS course (response defined by a 50% reduction in MADRS score).\n* Sufficient command of French to complete questionnaires and follow instructions during MRI assessments and TMS treatments.\n* Willingness to comply with all study procedures, including availability for the duration of the study, and to communicate with study staff about adverse events and other clinically relevant information.\n* Patients who have expressed their informed written consent to participate in the study.\n* Person affiliated with a social welfare scheme or other scheme.\n\nNon-inclusion Criteria:\n\n* Current psychiatric comorbidity (suicidal risk, psychotic episode).\n* Unstable somatic pathology: active cancer, unstabilized endocrinological pathology, untreated sleep apnea.\n* For neuroimaging: Contraindications to magnetic resonance imaging (MRI) such as ferromagnetic metal in the body or severe claustrophobia\n* Adults under legal protection (legal guardianship, conservatorship, trusteeship), persons deprived of their liberty\n* Pregnancy or breast-feeding.",{"count":20,"type":21},"Despite advances in the effective treatment of major depressive disorder using repetitive transcranial magnetic stimulation (rTMS), the processes that determine a patient's response trajectory remain poorly understood.\n\nCurrently, there are no validated clinical or neurophysiological markers that can identify factors predicting the durability of the response to rTMS at the individual level. This constitutes a major limitation for planning individualised treatments and highlights the need for precision medicine approaches and reliable biomarkers to predict the long-term efficacy of TMS-based interventions, thereby enabling more informed clinical decisions and optimised resource allocation.\n\nrTMS is assumed to work by inducing neuroplasticity on multiple levels of the nervous system, ranging from modulating neurotransmitter release to changing structural and functional brain circuits. While rTMS likely acts as a universal modulator of neuroplasticity, the exact mechanisms are not fully established, especially regarding long-term durability.\n\nThe LONGISTIM-BIO study (\"Longitudinal Study on the Durability of Transcranial Magnetic Stimulation Protocols - Biomarkers\") aims to explore the duration of the treatment effect following an initial response to a course of TMS treatment and examines potential neurophysiological and clinical\u002Fsociodemographic predictors associated with the trajectories of the treatment effect. More explicitly, it examines neuroplasticity as a biomarker of treatment response durability, and explores its association with heart-brain-coupling (HBC), a physiological marker of rTMS target engagement, as well as inflammation, as measured by a blood test (white blood cells, C-reactive protein (CRP)).\n\nDuring this study, participants undergo an rTMS treatment as per standard clinical care. They receive daily sessions of 20Hz rTMS targeting the left dorsolateral prefrontal cortex during which the heart rate will be recorded. Before the first rTMS session, after the last session, and one month after the last session, the severity of depression is evaluated using both the MADRS and the PHQ-8 questionnaire. At the one-month follow-up, the effectiveness of the course is determined by a 50% improvement in the MADRS score. Following the 1-month follow-up visit, if meeting the inclusion criteria, patients will receive bi-weekly assessments of depression severity (PHQ-8 as primary and MADRS self-rated questionnaire as secondary outcome). If two consecutive PHQ-8 questionnaires are pathological (score ≥10), a new rTMS course is scheduled with the shortest delay possible.\n\nDuring this new course of treatment, participation in the study includes:\n\n* a blood draw prior to the first TMS session\n* 4 magnetic resonance imaging (MRI) scans: #1 before the course of treatment, #2 at the end of the course, #3 one month after the end of the treatment, and #4 upon the expected date of relapse.\n\nPatients will again be monitored using self-report questionnaires (PHQ-8 and MADRS-SR) every 2 weeks until a relapse occurs.",[27,508,509],"Depression Bipolar","Depression Unipolar",[99,508,290,511,509,512,513,514,515],"rTMS","Durability","Neuroplasticity","Inflammation","heart rate","2026-06-29",{"date":492,"type":44},{"date":519,"type":44},"2026-06-04",{"date":521,"type":21},"2029-08",{"name":523,"class":51},"Hospital Center Guillaume Régnier",{"id":525,"slug":526,"hasResults":12,"nctId":527,"briefTitle":528,"officialTitle":529,"acronym":4,"eligibilityCriteria":530,"healthyVolunteers":12,"sex":423,"minAge":59,"maxAge":4,"enrollmentInfo":531,"targetDuration":4,"studyType":22,"phases":533,"briefSummary":534,"conditions":535,"keywords":538,"overallStatus":210,"whyStopped":4,"lastUpdateSubmitDate":516,"lastUpdatePostDateStruct":541,"startDateStruct":542,"completionDateStruct":543,"leadSponsor":545,"locationsCount":52},"100646910","debriefing-consult-for-psychiatric-symptoms-after-severe-maternal-morbidity-100646910","NCT07684521","Debriefing