[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ptsd\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ptsd":30},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,128,0,25,[9,50,74,104,133,160,187,214,243,268,291,321,343,378,401,435,460,482,508,530,554,579,602,621,644],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":33,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100647938","empowerment-self-defense-program-for-adult-native-women-survivors-of-sexual-violence-100647938",false,"NCT07712796","Empowerment Self Defense Program for Adult Native Women Survivors of Sexual Violence","Development and Evaluation of a Culturally Grounded Empowerment Self Defense Program for Adult Native Women Survivors of Sexual Violence: Open Pilot Trial","ESD","Inclusion Criteria:\n\n* Identify as Indigenous (including American Indian or Alaska Native), including individuals who identify as multiracial and Indigenous.\n* Identify as a woman, trans woman, and\u002For Two Spirit..\n* Be 18 years of age or older.\n* Have experienced sexual violence or unwanted sexual experiences.\n* Report moderate to high levels of Meet criteria for depression and\u002For PTSD.\n* NOT report high risk for suicidality\n* NOT report active psychosis\n* Live on or near the Pine Ridge Indian Reservation.\n* Be able to read and speak English.\n* Report an ability and willingness to participate in the program sessions and related research activities, including surveys and potential exit interviews.","FEMALE","18 Years",{"count":21,"type":22},14,"ESTIMATED","INTERVENTIONAL",[25],"NA","The purpose of this study is to culturally adapt and evaluate an empowerment self-defense (ESD) program (i.e., IMpower) for AI\u002FAN women who have experienced SV in their lifetime and currently experiencing moderate to severe levels of depression and\u002For PTSD symptoms (primary outcomes). Previous research with non-AI\u002FAN women finds that ESD reduces depression and PTSD symptoms, but no research has examined ESD among AI\u002FAN survivors despite calls from our tribal partners to implement ESD with AI\u002FAN adult women survivors. The investigators have assembled an interdisciplinary expert team and Elders\u002FTraditional Knowledge Keepers (TKKs) as well as Survivor Advisory Board (SAB) in the proposed work.",[28,29,30,31,32],"Depression and Quality of Life","Sexual Violence","PTSD","Suicidal Ideation","Problem Drinking",[34,35,36],"Native American","Sexual violence","Depression","NOT_YET_RECRUITING","2026-08-19",{"date":40,"type":41},"2026-08-21","ACTUAL",{"date":43,"type":22},"2026-09-30",{"date":45,"type":22},"2028-06-14",{"name":47,"class":48},"University of Michigan","OTHER",1,{"id":51,"slug":52,"hasResults":12,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":12,"sex":57,"minAge":19,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":23,"phases":60,"briefSummary":61,"conditions":62,"keywords":63,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":49},"100452010","facilitating-transition-to-recommended-ptsd-treatment-100452010","NCT05165940","Facilitating Transition to Recommended PTSD Treatment","Improving Care for Veterans by Understanding and Facilitating Transition to Recommended PTSD Treatment (CDA 21-194)","Inclusion Criteria:\n\n* Veteran\n* Diagnosed with PTSD as part of an intake assessment at the San Francisco Veterans Affairs Medical Center\n\nExclusion Criteria:\n\n* Inability to provide informed consent\n* Cognitive impairment that precludes comprehension of study materials\n* Active psychosis","ALL",{"count":59,"type":22},40,[25],"Cognitive processing therapy (CPT) and prolonged exposure therapy (PE) were widely disseminated as recommended posttraumatic stress disorder (PTSD) treatments. However, post-9\u002F11 Veterans with PTSD rarely initiate CPT or PE, especially as an initial treatment. Little research has explored the combinations and sequences of psychosocial and medication treatments that Veterans receive (\"treatment sequences\"). One common and understudied treatment sequence begins with stabilization treatment, which is designed to prepare Veterans for CPT or PE. There is a significant research gap in understanding how treatment sequence affects initiation of CPT or PE. The proposed research is an innovative, mixed-methods approach to assessing the impact of variability in treatment sequence, including stabilization treatment, on initiation of CPT or PE and applying this knowledge by developing a health services intervention that facilitates timely transition to CPT or PE. Research aims can improve PTSD treatment by increasing initiation of and reducing disparities in CPT\u002FPE.",[30],[30],"2026-08-17",{"date":66,"type":41},"2026-08-18",{"date":68,"type":22},"2026-12-01",{"date":70,"type":22},"2027-05-03",{"name":72,"class":73},"VA Office of Research and Development","FED",{"id":75,"slug":76,"hasResults":12,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":12,"sex":57,"minAge":19,"maxAge":81,"enrollmentInfo":82,"targetDuration":4,"studyType":23,"phases":84,"briefSummary":86,"conditions":87,"keywords":89,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":49},"100652167","phase-2-the-efficacy-of-a-pharmacological-treatment-reboxetine-plus-ritalin-versus-dog-assisted-therapy-in-ptsd-100652167","NCT07771530","The Efficacy of a Pharmacological Treatment (Reboxetine Plus Ritalin) Versus Dog-Assisted Therapy in PTSD","Evaluating the Efficacies of an Innovative Pharmacological Treatment (Reboxetine Plus Ritalin) Versus Dog-Assisted Therapy in PTSD: A Randomized Controlled Trial","Inclusion Criteria:\n\n* age between 18 and 70 years,\n* diagnosed with PTSD according to DSM-IV or DSM-5 criteria,\n* any psychotropic drug therapy that is being administered must be at a fixed dose for at least one month prior to the study initiation.\n\nExclusion Criteria:\n\n* any health condition for which the use of reboxetine or methylphenidate is contraindicated,\n* comorbidity with major psychiatric disorder,\n* significant\u002Factive cardiovascular disease,\n* previous or current severe traumatic brain injury,\n* active substance dependency,\n* participating in another treatment program for PTSD of any kind.","70 Years",{"count":83,"type":22},160,[85],"PHASE2","Posttraumatic stress disorder (PTSD) is a chronic and often treatment-resistant psychiatric condition that emerges following exposure to trauma and is characterized by intrusive thoughts, emotional dysregulation, and cognitive impairments. In Israel, the prevalence of PTSD has increased significantly in the aftermath of the October 7, 2023 terror attacks, emphasizing the urgent need for more effective, accessible, and personalized interventions.\n\nExisting treatments, such as trauma-focused CBT and SSRIs, remain only partially effective, with side effects that reduce adherence and limit long-term recovery. The proposed randomized controlled trial will assess and compare two promising treatment modalities: (i) a new pharmacological combination of reboxetine and methylphenidate, designed to enhance noradrenergic and dopaminergic pathways involved in attention and emotional regulation, and (ii) dog-assisted therapy (DAT), a non-pharmacological, group-based intervention shown to reduce PTSD symptoms and improve functioning. One hundred sixty adults with PTSD will be randomized into four groups: pharmacological treatment, placebo, DAT, or occupational therapy. The study will use validated clinical scales (CAPS-5, GAD-7, CAARS, DLQ, WHOQOLBREF) alongside neurophysiological tools (EEG, EDA, ASAT-based EMG). Data will feed into a machine-learning model to identify predictors of treatment response and support the development of personalized, neurobiologically informed approaches.",[30,88],"Posttraumatic Stress Disorder",[30,88,90,91,92,93,94],"Reboxetine","Methylphenidate","Randomized Controlled Trial","Dog-assisted Therapy","Occupational Therapy","RECRUITING","2026-08-14",{"date":66,"type":41},{"date":99,"type":41},"2026-08-01",{"date":101,"type":22},"2028-08-01",{"name":103,"class":48},"University of Haifa",{"id":105,"slug":106,"hasResults":12,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":110,"eligibilityCriteria":111,"healthyVolunteers":12,"sex":57,"minAge":19,"maxAge":4,"enrollmentInfo":112,"targetDuration":4,"studyType":23,"phases":114,"briefSummary":116,"conditions":117,"keywords":121,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":125,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":49},"100636820","phase-2-redefine-study-a-study-evaluating-the-efficacy-safety-and-tolerability-of-comp360-in-participants-with-post-traumatic-stress-disorder-100636820","NCT07570654","Redefine Study: A Study Evaluating the Efficacy, Safety, and Tolerability of COMP360 in Participants With Post-traumatic Stress Disorder","A Phase 2b\u002F3, Multicentre, Randomised, Double-blind, Controlled Trial, With an Open Label Extension, to Investigate the Efficacy, Safety, and Tolerability of COMP360 in Participants With Post-traumatic Stress Disorder","Redefine","Inclusion Criteria:\n\n* 18 years or older\n* Diagnosed with PTSD at least 6 months ago\n\nExclusion Criteria:\n\n\\- Diagnosed with certain psychiatric conditions such as bipolar disorder, schizophrenia, OCD, anorexia, or other conditions",{"count":113,"type":22},300,[85,115],"PHASE3","The Redefine Study (COMP202) is testing COMP360 to see if it may reduce post-traumatic stress disorder (PTSD) symptoms when administered alongside monitoring and support from a trained study team. COMP360 is a lab-made form of the naturally occurring chemical compound psilocybin.",[118,30,119,120],"PTSD - Post Traumatic Stress Disorder","PTSD Symptoms","PTSD, Post Traumatic Stress Disorder",[122,123,110,30,124],"COMP360","psilocybin","trauma",{"date":66,"type":41},{"date":127,"type":22},"2026-09",{"date":129,"type":22},"2029-09",{"name":131,"class":132},"COMPASS Pathways","INDUSTRY",{"id":134,"slug":135,"hasResults":12,"nctId":136,"briefTitle":137,"officialTitle":137,"acronym":4,"eligibilityCriteria":138,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":139,"targetDuration":4,"studyType":23,"phases":141,"briefSummary":142,"conditions":143,"keywords":145,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":159},"100536234","parenting-stair-adapting-a-trauma-focused-parenting-intervention-for-military-connected-mothers-and-their-children-100536234","NCT06262178","Parenting STAIR: Adapting a Trauma-Focused Parenting Intervention for Military-Connected Mothers and Their Children","Inclusion Criteria:\n\n1. Military-connected mother, defined as a mother who is either a female service member or veteran or female spouse of a service member or veteran;\n2. Has a child aged 2-10;\n3. Legal guardian of index child with legal and physical custody;\n4. Lifetime trauma exposure (Life Events Checklist (LEC-5); Adverse Childhood Experiences Questionnaire (ACE-Q));\n5. Screen positive for PTSD (defined as a PCL-5 score ≥32 or meeting ≥3 out of 4 DSM-5 symptom criteria \\[B, C, D, E\\] on the PCL-5), and\u002For depression (PHQ-9 score ≥8), and\u002For low parenting self-efficacy (PSOC score \\\u003C59);\n6. Able to speak and understand English or Spanish;\n7. Eligible to receive services at a Steven A. Cohen Military Family Clinic at Endeavors.