[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"schizophrenia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:schizophrenia":29},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,246,0,25,[9,43,79,101,123,142,164,189,223,251,276,302,325,345,365,392,423,443,465,488,512,541,571,591,614],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100624505","phase-2-a-study-of-brenipatide-in-adult-participants-with-schizophrenia-100624505",false,"NCT07410507","A Study of Brenipatide in Adult Participants With Schizophrenia","A Phase 2 Multicenter, Double-Blind, Parallel-Arm Study to Investigate the Efficacy and Safety of Adjunctive Treatment With Brenipatide in Adult Participants With Schizophrenia (RENEW-Scz-1)","RENEW-Scz-1","Inclusion Criteria:\n\n* Meet the diagnostic criteria of schizophrenia\n* Are on a stable standard of care medication regimen for schizophrenia\n* If the duration of illness is \\>6 years, participant has experienced at least one relapse of schizophrenia in last 3 years\n* Have at least 1 reliable study partner (for example, a family member, social worker, caseworker, residential facility staff, or nurse)\n* Are reliable and willing to make themselves available for the duration of the study and attend required study visits, and are willing and able to follow study procedures as required, such as\n\n  * self-inject study intervention store and use the provided study intervention as directed,\n  * maintain electronic or paper study diaries, as applicable, and\n  * complete the required questionnaires\n\nExclusion Criteria:\n\n* Have lifetime history of bipolar disorder, borderline personality disorder, or any eating disorder\n* Evidence of moderate or severe substance or alcohol use disorder within 180 days of screening\n* Have type 1 diabetes, or history of ketoacidosis or hyperosmolar state or coma\n* Are actively suicidal or deemed to be a significant risk for suicide\n* Are currently enrolled in any other clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study","ALL","18 Years","55 Years",{"count":22,"type":23},450,"ESTIMATED","INTERVENTIONAL",[26],"PHASE2","The purpose of this study is to assess the efficacy and safety of brenipatide when administered with standard of care (SoC) compared to placebo plus SoC for treatment of schizophrenia.\n\nThe trial is divided into three periods as follows: Screening period will last approximately 1 month, treatment period will last a maximum of 12 months, and the follow up period will last approximately 2 months. The length of time of your study participation may last up to approximately 15 months.",[29],"Schizophrenia","RECRUITING","2026-08-20",{"date":33,"type":34},"2026-08-21","ACTUAL",{"date":36,"type":34},"2026-02-10",{"date":38,"type":23},"2027-11",{"name":40,"class":41},"Eli Lilly and Company","INDUSTRY",103,{"id":44,"slug":45,"hasResults":12,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":12,"sex":18,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":24,"phases":54,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":78},"100651110","digital-therapeutics-for-social-cognitive-function-in-schizophrenia-spectrum-disorder-a-randomized-controlled-trial-100651110","NCT07755605","Digital Therapeutics for Social Cognitive Function in Schizophrenia Spectrum Disorder","A Prospective, Randomized Parallel, Single Institution, Researcher-led Clinical Trial on the Effect of Improving Social Cognitive Function by Using Digital Therapy Devices in Patients With Schizophrenia Spectrum Disorder","A. Inclusion Criteria\n\nParticipants must meet all of the following criteria:\n\n1. Adults aged 19 to 60 years.\n2. Meet the diagnostic criteria for schizophrenia or schizoaffective disorder according to DSM-5 and ICD-11.\n3. Have completed at least a middle school education.\n4. Be able to read and write in Korean.\n5. Be able to use a smartphone application independently.\n6. Provide written informed consent before participation.\n7. Receiving stable antipsychotic treatment (dose variation ≤30%) for at least 3 months before enrollment.\n\nExclusion Criteria\n\n1. Current or past diagnosis of intellectual disability.\n2. Initiation of or current participation in structured psychosocial interventions (e.g., cognitive behavioral therapy or social cognition training) within the past 3 months.\n3. Considered by the investigator to be at significant risk of suicide. 4, Pregnant or having a positive pregnancy test at screening.\n\n5\\. Any condition that, in the opinion of the investigator, would make participation unsafe or interfere with study participation or data interpretation.","19 Years","60 Years",{"count":53,"type":23},60,[55],"NA","The purpose of this study is to evaluate the safety and preliminary effectiveness of a smartphone-based digital therapeutic application (AffectUs) for improving social cognition, particularly emotion processing and social cue perception, in individuals with schizophrenia spectrum disorders.\n\nIn this randomized controlled trial, participants will be assigned either to use AffectUs for 10 weeks in addition to treatment as usual or to receive psychoeducational materials and treatment as usual. Participants will complete assessments at baseline, week 5, week 10, and week 15 to evaluate social cognition, clinical outcomes, and safety.",[29,58],"Schizoaffecitve Disorder",[60,61,62,63,64,65,66,67,68],"Schizophrenia Spectrum Disorder","Social Cognition","Emotion Recognition","Digital Therapeutics","Psychosocial Rehabilitation","AffectUs","Social Cue Perception","Emotion Processing","Mobile Application","2026-08-19",{"date":33,"type":34},{"date":72,"type":34},"2026-07-15",{"date":74,"type":23},"2027-03",{"name":76,"class":77},"Samsung Medical Center","OTHER",1,{"id":80,"slug":81,"hasResults":12,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":86,"targetDuration":4,"studyType":24,"phases":88,"briefSummary":90,"conditions":91,"keywords":92,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":94,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":98,"locationsCount":100},"100649302","phase-1-a-study-of-ltx-001-in-adult-participants-with-acute-exacerbation-of-schizophrenia-100649302","NCT07734493","A Study of LTX-001 In Adult Participants With Acute Exacerbation of Schizophrenia","A Phase 1b, Multicenter, Randomized, Double-Blind, Dose-Escalation, Placebo-Controlled Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, And Early Signs of Efficacy of Orally Administered LTX-001 As Monotherapy in Adult Participants With Acute Exacerbation of Schizophrenia","Inclusion Criteria:\n\n* BMI \\> 17.5 and \\\u003C 38.0 kg\u002Fm2 and a total body weight \\> 50.0 kg (110 lbs)\n* Primary diagnosis of schizophrenia per the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5-TR)\n* Experiencing an acute exacerbation or relapse of symptoms, with onset less than 2 months prior to screening for the study\n* PANSS total score ≥ 80 at the time of screening for the study\n* Not currently on antipsychotic medication, or is willing to discontinue all prohibited psychotropic medications prior to and during the trial period\n* Sexually active adults must be willing to use an acceptable contraceptive method throughout the study\n\nExclusion Criteria:\n\n* Evidence of organ dysfunction or any clinically significant abnormal finding at physical examination\n* History of treatment resistance (e.g., failure to respond to ≥ 2 adequate antipsychotic trials) or failure to respond to use of clozapine\n* Current DSM-5-TR diagnosis other than schizophrenia\n* Pregnant or lactating female\n* Substance use disorder within 1 year prior to screening or recreational use of drugs within 3 months prior to screening\n* Moderate to severe alcohol use disorder as per DSM-5-TR within the past year or excessive use of alcohol within 12 months prior to screening\n* Positive testing for human immunodeficiency virus (HIV)-1 and -2 antibody, hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibody at screening",{"count":87,"type":23},90,[89],"PHASE1","The purpose of this clinical trial is to learn whether the investigational drug LTX-001 is safe and well tolerated in adults with a diagnosis of schizophrenia who are having a recent worsening of their symptoms (an acute exacerbation). Additional questions it aims to answer are:\n\n* how does the amount of the study drug in the body change over time (pharmacokinetics)\n* how does the study drug affect the symptoms of schizophrenia\n* how do certain markers in the blood change after administration of LTX-001 (pharmacodynamics)\n\nResearchers will compare different dose levels of LTX-001 to an inactive product (placebo) to see what differences there are between the two treatments.\n\nAfter successfully screening for the study, participants will stay in a research unit for about five weeks and return one week later for a follow-up visit.",[29],[93],"schizophrenia",{"date":33,"type":34},{"date":96,"type":23},"2026-08",{"date":74,"type":23},{"name":99,"class":41},"Leal Therapeutics, Inc",10,{"id":102,"slug":103,"hasResults":12,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":4,"eligibilityCriteria":107,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":108,"targetDuration":4,"studyType":110,"phases":4,"briefSummary":111,"conditions":112,"keywords":113,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":122},"100622146","effectiveness-and-adverse-effect-switch-evaluation-of-xanomeline-and-trospium-chloride-karxt-100622146","NCT07379827","Effectiveness and Adverse-effect Switch Evaluation of Xanomeline and Trospium Chloride (KarXT)","Effectiveness and Adverse-effect Switch Evaluation","Inclusion Criteria:\n\n* Participants (or caregiver\u002Flegal guardian) must have signed and dated an Institutional Review Board (IRB)\u002FIndependent Ethics Committee (IEC)-approved written ICF or signed an electronic ICF in accordance with regulatory, local, and institutional guidelines.\n* Adults ≥ 18 years of age at Baseline who are willing and able, in the judgement of the treating clinician, to participate in routine clinical care and follow up.\n* Schizophrenia, confirmed by the treating clinician's judgement or physician decision to treat the patient with receiving xanomeline and trospium chloride (KarXT) for schizophrenia made prior to and independently of participation in this study. Current Antipsychotic Treatment: Participant must fall into one of the categories below:\n\n  * Be within \\\u003C16 weeks of initiating treatment with KarXT with intent to discontinue prior antipsychotic treatment(s) OR\n  * On a stable regimen (dose and frequency consistent with the drug label and\u002For at a stable dose based on the judgement of the Investigator for at least 30 days prior to screening) of treatment with 1 or more antipsychotics with plan to discontinue and switch to treatment with KarXT from a prior antipsychotic treatments(s). NOTE: The decision to switch for reasons of safety, tolerability, and\u002For efficacy will be made independently by the treating clinician and\u002For the patient and is not dictated by the study. Participants can be enrolled during tapering\u002Fdiscontinuing process from prior antipsychotic treatment(s). Individuals who are not currently receiving treatment for schizophrenia are not eligible for the study. Any antipsychotic treatments must be recorded as concomitant medications.\n* Concomitant psychiatric medications (eg, antidepressants, mood stabilizers, anxiolytics) are permitted and are recommended to remain at a stable dose during the study period.\n\nExclusion Criteria:\n\n* Prior use of KarXT that has been discontinued for any reason prior to Baseline.