Consult for Psychiatric Symptoms After Severe Maternal Morbidity","Does a Debriefing Intervention After a Delivery Complicated by Severe Maternal Morbidity Reduce Post-traumatic, Depression, or Anxiety Symptoms? A Randomized Controlled Trial","Inclusion Criteria:\n\n\\- Individuals with a delivery complicated by severe maternal morbidity, defined as intensive care unit (ICU) admission and\u002For blood product transfusion \\>4 units\n\nExclusion Criteria:\n\n* Age \\\u003C18 years\n* Non-English speakers\n* Any records flagged \"break the glass\" or \"research opt out\"",{"count":532,"type":21},52,[24],"The primary objective of this study is to determine if a maternal fetal medicine (MFM) debriefing consult six to eight weeks postpartum reduces self-reported post-traumatic stress, depression, and anxiety symptoms following a delivery complicated by severe maternal morbidity (SMM). Individuals with a delivery complicated an intensive care unit (ICU) admission and\u002For blood product transfusion \\>4 units will be included in this study. Participants will be randomized to an intervention or control group; all participants will complete patient questionnaires that screen for post-traumatic stress disorder, depression, and anxiety. Those in the control group will receive a virtual MFM debriefing consult at six weeks postpartum and those in the intervention group will have the option for a consult at twelve weeks postpartum, after the completion of the questionnaires.",[536,537,27,261],"PTSD (Childbirth-Related)","Severe Maternal Morbidity",[539,540,266,66],"severe materal morbidity","PTSD",{"date":492,"type":44},{"date":490,"type":21},{"date":544,"type":21},"2030-07",{"name":546,"class":51},"Cedars-Sinai Medical Center",{"id":548,"slug":549,"hasResults":12,"nctId":550,"briefTitle":551,"officialTitle":551,"acronym":4,"eligibilityCriteria":552,"healthyVolunteers":12,"sex":17,"minAge":59,"maxAge":553,"enrollmentInfo":554,"targetDuration":4,"studyType":22,"phases":556,"briefSummary":557,"conditions":558,"keywords":559,"overallStatus":210,"whyStopped":4,"lastUpdateSubmitDate":563,"lastUpdatePostDateStruct":564,"startDateStruct":566,"completionDateStruct":568,"leadSponsor":570,"locationsCount":52},"100642930","mobile-cognitive-behavioral-therapy-in-early-stroke-recovery-100642930","NCT07639606","Mobile Cognitive Behavioral Therapy in Early Stroke Recovery","Inclusion Criteria:\n\n* Age 18-79\n* Positive screen on the Hospital Anxiety and Depression Scale (HADS), either the HADSD (depression, score \\>= 8) and\u002For HADS-A (anxiety, score \\>= 8).\n* Stroke that occurred within 1 month prior to study initiation.\n* Capacity to provide consent as determined by the UCSD Brief Assessment for Capacity to Consent (UBACC)\n* Montreal Cognitive Assessment (MoCA) score greater than or equal to 18, indicating no more than mild cognitive difficulties\n* Ability to use iPhone or iPad independently or through the assistance of a caregiver (participants will use their own iPhone if they have one, otherwise they will be loaned an iPad by the study team)\n* Able to adhere to all study requirements and willingness to participate in the full study duration\n\nExclusion Criteria:\n\n* Aphasia or neglect that would interfere with use of the app, as determined through evaluation by speech-language pathology and occupational therapy conducted as part of standard clinical care\n* Non-fluency in English\n* History of a major neurologic disorder or of serious mental illness (bipolar or psychotic disorder, alcohol or substance use disorder as assessed through chart review)\n* Active suicidal ideation requiring a higher level of care\n* Severe depression and\u002For anxiety based on the initial evaluation and clinical judgment of the PI, which warrants a higher level of care and\u002For immediate referral to psychiatric services\n* Any other clinical or medical reason in the initial evaluation that suggests the study is not appropriate for the participant","79 Years",{"count":555,"type":21},10,[24],"This study aims to pilot \"Maya,\" a mobile cognitive behavioral therapy app, for use in adults with stroke experiencing depression and\u002For anxiety. This study will assess the acceptability, feasibility, and preliminary efficacy of Maya within the acute rehabilitation period.",[261,316,27],[560,561,562,378],"stroke recovery","stroke rehabilitation","cognitive behavioral therapy","2026-06-26",{"date":565,"type":44},"2026-06-30",{"date":567,"type":21},"2026-07",{"date":569,"type":21},"2029-03",{"name":571,"class":51},"Weill Medical College of Cornell University",{"id":573,"slug":574,"hasResults":12,"nctId":575,"briefTitle":576,"officialTitle":577,"acronym":4,"eligibilityCriteria":578,"healthyVolunteers":12,"sex":17,"minAge":579,"maxAge":160,"enrollmentInfo":580,"targetDuration":4,"studyType":22,"phases":582,"briefSummary":583,"conditions":584,"keywords":585,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":563,"lastUpdatePostDateStruct":587,"startDateStruct":588,"completionDateStruct":589,"leadSponsor":591,"locationsCount":52},"100604001","enhancing-slow-wave-sleep-in-depression-100604001","NCT07143838","Enhancing Slow Wave Sleep in Depression","Investigating Slow Wave Sleep Enhancement to Improve Cognitive Function in Adults With Depression","Inclusion Criteria:\n\n* Ability to complete overnight sleep study including placement of EEG leads\n* Ability to read and understand English.