\n\nExclusion Criteria:\n\n1. High risk for suicide (Ask Suicide-Screening Questions (ASQ));\n2. Current psychotic symptoms (DSM-5-TR Self-Rated Level 1 Cross-Cutting Symptom Measure Domain VII);\n3. Disability affecting communication, such as deafness;\n4. Index child with severe developmental disability;\n5. Severe substance or alcohol use (The Alcohol, Smoking and Substance Involvement Screening Test - Lite (ASSIST-Lite); Cannabis Use Disorder Identification Test-Short Form (CUDIT-SF));\n6. Currently receiving another trauma-focused individual mental health treatment.",{"count":140,"type":22},120,[25],"The goal of this study is to assess Parenting STAIR Modular (PSTAIR-M), a promising and innovative intervention for military-connected mothers (MCM) who have experienced trauma and their young children (ages 2-10). PSTAIR-M aims to help mothers manage the strong feelings that sometimes happen after experiencing something scary or stressful, as well as to better connect with their children and manage their behavior effectively.\n\nThe main questions the study aims to answer are: 1) Does PSTAIR-M reduce maternal PTSD and\u002For depression symptoms?, and 2) Does PSTAIR-M improve parental functioning?\n\nResearchers will compare PSTAIR-M to treatment as usual (TAU) - other EBTs offered at participating study sites - to determine if PSTAIR-M is more effective in improving mental health and parenting.\n\nParticipants will: 1) attend 12-16 weekly, 1-hour online treatment sessions with their assigned clinicians, 2) complete three 1-hour online assessments administered by research staff, 3) engage with their child in three 15-30-minute online, observed play sessions, 4) have assessments and observed play sessions audio and video recorded.\n\nParticipants may also be invited to participate in an optional, 30-minute online one-on-one qualitative interview, which would be audio and video recorded and would cover participants' experiences with the intervention, the clinic sites, and their providers.",[30,36,144],"Parent-Child Relations",[30,36,146,147,148,144,149],"STAIR","PC-CARE","Parenting","Military Family","2026-08-05",{"date":152,"type":41},"2026-08-07",{"date":154,"type":41},"2025-07-21",{"date":156,"type":22},"2027-09-30",{"name":158,"class":48},"New York University",3,{"id":161,"slug":162,"hasResults":12,"nctId":163,"briefTitle":164,"officialTitle":165,"acronym":4,"eligibilityCriteria":166,"healthyVolunteers":12,"sex":57,"minAge":19,"maxAge":167,"enrollmentInfo":168,"targetDuration":4,"studyType":23,"phases":169,"briefSummary":170,"conditions":171,"keywords":176,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":49},"100564429","cognitive-control-training-for-extinction-in-ptsd-100564429","NCT06629064","Cognitive Control Training for Extinction in PTSD","Identifying Clinically Relevant Neural Circuit Mechanisms of Cognitive Control Training for PTSD","Inclusion Criteria:\n\n* Fluent in English\n* Meet current DSM-5 criteria for Posttraumatic Stress Disorder\n* Are willing to attend 8 total remote sessions of working memory training over course of four weeks\n* Are willing to attend MRI scans pre and post working memory training\n* 4-week stability on pharmacological and psychosocial treatments\n\nExclusion Criteria:\n\n* A lifetime history of psychotic disorders, lifetime history of bipolar disorder\n* Past-year severe substance use and severe alcohol use disorder. Mild-to-moderate alcohol use disorder will be allowed to enhance generalizability in our sample due to the high comorbidity of alcohol use and PTSD\n* History of any neurological disorder that might be associated with cognitive dysfunction (e.g., cerebrovascular accident, intracranial surgery, aneurysm, seizure disorder)\n* Acute suicidality requiring immediate clinical intervention\n* Moderate to severe traumatic brain injury (TBI). However, mild to moderate levels of TBI (mTBI) will be included\n* Receiving benzodiazepines or medications with anticholinergic effects that may affect fear learning measures\n* Inability to safely complete fMRI session (i.e., metal in body, medical implants)","65 Years",{"count":140,"type":22},[25],"The proposed study will test whether a working memory training (WMT) program improves fear extinction learning and its underlying neural circuitry in Veterans with posttraumatic stress disorder (PTSD). WMT is designed to improves the ability to maintain task-relevant information in mind. The project will further validate the relationship between working memory and fear extinction using novel computational and multivariate analyses that link to specific PTSD symptoms. If WMT can enhance fear extinction learning, then WMT may be a powerful adjunctive treatment that can enhance exposure therapy outcomes or be leveraged as a stand-alone treatment. This project supports the Department of Veteran Affairs mission of developing viable targets of treatment for Veterans with PTSD.",[172,173,174,30,175],"Post-Traumatic Stress Disorders","Stress Disorders, Traumatic","Post Traumatic Stress Disorder","Trauma and Stressor Related Disorders",[175,30,177,178,179],"cognitive training","working memory","Fear Extinction","2026-08-04",{"date":152,"type":41},{"date":183,"type":41},"2024-10-01",{"date":185,"type":22},"2028-09-30",{"name":72,"class":73},{"id":188,"slug":189,"hasResults":12,"nctId":190,"briefTitle":191,"officialTitle":192,"acronym":193,"eligibilityCriteria":194,"healthyVolunteers":195,"sex":57,"minAge":19,"maxAge":4,"enrollmentInfo":196,"targetDuration":4,"studyType":23,"phases":198,"briefSummary":199,"conditions":200,"keywords":202,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":206,"lastUpdatePostDateStruct":207,"startDateStruct":209,"completionDateStruct":211,"leadSponsor":213,"locationsCount":49},"100501659","copeweb-training-for-providers-100501659","NCT05812131","COPEWeb Training for Providers","Web-Based Provider Training for Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure (COPEWeb)","COPEWeb","Inclusion Criteria:\n\n* currently a provider in a behavioral health field (e.g., psychology, psychiatry, counseling)\n* English speaking\n* able to consistently obtain reliable internet access\n* willing to attend a 2-day \"live\" in-person (or virtual) COPE training if randomly assigned to that condition\n* willing to engage in a standardized patient assessment after training\n* has no prior formal training in the COPE therapy\n\nExclusion Criteria:\n\n* received prior training in COPE\n* not a provider in the behavioral health field\n* non-English speaking\n* lack of reliable internet access",true,{"count":197,"type":22},248,[25],"Post-traumatic stress disorder (PTSD) and substance use disorders (SUD) are two of the most common and debilitating mental health conditions afflicting military Veterans. PTSD and SUD frequently co-occur and are associated with poorer treatment outcomes. The investigators' team developed a trauma-focused intervention, Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure (COPE), which is identified by the VA as a gold standard of behavioral healthcare and was designated as a first-line treatment in the 2025 APA Clinical Practice Guideline for PTSD. However, a critical barrier to ensuring that Veterans with co-occurring PTSD\u002FSUD receive evidence-based treatment is a lack of provider training. This project directly addresses this critical gap by developing a new web-based training program for providers (COPEWeb).",[30,201],"Substance Use Disorders",[30,203,204,205],"substance use disorders","training","providers","2026-08-03",{"date":208,"type":41},"2026-08-06",{"date":210,"type":41},"2025-05-11",{"date":212,"type":22},"2027-04-05",{"name":72,"class":73},{"id":215,"slug":216,"hasResults":12,"nctId":217,"briefTitle":218,"officialTitle":219,"acronym":220,"eligibilityCriteria":221,"healthyVolunteers":12,"sex":57,"minAge":19,"maxAge":222,"enrollmentInfo":223,"targetDuration":4,"studyType":23,"phases":225,"briefSummary":226,"conditions":227,"keywords":230,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":235,"lastUpdatePostDateStruct":236,"startDateStruct":237,"completionDateStruct":239,"leadSponsor":241,"locationsCount":4},"100650222","phase-2-assessing-of-behavioral-risk-and-response-to-electromagnetic-and-psychedelic-therapies-100650222","NCT07745569","Assessing of Behavioral Risk and Response to Electromagnetic and Psychedelic Therapies","Precision Phenotyping of Behavioral Risk and Response to Electromagnetic and Psychedelic Therapies","PRE-EMPT","Inclusion Criteria:\n\n1. 18-69 years old\n2. Have been on a stable psychiatric medication regimen for at least four weeks prior to study participation.\n3. Formal diagnosis of major depressive disorder or post-traumatic stress disorder by a mental health professional.\n4. Must be under the care of a medical provider (ex: primary care, therapist, psychiatrist, psychiatric nurse practitioner) for mental health treatment who can provide contact information and written confirmation that they will be willing and able to care for participant during their entire involvement in the study.