\n* Participation in an interventional study within the last 30 days or plans to participate in an interventional study at the time of eligibility or baseline through the study period.\n* Known hypersensitivity to xanomeline or trospium chloride, or history or high risk of urinary retention, gastric retention, moderate (Child-Pugh Class B) or severe (Child-Pugh Class C) hepatic impairment, or narrow-angle glaucoma.\n* In the opinion of the treating clinician, unstable psychiatric or medical conditions that would prevent the participant from safely switching to KarXT. Hospitalized individuals who have been switched to KarXT or are switching treatment to KarXT are permitted to be enrolled at discharge if they are \\\u003C 16 weeks from initiation of KarXT.\n* Participants who are pregnant, planning to become pregnant, or breastfeeding.",{"count":109,"type":23},1500,"OBSERVATIONAL","The purpose of this study is to describe real-world treatment patterns, effectiveness and adverse events of adults diagnosed with schizophrenia that have initiated xanomeline and trospium chloride (KarXT) treatment in the United States",[29],[29],"2026-08-18",{"date":69,"type":34},{"date":117,"type":34},"2026-02-26",{"date":119,"type":23},"2028-06-20",{"name":121,"class":41},"Bristol-Myers Squibb",55,{"id":124,"slug":125,"hasResults":12,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":4,"eligibilityCriteria":129,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":130,"targetDuration":4,"studyType":110,"phases":4,"briefSummary":132,"conditions":133,"keywords":134,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":135,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":141},"100600715","evaluation-of-treatment-satisfaction-and-karxt-utilization-registry-resku-100600715","NCT07101094","Evaluation of Treatment Satisfaction and KarXT Utilization Registry (RESKU)","Real-world Evaluation of Treatment Satisfaction and KarXT Utilization Registry (RESKU)","Inclusion Criteria:\n\n* Aged ≥18 years at index date.\n* Have a confirmed diagnosis of schizophrenia before index date.\n* Receipt of an initial prescription order for xanomeline and trospium chloride (XT) and plan to fill and initiate such therapy.\n* Provide a signed and dated Institutional Review Board (IRB)\u002FIndependent Ethics Committee (IEC)-approved written informed consent form (ICF) in accordance with regulatory, local, and institutional guidelines.\n* Agree to use an electronic device to record, or provide paper entry of, patient-reported outcomes (in English or Spanish).\n* English or Spanish speaking.\n\nExclusion Criteria:\n\n* Participation in an interventional study within the last 30 days or plan to participate in such study at the time of eligibility screening.\n* Evidence of use of XT prior to time of eligibility screening.",{"count":131,"type":23},300,"The purpose of this study is to understand treatment preference and satisfaction among adults with schizophrenia in the United States who are prescribed xanomeline and trospium chloride (X\u002FT) therapy",[29],[29],{"date":69,"type":34},{"date":137,"type":34},"2025-09-22",{"date":139,"type":23},"2029-05-14",{"name":121,"class":41},20,{"id":143,"slug":144,"hasResults":12,"nctId":145,"briefTitle":146,"officialTitle":146,"acronym":4,"eligibilityCriteria":147,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":148,"targetDuration":4,"studyType":24,"phases":150,"briefSummary":151,"conditions":152,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":156,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":163},"100524364","cerebellar-modulation-of-cognition-in-psychosis-100524364","NCT06107764","Cerebellar Modulation of Cognition in Psychosis","Inclusion Criteria:\n\n* Age between 18-55 years\n* Diagnosis of a psychotic disorder (i.e. schizophrenia or schizoaffective disorder or bipolar disorder type I)\n* Must be able to read, speak and understand English\n* Must be judged by study staff to be capable of completing the study procedures\n* Participants will be in stable outpatient treatment with no recent (within the past 30 days) hospitalizations or changes in their medication regimens.\n\nExclusion Criteria:\n\n* Diagnostic and Statistical Manual 5 diagnosis of moderate substance use disorder within the past month\n* Conditions that might result in increased risks of side effects or complications from rTMS or MRI, including:\n\n  * Intracranial pathology from a known genetic disorder (e.g., Neurofibromatosis 1, tuberous sclerosis) or from acquired neurologic disease (e.g. stroke, tumor), cerebral palsy, history of severe head injury, or significant dysmorphology;\n  * History of fainting spells of unknown or undetermined etiology that might constitute seizures\n  * History of multiple seizures or diagnosis of epilepsy\n  * Any progressive (e.g., neurodegenerative) neurological disorder such as multiple sclerosis or Parkinson's disease\n  * Chronic (particularly) uncontrolled medical conditions that may cause a medical emergency in case of a provoked seizure (cardiac malformation, cardiac dysrhythmia, asthma, etc.)\n  * Metal implants (excluding dental fillings) unless cleared by the responsible covering MD (i.e. MRI compatible joint replacement)\n  * Pacemaker\n  * Implanted medication pump\n  * Vagal nerve stimulator\n  * Deep brain stimulator or transcutaneous electric nerve stimulation unit\n  * Ventriculo-peritoneal shunt\n  * Signs of increased intracranial pressure\n  * Intracranial lesion\n  * History of head injury resulting in prolonged loss of consciousness (\\>15minutes) or neurological sequelae\n  * Pregnancy: All participants capable of becoming pregnant will be required to have a pregnancy test; any participant who is pregnant will not be enrolled in the study.",{"count":149,"type":23},95,[55],"The goal of this clinical trial is to learn about cognition in psychotic disorders (schizophrenia, bipolar disorder, and schizoaffective disorder). The main question it aims to answer is: Can we use magnetic stimulation to change processing speed (how quickly people can solve challenging tasks).\n\nParticipants will be asked to perform cognitive tasks (problem-solving) and undergo brain scans before and after transcranial magnetic stimulation (TMS). TMS is a way to non-invasively change brain activity. Forms of TMS are FDA-approved to treat depression and obsessive compulsive disorder. In this study, we will use a different form of TMS to temporarily change brain activity to observe how that changes speed in problem-solving.",[29,153,154,155],"Schizoaffective Disorder","Bipolar Disorder I","Psychosis",{"date":31,"type":34},{"date":158,"type":34},"2024-07-31",{"date":160,"type":23},"2029-12",{"name":162,"class":77},"Mclean Hospital",2,{"id":165,"slug":166,"hasResults":12,"nctId":167,"briefTitle":168,"officialTitle":169,"acronym":170,"eligibilityCriteria":171,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":172,"targetDuration":4,"studyType":24,"phases":174,"briefSummary":175,"conditions":176,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":181,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":188},"100492933","compassion-for-psychiatric-disorders-and-self-stigma-100492933","NCT05698589","COMpassion for Psychiatric Disorders And Self-Stigma","Compassion Focused Therapy (CFT) for the Reduction of the Internalized Stigma of Mental Disorders: a Multi-center, Prospective, Randomized, Controlled Study","COMPASS","Inclusion Criteria:\n\n1. Patient ≥18 years of age\n2. Patient informed of the results of the preliminary medical examination\n3. Patient affiliated to a social health insurance plan (beneficiary or beneficiary's family)\n4. Patient with one or several diagnoses of chronic psychiatric disorder (schizophrenia, schizoaffective disorder, bipolar disorder, recurrent major depression, borderline personality disorder) or a neurodevelopmental disorder (autism spectrum disorder) treated as an outpatient or in a day hospital\n5. CGI-Severity score\\\u003C6 assessed by the psychiatrist (Berk et al., 2008) ISMI score indicating moderate to high self-stigma (\\>2.5; Lysaker et al., 2007)\n\n   Exclusion criteria:\n6. Patient in an exclusion period determined by a previous or ongoing study\n7. Patient participating in an interventional study involving psychotherapy or an experimental drug\n8. Patient in acute episode of their disorder according to the CGI Severity score\n9. Patient in a medical emergency or immediate life-threatening situation\n10. Patients with an intellectual disability (IQ\\\u003C70) estimated via the fNART (Mackinnon \\& Mulligan, 2005)\n\n12\\. Legal issues: care under constraint or patient deprived of freedom because of a judicial measure 13. Patient who does not speak and read French sufficiently",{"count":173,"type":23},336,[55],"People with mental disorders face frequent stigmatizing attitudes and behaviors from others . In response to this, they tend to isolate themselves, with the risk of impeding care and the process of recovery and integration into society . Stigmatization can also be assimilated by patients themselves - i.e. self-stigma. Self-stigma is involved in diminished coping skills that lead to social avoidance and difficulties in adhering to care . Reducing self-stigma and its emotional corollary, shame, is thus crucial to attenuate the disability associated with mental illness. Shame is inherent to self-stigma and leads to difficulties in adhering to care as well as greater severity of clinical presentations . Compassion Focused Therapy (CFT) is a third wave cognitive behavioral therapy that targets shame reduction and hostile self-to-self relationship and allows for symptom improvement while increasing self-compassion, a major resilience factor . Although shame is a prominent part of the concept of self-stigma, the efficacy of CFT has never been evaluated in individuals with high levels of self-stigma.\n\nIn this study, the investigators will evaluate the efficacy and acceptability of a group based CFT program on decreasing self-stigma, compared to treatment as usual (TAU) and a psychoeducation program whose efficacy has been assessed in a previous trial.",[177,29,178,179,180],"Bipolar Disorder","Depression","Borderline Personality Disorder","Autism Spectrum Disorder",{"date":69,"type":34},{"date":183,"type":34},"2023-04-03",{"date":185,"type":23},"2028-03-01",{"name":187,"class":77},"University Hospital, Strasbourg, France",7,{"id":190,"slug":191,"hasResults":12,"nctId":192,"briefTitle":193,"officialTitle":194,"acronym":195,"eligibilityCriteria":196,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":197,"targetDuration":4,"studyType":24,"phases":199,"briefSummary":200,"conditions":201,"keywords":204,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":214,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":222},"100585170","enhancing-veteran-clinical-collaboration-in-va-prrcs-100585170","NCT06898879","Enhancing Veteran-Clinical Collaboration in VA PRRCs","Enhancing Veteran-Clinical Collaboration in VA Psychosocial Rehabilitation and Recovery Centers","EVCC VPRRC","Inclusion Criteria:\n\n1. Be a Veteran currently receiving Psychosocial Rehabilitation and Recovery Center (PRRC), Mental Health Intensive Case Management (MHICM) and\u002For Behavioral Health Interdisciplinary Program (BHIP) services at VA San Diego, Los Angeles, or Albuquerque (e.g., seen in the clinic in the past month or based on clinic criteria)\n2. Meet Substance Abuse and Mental Health Services Administration (SAMHSA) criteria of serious mental illness; i.e., \"having (within the past year) a diagnosable mental, behavior, or emotional disorder that causes serious functional impairment that substantially interferes with or limits one or more major life activities,\" based on chart