\n* Moderate depression\n* Self-reported cognitive complaints\n\nExclusion Criteria:\n\n* Previous adverse reaction to transcranial electrical stimulation\n* Presence of implanted devices (e.g. intracranial device, cochlear implant)\n* Presence of metal in head (e.g. surgical clip)\n* Sensitivity or allergy to silver\n* Presence of significant neurologic disease (e.g. Parkinson's disease, epilepsy\u002Fseizure disorder, severe migraine disorder)\n* History of significant head trauma\n* History of stroke or other ischemic event\n* Diagnosed with schizophrenia, bipolar disorder, substance use disorder, or presence of current suicidal ideation\n* Currently taking medications that could alter EEG or cognitive function\n* Presence of severe insomnia\n* Presence of severe, untreated sleep apnea\n* Currently pregnant\n* Planned travel outside time zone during the study","40 Years",{"count":581,"type":21},12,[24],"The goal of this pilot study is to determine if non-invasive brain stimulation during sleep can increase deep sleep in adults with depression. It will also determine if increased deep sleep improves cognitive performance and mood ratings. Participants will be asked to wear a non-invasive device that records their brain activity and delivers transcranial electrical stimulation during sleep. Participants will also wear an actigraphy watch that measures activity levels throughout the study. In addition, participants will complete several cognitive assessments and mood and sleep questionnaires throughout the study.",[27],[586,32],"Sleep",{"date":516,"type":44},{"date":519,"type":44},{"date":590,"type":21},"2027-03",{"name":415,"class":51},{"id":593,"slug":594,"hasResults":12,"nctId":595,"briefTitle":596,"officialTitle":597,"acronym":598,"eligibilityCriteria":599,"healthyVolunteers":12,"sex":17,"minAge":59,"maxAge":600,"enrollmentInfo":601,"targetDuration":4,"studyType":22,"phases":603,"briefSummary":605,"conditions":606,"keywords":4,"overallStatus":210,"whyStopped":4,"lastUpdateSubmitDate":610,"lastUpdatePostDateStruct":611,"startDateStruct":613,"completionDateStruct":614,"leadSponsor":616,"locationsCount":52},"100645335","phase-4-biomarker-guided-antidepressant-selection-100645335","NCT07680140","Biomarker-Guided Antidepressant Selection","Biomarker-Guided Antidepressant Selection for Treatment-Resistant Depression","BioSelect","Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form\n2. Adults of all genders aged 18-70 at the time of screening\n3. Diagnosis of Major Depressive Disorder (by DSM-5 criteria)\n4. Depressive symptoms of at least moderate severity (GRID HDRS-17 score \\>= 14 or as determined by a study clinician)\n5. Failed at least 1 prior trial of standard first-line treatment for MDD per the modified Antidepressant Treatment History form, the Maudsley Staging Method, and APA Practice Guidelines (e.g., SSRI, SNRI, CBT) OR initiated and discontinued a trial of a first-line treatment for MDD (e.g. could not tolerate side effects, etc.)\n6. Not currently taking antidepressants OR on a stable dose of antidepressant for at least 1month prior to screening and plans to remain off antidepressants OR on this stable dose for the duration of participation\n7. Current medication regimen is compatible with safe participation in the trial in the assessment of a study clinician\n8. Access to psychiatric care before, during, and after completion of the study\n9. For females of reproductive potential: agreement to use effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation\n10. Proficiency in English sufficient to complete assessments and follow study procedure instructions\n11. Stated willingness to comply with all study procedures and availability for the duration of the study\n\nExclusion Criteria:\n\n1. Imminent risk of suicide\n2. Presence of primary psychiatric diagnosis other than MDD (e.g., post-traumatic stress disorder, obsessive-compulsive disorder, MDD with psychotic features, primary psychotic illness, bipolar I or II disorder)\n3. History of epilepsy or a history of seizures that would influence the participant's risk for TMS-evoked seizures; history of any condition \u002F concurrent medication that could notably lower seizure threshold in the estimation of a study clinician\n4. Met criteria for any clinically significant substance use disorder (by DSM-V criteria) with active substance misuse in the 6 months prior to screening\n5. Lifetime history of PCP\u002Fketamine abuse\n6. History or presence of significant