\n\nExclusion Criteria:\n\n1. A prior history of other central nervous system disease or any history of seizures;\n2. history of psychotic disorders (e.g., schizophrenia, schizoaffective disorder, bipolar disorder type I);\n3. history of current or recent (within one year) substance\u002Falcohol use disorder, with the exception of tobacco use disorder;\n4. meet criteria for Very High risk of suicide, or require inpatient hospital-level care for psychiatric reasons at time of consent, to reduce exacerbation of risk of harm to self during study;\n5. presence of any implanted metal or electrical device (e.g. pacemaker);\n6. recent medical hospitalization (within three weeks);\n7. any condition that would prevent the participant from completing the protocol, such as significant agitation;\n8. appointment of a legal representative or treatment guardian;\n9. any ongoing litigation related to a health condition;\n10. any other contraindication to exposure to strong magnetic fields or MRI, such as severe claustrophobia;\n11. pregnancy or lactation;\n12. a family history of schizophrenia or schizoaffective disorder (first or second degree relatives), or bipolar disorder type 1 (first degree relatives), to reduce risk of exacerbation of an undiagnosed psychotic condition;\n13. other medical conditions that would preclude safe participation in the trial (e.g., decompensated heart failure);\n14. starting or planning to start psychotherapy or changing the frequency or intensity of existing psychotherapy during the trial (current psychotherapy can be continued provided the frequency and intensity has been stable for ≥2 months prior to screening);\n15. membership in a vulnerable population (minors, prisoners);\n16. any contraindication for blood draws.\n\nArm 1:\n\nInclusion:\n\n1. PRE-EMPT Risk Level Low or Intermediate (recent suicidal ideation, but no intent\u002Fplan; C-SSRS level low; mild-to-moderate depression (QIDS score 6-15) or PTSD (PCL-5 score 20-32))\n2. Right-handed.\n\nArm 2:\n\nInclusion:\n\n1\\) PRE-EMPT Risk Level Intermediate or High (recent suicidal ideation, but no intent or plan; C-SSRS level low to moderate; moderate to severe depression (QIDS score \\>16) or PTSD (PCL-5 score greater than or equal to 33))\n\nArm 3:\n\nInclusion:\n\n1\\) PRE-EMPT Risk Level Intermediate or High (recent suicidal ideation, but no intent or plan; C-SSRS level low to moderate; moderate to severe depression (QIDS score ≥16) or PTSD (PCL-5 score greater than or equal to 33))\n\nExclusions:\n\n1. Other additional medical conditions that would preclude safe participation in this arm of the trial:\n\n   1. significantly impaired liver function,\n   2. severe coronary artery disease,\n   3. heart failure,\n   4. uncontrolled hypertension (above 140\u002F90 mmHg upon screening) ,\n\n   i. If blood pressure is consistently elevated \\> 140\u002F90 mmHg across 3 attempts, subjects may be referred to their primary care provider for management of hypertension. Upon management of blood pressure, subjects will have an opportunity to return once within the 30 day screening window to make 3 additional attempts at a blood pressure reading ≤ 140\u002F90 mmHg. Subjects will be considered eligible upon registering 1 blood pressure reading ≤ 140\u002F90 mmHg during the screening period. Blood pressure will be reassessed on Day 0 prior to dosing, and must be less than or equal to 140 systolic, 90 diastolic, with resting pulse ≤ 100 (ascertained within 20 minutes of IP administration in order for the participant to receive study medication.) e. history of cerebrovascular accident, f. severe obesity (BMI ≥ 35), g. untreated asthma, h. untreated hyperthyroidism, i. narrow-angle glaucoma, j. stenosing peptic ulcer, k. pyloroduodenal obstruction, l. symptomatic prostatichypertrophy, or m. bladder-neck obstruction, n. history of valvular heart disease or any heart condition that affects the valves\n2. serious ECG abnormalities (e.g., evidence of ischemia, myocardial infarction, QT interval corrected for heart rate \\[QTc\\] prolongation (QTc \\> 0.45 seconds), arrhythmia, or conduction abnormalities that increase the risk of arrhythmia);\n3. allergy or hypersensitivity to psilocybin or chocolate","69 Years",{"count":224,"type":22},150,[85],"PRE-EMPT will assemble a cohort of 150 participants from three populations (low risk, intermediate risk, and high risk for self-harm). We will obtain clinical assessments, structural and functional MRI utilizing tasks pioneered by our team to assess cognitive control (CC) and emotion regulation (ER), and peripheral circular RNA (circRNA) levels to characterize the molecular brain states associated with behavioral risk. The clinical, imaging, and transcriptomic data will be fused and jointly analyzed to increase the accuracy of our risk prediction models. PRE-EMPT in three separate Aims will then prospectively assess three promising and innovative interventions for their potential to reduce suicidal ideation and alter activity in key neural networks: 1) neurofeedback (NF) using real-time fMRI with simultaneous electroencephalography (EEG), 2) a form of transcranial magnetic stimulation (TMS) called accelerated intermittent theta burst stimulation (aiTBS) with dose optimization through electric field modeling; and 3) psilocybin assisted therapy (PSI), with flexible dosing plan to maximize the depth of psychedelic experience. These therapies were chosen based on our team's prior work in all three interventions demonstrating rapid action and large effects.",[30,118,228,229],"Major Depression","Suicidality",[231,232,233,123,234],"TMS","Transcranial magnetic stimulation","neuromodulation","neurofeedback","2026-07-29",{"date":180,"type":41},{"date":238,"type":22},"2026-08-31",{"date":240,"type":22},"2030-06-30",{"name":242,"class":48},"University of New Mexico",{"id":244,"slug":245,"hasResults":12,"nctId":246,"briefTitle":247,"officialTitle":248,"acronym":249,"eligibilityCriteria":250,"healthyVolunteers":12,"sex":57,"minAge":19,"maxAge":81,"enrollmentInfo":251,"targetDuration":4,"studyType":23,"phases":253,"briefSummary":254,"conditions":255,"keywords":256,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":261,"startDateStruct":262,"completionDateStruct":264,"leadSponsor":266,"locationsCount":267},"100605854","phase-3-rapid-acceleration-process-for-intensive-treatment-of-ptsd-in-5-days-100605854","NCT07167940","Rapid Acceleration Process for Intensive Treatment of PTSD in 5 Days","RAPID5: Rapid Acceleration Process for Intensive Treatment of PTSD in 5 Days","RAPID5","Inclusion Criteria:\n\n* Diagnosis of chronic PTSD, meeting DSM-5 criteria\n* Eligible Veterans\n* Symptomatic despite ongoing stable treatment (medications, psychotherapy, etc.) for at least 6 weeks before study procedures\n* Ongoing medications and psychotherapy will be allowed to continue unchanged during the study\n* For safety, participants must meet established screening criteria for magnetic resonance imaging (MRI)\n\n  * This is implemented as a conservative measure given the novel application of TBS in this population since MRI involves magnetic fields at a similar intensity to those emitted from the stimulation coil\n  * These measures require a patient not to have the following (unless MRI-safe):\n\n    * A cardiac pacemaker\n    * implanted device (deep brain stimulation) or metal in the brain\n    * cervical spinal cord\n    * upper thoracic spinal cord\n* Willingness to participate in a clinical trial for approximately 4 to 6 months (consisting of a treatment phase with a 4-month follow-up period)\n* Veterans must also be willing and able to comply with all study-related procedures and visits and be capable of independently reading and understanding information materials and providing written informed consent\n* Sufficient visual and auditory acuity to allow neuropsychological testing\n\nExclusion Criteria:\n\nPsychiatric Exclusions\n\n* Primary psychotic disorder, bipolar I disorder, and greater than moderate substance use disorder (within the last month, excluding nicotine\u002Fcaffeine, assessed by a urine drug screen as indicated), determined by the Mini International Neuropsychiatric Interview (MINI)\n* Active suicidal intent or plan, as detected on screening instruments or in the investigator team's opinion, is likely to attempt suicide within 6 months\n* The presence of any other condition or circumstance that, in the opinion of the investigator team, has the potential to prevent study completion and\u002For to have a confounding effect on outcome assessments\n\nMedical Exclusions\n\n* History of neurological disorder (e.g., multiple sclerosis, seizure disorder, etc.) or systemic illness affecting CNS function (e.g., liver failure, kidney failure, congestive heart failure, metastatic cancer) or that could meaningfully impact cortical excitability\n* Acute illness or unstable chronic illness, e.g., history of severe liver disease (cirrhosis, esophageal varices, ascites, portal hypertension, hepatic encephalopathy)\n* Pregnant or breastfeeding and planning to become pregnant within the next 3 months\n* Have a mass lesion, cerebral infarct, or other neuroanatomical abnormality located at the TMS treatment site (DLPFC)\n\n  * a lifetime history of a) seizure disorder b) primary or secondary CNS tumors c) stroke or d) cerebral aneurysm\n* Greater than mild traumatic brain injury (following VA\u002FDoD definitions)\n* Inability to read, unable to verbalize understanding, and voluntarily sign the Informed Consent",{"count":252,"type":22},90,[115],"Veterans with posttraumatic stress disorder (PTSD) need more effective treatments. Existing options can have limited adherence and can be very time-consuming. As such, alternative interventions are needed. Transcranial magnetic stimulation (TMS) has been FDA-cleared for depression since 2008 and has recently been cleared to treat smoking cessation and obsessive-compulsive disorder. It has demonstrated promise for