review and clinician consultation if needed\n3. Be fluent and literate in English\n4. Agree to have a subset of VA mental health treatment appointments audiotaped\n\nExclusion Criteria:\n\n1. Primary substance use or organic neurological disorder diagnosis determined by chart review\n2. Are determined by clinician and\u002For study staff to be at significant risk of exacerbation of symptoms, suicidal ideation, or other risk due to study participation\n3. Have a history and\u002For current risk of violence that clinicians and\u002For study staff determine to be too high risk to manage effectively in the study setting (e.g., poses a risk to Veterans or study staff)",{"count":198,"type":23},119,[55],"Over 60% of Veterans with serious mental illness have a service-connected disability that impairs their ability to work, go to school, and\u002For have successful personal lives. Although traditional treatments tend to focus on symptom remission, Veterans prioritize a range of treatment goals, including personal empowerment and gaining personally meaningful skills. Increasing Veteran-clinician collaboration can help effectively align care with each Veteran's goals and support an empowering therapeutic experience. This project will evaluate the effectiveness of a group-based intervention intended to increase Veterans' comfort, confidence, knowledge, and skills to collaborate with their treatment teams. Findings from this study will contribute important knowledge about this intervention's effectiveness and how to enhance its effectiveness, especially for Veterans from minoritized groups. If the decision-making intervention is effective, it would help Veterans with serious mental illness, and might also help Veterans with other chronic health conditions, like PTSD and chronic pain.",[29,153,202,177,203],"Delusional Disorder","Major Depressive Disorder",[205,206,207,208,209,210,211,212],"serious mental illness","psychosis","collaborative decision-making","shared decision-making","veterans","recovery","personal recovery","empowerment","2026-08-17",{"date":69,"type":34},{"date":216,"type":34},"2026-08-12",{"date":218,"type":23},"2029-09-30",{"name":220,"class":221},"VA Office of Research and Development","FED",3,{"id":224,"slug":225,"hasResults":12,"nctId":226,"briefTitle":227,"officialTitle":228,"acronym":4,"eligibilityCriteria":229,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":230,"enrollmentInfo":231,"targetDuration":4,"studyType":24,"phases":233,"briefSummary":234,"conditions":235,"keywords":238,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":243,"lastUpdatePostDateStruct":244,"startDateStruct":245,"completionDateStruct":247,"leadSponsor":249,"locationsCount":78},"100593476","reach-study-recovery-environments-assessing-cognitive--brain-health-in-community-mental-health-100593476","NCT07006935","REACH Study (Recovery Environments: Assessing Cognitive & Brain Health in Community Mental Health)","Pilot Study of the Cognitive and Neurobiological Effects of the Clubhouse Model of Psychosocial Rehabilitation for Schizophrenia and Related Conditions","Inclusion Criteria:\n\n* (1) have a DSM-V diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform confirmed by diagnostic assessment and medical record review\n* (2) between the ages of 18-50\n* (3) stabilized on psychotropic medication as indicated by no changes to the primary psychiatric medication in the last month\n* (4) able to read and speak fluent English at a sixth grade level or higher for purposes of informed consent and cognitive testing\n* For Clubhouse members, they must be a first-time, newly enrolled member\n\nExclusion Criteria:\n\n* (1) had previous membership at a Clubhouse (Magnolia or elsewhere)\n* (2) have a current severe substance use disorder\n* (3) have persistent suicidal or homicidal behavior\n* (4) a co-occurring diagnosis of an intellectual or learning disability or neurodevelopment condition (e.g., Autism; based on chart review)\n* (5) had recent psychiatric instability requiring hospitalization in the past month;\n* (6) history of a traumatic brain injury (TBI; based on record review)\n* (7) contraindicators for MRI (e.g., pacemaker, claustrophobia)\n* Participants in the usual care will be excluded if they are a current Clubhouse member or join a Clubhouse during participation in this research","50 Years",{"count":232,"type":23},30,[55],"The purpose of this study is to understand how different types of community-based mental health care affect thinking abilities, daily functioning, and brain activity in adults with schizophrenia and related conditions. The investigators are especially interested in learning whether the Clubhouse Model-a structured, supportive community for individuals with mental illness-has unique benefits compared to standard outpatient mental health services. If participants decide to join, they will be asked to complete a total of six study visits with the research team over the course of your participation. Three of these study visits are at the beginning (baseline) and the remaining three are six months later. Two of the three visits will includes interviews, questionnaires, and thinking and memory tasks (cognitive testing) and one session will be an MRI brain scan, which is a safe and non-invasive imaging procedure. The total time required for each visit will be approximately 90 minutes to two hours. Participants may take breaks as needed.",[29,236,237],"Schizo Affective Disorder","Schizophreniform Disorders",[239,240,241,242],"Clubhouse Model of Psychosocial Rehabilitation","Community mental health interventions","Cognition","Brain functioning","2026-08-14",{"date":213,"type":34},{"date":246,"type":23},"2026-08-30",{"date":248,"type":23},"2028-01-30",{"name":250,"class":77},"Case Western Reserve University",{"id":252,"slug":253,"hasResults":12,"nctId":254,"briefTitle":255,"officialTitle":255,"acronym":4,"eligibilityCriteria":256,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":51,"enrollmentInfo":257,"targetDuration":4,"studyType":24,"phases":259,"briefSummary":260,"conditions":261,"keywords":262,"overallStatus":267,"whyStopped":4,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":269,"startDateStruct":270,"completionDateStruct":272,"leadSponsor":274,"locationsCount":78},"100652313","enhancing-brain-connectivity-in-schizophrenia-through-neuromodulation-study-3-100652313","NCT07772349","Enhancing Brain Connectivity in Schizophrenia Through Neuromodulation (Study 3)","Inclusion Criteria:\n\n1. Male and female ages between ages 18-60 years\n2. Ability to give written informed consent (age 18 or above)\n3. Diagnosed with schizophrenia-spectrum disorder and Evaluation to Sign Consent (ESC) above 10.\n\nExclusion Criteria:\n\n1. Inability to sign informed consent.\n2. Any history of seizures.\n3. Any acute and unstable major medical illnesses that may affect normal brain functioning. Examples of these conditions include, but not limited to, recent stroke, seizure, history of significant head trauma, CNS infection or tumor, other significant brain neurological conditions (As this is a study of medical comorbidity, most medical conditions, once stable, are not exclusion criteria).\n4. Taking \\> 400 mg clozapine\u002Fday and not on anti-seizure medication(s) with sufficient dose.\n5. Failed TMS screening questionnaire.\n6. Significant alcohol or other drug use (substance abuse within 1 month or substance dependence history within 6 months and having substance usage within 1 month) other than nicotine or marijuana dependence.\n7. A history of thrombosis, family history of thrombosis, or medical conditions that may lead to a hypercoagulable state (increased chance to develop blood clots)\n8. Woman who is pregnant (child-bearing potential but not on contraceptive and missing menstrual period; or by self-report; or by positive urine pregnancy test).\n9. History of head injury with loss of consciousness over 10 minutes; history of brain surgery\n10. Cannot refrain from using alcohol and\u002For marijuana 24 hours or more prior to experiments.\n11. Students and employees currently involved with our lab (lab employees and personnel will be excluded from the study to avoid possible coercion or possible appearance of coercion, or chance of breach of privacy and confidentiality).\n12. For MRI, unable to undergo MRI scanning due to metallic devices or objects (cardiac pacemaker or neurostimulator, some artificial joints, metal pins, surgical clips, or other implanted metal parts) or claustrophobic to the scanner.",{"count":258,"type":23},120,[55],"The aim of the study is to assess the treatment effects of deep active repetitive transcranial magnetic stimulation (rTMS) with H4 coil combined with cognitive training for improving frontal white matter microstructural integrity in patients with schizophrenia spectrum disorder (SSD).",[29],[263,93,264,265,266],"Transcranial magnetic stimulation","white matter","connectivity","myelination","NOT_YET_RECRUITING","2026-08-13",{"date":69,"type":34},{"date":271,"type":23},"2026-10-01",{"date":273,"type":23},"2029-05-01",{"name":275,"class":77},"The University of Texas Health Science Center, Houston",{"id":277,"slug":278,"hasResults":12,"nctId":279,"briefTitle":280,"officialTitle":281,"acronym":282,"eligibilityCriteria":283,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":284,"enrollmentInfo":285,"targetDuration":4,"studyType":24,"phases":287,"briefSummary":288,"conditions":289,"keywords":291,"overallStatus":267,"whyStopped":4,"lastUpdateSubmitDate":216,"lastUpdatePostDateStruct":296,"startDateStruct":297,"completionDateStruct":298,"leadSponsor":300,"locationsCount":78},"100651933","phase-1-xingqi-daozhi-decoction-for-antipsychotic-induced-constipation-100651933","NCT07767526","Xingqi Daozhi Decoction for Antipsychotic-Induced Constipation","A Randomized, Double-Blind, Placebo-Controlled Exploratory Trial of Xingqi Daozhi Decoction for Antipsychotic-Induced Constipation With Qi Stagnation Pattern","XQD-AIC","Inclusion Criteria:\n\nMeets the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnostic criteria for schizophrenia.\n\nPositive and Negative Syndrome Scale (PANSS) total score ≤95, with a PANSS negative symptom subscale score ≤28.\n\nMeets the Rome IV diagnostic criteria for functional constipation with a qi stagnation pattern.\n\nAged 18 to 65 years. Has at least a junior high school education and is able to complete self-report questionnaires.\n\nHas not used other medications known to cause constipation within the past 3 months.\n\nHas had no history of constipation within the past 2 years and no previous gastrointestinal disease.\n\nDeveloped constipation after initiation of antipsychotic medication.\n\nExclusion Criteria:\n\nMeets DSM-5 diagnostic criteria for any psychiatric disorder other than schizophrenia.\n\nIs unable to maintain a normal diet because of psychiatric symptoms, or requires a special diet such as a diabetic diet, soft diet, liquid diet, fasting, or restriction of oral intake due to individual clinical circumstances.\n\nUses other medications that may cause or aggravate constipation. Has had constipation within the past 2 years or has a history of gastrointestinal disease.\n\nHas lactose intolerance. Has clinically significant medical conditions, including diabetes mellitus, hypothyroidism, connective tissue disease, or other significant physical illnesses.\n\nIs pregnant, planning pregnancy in the near future, or breastfeeding.","65 Years",{"count":286,"type":23},46,[89,26],"Antipsychotic medications are widely used to treat schizophrenia but may cause constipation, which can lead to abdominal discomfort, reduced quality of life, and poor treatment adherence. Xingqi Daozhi Decoction is a traditional Chinese medicine formula used to relieve constipation associated with qi stagnation. This study aims to evaluate the effectiveness and safety of Xingqi Daozhi Decoction for antipsychotic-induced constipation with a qi stagnation pattern.