neurological disorder that may be contributing to current depressive symptoms in the judgment of a study clinician (e.g., traumatic brain injury, stroke, Parkinson's disease or other movement disorder, epilepsy)\n7. Presence of medical contraindications to ketamine, including liver function tests \\> 2.5x normal limit, recent myocardial infarction, congestive heart failure \\> stage 2, angina pectoris, clinically significant bradycardia or tachycardia at the baseline assessment, or uncontrolled hypertension\n8. MRI contraindication, including presence of ferromagnetic foreign metal bodies or implants, implanted or conductive ferromagnetic objects in or near the head (e.g., stents, deep brain stimulators, vagus nerve stimulators, aneurysm coils, ocular implants, cochlear implants), and ferromagnetic permanent make-up that may undergo heating in an MRI scanner\n9. Individuals who are nursing, pregnant, or contemplating pregnancy within the length of study participation\n10. Abnormal bloodwork that may be contributing to depressive symptoms in the estimation of a study clinician (e.g. indicators of clinically significant hypothyroidism, kidney failure, liver failure, etc.)\n11. History or presence of any disorder or medical condition that, in the opinion of the study team, may compromise, interfere, or limit the individual's ability to complete the intervention or study procedures","70 Years",{"count":602,"type":21},27,[604],"PHASE4","Depression is one of the leading causes of disability worldwide. Common treatments like antidepressant medications and talk therapy work well for some people, but many others do not improve, even after trying multiple treatments.\n\nThis study will investigate two alternative treatment options for people whose depression has not responded to standard treatments: repetitive transcranial magnetic stimulation (rTMS), a non-invasive form of brain stimulation, and ketamine, a fast-acting medication. It can be difficult to decide between these interventions in clinical practice, and selecting between them often comes down to patient preference and trial and error. This study is working to optimize the selection approach: using biological and behavioral markers to match each person to identify biomarkers that may predict response to rTMS or ketamine. Investigators believe that differences in how individuals respond to rTMS versus ketamine are partly explained by differences in how their brains are organized, and that these differences can be measured and used to guide intervention decisions. This is an early-stage pilot study designed to test whether this biomarker-based approach is practical and acceptable to patients. Investigators will evaluate how well a combination of brain imaging and clinical data can predict, at the individual level, who is likely to respond to rTMS versus ketamine. The ultimate goal is to develop a reliable, scalable tool that helps clinicians make faster and more informed intervention decisions, reducing the time people with treatment-resistant depression spend searching for an antidepressant that works.",[27,607,511,608,609],"Treatment-resistant Depression (TRD)","Ketamine","fMRI","2026-06-25",{"date":612,"type":44},"2026-07-02",{"date":567,"type":21},{"date":615,"type":21},"2028-12",{"name":571,"class":51},{"id":618,"slug":619,"hasResults":12,"nctId":620,"briefTitle":621,"officialTitle":622,"acronym":4,"eligibilityCriteria":623,"healthyVolunteers":12,"sex":17,"minAge":310,"maxAge":18,"enrollmentInfo":624,"targetDuration":4,"studyType":22,"phases":625,"briefSummary":626,"conditions":627,"keywords":629,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":633,"lastUpdatePostDateStruct":634,"startDateStruct":635,"completionDateStruct":636,"leadSponsor":638,"locationsCount":52},"100601009","phase-2-mindfulness-based-psilocybin-therapy-for-ptsd-100601009","NCT07104916","Mindfulness-based Psilocybin Therapy for PTSD","A Pilot Mechanistic RCT of Psilocybin With Mindfulness-based Therapy vs Support for Posttraumatic Stress Disorder (PTSD)","Inclusion Criteria\n\nParticipants meeting the following criteria will be included in the study:\n\n1. Participant is assigned female or male at birth.\n2. Participant is aged between 21 to 65 years, inclusive, at Screening. This is to reduce variability in brain function and connectivity in this small pilot study that may be related to age \u002F developmental factors in persons under 21 and over 65.\n3. Participant has a BMI of 18 to 30 kg\u002Fm2, inclusive, at Screening.\n4. Participant has a diagnosis of PTSD (as defined in the Diagnostic and Statistical Manual of Mental Disorders, 5th edition \\[DSM-5\\] established through a clinician interview that includes the Mini-International Neuropsychiatric Interview \\[MINI\\]) and the Clinician Administered PTSD Scale for DSM-5 (CAPS-5).\n5. PTSD severity moderate to severe based on CAPS-5 score ≥25, and with moderate depression MADRS ≥20.