reducing PTSD symptom severity but standard TMS has a significant time requirement. This study will compare an accelerated 5-day form of TMS versus sham for PTSD, characterizing efficacy and durability. This project will provide important information that can be implemented in the near term for Veterans with PTSD.",[30],[257,258,259],"Post-traumatic Stress Disorder","Transcranial Magnetic Stimulation","Veterans","2026-07-27",{"date":235,"type":41},{"date":263,"type":22},"2026-10-01",{"date":265,"type":22},"2030-12-06",{"name":72,"class":73},2,{"id":269,"slug":270,"hasResults":12,"nctId":271,"briefTitle":272,"officialTitle":273,"acronym":4,"eligibilityCriteria":274,"healthyVolunteers":12,"sex":57,"minAge":19,"maxAge":4,"enrollmentInfo":275,"targetDuration":4,"studyType":23,"phases":277,"briefSummary":278,"conditions":279,"keywords":281,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":284,"lastUpdatePostDateStruct":285,"startDateStruct":286,"completionDateStruct":288,"leadSponsor":290,"locationsCount":267},"100454237","treatments-for-insomnia-in-veterans-with-ptsd-100454237","NCT05194930","Treatments for Insomnia in Veterans With PTSD","A Novel Acceptance-based Treatment for Insomnia in Veterans With Post-Traumatic Stress Disorder","Inclusion Criteria:\n\n* community-dwelling Veterans aged 18 years and older,\n* received care from VAGLAHS in the prior year,\n* live within a 50-mile radius of the research offices at the VA Sepulveda Ambulatory Care Center,\n* have symptoms of PTSD,\n* have symptoms of insomnia.\n\nExclusion Criteria:\n\n* current pregnancy or has a child less than 6 months of age (men and women),\n* active substance users or in recovery with less than 90 days of sobriety,\n* too ill to engage in the study procedures,\n* unable to self-consent to participate,\n* unstable housing (since we may not be able to retrieve costly and difficult to replace monitoring equipment),\n* severe, untreated sleep disordered breathing (AHI\\>15 with excessive daytime sleepiness, or AHI\\>30),\n* restless legs syndrome that accounts for the sleep disturbances reported,\n* a circadian rhythm sleep disorder that accounts for the sleep disturbances reported (including shift work sleep disorder),\n* unstable medical or psychiatric disorders (which is a contraindication for behavioral treatment of insomnia);\n* remission of insomnia symptoms prior to randomization;\n* current participation in prolonged exposure therapy for PTSD.",{"count":276,"type":22},400,[25],"This randomized trial will compare a novel treatment, Acceptance of the Behavioral Changes to Treat Insomnia (ABC-I) to Cognitive Behavioral Therapy for Insomnia (CBT-I) among Veterans with comorbid Post-Traumatic Stress Disorder (PTSD) and insomnia disorder. ABC-I combines the behavioral components of CBT-I with components of another behavioral therapy (Acceptance and Commitment Therapy) and has been shown to improve treatment adherence.\n\nThe study objectives are: 1) to evaluate the benefits of ABC-I in reducing post-traumatic stress disorder (PTSD) symptoms among Veterans with comorbid PTSD and insomnia disorder compared to CBT-I, and 2) to evaluate the effectiveness of ABC-I in improving insomnia symptoms and sleep quality among Veterans with comorbid PTSD and insomnia disorder as compared to CBT-I.\n\nVeterans with insomnia and comorbid PTSD who receive care at Sepulveda and West Los Angeles facilities will be recruited for the study. Those who pass an initial eligibility screen will be enrolled and written informed consent will be obtained. A baseline assessment will be completed that includes measures of sleep, PTSD, and quality of life. Veterans who meet all eligibility criteria will be randomly assigned to the ABC-I (n=100) or CBT-I (n=100) treatment. Both treatments will be provided in 5 one-on-one sessions by a trained instructor who is supervised by a behavioral sleep medicine specialist. All randomized participants (n=200) will have 3 follow-up assessments (post-treatment, 3-months, and 6-months after randomization). The follow-up assessments will collect information on PTSD symptoms, insomnia symptoms and sleep quality.",[280,30],"Insomnia",[282,283],"Insomnia disorder","Chronic Post-Traumatic Stress Disorder","2026-07-23",{"date":260,"type":41},{"date":287,"type":41},"2022-09-01",{"date":289,"type":22},"2027-06-30",{"name":72,"class":73},{"id":292,"slug":293,"hasResults":12,"nctId":294,"briefTitle":295,"officialTitle":296,"acronym":297,"eligibilityCriteria":298,"healthyVolunteers":12,"sex":57,"minAge":19,"maxAge":299,"enrollmentInfo":300,"targetDuration":4,"studyType":23,"phases":302,"briefSummary":303,"conditions":304,"keywords":306,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":313,"lastUpdatePostDateStruct":314,"startDateStruct":316,"completionDateStruct":318,"leadSponsor":320,"locationsCount":49},"100396084","vagal-nerve-stimulation-in-mtbi-100396084","NCT04437498","Vagal Nerve Stimulation in mTBI","Non-Invasive Vagal Nerve Stimulation in Veterans With Mild Traumatic Brain Injury (mTBI)","VNS mTBI","Inclusion Criteria:\n\n* Veterans with mTBI and PTSD\n\nExclusion Criteria:\n\n* amnesia for the inciting event lasted longer than 24 hours\n* Glasgow Coma Scale Score after 30 minutes was less than 13\n* loss of consciousness more than 30 minutes\n* positive pregnancy test\n* meningitis or other neurological disorder other than mTBI\n* alcohol or substance abuse use disorder based on the SCID within the past 12 months\n* current or lifetime history of schizophrenia, schizoaffective disorder, bipolar disorder, anorexia nervosa or bulimia, based on the SCID\n* active suicidal ideation based on criteria outlined below\n* a history of serious medical or neurological illness, such as cardiovascular, gastrointestinal, hepatic, renal, neurologic or other systemic illness\n* active neuroleptic, opiate, or benzodiazepine treatment\n* structural abnormality on brain MRI or CT","55 Years",{"count":301,"type":22},100,[25],"Mild traumatic brain injury (mTBI) and posttraumatic stress disorder (PTSD) are important conditions for the Veterans Administration (VA) that frequently occur together in combat Veterans from the conflicts in Afghanistan and Iraq. In many Veterans these become chronic, raising the risk the burden of neurotrauma can worsen over time. This study will examine a new intervention called non-invasive Vagal Nerve Stimulation (nVNS) and its effects on memory and symptoms of PTSD and mTBI as well as brain and physiology in Veterans with mTBI and PTSD.",[30,305],"mTBI",[307,308,309,310,311,312],"vagus nerve","stress disorders, posttraumatic","traumatic brain injury","memory","hippocampus","emission tomography","2026-07-16",{"date":315,"type":41},"2026-07-20",{"date":317,"type":41},"2021-02-25",{"date":319,"type":22},"2026-12-10",{"name":72,"class":73},{"id":322,"slug":323,"hasResults":12,"nctId":324,"briefTitle":325,"officialTitle":325,"acronym":4,"eligibilityCriteria":326,"healthyVolunteers":12,"sex":57,"minAge":19,"maxAge":167,"enrollmentInfo":327,"targetDuration":4,"studyType":23,"phases":328,"briefSummary":329,"conditions":330,"keywords":332,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":334,"lastUpdatePostDateStruct":335,"startDateStruct":337,"completionDateStruct":339,"leadSponsor":341,"locationsCount":49},"100635905","temporal-interference-in-psychiatry-tip-neuromodulation-using-temporal-interference-100635905","NCT07558759","Temporal Interference in Psychiatry (TIP): Neuromodulation Using Temporal Interference","Inclusion Criteria:\n\n* Written informed consent.\n* Fluent English speaker.\n* Both sexes and all ethnic origins, between 18 and 65 years old.\n* Absence of current moderate to severe illicit drug use as assessed by subject history (AUDIT\\>=8 and\u002For DAST\\>2).\n\nExclusion Criteria:\n\n* Pregnant or currently breast-feeding women or any woman of childbearing potential who is seeking to become pregnant or suspects that she may be pregnant, as assessed by subject report and\u002For urine pregnancy screen.\n* Contraindications to MRI scanning (including presence of a cardiac pacemaker or pacemaker wires, metallic particles in the body, vascular clips in the head or previous neurosurgery, prosthetic heart valves, claustrophobia, as assessed with the standard MRI screening form from the CABI, FERN or CSI.\n* Unable to fit comfortably in the scanner.\n* Contraindication to TI and\u002For TMS (including history of epilepsy, metallic implants in the head and\u002For neck, brain stimulators, vagus nerve stimulators, VP shunt, pacemakers)\n* Current use of medications that may increase the risk of seizures (e.g., bupropion, varenicline, chlorpromazine, theophylline).\n* History or current serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease, as assessed by subject history.\n* History of head injury resulting in more than brief loss of consciousness, as assessed by subject history.\n* Current cocaine or stimulant use (e.g., amphetamine, cocaine, methamphetamine), as assessed by subject history.\n* Evidence of significant inconsistencies in self-report measures.