\n\nThis is a single-center, randomized, double-blind, placebo-controlled exploratory study. A total of 46 participants with schizophrenia who developed constipation after taking antipsychotic medications will be enrolled. Participants will be randomly assigned to receive either Xingqi Daozhi Decoction granules or matching placebo granules twice daily for 8 weeks. Neither the participants nor the treating clinicians and outcome assessors will know the treatment assignment during the study.\n\nParticipants will be evaluated regularly during treatment. The study will assess changes in bowel movements, constipation symptoms, constipation-related quality of life, and treatment safety. Participants will also undergo routine clinical and laboratory safety assessments, and adverse events will be recorded throughout the study. The primary outcome focuses on the proportion of participants who achieve an improvement in complete spontaneous bowel movements during treatment.",[29,290],"Antipsychotic Drug",[29,292,293,294,295],"Xingqi Daozhi Decoction","Constipation","Antipsychotic drug","Traditional Chinese Medicine",{"date":213,"type":34},{"date":271,"type":23},{"date":299,"type":23},"2028-12-31",{"name":301,"class":77},"Shanghai Mental Health Center",{"id":303,"slug":304,"hasResults":12,"nctId":305,"briefTitle":306,"officialTitle":307,"acronym":4,"eligibilityCriteria":308,"healthyVolunteers":12,"sex":18,"minAge":309,"maxAge":310,"enrollmentInfo":311,"targetDuration":4,"studyType":24,"phases":313,"briefSummary":315,"conditions":316,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":216,"lastUpdatePostDateStruct":318,"startDateStruct":319,"completionDateStruct":321,"leadSponsor":323,"locationsCount":149},"100625574","phase-3-a-study-to-evaluate-the-long-term-safety-and-tolerability-of-karxt-and-karx-ec-for-the-treatment-of-schizophrenia-and-autism-related-irritability-in-adolescents-respectively-100625574","NCT07424404","A Study to Evaluate the Long-term Safety and Tolerability of KarXT and KarX-EC for the Treatment of Schizophrenia and Autism-Related Irritability in Adolescents, Respectively","A Phase 3 Multicenter, Open-label Study to Assess the Long-term Safety and Tolerability of KarXT in Adolescents (13 to 17 Years of Age) With Schizophrenia and KarXT+KarX-EC in Children and Adolescents (5 to 17 Years of Age) With Irritability Associated With Autism Spectrum Disorder","Inclusion Criteria\n\n\\- Participants must have completed the double-blind treatment period (ie, Visit 8) of Study CN0120020 or the double-blind treatment period (ie, Week 8) of Study CN0120044 or CN0120045, without an adverse event (AE) that, in the investigator's opinion, may indicate an unacceptable safety risk.\n\nExclusion Criteria\n\n* Participants must not have a significant risk of committing violent acts, serious self-harm, or attempting suicide based on history or routine psychiatric status examination, or those who are homicidal or are considered to be a high risk to others, or who have an answer of \"Yes\" on Questions 4 or 5 on the suicidal ideation section of the \"Since Last Visit\" version of the C-SSRS at baseline (Visit 1). Nonsuicidal, self-injurious behavior is not exclusionary.\n* Participants must not have any clinically significant abnormality including any finding(s) from the physical examination, vital signs, ECG at the end of treatment visit of Study CN0120020, CN0120044, or CN0120045 that the investigator, in consultation with the Sponsor Medical Monitor, would jeopardize the safety of the participant.\n* Participants must not have either a systolic blood pressure (sBP) or diastolic blood pressure (dBP) meeting criteria for stage 2 hypertension (HTN), regardless of the presence or absence of symptoms.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.","5 Years","17 Years",{"count":312,"type":23},400,[314],"PHASE3","The purpose of this study is to evaluate the long-term safety and tolerability of KarXT and KarX-EC for the treatment of Schizophrenia and autism-related irritability in adolescents, respectively",[29,317],"Autism-Related Irritability",{"date":268,"type":34},{"date":320,"type":34},"2026-04-07",{"date":322,"type":23},"2030-03-08",{"name":324,"class":41},"Karuna Therapeutics, Inc., a Bristol Myers Squibb company",{"id":326,"slug":327,"hasResults":12,"nctId":328,"briefTitle":329,"officialTitle":330,"acronym":4,"eligibilityCriteria":331,"healthyVolunteers":12,"sex":18,"minAge":332,"maxAge":310,"enrollmentInfo":333,"targetDuration":4,"studyType":24,"phases":335,"briefSummary":336,"conditions":337,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":216,"lastUpdatePostDateStruct":338,"startDateStruct":339,"completionDateStruct":341,"leadSponsor":343,"locationsCount":344},"100615127","phase-3-a-study-to-evaluate-the-efficacy-and-safety-of-karxt-for-the-treatment-of-schizophrenia-in-adolescents-emergent-teen-100615127","NCT07288567","A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Schizophrenia in Adolescents (EMERGENT TEEN)","A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Schizophrenia in Adolescents (13 to 17 Years of Age)","Inclusion Criteria:\n\n* Diagnosis of schizophrenia as defined by the The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition,Text Revision (DSM-5-TR) criteria, confirmed by the Kiddie Schedule for Affective Disorders and Schizophrenia-Present and Lifetime version (K-SADS-PL) and experiencing symptoms of psychosis at screening (Visit 1).\n* PANSS total score of at least 70 at screening (Visit 1) and randomization (Visit 2).\n* Participant has a CGI-S score of ≥ 4 at screening (Visit 1) and randomization (Visit 2).\n\nExclusion Criteria:\n\n* Any primary DSM-5-TR disorder other than schizophrenia within 12 months before screening.\n* History or presence of clinically significant cardiovascular, pulmonary, hepatic impairment, renal, hematologic, GI, endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other condition that, in the opinion of the investigator, would jeopardize the safety of the participant or the validity of the study results.\n* All grades of hepatic impairment (mild \\[Child-Pugh Class A\\], moderate \\[Child-Pugh Class B\\], and severe \\[Child-Pugh Class C\\]). Participants with known intellectual disability defined as an IQ less than 70; or, either clinical evidence or known social or school history indicative of intellectual disability.\n* Any neurological disorder, except for Tourette's Syndrome.\n* Participants who have either a systolic blood pressure (sBP) or diastolic blood pressure (dBP) meeting criteria for stage 2 HTN, regardless of the presence or absence of symptoms.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.","13 Years",{"count":334,"type":23},166,[314],"The purpose of this study is to evaluate the efficacy and safety of KarXT for treatment of Schizophrenia in adolescents.",[29],{"date":268,"type":34},{"date":340,"type":34},"2026-01-29",{"date":342,"type":23},"2029-12-18",{"name":121,"class":41},39,{"id":346,"slug":347,"hasResults":12,"nctId":348,"briefTitle":349,"officialTitle":350,"acronym":4,"eligibilityCriteria":351,"healthyVolunteers":352,"sex":18,"minAge":19,"maxAge":284,"enrollmentInfo":353,"targetDuration":4,"studyType":24,"phases":355,"briefSummary":356,"conditions":357,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":216,"lastUpdatePostDateStruct":358,"startDateStruct":359,"completionDateStruct":361,"leadSponsor":362,"locationsCount":364},"100554838","phase-1-evaluating-safety-tolerability-and-pharmacokinetic-of-multiple-ascending-doses-of-vv119-100554838","NCT06504290","Evaluating Safety, Tolerability and Pharmacokinetic of Multiple Ascending Doses of VV119","A Phase I Clinical Study Evaluating the Safety, Tolerability, and Pharmacokinetics of VV119 Capsules With Multiple Ascending Doses in Chinese Healthy Adult Subjects and Patients With Schizophrenia","Inclusion Criteria:\n\nHealthy adult subjects：\n\n1. Males: aged 18 to 45 years old, Body weight no less than 50.0kg; females: Aged 18 to 60 years old, Body weight no less than 45.0kg, Body Mass Index of 19.0 to 26.0kg\u002Fm2.\n2. Medically healthy, physical examination, vital signs examination, laboratory examination, electrocardiogram examination results were normal or abnormal without clinical significance.\n3. Males' subjects who are willing to take effective contraceptive during the study and within 6 months after the study completed; females of non-child-bearing potential.\n4. Subjects who are able to understand and follow study plans and instructions; Subjects who have voluntarily decided to participate in this study and signed the informed consent form.\n\nAdult patients with schizophrenia:\n\n1. Aged 18 to 65 years old, Body Mass Index of 18.5 to 30kg\u002Fm2, males, Body weight no less than 50.0kg; females: Body weight no less than 45.0kg.\n2. Males' subjects who are willing to take effective contraceptive during the study and within 6 months after the study completed; females of non-child-bearing potential.\n3. Subject has a primary diagnosis of schizophrenia established by a comprehensive psychiatric evaluation based on the DSM-5 and MINI at least 1 year.\n4. Subject is experiencing an acute exacerbation or relapse of psychotic symptoms.\n5. PANSS total score at least 70 and CGI-S score of ≥4 at screening.\n6. Subjects who have a history of antipsychotics.\n7. The subjects and their guardians fully understand the purpose and requirements of the trial, voluntarily participate in the clinical trial and sign the written informed consent form and are willing to complete the whole trial process according to the trial requirements.\n\nExclusion Criteria:\n\nHealthy adult subjects：\n\n1. With current or past medical history diseases or dysfunction that affect the clinical trial, evaluated by the investigator, including but not limited to central nervous system, cardiovascular system, respiratory system, digestive system, urinary system, endocrine system, blood system, ophthalmology and other diseases, history of malignant tumor or other diseases that are not suitable for participating in the clinical trial.\n2. With current or previous mental disorders and brain dysfunction, or suicide risk according to the clinical judgment of the investigator, or a history of self-mutilation.\n3. With any surgical condition or condition that may significantly affect the absorption, distribution, metabolism and excretion of the drug, or may pose a hazard to the subjects participating in the trial, such as history of gastrointestinal surgery (gastrectomy, gastrointestinal anastomosis, intestinal resection, etc.), urinary tract obstruction or dysuria, gastroenteritis, gastrointestinal ulcers, history of gastrointestinal bleeding, etc.\n4. With a known history of allergy to investigating drug ingredients or similar drugs, a history of allergic diseases or allergic constitution.\n5. Positive for hepatitis B virus surface antigen （HBsAg）, or syphilis antibody (Anti-TP), or hepatitis C antibody (anti-HCV), or human immunodeficiency virus antigen\u002Fantibody combined detection (HIV-Ag\u002FAb).\n6. With a history of surgery within 3 months before screening, or have not recovered from surgery, or have an expected surgical plan during the trial.\n7. With a blood donation or blood loss ≥ 400mL within 3 months before screening, or a blood donation or blood loss ≥ 200mL within 1 month, or a history of blood product use within 3 months before screening.