\n6. Participants capable of producing sperm must use a condom during the trial and for 3 months after their dose of trial medication, if their partner is a person of childbearing potential. In addition, their partner of childbearing potential must also use a highly effective method of contraception (i.e., failure rate less than 1% when used consistently and correctly) from dosing until 3 months following dosing. Condoms alone and abstinence are not considered highly effective methods of contraception.\n7. Participants of childbearing potential must agree to use a highly effective method of contraception (i.e., failure rate less than 1% when used consistently and correctly) in combination with use of a condom by a partner who is capable of producing sperm, during the trial and for 3 months after dosing. Condoms alone and abstinence are not considered highly effective methods of contraception. Such participants must have a negative pregnancy test at Screening and Day 1.\n8. Participants of non-childbearing potential who are or were capable of producing eggs (ova) must be postmenopausal or permanently sterile following hysterectomy, bilateral salpingectomy or bilateral oophorectomy. Postmenopausal is defined as spontaneous amenorrhea for at least 12 months, and a serum follicle stimulating hormone (FSH) level in the menopausal range, unless the participant is taking hormone replacement therapy or is using hormonal contraception.\n9. Provision of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.\n\nIf appropriate, describe why certain populations may be excluded (e.g., non-English speaking individuals for studies involving informed consent).\n\nExclusion Criteria\n\nParticipants with the following will be excluded from study participation:\n\n1. Cardiovascular disease, including coronary artery disease (CAD) and congestive heart failure (CHF). This is an FDA requirement.\n2. Current or previously diagnosis of schizophrenia spectrum or other psychotic disorders, including schizophrenia, schizoaffective disorder, schizotypal disorder, schizophreniform disorder or brief psychotic disorder; current or previous history of bipolar disorder, or current personality disorder (as determined by MINI at Screening). This is an FDA requirement.\n3. Clinically significant risk of suicidality, as determined through a comprehensive psychiatric interview that incorporates the Columbia Suicide Severity Rating Scale (CSSRS); a score of 4 or higher on the suicidal ideation subscale of C-SSRS (past 6 months) or any suicidal behaviour (lifetime), would be exclusionary.\n4. History of substance use disorder within the 12 months, as assessed by a structured clinical interview (Mini International Neuropsychiatric Interview \\[MINI\\], Version 7.0.2) or determined by self-report, or intake of \\>21 units of alcohol weekly, and the inability to refrain from alcohol use from 48 hours before Screening and each scheduled visit until discharge from the study site. One unit is equivalent to a 285 mL glass of full-strength beer or 1 (30 mL) measure of spirits or 1 glass (100 mL) of wine.\n5. Currently receiving a monoamine oxidase inhibitor, tricyclic antidepressant, other non-SSRI or non-SNRI antidepressants (e.g. bupropion, mirtazapine, etc), an antipsychotic or a mood stabilizer.\n6. Exposure to psilocybin, or any other psychedelics, such as ayahuasca, mescaline, LSD or peyote more than 10 times in the last 10 years, or any psychedelic use within 6 months prior to Screening.\n7. Use of psychotropic medicine\u002Fsupplement (or medicine\u002Fsupplement that would interact with psilocybin) including buspirone and venlafaxine, during the 28 days before dosing. Participants may take a stable chronic dose of other SSRI antidepressant medication(s) and\u002For sedatives\u002Fhypnotics. The Investigator and study team may review medication on a case-by-case basis to determine if its use would compromise participant safety or interfere with study procedures or data interpretation.\n8. Family history of schizophrenia or schizoaffective disorder (first degree relatives), or bipolar disorder type 1 (first degree relatives).\n9. Clinically relevant history of abnormal physical health interfering with the study as determined by medical history and physical examinations obtained during Screening as judged by the Investigator (including \\[but not limited to\\], neurological, endocrine, cardiovascular, respiratory, gastrointestinal (including dyspepsia or gastroesophageal reflux disease), hepatic, or renal disorder).\n10. Participant has a presence or relevant history of any of the following medical conditions: organic brain disorders (e.g., epilepsy, seizure, intracranial hypertension, intracranial bleed and aneurysmal disease, brain tumor or other medical conditions associated with seizures or convulsions).\n11. Diagnosis of hypertension or arrhythmia.