\n* Non-English speakers will be excluded from this study because the research procedures rely heavily on the administration of validated self-report questionnaires, clinical interviews, and task instructions that at this time, are only available in English. Additionally, study staff are trained to administer these assessments and obtain informed consent in English only. Including non-English speakers would therefore pose a risk of misunderstanding study procedures, consent materials, or questionnaire items, which could affect both participant comprehension and data integrity.",{"count":113,"type":22},[25],"This study aims to understand the neural, behavioral and clinical effects of temporal interference (TI), a type of neuromodulation method, in healthy populations and in individuals with anxiety and stress-related conditions.",[331,30],"Anxiety",[333],"Temporal Interference","2026-07-14",{"date":336,"type":41},"2026-07-15",{"date":338,"type":41},"2026-04-07",{"date":340,"type":22},"2031-04",{"name":342,"class":48},"Emory University",{"id":344,"slug":345,"hasResults":12,"nctId":346,"briefTitle":347,"officialTitle":348,"acronym":349,"eligibilityCriteria":350,"healthyVolunteers":12,"sex":57,"minAge":19,"maxAge":351,"enrollmentInfo":352,"targetDuration":4,"studyType":23,"phases":354,"briefSummary":356,"conditions":357,"keywords":364,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":369,"lastUpdatePostDateStruct":370,"startDateStruct":372,"completionDateStruct":374,"leadSponsor":376,"locationsCount":49},"100647716","early-phase-1-float-for-healthcare-ptss-100647716","NCT07710417","FLOAT for Healthcare PTSS","Neural Mechanisms of Floatation-REST Therapy for Post-Traumatic Stress Symptoms in Frontline Healthcare Workers","PTSS FLOAT","Inclusion Criteria:\n\n1. Work-related post-traumatic stress dysfunction as measured by either of the following inclusion pathways:\n\n   (A) PTSS Pathway: PCL-5 greater than or equal to 20, OR meets criteria for full or partial PTSD on the MINI International Neuropsychiatric Interview 7 (DSM-V) (Criteria A + at least 2 B-E Criteria) OR (B) Functionally Anchored Pathway: evidence of work-related trauma exposure on the MINI International Neuropsychiatric Interview 7 (DSM-V) (Criterion A) or Life Events Checklist-5, and at least one of the following: Moral Injury and Distress Scale greater than or equal to 27, Sheehan Disability Scale greater than or equal to 5 on at least 1 of the 3 subscales, high or very high level of perceived stress (measured by PhenX Perceived Stress Scale greater than or equal to 16).\n2. First responder or other emergency medical personnel\n3. Ability to read, speak and understand English\n4. Capable of providing consent\n\nExclusion Criteria:\n\n1. History of neurological conditions\n2. Skin conditions or open wounds\n3. DSM-5 diagnosis of psychotic spectrum disorders, obsessive-compulsive disorder, bipolar disorder, severe substance use disorder, or eating disorder\n4. Inability to lay comfortably in a shallow pool of water\n5. Failure to adhere to \"pre-float checklist\"\n6. Breathalyzer test positive for alcohol or a drug-positive urine test\n7. Unwillingness to provide consent or complete major aspects of protocol\n8. MRI contraindications\n9. Unstable medical diagnoses\n10. Pregnancy\n11. Evidence of inability to comply with study procedures based on experimenter judgement\n12. Change in the dose or prescription of a medication within the 6 weeks before enrolling in the study that could affect brain functioning (e.g., anxiolytics, antipsychotics, antidepressants, benzodiazepines, or mood stabilizers)","64 Years",{"count":353,"type":22},15,[355],"EARLY_PHASE1","This early-stage pilot trial aims to examine the feasibility, tolerability, and safety of Floatation-REST, or Reduced Environmental Stimulation Therapy via floatation in frontline healthcare workers, first responders, and emergency medical personnel who experience post-traumatic stress symptoms.",[358,359,360,361,30,362,363],"Posttraumatic Stress Symptoms","Burnout","Burnout, Healthcare Workers","First Responders","Healthcare Workforce Well-Being","Post-traumatic Stress Symptoms",[365,358,30,361,359,366,367,368,363],"Floatation-REST","Healthcare Workers","Emergency Medical Personnel","Occupational Stress","2026-07-13",{"date":371,"type":41},"2026-07-17",{"date":373,"type":41},"2026-06-10",{"date":375,"type":22},"2026-12",{"name":377,"class":48},"Laureate Institute for Brain Research, Inc.",{"id":379,"slug":380,"hasResults":12,"nctId":381,"briefTitle":382,"officialTitle":383,"acronym":384,"eligibilityCriteria":385,"healthyVolunteers":12,"sex":57,"minAge":19,"maxAge":4,"enrollmentInfo":386,"targetDuration":4,"studyType":23,"phases":388,"briefSummary":389,"conditions":390,"keywords":4,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":393,"lastUpdatePostDateStruct":394,"startDateStruct":395,"completionDateStruct":397,"leadSponsor":399,"locationsCount":49},"100574163","patient-engagement-in-ptsd-treatment-pep-100574163","NCT06755710","Patient Engagement in PTSD Treatment (PEP)","Patient Engagement in PTSD Treatment (PEP) - Advancing PTSD Treatment Outcomes","PEP","In- and exclusion criteria of the randomised controlled trial for Psychotherapeutic Unit\n\nInclusion Criteria:\n\n* Adults (18 years or older)\n* PTSD pursuant to the ICD-10 research criteria\n* Signed informed consent\n* patients referred to \"Main Level\" treatment\n\nExclusion Criteria:\n\n* Severe psychotic disorder (defined as patients with an ICD-10 diagnosis F2x and F30.1-F31.9). Participants are excluded only if the psychotic experiences are assessed to be part of an independent psychotic disorder and not part of a severe PTSD and\u002For depression.\n* Dependence syndrome of drugs or alcohol: Active dependence and use (F1x.24-F1x.26).\n\nIn- and exclusion criteria of the randomised controlled trial for Competencecenter of Transcultural Psychiatry:\n\nInclusion criteria:\n\n* Adult (18 years or older)\n* Refugees or persons who have been family reunified with a refugee\n* PTSD pursuant to the ICD-10 research criteria\n* Psychological trauma experienced outside Denmark in the anamnesis. Trauma is imprisonment or detention with torture (according to the United Nations' definition of torture) or acts of cruel, inhuman and degrading treatment or punishment. Trauma can also be organised violence, long-term political persecution and harassment, or war and civil war experiences.\n* Signed informed consent\n\nExclusion criteria:\n\n* Severe psychotic disorder (defined as patients with an ICD-10 diagnosis F2x and F30.1-F31.9). Participants are excluded only if the psychotic experiences are assessed to be part of an independent psychotic disorder and not part of a severe PTSD and\u002For depression.\n* Dependence syndrome of drugs or alcohol: Active dependence and use (F1x.24-F1x.26).",{"count":387,"type":22},427,[25],"The goal of this clinical study is to improve the outcome of outpatient PTSD treatment at two clinics treating majority ethnic Danes and refugees with PTSD respectively. The study will consist of two similar randomized controlled trials.\n\nThe main questions the study aims to answer are:\n\n* Does an added motivation enhancement module as a precursor for PTSD treatment reduce dropout and increase treatment outcome?\n* Does an added Shared Decision-Making session which facilitate individualized treatment yield a superior outcome compared to PTSD treatment and PTSD treatment supplemented by motivation enhancement?\n\nParticipants are recruited at two different clinics, Psychotherapeutic Unit (PU) and Competence Centre for Transcultural Psychiatry (CTP). At PU the participants are randomized to one of two arms, and at CTP to one of three arms. One arm is the control group where participants will receive treatment as usual (TAU), one arm is the first intervention group where the participants will receive an Introductory PTSD module consisting of four sessions focusing on enhancing motivation for PTSD treatment, before continuing in TAU. The last arm is the second intervention group, which will only take place at CTP. Here the patient will receive the Introductory PTSD module followed by a session of Shared Decision Making, where the participant together with the MD decides which of four standardized treatment courses they will receive.\n\nThe treatment for all patients will last between 8-13 months.",[30,391,392],"Depression Disorders","Patient Engagement","2026-07-10",{"date":334,"type":41},{"date":396,"type":41},"2025-01-02",{"date":398,"type":22},"2028-08-31",{"name":400,"class":48},"Herlev and Gentofte Hospital",{"id":402,"slug":403,"hasResults":12,"nctId":404,"briefTitle":405,"officialTitle":406,"acronym":4,"eligibilityCriteria":407,"healthyVolunteers":12,"sex":57,"minAge":19,"maxAge":4,"enrollmentInfo":408,"targetDuration":4,"studyType":23,"phases":410,"briefSummary":411,"conditions":412,"keywords":414,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":428,"lastUpdatePostDateStruct":429,"startDateStruct":430,"completionDateStruct":431,"leadSponsor":433,"locationsCount":4},"100647183","phase-2-clinical-trial-of-mdma-assisted-therapy-for-military-service-members-with-posttraumatic-stress-disorder-100647183","NCT07704762","Clinical Trial of MDMA-Assisted Therapy for Military Service Members With Posttraumatic Stress Disorder","A Randomized, Double-Blind, Active-Controlled, Clinical Trial of the Safety, Efficacy, and Durability of MDMA-Assisted Therapy for Military Service Members With Posttraumatic Stress Disorder","Inclusion Criteria:\n\n1. Positive endorsement of at least 1 index trauma on the LEC-5.\n2. Have a PCL-5 total score of 38 or greater at screening.\n3. Meet DSM-5-TR criteria for current PTSD per Mini International Neuropsychiatric Interview (MINI) at screening with a symptom duration of 6 months or longer.\n4. Meet criteria for PTSD diagnosis per CAPS-5-R with a score of 26 or greater.\n5. Are at least 18 years old at the time of enrollment.\n6. Weigh greater than 48 kilograms.\n7. Are able to swallow pills.\n8. Are fluent in speaking, reading, and comprehending English.\n9. Must agree to inform the investigators within 48 hours of any new medications, medical conditions, and procedures.\n10. Females of childbearing potential must have a negative pregnancy test at study entry and prior to each Dosing Session and must agree to use adequate birth control for the duration of the study until at least 30 days after the final dosing session. Adequate birth control methods include intrauterine device (IUD), injected, implanted, intravaginal, or transdermal hormonal methods, abstinence, oral hormones plus a barrier contraception, vasectomized sole partner, or double barrier contraception. Two forms of contraception are required with any barrier method or oral hormones (i.e. condom plus diaphragm, condom or diaphragm plus spermicide, oral hormonal contraceptives plus spermicide or condom). Non-childbearing potential is defined as permanent sterilization, postmenopausal, or assigned male at birth.