\n8. Taking any prescription drugs, over-the-counter drugs, and any functional vitamins or herbal products within 2 weeks before screening.\n9. Using any drugs that inhibit or induce hepatic drug metabolizing enzymes CYP3A4, CYP3A5, CYP2D6 (such as inducers - phenobarbital, rifampicin, carbamazepine, phenytoin sodium, glucocorticoids, etc.; inhibitors - ketoconazole, itraconazole, cimetidine, clarithromycin, verapamil, erythromycin, etc.) within 4 weeks (or 5 half-lives, whichever is longer) before screening.\n10. Participating in any clinical trial and taking clinical trial drugs within 3 months before screening, or being participating in other clinical trials.\n11. Smoke test positive or smoking more than 5 cigarettes per day or average intake of coffee or tea more than 5 cups per day (200 mL\u002Fcup) within 3 months before screening, or unable to stop users during the study.\n12. With alcohol abuse within 1 year before screening, average weekly alcohol intake more than 14 standard units \\[1 unit = 360 mL beer (alcohol content 5%) or 45 mL spirits (alcohol content 40%) or 150 mL wine (alcohol content 12%)\\] or positive for alcohol breath test.\n13. With a history of drug abuse within 1 year before screening, or positive for urine drug screening.\n14. With a family history of sudden cardiac death (sudden death age less than 40 years).\n15. With a resting pulse \\\u003C 50 beats\u002Fmin or ≥ 100 beats\u002Fmin; resting systolic blood pressure \\\u003C 85 mmHg or ≥ 140 mmHg; resting diastolic blood pressure \\\u003C 50 mmHg or ≥ 90 mmHg; systolic blood pressure decreased by ≥ 20 mmHg and\u002For diastolic blood pressure decreased by ≥ 10 mmHg and\u002For accompanied by clinical symptoms within 3 minutes of standing.\n16. Abnormal in 12-lead electrocardiogram (ECG), clinically significant judged by the investigator (e.g., QTcF\\> 450 ms in men and \\> 470 ms in women).\n17. With the aspartate aminotransferase (AST), alanine aminotransferase (ALT), creatinine (Cr), urea (Urea), serum prolactin levels beyond the upper limit of normal (ULN)，Neutrophil count below the lower limit of normal (LLN).\n18. Having special requirements for food, unable to observe a unified diet or having dysphagia.\n19. Rejecting abide by the following conditions during the trial: smoking, alcohol or caffeine-containing beverages are prohibited, and strenuous exercise is avoided.\n20. Directly related to this clinical trial.\n21. Other subjects that the investigator considers inappropriate for this trial.\n\nAdult patients with schizophrenia:\n\n1. Patients who meet the DSM-5 diagnostic criteria for other mental diseases.\n2. Patients with refractory schizophrenia to be defined as patients with treatment-resistant schizophrenia who have not achieved clinical improvement after a full course of treatment with at least 2 antipsychotics in the past 5 years.\n3. The answer to question 4 or 5 of the Columbia Suicide Scale (C-SSRS) suicide ideation in the screening period is \"yes\", or the person who has obvious suicide tendency at present or in the past 12 months, or the researcher believes that there is a risk of suicide and violence based on the clinical evaluation of the investigator.\n4. There are diseases or functional disorders that affect the clinical trial, including but not limited to neuropsychiatric, cardiovascular, urinary, digestive, respiratory, muscular, metabolic endocrine, hematology, immunology, skin and tumors, etc., clinically significant chronic diseases or poorly controlled diseases that have an impact on this trial as assessed by the investigator.\n5. With any surgical condition or condition that may significantly affect the absorption, distribution, metabolism and excretion of the drug, or may pose a hazard to the subjects participating in the trial, such as history of gastrointestinal surgery (gastrectomy, gastrointestinal anastomosis, intestinal resection, etc.), urinary tract obstruction or dysuria, gastroenteritis, gastrointestinal ulcers, history of gastrointestinal bleeding, etc.\n6. With a history of epilepsy (except for febrile convulsion).\n7. With a history of Malignant syndrome.\n8. With a history of severe allergies.\n9. Received electric shock treatment, and transcranial magnetic stimulation (rTMS) within 3 months before screening;\n10. Subjects are receiving or have recently received (within 5 half-lives, before baseline \\[Day -1\\]) oral antipsychotic medications, antidepressants or mood stabilizers.\n11. CYP3A4 or CYP2D6 potent inhibitors, moderate inhibitors, potent inducers and moderate inducers used within 5 half-lives before enrollment.\n12. Those who have physical examination abnormalities unrelated to schizophrenia at screening, which are judged by the investigator to have an impact on this trial.\n13. With a resting pulse \\\u003C 50 beats\u002Fmin or ≥ 100 beats\u002Fmin; resting systolic blood pressure \\\u003C 85 mmHg or ≥ 140 mmHg; resting diastolic blood pressure \\\u003C 50 mmHg or ≥ 90 mmHg; systolic blood pressure decreased by ≥ 20 mmHg and\u002For diastolic blood pressure decreased by ≥ 10 mmHg and\u002For accompanied by clinical symptoms within 3 minutes of standing.\n14. Abnormal in 12-lead electrocardiogram （ECG）, clinically significant judged by the investigator (e.g., QTcF\\> 450ms in men and \\> 470ms in women).\n15. The laboratory examination during the screening period was abnormal, and the researcher determined that it was of obvious clinical significance, such as: glutamate aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 1.5 times the upper limit of the normal value;creatinine (Cr)\\>upper limit of normal value;serum prolactin levels ≥ 5 times the upper limit of the normal value\n16. With a history of drug abuse within 1 year before screening, or positive for urine drug screening.\n17. With alcohol abuse within 1 year before screening, average weekly alcohol intake more than 14 standard units \\[1 unit = 360mL beer (alcohol content 5%) or 45mL spirits （alcohol content 40%） or 150mL wine （alcohol content 12%）\\] or positive for alcohol breath test.\n18. Rejecting abides by the following conditions during the trial: smoking, alcohol or caffeine-containing beverages are prohibited, and strenuous exercise is avoided.\n19. Positive for hepatitis B virus surface antigen （HBsAg）, or syphilis antibody (Anti-TP), or hepatitis C antibody (anti-HCV), or human immunodeficiency virus antigen\u002Fantibody combined detection (HIV-Ag\u002FAb).\n20. With a blood donation or blood loss ≥ 400mL within 3 months before screening, or a blood donation or blood loss ≥ 200mL within 1 month.\n21. Participation in another clinical study within 3 months before screening in which the subject received an experimental or investigational drug agent,or are participating in clinical trials.\n22. Other subjects that the investigator considers inappropriate for this trial.",true,{"count":354,"type":23},40,[89],"This study will consist of 2 parts: Part Ⅰ-in healthy adult subjects, Part Ⅱ-in adult patients with schizophrenia",[29],{"date":243,"type":34},{"date":360,"type":34},"2024-07-16",{"date":271,"type":23},{"name":363,"class":41},"Vigonvita Life Sciences",4,{"id":366,"slug":367,"hasResults":12,"nctId":368,"briefTitle":369,"officialTitle":370,"acronym":4,"eligibilityCriteria":371,"healthyVolunteers":12,"sex":18,"minAge":372,"maxAge":310,"enrollmentInfo":373,"targetDuration":4,"studyType":24,"phases":375,"briefSummary":376,"conditions":377,"keywords":379,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":216,"lastUpdatePostDateStruct":384,"startDateStruct":385,"completionDateStruct":387,"leadSponsor":389,"locationsCount":391},"100462546","phase-3-study-to-evaluate-weight-gain-as-assessed-by-change-in-bmi-z-score-in-pediatric-subjects-with-schizophrenia-or-bipolar-i-disorder-100462546","NCT05303064","Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder","A Phase 3, Randomized, Double-Blind, 52-Week Study of OLZ\u002FSAM vs Olanzapine to Evaluate Weight Gain as Assessed by Change in BMI Z-Score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder (ENLIGHTEN-Youth)","Inclusion Criteria:\n\n* Subjects aged 13 to 17 years with schizophrenia or aged 10 to 17 years with bipolar I disorder, diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria\n* Subject is an outpatient or will be able to be treated on an outpatient basis (per Investigator judgement) by study Week 2\n* Subject has reliable family\u002Flegal guardian support available for outpatient management\n* Subject is either currently treated with olanzapine, or if treated with another antipsychotic, the subject has had an inadequate response (eg, unsatisfactory clinical response, AEs, or nonadherence to current medication) based on Investigator judgment\n* Subject must not be a danger to self or others (per Investigator judgement)\n\nExclusion Criteria:\n\n* Subject presents with a major depressive episode(bipolar I disorder) or other neuropsychiatric diagnosis (according to DSM-5 criteria) including schizoaffective disorder, current major depressive disorder that is untreated and\u002For unstable, or any other psychiatric condition that could interfere with participation in the study\n* Subject has a history of seizure disorder (exception: history of febrile seizures), severe head trauma with loss of consciousness within the 12 months prior to Screening, or other clinically significant neurological condition within the 12 months prior to Screening\n* Subject poses a current suicide risk as assessed by the Investigator or as confirmed by the baseline Columbia-Suicide Severity Rating Scale (C-SSRS)\n* Subject has received olanzapine for \\>= 14 days during the month prior to screening, or has a history of poor or inadequate response to treatment with olanzapine\n* Subject has taken opioid agonists within 14 days prior to Screening, or within 30 days prior to Screening (for long-acting opioid agonists)\n* Subject anticipates needing to take opioid medication during the study period (eg, planned surgery, including oral surgery)\n* Subject has taken opioid antagonists including naltrexone (any formulation) or naloxone within 60 days prior to Screening\n* Subject has used a long-acting injectable antipsychotic medication within 3 injection cycles prior to Screening\n* Subject has a BMI percentile \\>98th or \\\u003C5th\n* Subject has a diagnosis of diabetes mellitus or presents with prediabetes lab results at Screening (hemoglobin A1c \\[HbA1c\\] \\>= 6%)\n* Subject has started a smoking cessation program within the 6 months prior to Screening or has joined a weight management program or has had significant changes in diet or exercise regimen within 6 weeks prior to Screening\n* Subject has participated in a clinical study of an investigational product within the last 30 days prior to Screening","10 Years",{"count":374,"type":23},220,[314],"To compare changes in body mass index (BMI) Z-score following treatment with OLZ\u002FSAM vs olanzapine",[29,378],"Bipolar I Disorder",[380,29,378,381,382,383],"LYBALVI","Pediatric","Olanzapine","Samidorphan",{"date":243,"type":34},{"date":386,"type":34},"2022-06-30",{"date":388,"type":23},"2026-09",{"name":390,"class":41},"Alkermes, Inc.",47,{"id":393,"slug":394,"hasResults":12,"nctId":395,"briefTitle":396,"officialTitle":397,"acronym":4,"eligibilityCriteria":398,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":284,"enrollmentInfo":399,"targetDuration":4,"studyType":24,"phases":401,"briefSummary":402,"conditions":403,"keywords":404,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":414,"lastUpdatePostDateStruct":415,"startDateStruct":416,"completionDateStruct":418,"leadSponsor":420,"locationsCount":422},"100628285","phase-2-a-long-term-open-label-study-of-ml-007c-ma-in-adults-with-schizophrenia-100628285","NCT07459647","A Long-Term Open-Label Study of ML-007C-MA in Adults With Schizophrenia","An Open-Label Study to Assess the Long-Term Safety, Tolerability, and Effectiveness of ML-007C-MA in Adult Participants With Schizophrenia","Key Inclusion Criteria:\n\n1. Must be able and willing to provide informed consent for all required study procedures.