\n12. Clinically relevant abnormal heart rate (resting supine heart rate \\>100 bpm) or blood pressure (resting supine systolic blood pressure (SBP) above 140 mmHg or diastolic blood pressure (DBP) above 90 mmHg) at screening. Screening supine SBP, DBP and heart rate for evaluation will be the average of 3 readings obtained after at least 5 minutes rest. Participants with abnormal vital signs which are out of range and deemed clinically significant by the Investigator at Day 1, following triplicate readings.\n13. Presence of clinically significant ECG abnormalities at the Screening visit, as defined by medical judgement.\n14. QT interval corrected for heart rate using Fridericia's formula (QTcF) \\>450 msec at Screening, following triplicate ECG readings.\n15. Hypothyroidism and\u002For current abnormal thyroid function tests. In case of uncertain or questionable screening thyroid function test results, the TSH test may be repeated once during screening. The TSH test must be reviewed to ensure that it is within normal limits before randomizing a participant into the study.\n16. Clinically relevant abnormal laboratory results (including hepatic and renal panels, complete blood count, chemistry panel and urinalysis), 12-lead ECG and vital signs, or physical findings at Screening. In case of uncertain or questionable results, tests performed during Screening may be repeated once to confirm eligibility or judged to be clinically irrelevant.\n17. Other eligibility considerations (i.e., participant personal circumstances, behavior, and\u002For any current problem that might interfere with participation or that is incompatible with establishment of rapport or safe exposure to psilocin), as judged by the Investigator.\n18. History or clinical evidence of any disease and\u002For existence of any surgical or medical condition which might interfere with the absorption, distribution, metabolism or excretion (ADME) of the study drug.\n19. Any other concomitant disease or condition that could interfere with, or for which the treatment might interfere with, the conduct of the study as outlined in this Protocol, or that would, in the opinion of the Investigator, pose an unacceptable risk to the participant in this study.\n20. Participant is not fluent in English. Participants must be fluent in English because the consent form as well as all assessments are written and will be administered\u002Fcommunicated in English.\n21. Aspartate aminotransferase (AST), alanine transaminase (ALT), gamma-glutamyl transferase (GGT) or total bilirubin levels ≥1.5 x the upper limit of normal (ULN) at Screening. These laboratory evaluations may be repeated once at the discretion of the Investigator. If the repeat test is within the reference range, the participant may be included if the Investigator considers that the previous finding will not introduce additional risk factors.\n22. Positive urine test for drugs of abuse or alcohol breath test at Screening or Day 1. A positive test for cannabinoids (e.g., marijuana) at Screening may not exclude a participant if after discussion with and evaluation by the Investigator, the participant agrees not to use any marijuana or other cannabinoid products during the study, and if allowed to participate, the participant must test negative for cannabinoids on Day 1.\n23. Participant who consumes excessive amounts of caffeine (e.g., coffee, tea, caffeinated sodas) or (methyl) xanthines (e.g., chocolate) based on the Investigator's determination and discretion.\n24. The participant has participated in a clinical study and has received a medication or a new chemical entity within 3 months prior to dosing of current study medication.\n25. Known sensitivity to psilocybin, psilocin and\u002For any excipients present in the formulation.\n26. Participant is taking or has taken any drugs known to inhibit monoamine oxidase within 28 days prior to study drug administration.\n27. Participant is taking or has taken OTC doses of 5-hydroxytryptophan or St John's Wort within 28 days prior to study drug administration.\n28. Strenuous exercise within 48 hours prior to each visit, and while at the study site.\n29. Participants capable of producing sperm who will not abstain from sperm donation between first dosing and 3 months after final dosing.\n30. Participants of childbearing potential who are pregnant, breastfeeding or planning to conceive. This is an FDA requirement.",{"count":20,"type":21},[126],"The goal of this study is to learn how psilocybin delivered with mindfulness-based therapy may help symptoms of posttraumatic stress disorder (PTSD). This is an assessor-blinded, randomized, controlled study in participants with PTSD. The study will investigate the changes in brain activity, connectivity, and microstructural neuroplasticity assessed using EEG\u002FEMG and multimodal MRI measures after administration of one oral dose of psilocybin, accompanied either with standard \"psychological support\" only; or with standard support plus Mindfulness-based Cognitive Therapy (MBCT).",[628,27],"Post Traumatic Stress Disorder",[98,630,631,103,632],"functional MRI","Mindfulness-based Cognitive Therapy","microstructural