\n11. Males must agree to use adequate birth control for the duration of the study until at least 30 days after the final dosing session. Adequate birth control methods for males include double barrier contraception (condom with spermicidal gel or foam), surgical sterility (defined as a vasectomy at least 3 months prior to the screening visit), or abstinence.\n12. Must agree to refrain from sperm, egg, blood, and bone marrow donations for at least 30 days after the final dosing session.\n13. Must have a 12-lead electrocardiogram (EKG) with QTc \\\u003C 450 ms and no clinically significant abnormalities, as determined by a cardiologist.\n14. Are able to demonstrate comprehension of consent form and study instructions, and provide informed consent.\n15. Agree to have study visits recorded, including Dosing Sessions, Independent Rater assessments, and non-drug therapy sessions.\n16. Must provide an emergency contact (relative, spouse, close friend, or other support person) who is willing and able to be reached by the investigators in the event a participant is imminently unsafe or unreachable.\n17. Agree to the following lifestyle modifications (described in more detail in the Informed Consent Form): comply with requirements for fasting and refraining from certain medications prior to Dosing Sessions; not participate in any other interventional clinical trials during the duration of this study without prior approval of the Independent Safety Monitor; remain overnight at the study site or have an identified support person that can remain with the participant and escort them to the therapy session the day after each dosing; and commit to medication dosing, therapy, and study procedures.\n18. Must be Active Duty, National Guard, or Reserve in the United States military.\n19. Must receive approval from their command to participate in the study.\n20. Must be DEERS eligible.\n\nExclusion Criteria:\n\n1. History of or current primary psychotic disorder to include Schizophrenia, Schizoaffective Disorder, or Bipolar Disorder 1 assessed via MINI or clinical evaluation.\n2. Current Major Depressive Disorder with Psychotic Features assessed via MINI or clinical evaluation.\n3. Current eating disorder with active purging assessed via MINI or clinical evaluation.\n4. Current Borderline Personality Disorder assessed via SCID-5-PD or clinical evaluation.\n5. Any of the following findings on Screening C-SSRS:\n\n   1. Suicidal ideation score of 5 within the last month\n   2. Suicidal ideation score of 4 or greater in the last month at a frequency of once per week or more\n   3. Any suicidal behaviors within the last 3 months. The exception is that non suicidal self-injurious behavior is not exclusionary if approved by the PI.\n6. Current high suicide risk or is likely to require psychiatric hospitalization, as determined through C-SSRS, clinical interview, or clinical judgment of the investigator. Distant history of suicide attempts without current high suicide risk factors is not exclusionary.\n7. Current severe substance use disorder (6 or more criteria per MINI) not in sustained remission (criteria not met for past 12 months) at time of enrollment. I.e., severe substance use disorders may only be included if in sustained remission. Tobacco\u002Fnicotine use disorders may be included regardless of severity.\n8. Current moderate substance use disorder (4-5 criteria per MINI) not in early remission (criteria not met for past 3-12 months) or sustained remission (criteria not met for past 12 months) at time of enrollment. I.e., moderate substance use disorders may only be included if in early or sustained remission (criteria not met for 3 or more months). Tobacco\u002Fnicotine use disorders may be included.\n9. For any illicit or prescribed substance: current substance use disorder of any severity, not in sustained remission (criteria not met for past 12 months). I.e., substance use disorders of any severity with illicit or prescribed substances may only be included if in sustained remission.\n10. Any urine drug testing during screening or enrollment that is confirmed positive for a non-prescribed substance, and the result cannot be better explained as a false positive due to another concomitant prescribed medication or proven dietary practice.\n11. Have current or history of psychiatric diagnoses or symptoms that may negatively affect study participation.\n12. Clinically significant abnormalities on screening 12-lead EKG or 1 minute 12-lead rhythm strip that precludes administration of MDMA, stimulants, or sympathomimetics, as determined by a cardiologist.\n13. Two or more premature ventricular contractions (PVCs) on 1-minute rhythm strip. 1 minute 12-lead rhythm strip will be obtained when there are one or more PVCs on screening EKG or when indicated by a cardiologist.\n14. Resting QTc ≥ 450 ms.\n15. History of drug-induced QTc prolongation.\n16. Inability to hold or discontinue concomitant medications that significantly prolong the QTc interval.\n17. Clinically significant cardiac or cardiovascular abnormalities, including history of myocardial infarction, unexplained exertional syncope, Torsade de Pointes, congenital long QT syndrome, hypertrophic cardiomyopathy, congestive heart failure, family history of Long QT Syndrome, persistent atrial fibrillation, symptomatic valvular heart disease, asymptomatic severe aortic stenosis, asymptomatic severe mitral stenosis, history of diagnosis of aortic dissection or asymptomatic aortic aneurysm \\> 4.5 cm at the sinus of Valsalva, or history of untreated angina pectoris or unrevascularized coronary stenosis \\> 70%.\n18. Current clinically significant electrolyte abnormalities, to include hyponatremia and hypokalemia.\n19. Has clinically significant abnormal laboratory results during screening that indicate impaired liver function, to include ALT or AST \\>2x ULN or Total bilirubin \\>1.5 mg\u002FdL unless history of Gilbert's Syndrome\n20. Renal disease defined as eGFR \\\u003C45 mL\u002Fmin\u002F1.73m² or creatinine \\>2.0 mg\u002FdL, end-stage kidney disease, dialysis, history of renal transplant, clinically significant or progressive renal disease deemed to increase risk, or recent\u002Funstable renal function consistent with acute kidney injury at screening. Participants with eGFR 45-59 mL\u002Fmin\u002F1.73m² may be eligible only if renal function is stable and cleared by the study physician.\n21. Uncontrolled essential hypertension defined as blood pressures of greater than 140\u002F90 mmHg assessed on three separate occasions. May have well-controlled hypertension that has been successfully treated with anti-hypertensive medicines, if additional screening is passed to rule out underlying cardiovascular disease.\n22. Uncontrolled hypothyroidism. May have hypothyroidism if taking adequate and stable thyroid replacement medication.\n23. Type 2 Diabetes Mellitus with comorbid cardiovascular disease. May have a history of or current Type 2 Diabetes Mellitus if additional screening measures rule out underlying cardiovascular disease, if the condition is judged to be stable on effective management, and with approval by the Independent Safety Monitor.\n24. Glaucoma without approval from an ophthalmologist. May have a history of, or current, glaucoma if approval for study participation is received from an ophthalmologist.\n25. History of any medical condition that could make receiving a sympathomimetic drug harmful because of increases in blood pressure and heart rate. This includes, but is not limited to, a history of cerebrovascular disorders (cerebrovascular accident, aneurysm, arteriovenous malformations, or carotid stenosis). Participants with other mild, stable chronic medical conditions may be enrolled if the study physician and Independent Safety Monitor agree the condition is unlikely to confer a significant additional health risk with administration of MDMA. This includes conditions such as gastroesophageal reflux disease and chronic low back pain.\n26. Current medical diagnoses or physical health symptoms that may negatively affect study participation.\n27. Report any prescribed or non-prescribed lifetime personal use history of MDMA, 3,4 methylenedioxymethamphetamine, midomafetamine, \"Ecstasy,\" \"Molly,\" \"Mandy,\" or \"Adam.\"\n28. Lack adequate social support, in the judgement of the PI.\n29. Unable to safely taper off prohibited concomitant medications.\n30. Are pregnant or nursing, or are able to become pregnant and are not practicing an effective means of birth control.\n31. Have any current or anticipated problem which, in the opinion of the PI or Independent Safety Monitor, may interfere with study participation.",{"count":409,"type":22},86,[85],"This study is a Phase 2, randomized, double-blind, active-controlled, two-arm, single-site clinical trial designed to evaluate the safety, tolerability, and feasibility of MDMA-Assisted Therapy (MDMA-AT) for Service Members (Active Duty, Guard, or Reserve) diagnosed with moderate-to-severe Post-Traumatic Stress Disorder (PTSD) within a Military Health System (MHS) setting.