\n2. Has a primary diagnosis of schizophrenia based on the DSM-5 criteria that is confirmed by semi-structured clinical interview (Mini International Neuropsychiatric Interview for DSM-5).\n3. May benefit from long-term pharmacotherapy for schizophrenia, based on assessment of the investigator.\n4. Is appropriate for an outpatient level of care and resides in a stable living situation, based on assessment of the investigator.\n5. Has an identified reliable informant(s) available to participate in relevant assessments. Site staff may serve as the informant if the site has had regular contact with the participant for \\>1 year.\n\nKey Exclusion Criteria:\n\n1. Has any DSM-5 disorder, other than schizophrenia, within the 12 months before Screening that is primarily responsible for the current symptoms or functional impairment.\n2. Is discontinuing effective and well-tolerated antipsychotic therapy for the purpose of enrolling in this study.\n3. Has received any prohibited therapy within the Screening Period unless discontinued before Baseline.\n4. Has current evidence of a clinically significant and\u002For unstable medical comorbidity at Screening or Baseline.\n5. Has clinically significant abnormal physical examination, ECG, or clinical safety laboratory result at Screening or Baseline.\n6. Has an elevated risk of suicidal behavior.\n7. Has a known allergy to ML-007C-MA, its active ingredients or their excipients.\n8. Has a DSM-5 diagnosis of moderate to severe substance use disorder (except tobacco or caffeine use disorder) within the 12 months before Screening (confirmed using MINI version 7.0.2 at Screening).\n9. Has an elevated risk of violent or destructive behavior, based on participant history and investigator judgment.",{"count":400,"type":23},500,[26],"ML-007C-MA-212 is a 52-week open-label study designed to evaluate the long-term safety, tolerability, and effectiveness of ML-007C-MA in participants with schizophrenia who have recently completed an antecedent study (ML-007C-MA-211) or enroll directly (De Novo Cohort).",[29],[405,406,407,29,408,409,410,411,412,413],"Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders","Mental Disorders","Psychotic Disorders","Muscarinic Antagonists","Muscarinic Agonists","Cholinergic Agents","Nervous System Diseases","Central Nervous System Diseases","Brain Diseases","2026-08-11",{"date":268,"type":34},{"date":417,"type":34},"2026-03-31",{"date":419,"type":23},"2030-02",{"name":421,"class":41},"MapLight Therapeutics",41,{"id":424,"slug":425,"hasResults":12,"nctId":426,"briefTitle":427,"officialTitle":428,"acronym":4,"eligibilityCriteria":429,"healthyVolunteers":12,"sex":18,"minAge":309,"maxAge":310,"enrollmentInfo":430,"targetDuration":4,"studyType":24,"phases":431,"briefSummary":432,"conditions":433,"keywords":434,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":414,"lastUpdatePostDateStruct":435,"startDateStruct":436,"completionDateStruct":438,"leadSponsor":440,"locationsCount":442},"100533699","phase-3-safety-and-tolerability-trial-of-lumateperone-in-pediatric-patients-with-schizophrenia-bipolar-disorder-or-autism-spectrum-disorder-100533699","NCT06229210","Safety and Tolerability Trial of Lumateperone in Pediatric Patients With Schizophrenia, Bipolar Disorder or Autism Spectrum Disorder","An Open-label, Multicenter Trial to Assess the Safety and Tolerability of Lumateperone in the Treatment of Pediatric Patients With Schizophrenia, Bipolar Disorder, or Autism Spectrum Disorder","Inclusion Criteria:\n\n* Able to provide consent as follows:\n\n  * The patient's legally authorized representative (LAR) (eg, parent or guardian) must provide written, informed consent;\n  * The patient must provide written assent to study enrollment;\n* Male or female patients aged 13 to 17 years (inclusive) with schizophrenia; male or female patients aged 10 to 17 years (inclusive) with bipolar I or II disorder; or male or female patients aged 5 to 17 years (inclusive) with autism spectrum disorder;\n* Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM-5-TR) primary diagnosis of schizophrenia, bipolar I or II disorder, or autism spectrum disorder as confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL).\n* Is currently an outpatient and is anticipated to maintain outpatient status for the duration of the study.\n\nRollover Patients entering from the lead-in study must have safely completed the lead-in study, in the opinion of the Investigator.\n\nExclusion Criteria:\n\n* Has a primary psychiatric diagnosis other than schizophrenia, bipolar I or bipolar II disorder or autism spectrum disorder. Schizophrenia with catatonia, or bipolar disorder with psychotic features are not allowed. Exceptions include:\n\n  * ADHD: If a subject is taking psychostimulant(s) for ADHD, they must have been on a stable treatment regimen of these medication(s) for 30 days prior to Screening. The treatment regimen should remain stable throughout the study. This must be confirmed by the Investigator and noted in the source records.\n  * For ASD patients only, based on Investigator opinion and DSM-5 criteria, mild or moderate intellectual disability is allowed. Severe or profound intellectual disability is exclusionary.\n* In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during their participation in the study or\n\n  * At Screening, the patient scores \"yes\" on Suicidal Ideation Items 3, 4, or 5 of the Columbia-Suicide Severity Rating Scale (C SSRS) within 6 months prior to Screening or, at Baseline, the patient scores \"yes\" on Suicidal Ideation Items 3, 4, or 5 since the Screening Visit;\n  * At Screening, the patient has had 1 or more suicidal attempts within the 2 years prior to Screening; or\n  * At Screening or Baseline, scores \\> 3 on Item 13 (suicidal ideation) of the CDRS-R (for bipolar disorder patients only); or\n  * The patient is considered to be an imminent danger to him\u002Fherself or others.",{"count":131,"type":23},[314],"This is a multicenter, global, 26-week, open-label study to assess the safety and tolerability of lumateperone in pediatric patients with schizophrenia, bipolar disorder or autism spectrum disorder.",[29,177,180],[381],{"date":268,"type":34},{"date":437,"type":34},"2024-01-25",{"date":439,"type":23},"2032-04-28",{"name":441,"class":41},"Intra-Cellular Therapies, Inc.",61,{"id":444,"slug":445,"hasResults":12,"nctId":446,"briefTitle":447,"officialTitle":448,"acronym":449,"eligibilityCriteria":450,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":451,"enrollmentInfo":452,"targetDuration":4,"studyType":24,"phases":454,"briefSummary":455,"conditions":456,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":457,"lastUpdatePostDateStruct":458,"startDateStruct":459,"completionDateStruct":461,"leadSponsor":463,"locationsCount":78},"100447168","enhancing-prefrontal-oscillations-and-working-memory-in-early-course-schizophrenia-100447168","NCT05102929","Enhancing Prefrontal Oscillations and Working Memory in Early-course Schizophrenia","Enhancing Prefrontal Oscillatory Activity and Working Memory Performance With Noninvasive Brain Stimulation in Early-course Schizophrenia","REDOCS","Inclusion Criteria:\n\n1. ages 18-40 years\n2. DSM diagnoses of Schizophrenia Spectrum Axis I disorders\n3. a duration of less than three years from beginning of psychosis, defined by report of symptoms and\u002For history of treatment, based on clinical guidelines employed in our UPMC psychoses clinics in Pittsburgh.\n\nExclusion Criteria:\n\n1. DSM intellectual developmental disorder\n2. significant head injury\n3. medical illness affecting brain structure or function\n4. significant neurologic disorder (e.g. seizure disorder)\n5. personal history or family history of epilepsy\n6. inability to provide informed consent\n7. concussion with loss of consciousness (LOC) greater than 10 minutes\n8. history of electroconvulsive therapy\n9. diabetes with associated seizures, loss of sensation\u002Fweakness in arms or legs, or momentary LOC\n10. pregnancy or postpartum (\\\u003C6 weeks after delivery or miscarriage), as determined by self-report\n11. a psychotic illness with a temporal relation to substance use or head injury.\n12. current or past co-morbidity for alcohol or psychoactive substance dependence\n13. substance abuse, other than cannabis and\u002For alcohol, within the past one year","40 Years",{"count":453,"type":23},75,[55],"This study will investigate the effects of intermittent Theta Burst Stimulation (iTBS) on natural oscillatory frequency of the dorsolateral prefrontal cortex (DLPFC) and working memory in early-course schizophrenia (EC-SCZ). Transcranial magnetic stimulation (TMS) will be used to evoke oscillatory activity, and EEG will record the responses of EC-SCZ participants. A working memory task will also be incorporated in order to determine how DLPFC natural frequency (NF) is related to working memory performance. iTBS (active or sham) will be administered, then the oscillatory activity of DLPFC and working memory performance will be reassessed. The overarching goal is to determine whether iTBS can acutely enhance the oscillatory activity of the DLPFC and to evaluate the relationship between changes in the DLPFC and working memory performance.",[29],"2026-08-07",{"date":414,"type":34},{"date":460,"type":34},"2021-11-05",{"date":462,"type":23},"2026-10",{"name":464,"class":77},"Fabio Ferrarelli",{"id":466,"slug":467,"hasResults":12,"nctId":468,"briefTitle":469,"officialTitle":470,"acronym":4,"eligibilityCriteria":471,"healthyVolunteers":12,"sex":18,"minAge":372,"maxAge":310,"enrollmentInfo":472,"targetDuration":4,"studyType":24,"phases":474,"briefSummary":475,"conditions":476,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":457,"lastUpdatePostDateStruct":480,"startDateStruct":481,"completionDateStruct":483,"leadSponsor":485,"locationsCount":487},"100441227","phase-1-determining-efficacy-and-safety-of-bxcl501-in-agitation-associated-with-pediatric-schizophrenia-and-bipolar-disorder-100441227","NCT05025605","Determining Efficacy and Safety of BXCL501 in Agitation Associated With Pediatric Schizophrenia and Bipolar Disorder","A Randomized, Double-blind, Placebo-controlled Study to Determine Efficacy and Safety of BXCL501 in Agitation Associated With Pediatric Schizophrenia and Bipolar Disorder","Inclusion Criteria:\n\n1. Male and female subjects between the ages of 10-17 years, inclusive, with bipolar disorder (DSM-5 criteria) and 13-17 years, inclusive, in subjects with schizophrenia (DSM-5 criteria).\n2. Patients who are judged to be clinically agitated at Screening and Baseline with a total score of ≥14 on the 5 items comprising the PANSS Excited Component (PEC).\n3. Patients who have a score of ≥ 4 on at least 1 of the 5 items on the PEC at Baseline.\n4. Participants who agree to use a medically acceptable and effective birth control method\n\nExclusion Criteria:\n\n1. Patients with agitation caused by acute intoxication, including alcohol or drugs of abuse (with the exception of THC) during urine screening.\n2. Use of benzodiazepines or other hypnotics or oral or short-acting intramuscular antipsychotic drugs in the 4 hours before study treatment.\n3. Patients who are judged to be at significant risk of suicide.\n4. Patients with serious or unstable medical illnesses.