neuroplasticity","2026-06-24",{"date":610,"type":44},{"date":490,"type":21},{"date":637,"type":21},"2029-12",{"name":639,"class":51},"Anthony P King",{"id":641,"slug":642,"hasResults":12,"nctId":643,"briefTitle":644,"officialTitle":645,"acronym":646,"eligibilityCriteria":647,"healthyVolunteers":648,"sex":17,"minAge":59,"maxAge":579,"enrollmentInfo":649,"targetDuration":4,"studyType":22,"phases":650,"briefSummary":651,"conditions":652,"keywords":654,"overallStatus":210,"whyStopped":4,"lastUpdateSubmitDate":662,"lastUpdatePostDateStruct":663,"startDateStruct":664,"completionDateStruct":666,"leadSponsor":668,"locationsCount":52},"100644284","fasting-exercise-and-diet-to-activate-autophagy-in-depression-100644284","NCT07664540","Fasting, Exercise, and Diet to Activate Autophagy in Depression","Targeting Autophagy in Depression: Fasting, Exercise, Diet","AutoFast","Inclusion Criteria:\n\n* age: 18-40 years\n* BMI: between 18.5 and 24.9 kg\u002Fm2 (SG1\u002F2) or BMI between 25.0 and 39.9 kg\u002Fm2 (SG3\u002F4)\n* ability to understand the study procedure and give consent\n* Written informed consent\n* SG1 women: any fitness level\n* SG2 men: VO2max \\\u003C 45 ml\u002Fkg\u002FKG29,30\n* Available to conduct CPET on menstrual cycle days 1-5 (SG1\u002F3)\n* No infection with HIV or Hepatitis B\u002FC\n\nExclusion Criteria:\n\n* No infectious illness for at least two weeks prior to the test\n* No vitamin supplementation during the week prior to the performance test\n* SG3 and SG4: More than 1 hour moderate exercise per week\n* No use of hormonal contraceptives in the last 6 months before the onset of the study (SG1\u002F3)\n* a clinically diagnosed menstrual disorder (e.g., polycystic ovarian syndrome or amenorrhea) (SG1\u002F3)\n* having given birth within the 12 months before inclusion in the study (SG1\u002F3)\n* pregnancy or breastfeeding (SG1\u002F3)\n* premenstrual dysphoric disorder (PMDD) (SG1\u002F3)\n* history of epileptic seizure\n* history of depression\n* history of manic or psychotic episode\n* existing\u002Fcurrent eating disorders (bulimia nervosa, anorexia nervosa) within the past 5 years\n* inability to communicate adequately in speech\n* inability to follow instructions\n* regular use of medication other than thyroxine\n* alcohol consumption as equivalent doses of more than 12 g of pure alcohol per day on average for women and 24 g of pure alcohol per day for men\n* vegan diet\n* daily nicotine consumption\n* currently or history of (regular) consumption of illegal drugs within the last year\n* known diseases of the cardiovascular system\n* arterial hypertension above 160\u002F90 mmHg at rest\n* known pulmonary diseases\n* arthritis and rheumatic diseases and conditions\n* hematologic diseases\n* bronchial asthma\n* surgery less than 4-6 months ago\n* orthopedic or other diseases (e.g. neurological) that preclude maximum load on the bicycle ergometer\n* anemia (\\\u003C12.0 g\u002Fdl for women and \\\u003C14.0 g\u002Fdl for men)",true,{"count":478,"type":21},[24],"Depression is a common mental health condition that affects millions of people worldwide and is a leading cause of disability. Although current treatments can be effective, many patients do not fully recover or experience long-term improvement. This study aims to better understand how lifestyle factors such as physical activity and diet-related processes may influence biological mechanisms that could be linked to depression.\n\nThe study focuses on a natural cellular process called autophagy, which helps cells remove damaged components and maintain healthy function. Autophagy is influenced by energy availability in the body and may be affected by behaviors such as physical exercise and caloric restriction. Early evidence suggests that changes in autophagy may also be linked to mood regulation and depression, but this relationship is not yet well understood in humans.\n\nIn this exploratory study, we will investigate how physical activity influences autophagy and related metabolic and molecular processes in healthy adults. We will also examine whether these effects differ between individuals with different body weight and fitness levels, and between women and men.\n\nA total of approximately 120 healthy adults aged 18 to 40 years will participate. Participants will be divided into four groups based on sex and body weight (normal weight or overweight). Each participant will attend study visits at the University Hospital Zurich and perform a standardized cycling exercise test under medical supervision.\n\nDuring the exercise test, participants will perform a graded cycling protocol that gradually increases in intensity until exhaustion. We will collect small blood samples from a vein and from a fingertip at several time points before, during, and after exercise. Saliva samples will also be collected to measure stress-related hormones. Additional measurements include heart rate, breathing parameters, oxygen consumption, and physical performance.