\n\nThe trial incorporates Acceptance and Commitment Therapy (ACT) as a core therapeutic modality. Participants will receive MDMA-AT utilizing either full-dose or active-control low-dose MDMA. The trial will also assess a regional referral center model by recruiting participants locally from the National Capital Region and non-locally across the MHS.",[30,413,174],"Post Traumatic Stress Disorder PTSD",[415,416,417,418,419,420,421,422,423,424,425,426,427],"Post-Traumatic Stress Disorder (PTSD)","Acceptance and Commitment Therapy (ACT)","Service Members","Trauma","Psychotherapy Modality","Psychiatric Disorders","3,4-Methylenedioxymethamphetamine","MDMA","Active Duty","MDMA-Assisted Therapy","Phase II","Active Controlled","Psychedelic-Assisted Therapy","2026-07-09",{"date":336,"type":41},{"date":263,"type":22},{"date":432,"type":22},"2028-10-01",{"name":434,"class":73},"U.S. Army Medical Research and Development Command",{"id":436,"slug":437,"hasResults":12,"nctId":438,"briefTitle":439,"officialTitle":440,"acronym":441,"eligibilityCriteria":442,"healthyVolunteers":195,"sex":57,"minAge":443,"maxAge":444,"enrollmentInfo":445,"targetDuration":4,"studyType":23,"phases":447,"briefSummary":448,"conditions":449,"keywords":4,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":452,"lastUpdatePostDateStruct":453,"startDateStruct":454,"completionDateStruct":456,"leadSponsor":458,"locationsCount":49},"100608124","adolescent-stress-and-substance-intervention-subsequent-to-trauma-100608124","NCT07197476","Adolescent Stress and Substance Intervention Subsequent to Trauma","Adolescent Injury: Intervening to Prevent Posttraumatic Stress and Substance Use Outcomes","ASSIST","Inclusion Criteria for Youth:\n\n* Must be 12-17 years\n* Fluent in English or Spanish\n* Able to provide informed assent\n* Have a parent able to provide informed consent\n\nInclusion Criteria for Parents:\n\n* Live with an admitted pediatric trauma patient\n* Fluent in English or Spanish\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* Prisoner or in police custody\n* Involvement with child protective services\n* Admitted due to suicide attempt or non-suicidal self-injury\n* Any acute condition that would preclude provision of informed consent or assent","12 Years","17 Years",{"count":446,"type":22},92,[25],"The long-term goal of this study is to address the adoption of the new trauma center requirement to establish best practices of screening for acute stress with an intervention to prevent both adolescent PTSD and substance use. The investigators will develop, refine, and pilot test the Adolescent Stress and Substance Intervention Subsequent to Trauma (ASSIST) video interventions that build upon the American College of Surgeons Committee on Trauma guidelines to improve mental health care during and after hospitalization for traumatic injury. The aims are:\n\nPHASE I - Primary Aim 1: To develop and refine two ASSIST video interventions for adolescents and parents admitted to a level 1 pediatric trauma center.\n\nPHASE II\n\n* Primary Aim 2a: To evaluate the feasibility, acceptability and implementation potential of the ASSIST video interventions.\n* Primary Aim 2b: Develop the ASSIST implementation protocol using a national advisory panel of pediatric trauma center leaders.\n\nParticipants in PHASE 1:\n\nParent and child duo:\n\n* Review storyboards for the video interventions\n* Participate in qualitative interviews at hospital admission and 1 month following discharge\n\nPediatric trauma center clinical staff members:\n\n\\- Complete qualitative interviews\n\nParticipants in PHASE II:\n\nParent and child duo:\n\n* Shown their own video interventions\n* Complete assessments at admission and 1-, 2-, 3- months after discharge",[30,450,451],"Substance Use Disorder (SUD)","Acute Stress Disorder","2026-07-07",{"date":428,"type":41},{"date":455,"type":41},"2026-03-03",{"date":457,"type":22},"2027-04",{"name":459,"class":48},"Rhode Island Hospital",{"id":461,"slug":462,"hasResults":12,"nctId":463,"briefTitle":464,"officialTitle":465,"acronym":4,"eligibilityCriteria":466,"healthyVolunteers":195,"sex":57,"minAge":19,"maxAge":4,"enrollmentInfo":467,"targetDuration":4,"studyType":23,"phases":469,"briefSummary":470,"conditions":471,"keywords":4,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":452,"lastUpdatePostDateStruct":475,"startDateStruct":476,"completionDateStruct":478,"leadSponsor":479,"locationsCount":481},"100581880","improving-behavioral-health-for-caregivers-and-children-after-pediatric-injury-100581880","NCT06856057","Improving Behavioral Health for Caregivers and Children After Pediatric Injury","Improving Quality of Life and Behavioral Health Service Access for Caregivers and Young Children After Pediatric Traumatic Injury","Inclusion Criteria:\n\n* Caregivers (≥18 years old) of children hospitalized with pediatric injury\n* Children hospitalized with pediatric injury \\<12 years old\n* Screen positive on the ASC-Kids (aged 6-11 years) or PDI Caregiver measure of acute distress.\n\nExclusion Criteria:\n\n* A caregiver whose primary language is not English or Spanish\n* A cognitive challenge (caregiver or child) that would impair ability to consent\n* Presence of a self-afflicted injury\n* Presence of injuries resulting from caregiver abuse or neglect (these patients will follow an alternative treatment path).",{"count":468,"type":22},348,[25],"Pediatric traumatic injury (PTI) is a public health priority, with more than 125,000 children experiencing injuries that require hospitalization each year. These children, and their caregivers, are affected in many ways that may affect quality of life, emotional and behavioral health, physical recovery, family roles and routines, and academic functioning; yet US trauma centers do not adequately address these outcomes and a scalable national model of care for these families is needed. This proposal builds on prior research from the investigative team to test a technology-assisted, stepped care behavioral health intervention for children (\\<12 years) and their caregivers after PTI, CAARE (Caregivers' Aid to Accelerate Recovery after pediatric Emergencies), via a hybrid type I effectiveness-implementation trial with 348 families randomly assigned to CAARE (n=174) vs. guideline-adherent enhanced usual care (EUC) (n=174).",[472,30,473,474],"Quality of Life","Depression Not Otherwise Specified","Child Externalizing Behavior",{"date":428,"type":41},{"date":477,"type":41},"2025-05-28",{"date":398,"type":22},{"name":480,"class":48},"Medical University of South Carolina",4,{"id":483,"slug":484,"hasResults":12,"nctId":485,"briefTitle":486,"officialTitle":487,"acronym":4,"eligibilityCriteria":488,"healthyVolunteers":195,"sex":57,"minAge":489,"maxAge":167,"enrollmentInfo":490,"targetDuration":4,"studyType":23,"phases":492,"briefSummary":493,"conditions":494,"keywords":495,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":452,"lastUpdatePostDateStruct":501,"startDateStruct":502,"completionDateStruct":504,"leadSponsor":506,"locationsCount":49},"100459964","phase-2-safety-and-efficacy-of-cannabidiol-cbd-for-symptoms-of-ptsd-in-adults-100459964","NCT05269459","Safety and Efficacy of Cannabidiol (CBD) for Symptoms of PTSD in Adults","Safety and Efficacy of Cannabidiol (CBD) for Symptoms of Post-Traumatic Stress Disorder (PTSD) in Adults Using Liquid StructureTM Formulation (NantheiaTM ATL5).","Inclusion Criteria All Participants\n\n* Ability and willingness to provide informed consent\n* Stated willingness to comply with all study procedures and availability for duration of the study\n* Aged 21-65 years\n* Able to read and communicate in English\n* Tetrahydrocannabinol (THC) use less than 3 days per week\n\nPTSD Participants\n\n* Meets Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnostic criteria for a current diagnosis of Post-Traumatic Stress Disorder (PTSD) on the Mini-Mental State examination (MMS), with symptoms present for at least 1 month\n* Clinician administered Clinical Assessment of Pragmatics (CAPs) score ≥27 at study enrollment and start of Cannabidiol (CBD) observation\n* Stable psychopharmacologic and\u002For psychotherapeutic intervention for 4 weeks prior to enrollment\n\nExclusion Criteria All Participants\n\n* Current use of prescribed or commercially available CBD products, including Epidiolex®\n* Suicidal ideation (as defined by answer of \"yes\" to item 4 or 5 on the baseline Columbia Suicide Severity Rating Scale (C-SSRS) or attempt within 6 months prior to enrollment)\n* Cognitive impairment in the clinical judgment of the investigator that would impact ability to complete study assessments or confound study results (e.g., neurodegenerative condition or other)\n* Meets criteria for substance or alcohol use disorder of moderate or greater severity within 6 months prior to study enrollment based on the Mini-Mental State examination (MMS); nicotine dependence permitted\n* Self-reported cannabis use on \\> 3 days\u002Fweek starting 4 weeks prior to enrollment\n* Positive urine drug screen for illicit substances other than cannabis\n* Pregnant \\[confirmed by serum human chorionic gonadotropin (hCG) test\\], or breastfeeding\n* Co-morbid medical conditions or concomitant treatments that may adversely impact ability to participate in the trial in the clinical judgment of the investigator \\[e.g., significant immunosuppression due to active chemotherapy, recent organ transplant, uncontrolled diabetes, glomerular filtration rate (GFR) \\\u003C 25ml\u002Fmin or on dialysis, recent acute myocardial infarction (MI), Class IV heart failure, or taking any high-risk drugs for drug-drug interactions\\]\n* Treatment with another investigational drug or other intervention within 3 months prior to enrollment\n* History of psychosis (schizophrenia, schizophreniform disorder, schizoaffective disorder, or substance induced psychosis), active bipolar disorder, or borderline personality disorder diagnosed by a mental health professional\n* History of open head injury\n* Self-report of exposure to trauma within 30 days prior to enrollment\n* Active military service in the 30 days prior to enrollment\n* Inpatient psychiatric hospitalization within 6 months prior to enrollment\n* Seizure in the last 6 months\n* Use of concomitant anti-viral human immunodeficiency virus (HIV) medications (PrEP permitted)\n\nControl Participants\n\n* History of diagnosed PTSD\n* Pregnant (self-reported) or breastfeeding\n\nParticipants who consent to functional magnetic resonance imaging (fMRI) procedures\n\n* Claustrophobia, pregnancy, or any condition (e.g., significant hearing difficulties) that would preclude MRI scanning, in the clinical judgment of the investigator\n* Presence of metal objects in or on the body (e.g., pacemakers, aneurysm clips, metallic prostheses, bone plates, braces, orthodontic devices, cochlear implants\u002Fhearing aids, non-removable piercings\u002Fimplants or metallic-ink tattoos, or shrapnel fragments)\n* Other confounding medical conditions (e.g., Tourette's or Tic Disorder) that would preclude MRI scanning, in the clinical judgement of the investigator\n\nPTSD Participants\n\n* Index trauma before age 18 and no other traumatic experiences which