\n5. Patients who have received an investigational drug within 30 days prior to the current agitation episode.\n6. Patients who are considered by the investigator, for any reason, to be an unsuitable candidate for receiving the study drug.",{"count":473,"type":23},140,[89],"This is a study of the efficacy and safety of BXCL501 in children and adolescents with acute agitation and either bipolar disorder or schizophrenia.",[29,477,478,154,479],"Schizo-Affective Disorder","Schizophreniform; Schizophrenic","Bipolar Disorder II",{"date":414,"type":34},{"date":482,"type":34},"2021-08-27",{"date":484,"type":23},"2027-12-31",{"name":486,"class":41},"BioXcel Therapeutics Inc",5,{"id":489,"slug":490,"hasResults":12,"nctId":491,"briefTitle":492,"officialTitle":493,"acronym":494,"eligibilityCriteria":495,"healthyVolunteers":352,"sex":18,"minAge":19,"maxAge":230,"enrollmentInfo":496,"targetDuration":4,"studyType":24,"phases":497,"briefSummary":498,"conditions":499,"keywords":500,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":504,"lastUpdatePostDateStruct":505,"startDateStruct":507,"completionDateStruct":508,"leadSponsor":510,"locationsCount":78},"100645252","overnight-thalamic-tes-ti-to-modulate-sleep-spindles-in-individuals-with-schizophrenia-spectrum-disorders-and-matched-healthy-controls-100645252","NCT07680114","Overnight Thalamic TES-TI to Modulate Sleep Spindles in Individuals With Schizophrenia Spectrum Disorders and Matched Healthy Controls","A Pilot Feasibility Study of Overnight Thalamic TES-TI to Modulate Sleep Spindles in Individuals With Schizophrenia Spectrum Disorders and Matched Healthy Controls","ONSETS","Inclusion Criteria (all participants):\n\n* U.S. citizen or holding permanent resident status\n* English-speaking\n\nInclusion Criteria (Participants with SSD):\n\n* DSM-5 schizophrenia spectrum disorder (SSD) diagnosis, defined as schizophrenia, schizoaffective disorder, or schizophreniform disorder (confirmed by clinical interview and\u002For chart review)\n* Chronic illness, defined as diagnosis of SSD for at least 1 year\n* Clinically stable outpatient (no psychiatric hospitalization in past 6 months; no change in antipsychotic medication in the past 6 weeks)\n\nInclusion Criteria (Healthy Controls):\n\n* Medically healthy (based on self-report and study team review)\n* Matched to SSD participants on age (±5 years) and sex\n\nExclusion Criteria (all participants):\n\n* Current or past history of clinically significant neurological disorder or acquired neurological disease (e.g., stroke, traumatic brain injury), including intracranial lesions (including clinically significant findings identified on the structural MRI)\n* Active suicidal ideation, plan, or intent (assessed via PHQ-9 item 9 and follow-up Columbia-Suicide Severity Rating Scale (C-SSRS) Screener; see Safety Response Procedure)\n* Inability to provide informed consent, including inadequate decisional capacity in the judgment of the study team and\u002For study psychiatrist\n* History of head trauma resulting in prolonged loss of consciousness; or a history of \\>3 grade I concussions\n* Current poorly controlled headaches, including intractable or frequent migraines\n* Any systemic illness or unstable medical condition that may cause a medical emergency in case of a provoked seizure (cardiac malformation, cardiac dysrhythmia, asthma, etc.)\n* History of seizures, diagnosis of epilepsy, history of abnormal (epileptiform) EEG, or family history of treatment resistant epilepsy except for a single seizure of benign etiology (e.g. febrile seizures) in the judgment of a board-certified neurologist\n* Possible pregnancy or plan to become pregnant in the next 6 months (self reported)\n* Any metal in the head\n* Any medical devices or implants (i.e. cardiac pacemaker, medication infusion pump, cochlear implant, vagal nerve stimulator)\n* Dental implants\n* Permanent retainers\n* Any hair braid, dreadlocks, hair pieces, or extensions which cannot be taken out before the study sessions\n* Any head coverings or headdress that participant feels uncomfortable removing for the purposes of study sessions\n* Current use of medications known to substantially lower seizure threshold, specifically chlorpromazine, clozapine, bupropion, clomipramine, or maprotiline; or other medications at doses known to substantially lower seizure threshold in the judgment of the PI or Study Psychiatrist\n* Current use of medications known to directly and substantially enhance sleep spindle activity, including benzodiazepines; non-benzodiazepine \"Z-drug\" hypnotics (zolpidem, eszopiclone, zaleplon); barbiturates; and gabapentin or pregabalin, within 2 weeks of the overnight study visits. Other sedating medications used as sleep aids (e.g., trazodone, hydroxyzine, mirtazapine) are permitted provided the regimen is stable across the two overnight visits; dose and timing will be recorded as covariates\n* Current moderate-to-severe alcohol or other substance use disorder (DSM-5) other than nicotine or caffeine\n* Active scalp lesions, broken skin, or skin conditions at planned electrode sites that would preclude safe electrode application\n* Claustrophobia (a fear of small or closed places)\n* Back problems that would prevent lying flat for up to two hours\n* Regular night-shift work (second or third shift)\n* Sleep apnea or other sleep disorder (self-reported)\n\nExclusion Criteria (Healthy Controls):\n\n* Self-reported history of inpatient psychiatric hospitalization\n* Self-reported current or past diagnosis of schizophrenia or any other psychotic disorder\n* Self-reported first-degree relative with schizophrenia or any other psychotic disorder\n* Self-reported current or past diagnosis of bipolar disorder or major depressive disorder with psychotic features, or current treatment for any psychiatric disorder other than depression or anxiety (handled via the medication rule below)\n* Current use of any psychotropic medication, with the exception of a single SSRI or SNRI taken at a stable dose for at least 6 weeks for depression or anxiety. Current use of antipsychotics, tricyclic antidepressants, mirtazapine, trazodone, lithium or other mood stabilizers, benzodiazepines, non-benzodiazepine hypnotics, other anxiolytics, or stimulants will result in exclusion.",{"count":141,"type":23},[55],"This study to find out whether a type of non-invasive electrical brain stimulation called transcranial electrical stimulation with temporal interference (TES-TI) can temporarily change brain activity during sleep-especially sleep spindles (brain rhythms in the \\~8-16 Hz range). The investigators are focusing on the thalamus, a deep brain region that helps coordinate brain activity during non-REM sleep. Sleep spindles are often reduced in schizophrenia, so this study is to see whether TES-TI can change spindle activity in individuals with schizophrenia spectrum disorders (SSD) and in healthy adults. To study this, a structural MRI scan will be used to customize where the stimulation electrodes are placed, and then TES-TI will be applied during one of two overnight sleep lab visits while brain activity is recorded with high-density EEG and standard sleep sensors. The other overnight is a baseline\u002Fcontrol night during which only sham stimulation is delivered. The goal is to determine whether TES-TI during sleep can increase spindle-frequency activity in this population.",[29],[501,502,503],"schizophrenia spectrum disorders","sleep spindles","transcranial electrical stimulation with temporal interference","2026-08-06",{"date":506,"type":34},"2026-08-10",{"date":96,"type":23},{"date":509,"type":23},"2027-12",{"name":511,"class":77},"University of Wisconsin, Madison",{"id":513,"slug":514,"hasResults":12,"nctId":515,"briefTitle":516,"officialTitle":517,"acronym":518,"eligibilityCriteria":519,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":520,"enrollmentInfo":521,"targetDuration":4,"studyType":24,"phases":523,"briefSummary":524,"conditions":525,"keywords":527,"overallStatus":267,"whyStopped":4,"lastUpdateSubmitDate":532,"lastUpdatePostDateStruct":533,"startDateStruct":535,"completionDateStruct":537,"leadSponsor":539,"locationsCount":78},"100647671","lifu-effects--outcomes-mechanisms-evaluating-striatal-systems-imaging-leo-messi-100647671","NCT07710989","LIFU Effects & Outcomes: Mechanisms Evaluating Striatal Systems Imaging (LEO MESSI)","Mechanisms of Low-intensity Focused Ultrasound Targeting Striatal Circuits Underlying Auditory Hallucinations in Schizophrenia","MESSI-LEO","Inclusion Criteria:\n\n1. 18-64 years of age, inclusive of all gender identities\n2. Current DSM-5 diagnosis of schizophrenia\n3. Persistent clinically-significant auditory hallucinations\n4. No contraindications for MRI, confirmed via standard safety screening procedures\n5. No neurological disorder\n6. Clinically stable (outpatient past 12 weeks; same dose medications in 4 weeks)\n7. Females will be tested for pregnancy and pregnant women will be excluded.\n\nExclusion Criteria:\n\nClinically significant neurological disorder or MRI incompatibility","64 Years",{"count":522,"type":23},12,[55],"Individuals with schizophrenia often experience persistent auditory hallucinations despite treatment with antipsychotic medications. Research suggests that abnormal communication between the striatum and the auditory cortex contributes to hallucinations. This first-in-human, proof-of-concept Phase 1 study will evaluate the safety, feasibility, and preliminary effects of repeated-session low-intensity focused ultrasound (LIFU), a non-invasive neuromodulation technique targeting the striatum. The study will examine whether LIFU can safely modulate brain circuits involved in hallucinations, reduce abnormal communication between the striatum and auditory cortex, and improve auditory hallucination symptoms.",[29,526],"Auditory Hallucinations",[528,93,529,530,531],"LIFU","auditory hallucinations","striatum","caudate","2026-08-03",{"date":534,"type":34},"2026-08-05",{"date":536,"type":23},"2027-02-01",{"date":538,"type":23},"2027-12-01",{"name":540,"class":77},"University of California, San Francisco",{"id":542,"slug":543,"hasResults":12,"nctId":544,"briefTitle":545,"officialTitle":545,"acronym":4,"eligibilityCriteria":546,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":547,"enrollmentInfo":548,"targetDuration":4,"studyType":24,"phases":550,"briefSummary":551,"conditions":552,"keywords":554,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":562,"lastUpdatePostDateStruct":563,"startDateStruct":565,"completionDateStruct":567,"leadSponsor":569,"locationsCount":78},"100507653","improving-cognition-through-telehealth-aerobic-exercise-and-cognitive-training-after-a-first-schizophrenia-episode-100507653","NCT05890183","Improving Cognition Through Telehealth Aerobic Exercise and Cognitive Training After a First Schizophrenia Episode","Inclusion Criteria:\n\n1. a first episode of a psychotic illness that began within the past three years;\n2. a diagnosis by DSM-5 of schizophrenia, schizoaffective disorder, or schizophreniform disorder;\n3. age 18 to 45 years of age;\n4. sufficient acculturation and fluency in the English language to avoid invalidating research measures; and\n5. residence likely to be within commuting distance of the UCLA Aftercare Research Program.