\n\nBlood and saliva samples will be analyzed using advanced laboratory techniques to study changes in metabolism, immune signaling, hormones, gene activity, and markers related to autophagy. These analyses will help identify biological pathways that are activated by exercise and may be relevant to brain health and depression.\n\nParticipants will undergo medical screening before inclusion to ensure safety. Individuals with certain medical conditions or factors that could interfere with the study results will not be included. Participation is voluntary, and participants may withdraw at any time without consequences.\n\nThe study involves minimal risks associated with blood sampling and intense physical exercise, which will be performed under close medical supervision. The expected benefit is improved scientific understanding of how lifestyle-related biological processes may be linked to mental health, which could support the development of new preventive or therapeutic strategies for depression in the future.",[27,653],"Overweight (BMI > 25)",[655,656,66,657,658,659,660,661],"autophagy","multi-omics","steroid hormones","autophagy flux","performance testing","metabolomics","proteomics","2026-06-17",{"date":633,"type":44},{"date":665,"type":21},"2026-09-11",{"date":667,"type":21},"2029-09-30",{"name":669,"class":51},"University of Zurich",{"id":671,"slug":672,"hasResults":12,"nctId":673,"briefTitle":674,"officialTitle":675,"acronym":4,"eligibilityCriteria":676,"healthyVolunteers":12,"sex":17,"minAge":59,"maxAge":4,"enrollmentInfo":677,"targetDuration":4,"studyType":22,"phases":679,"briefSummary":680,"conditions":681,"keywords":685,"overallStatus":210,"whyStopped":4,"lastUpdateSubmitDate":662,"lastUpdatePostDateStruct":691,"startDateStruct":693,"completionDateStruct":695,"leadSponsor":697,"locationsCount":52},"100614420","deaf-cbt-ts-to-reduce-suicide-risk-100614420","NCT07279363","Deaf CBT-TS to Reduce Suicide Risk","Cognitive Behavioral Therapy for Treatment-Seeking to Improve Treatment Engagement and Reduce Suicide Risk Among Deaf Individuals","Inclusion criteria:\n\n* adult (aged 18 years or older)\n* Self-identify as Deaf or hard of hearing (any degree of hearing loss)\n* Primary method of communication is American Sign Language\n* Positive screen for one or more mental health disorders including depression (PHQ-9 \\> 10), anxiety (GAD-7 \\> 10), posttraumatic stress disorder (PCL-5 \\> 31), insomnia (ISI \\> 15), or alcohol use disorder (AUDIT \\> 16)\n* No current professional mental health or alcohol specialty treatment (e.g., counseling, psychiatric services) per standardized self-report\n* Access to video chat technology with internet and webcam.\n\nExclusion criteria:\n\n* unable to communicate with the researcher in American Sign Language\n* current alcohol withdrawal necessitating medical evaluation\n* current psychiatric impairment necessitating emergency services or inpatient admission (i.e., imminent danger of harm to self or others)\n* unable to comprehend the nature of the study",{"count":678,"type":21},110,[24],"The goal of this clinical trial is to learn if a short, Zoom-based intervention, Cognitive Behavioral Therapy for Treatment-Seeking for Deaf Individuals (Deaf CBT-TS) can change beliefs about mental health treatment and increase treatment-seeking behaviors in Deaf adults with untreated mental health or alcohol use problems. It will also see if Deaf CBT-TS may reduce suicide risk and explore factors that may increase the effectiveness of Deaf CBT-TS. The main questions it aims to answer are:\n\n* Does Deaf CBT-TS increase positive beliefs about treatment and increase treatment-seeking behaviors?\n* Does Deaf CBT-TS increase hope and reduce mental health symptoms, suicide ideation, and alcohol use?\n* Is Deaf CBT-TS more effective for individuals with less cultural stress compared to those with high levels of cultural stress?\n* Is Deaf CBT-TS more effective for Deaf individuals in residential areas with more Deaf resources than those with less Deaf resources? Researchers will compare individuals who complete Deaf CBT-TS to those on a waitlist to see if Deaf CBT-TS works to increase positive beliefs about treatment and treatment-seeking behaviors.\n\nParticipants will:\n\n* Complete a baseline assessment including demographic information, measures of hope, general mental health and functioning, alcohol use, suicide ideation, cultural stress, and beliefs about treatment.\n* Receive Deaf CBT-TS (2 sessions) or be placed on a waitlist with the option of receiving Deaf CBT-Ts after 4 months\n* Complete two follow-up assessments in 2 and 4 months.",[27,261,682,405,683,684],"PTSD - Post Traumatic Stress Disorder","Alcohol Use Disorder (AUD)","Suicide Ideation",[686,687,688,689,690],"Deaf","Mental Health","Treatment-Seeking","Suicide","Cognitive Behavioral Therapy for Treatment-Seeking",{"date":692,"type":44},"2026-06-22",{"date":694,"type":21},"2026-09",{"date":696,"type":21},"2029-05",{"name":698,"class":51},"University of Rochester"]