\n\nExclusion Criteria:\n\n1. premorbid IQ less than 70;\n2. evidence of a known neurological disorder (e.g., epilepsy) or significant head injury;\n3. evidence of moderate or severe substance use disorder within the six months prior to the first episode or evidence of a substance-induced psychosis.","45 Years",{"count":549,"type":23},100,[55],"The participants in the study will receive psychiatric treatment at the UCLA Aftercare Research Program. All participants in this 12-month RCT will receive cognitive training. Half of the patients will also be randomly assigned to the aerobic exercise and strength training condition, and the other half will be randomly assigned to the Healthy Living Group condition. The primary outcome measures are improvement in cognition and level of engagement in the in-group and at-home exercise sessions. Increases in the level of the patient's serum brain-derived neurotropic factor (specifically Mature BDNF) which causes greater brain neuroplasticity and is indicator of engagement in aerobic exercise, will be measured early in the treatment phase in order to confirm engagement of this target. In order to demonstrate the feasibility and portability of this intervention outside of academic research programs, the interventions will be provided via videoconferencing. The proposed study will incorporate additional methods to maximize participation in the exercise condition, including the use of the Moderated Online Social Therapy (MOST) platform to enhance motivation for treatment based on Self-Determination Theory principles, and a \"bridging\" group to help the participants generalize gains to everyday functioning. In addition, the exercise group participants will receive personally tailored text reminders to exercise.",[29,553,153],"Schizophreniform Disorder",[555,556,557,558,559,560,561],"First-Episode Schizophrenia","Cognitive Remediation","Physical Exercise","Brain Derived Neurotrophic Factor","Telehealth Intervention","Moderated Online Social Therapy (MOST)","Motivational Text Messaging Program (Chorus)","2026-08-01",{"date":564,"type":34},"2026-08-04",{"date":566,"type":34},"2023-05-23",{"date":568,"type":23},"2028-05-31",{"name":570,"class":77},"University of California, Los Angeles",{"id":572,"slug":573,"hasResults":12,"nctId":574,"briefTitle":575,"officialTitle":576,"acronym":4,"eligibilityCriteria":577,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":284,"enrollmentInfo":578,"targetDuration":4,"studyType":24,"phases":580,"briefSummary":581,"conditions":582,"keywords":4,"overallStatus":267,"whyStopped":4,"lastUpdateSubmitDate":584,"lastUpdatePostDateStruct":585,"startDateStruct":586,"completionDateStruct":588,"leadSponsor":589,"locationsCount":78},"100650214","the-effect-of-combined-brain-stimulation-and-exercise-for-improving-cognitive-function-in-schizophrenia-100650214","NCT07745140","The Effect of Combined Brain Stimulation and Exercise for Improving Cognitive Function in Schizophrenia","Feasibility of an Integrative Treatment of Brain Stimulation and Exercise on Cognitive Function in Schizophrenia: A Pilot Randomized Controlled Trial","Inclusion Criteria:\n\n* Schizophrenia spectrum disorders;\n* Aged from 18 to 65.\n* Chinese-speaking (to enable cognitive testing).\n* Ability to understand the nature of the study and to give informed consent.\n* Fewer than 10 hours of physical exercise in the previous 3 months.\n\nExclusion Criteria:\n\n* Severe physical illness (Myocardial Infarction, Hypertension, Fracture, Spinal problems in which exercise with mild-to-moderate intensity may be contraindicated).\n* Comorbid diagnoses of organic brain syndrome, substance misuse, history of epilepsy or seizure, intellectual disability, significant head trauma, active suicidal ideation or self-harm behaviors.\n* Known pregnancy, or other contraindication to tDCS or MRI (e.g., have a cardiac\u002Fheart pacemaker, brain aneurysm clips, any implanted metallic or electrical device, or any internal metal foreign objects).",{"count":579,"type":23},66,[55],"The study will investigate the (1) additive and synergistic effects of tDCS and aerobic exercise on cognitive function and clinical symptoms in schizophrenia, and (2) neurophysiological mechanisms (mediators) underlying these effects.",[29,583],"Cognitive Functions","2026-07-30",{"date":564,"type":34},{"date":587,"type":23},"2026-09-01",{"date":299,"type":23},{"name":590,"class":77},"The Hong Kong Polytechnic University",{"id":592,"slug":593,"hasResults":12,"nctId":594,"briefTitle":595,"officialTitle":596,"acronym":4,"eligibilityCriteria":597,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":284,"enrollmentInfo":598,"targetDuration":4,"studyType":24,"phases":599,"briefSummary":600,"conditions":601,"keywords":602,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":584,"lastUpdatePostDateStruct":606,"startDateStruct":607,"completionDateStruct":609,"leadSponsor":611,"locationsCount":613},"100596414","phase-3-metformin-alleviates-abnormal-glucose-metabolism-induced-by-statins-in-schizophrenia-patients-100596414","NCT07045142","Metformin Alleviates Abnormal Glucose Metabolism Induced by Statins in Schizophrenia Patients","Metformin Alleviates Abnormal Glucose Metabolism Induced by Statins in Schizophrenia Patients: A Randomized, Double-Blind, Placebo-Controlled Multicenter Clinical Study","Inclusion criteria:\n\n1. Aged between 18 and 65 years, regardless of gender, and meets the diagnostic criteria for schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5);\n2. Symptoms and medication regimen stable for more than 3 months, with the allowance of up to two antipsychotic medications in combination (concurrent use of antidepressants, anxiolytics, and mood stabilizers is permitted);\n3. Temporary use of benzodiazepines is allowed;\n4. Meets at least one of the following conditions: fasting total cholesterol (TC) ≥ 5.2 mmol\u002FL; fasting triglycerides (TG) ≥ 1.7 mmol\u002FL; fasting low-density lipoprotein cholesterol (LDL-C) ≥ 3.4 mmol\u002FL;\n5. Two fasting blood glucose (FPG) tests must be \\\u003C 6.1 mmol\u002FL (with an interval of 1-4 weeks);\n6. It is anticipated that there will be no issues related to relocation, transportation difficulties, or access to medical care throughout the study;\n7. Informed consent must be obtained from the patient and their guardian, and a consent form must be signed.\n\nExclusion criteria:\n\n1. Patients with a prior diagnosis of diabetes or complications such as diabetic ketoacidosis;\n2. Patients with liver or kidney dysfunction, indicated by aspartate aminotransferase (AST), alanine aminotransferase (ALT), or gamma-glutamyl transferase (GGT) levels exceeding twice the normal limits, and\u002For creatinine levels exceeding 1.2 times the upper limit of the reference range or greater than 2 mg\u002FdL, or deemed by the investigator to have liver and\u002For kidney impairment that warrants exclusion from the study;\n3. Patients with severe gastrointestinal, respiratory, endocrine, hematologic diseases, or metabolic absorption disorders: including but not limited to poorly controlled diabetes, severe acute systemic infections or immunological diseases, ischemic heart disease, cerebrovascular accidents within the past year, history of prolonged QT interval, active hepatitis B virus, chronic active hepatitis C, and malabsorption syndromes;\n4. Clinically significant abnormal ECG findings at screening that the investigator deems unsuitable for inclusion, such as male QTc interval \\> 470 ms, female QTc interval \\> 480 ms;\n5. Pregnant or nursing women.",{"count":312,"type":23},[314],"Schizophrenia is a severe mental illness associated with significant morbidity and disability. Patients often experience metabolic side effects from antipsychotic medications, including weight gain and dyslipidemia. Statins, commonly used to manage dyslipidemia, can lower cholesterol levels but may increase the risk of new-onset diabetes.\n\nThis study aims to investigate how atorvastatin affects glucose metabolism in schizophrenia patients and assess whether metformin can help improve these metabolic issues. The investigators will include 200 patients with dyslipidemia from the Second Xiangya Hospital and other sites, randomly assigning them to receive either atorvastatin with metformin or atorvastatin with placebo over six months.\n\nKey goals include evaluating the impact of atorvastatin on insulin resistance and blood glucose levels and determining the effectiveness of metformin in mitigating glucose metabolism abnormalities while managing lipid levels.\n\nUnderstanding these interactions will help improve treatment strategies for schizophrenia patients, potentially lowering their risk of cardiovascular diseases and diabetes and enhancing overall health outcomes.",[29],[29,603,604,605],"Dyslipidemia","Metformin","Statin",{"date":532,"type":34},{"date":608,"type":34},"2025-07-01",{"date":610,"type":23},"2028-06-01",{"name":612,"class":77},"Central South University",8,{"id":615,"slug":616,"hasResults":12,"nctId":617,"briefTitle":618,"officialTitle":619,"acronym":4,"eligibilityCriteria":620,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":284,"enrollmentInfo":621,"targetDuration":4,"studyType":24,"phases":623,"briefSummary":624,"conditions":625,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":626,"lastUpdatePostDateStruct":627,"startDateStruct":629,"completionDateStruct":631,"leadSponsor":633,"locationsCount":635},"100584811","phase-3-a-trial-of-the-efficacy-and-safety-of-sep-363856-in-acutely-psychotic-participants-with-schizophrenia-100584811","NCT06894212","A Trial of the Efficacy and Safety of SEP-363856 in Acutely Psychotic Participants With Schizophrenia","A Phase 3, Randomized, Double-blind, Parallel-group, Placebo-controlled, Multicenter Trial to Evaluate the Efficacy and Safety of SEP-363856 in Acutely Psychotic Participants With Schizophrenia","Key Inclusion Criteria:\n\n* Male or female participants between 18 to 65 years of age (inclusive) at the time of consent.\n* Participant has an identified reliable informant (eg, caregiver, relative, friend, case worker, residential treatment staff).\n* Participant is experiencing an acute exacerbation or relapse of symptoms, with onset ≤ 2 months prior to screening\n\n  1. The participant requires hospitalization for this acute exacerbation or relapse of symptoms.\n  2. If already an inpatient at screening, has been hospitalized for less than 2 weeks for the current exacerbation at the time of screening.\n* Participants who are experiencing an acute exacerbation of psychotic symptoms and marked deterioration of usual function as demonstrated by meeting ALL of the following criteria at the screening and baseline visits:\n\n  1. Participant must have a PANSS total score ≥ 80\n\n     AND\n  2. Participant must have a CGI-S score ≥ 4.\n* Participants who have received previous outpatient antipsychotic treatment at an adequate dose (minimal recommended dose for the treatment of schizophrenia according to the manufacturer labeling) for an adequate duration (at least 6 weeks) and who showed a previous good response.\n\nKey Exclusion Criteria:\n\n* Sexually active participants or persons of childbearing potential who do not agree to practice 2 different clinical trial sponsor approved methods of birth control or remain abstinent during the course of the trial and for 30 days after the last dose of study drug.\n* Participant has a current DSM-5 diagnosis or presence of symptoms consistent with a DSM-5 diagnosis other than schizophrenia.\n* Participant has had psychiatric hospitalization(s) for more than 30 days (cumulative) during the 90 days prior to screening.\n* Participant has previously received SEP-363856 or was previously enrolled in a SEP-363856 clinical study",{"count":622,"type":23},522,[314],"Evaluate the efficacy and safety of Ulotaront (SEP-363856) in acutely psychotic subjects with schizophrenia",[29],"2026-07-29",{"date":628,"type":34},"2026-07-31",{"date":630,"type":34},"2025-02-28",{"date":632,"type":23},"2026-10-29",{"name":634,"class":41},"Otsuka Pharmaceutical Development & Commercialization, Inc.",73]