could relate\u002Fidentify as part of PTSD\n* History of allergic reaction or significant adverse events (AE) related to cannabis, CBD, or THC\n* Currently involved in events giving rise to PTSD\n* Alanine transaminase (ALT)\u002FAspartate transaminase (AST)\u002FBilirubin \\> 2 x upper limit of normal (ULN) at screening (abnormalities on the comprehensive metabolic panel or complete blood count deemed to be of clinical significance in the judgement of the investigator and clinical team will be evaluated in the clinical context of the participant's history and physical examination to determine eligibility and testing may be repeated if clinically appropriate at the discretion of the investigator)\n* Refusal to use at least one form of birth control throughout study participation \\[including, but are not limited to, male or female condoms, diaphragm, or cervical cap (all with or without spermicide) abstinence, or hormonal\u002Fimplanted birth control, e.g., pill, injection, intra-uterine device (IUD), implant\\] by participants who can become pregnant","21 Years",{"count":491,"type":22},180,[85],"Post-traumatic stress disorder (PTSD) is a psychiatric disorder than may develop following a traumatic event including serious incidents, natural or human-caused disasters, violence, death of a loved one, receipt of traumatic news, or serious illness\u002Fhospitalization. While half of US adults experience trauma in their lifetime, most do not develop PTSD. However, those who do develop the disorder may have significant impairments and risk for functional dysfunction across multiple domains. While short term symptoms are the most common, some individuals develop chronic PTSD. These individuals may experience frightening and intrusive thoughts and memories of the event (flashbacks), have sleep disturbances, feel numb or detached, and be easily startled (hypervigilance).\n\nThis trial is a double-blind placebo controlled study of cannabidiol (CBD) for symptoms of PTSD in adults using liquid structure Formulation (Nantheia ATL5). Participants complete three weeks of baseline data collection including assessments of activity and sleep. Intervention is Nantheia ATL5 or placebo. Dose is initiated at 400mg BID and maintained over 8 weeks. Standardized symptom profile measurements, clinician assessments, laboratory testing, collection of inflammatory biomarkers, and suicide screening is completed throughout. Age- and gender-matched healthy population participants are enrolled and complete baseline data collection only. All participants may complete optional functional magnetic resonance imaging (fMRI).",[30],[30,496,497,472,498,499,500],"CBD","Nantheia ATL5","Mobility","Tolerability","Cannabidiol",{"date":428,"type":41},{"date":503,"type":41},"2022-12-01",{"date":505,"type":22},"2029-04",{"name":507,"class":48},"University of Nebraska",{"id":509,"slug":510,"hasResults":12,"nctId":511,"briefTitle":512,"officialTitle":513,"acronym":4,"eligibilityCriteria":514,"healthyVolunteers":12,"sex":57,"minAge":19,"maxAge":167,"enrollmentInfo":515,"targetDuration":4,"studyType":23,"phases":517,"briefSummary":518,"conditions":519,"keywords":4,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":521,"lastUpdatePostDateStruct":522,"startDateStruct":524,"completionDateStruct":526,"leadSponsor":528,"locationsCount":353},"100631343","phase-2-safety-and-efficacy-of-hb-1-for-post-traumatic-stress-disorder-100631343","NCT07499440","Safety and Efficacy of HB-1 for Post-Traumatic Stress Disorder","Safety and Efficacy of HB-1 for PTSD: A Multi-center, Randomized, Double-Blind, Placebo-Controlled Study","Inclusion Criteria:\n\n* Male or female aged 18 to 65 years old, inclusive, at the time of informed consent.\n* Meets DSM-V Criteria for PTSD.\n* Minimum CAPS-5 score of at least 26 (based on the optimal diagnostic correspondence in the definitive CAPS-5 psychometric validation study).\n* Clinically stable on current medication and\u002For therapy regimen for at least 2 months, as determined by Investigator.\n* Willing to remain on current doses of other psychiatric medications throughout the length of the trial.\n* Willing and able to safely stop any medications that are contraindicated to be taken together with HB-1, as determined by Investigator.\n* Fluent in English.\n* Willing to take HB-1.\n* Willing and able to provide informed consent indicating an understanding of the requirements of the study and a willingness to comply with scheduled visits and all study procedures.\n* Female subjects must be surgically sterile (or have a monogamous partner who is surgically sterile) or be at least 2 years postmenopausal or agree to commit to use acceptable forms of birth control (defined as the use of an intrauterine device, a barrier method with spermicide, condoms, any form of hormonal contraceptives, or abstinence) for the duration of the study. Investigator shall use discretion and familiarity with subject's preferred and usual lifestyle to understand if reporting of abstinence may be trusted to achieve 100% effectiveness. Male subjects must be sterile (biologically or surgically) or commit to the use of a reliable method of birth control (condoms with spermicide) for the duration of the study and for 4 months following the last dose of study treatment. Individuals who are involved exclusively in same-sex relationships are exempt from the birth control requirements but must agree to abide by the recommendations if they do engage in a heterosexual relationship.\n* Female subjects who are women of childbearing potential (WOCBP) must have a negative pregnancy test at Screening within 7 days of dosing with study treatment.\n\nExclusion Criteria:\n\n* Any ongoing concomitant disease, condition, or treatment that could interfere with the conduct of the study, or that would, in the opinion of the Investigator or Sponsor, pose an unacceptable risk to the participant in the study or interfere with the interpretation of study data.\n* Ongoing treatment with benzodiazepines (e.g. alprazolam, diazepam, clonazepam, lorazepam) or opiates (e.g., codeine, morphine) as assessed by clinical interview and urine toxicology testing.\n* Ongoing treatment with any medication that has a clinically significant drug-drug interaction with either telmisartan or verapamil, per the verapamil SR and telmisartan FDA labels and per standard drug interaction compendia. These include but are not limited to: Inhibitors or inducers of cytochrome P450 (CYP)3A4 (including certain β-hydroxy β-methylglutaryl-CoA \\[HMG-CoA\\] reductase inhibitors), Ivabradine, Antihypertensive Agents (including Beta Blockers), Antiarrhythmic Agents, Lithium, Carbamazepine, Rifampin, Phenobarbital, cyclosporin, theophylline, Inhalation Anesthetics, Neuromuscular Blocking Agents, Telithromycin, mTOR inhibitors as well as strong P-glycoprotein inhibitors (e.g., macrolides, ritonavir, itraconazole, ketoconazole, cyclosporin, ritonavir, and ivermectin).\n* Diagnosis of Severe Substance Use Disorder, Obsessive-Compulsive Disorder (OCD), Bipolar I, Bipolar II disorder, or Psychotic disorder (per SCID-V) or Borderline Personality Disorder (per Short-Bord).\n* Active suicidal ideation and behavior (Columbia-Suicide Severity Rating Scale \\[C-SSRS\\] score ≥ 4 at Screening, or who has made a serious suicide attempt in the last 3 months).\n* Severe uncontrolled cardiac disease within 6 months of Screening, including but not limited to: severe uncontrolled hypertension, hypotension (below 90\u002F60 mmHg); unstable angina; myocardial infarction (MI) or cerebrovascular accident (CVA).\n* Any clinically significant electrocardiogram (ECG) abnormalities at screening.\n* Inadequate hepatic function defined as total bilirubin \\> 1.5 × the upper limit of normal (ULN) ranges of each institution, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\> 3 × the ULN range of each institution.\n* Inadequate renal function defined as serum creatinine \\> 1.5 × the ULN range of each institution and\u002For estimated glomerular filtration rate (eGFR) \\\u003C 60 mL\u002Fmin.\n* Any clinically significant abnormalities in clinical laboratory assessments as assessed by the Investigator.\n* Already on treatment with either telmisartan or verapamil or both.\n* Documented contraindication to taking telmisartan or verapamil: (eg, prior drug allergy, Duchenne's muscular dystrophy, myasthenia gravis).\n* Pregnant or breastfeeding.\n* Participation in another current clinical trial or prior trial within the last three months.\n* Urinalysis evidence of exposure to substances that may interfere with HB-1 testing (per investigator discretion).",{"count":516,"type":22},200,[85],"The purpose of this study is to determine the safety and efficacy of HB-1, versus placebo in male and female adult patients aged 18 to 65 years, inclusive, with Post-Traumatic Stress Disorder (PTSD).",[30,520],"Mental Illness","2026-07-01",{"date":523,"type":41},"2026-07-06",{"date":525,"type":22},"2026-06",{"date":527,"type":22},"2027-10",{"name":529,"class":132},"HB BioTech, LLC",{"id":531,"slug":532,"hasResults":12,"nctId":533,"briefTitle":534,"officialTitle":535,"acronym":536,"eligibilityCriteria":537,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":538,"targetDuration":4,"studyType":23,"phases":540,"briefSummary":541,"conditions":542,"keywords":543,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":546,"lastUpdatePostDateStruct":547,"startDateStruct":548,"completionDateStruct":550,"leadSponsor":552,"locationsCount":49},"100585485","phase-2-psilocybin-assisted-therapy-for-sexual-assault-related-ptsd-100585485","NCT06902974","Psilocybin-Assisted Therapy for Sexual Assault-Related PTSD","A Phase 2, Open-Label Study Investigating the Safety and Efficacy of Psilocybin-Assisted Therapy for Sexual Assault-Related Posttraumatic Stress Disorder (PTSD)","SUN004","Inclusion Criteria:\n\n* Cisgender women who are at least 18 years old.\n* Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for current PTSD secondary to sexual assault (i.e., index trauma is sexual assault that occurred 6 or more months in the past).\n* CAPS-5 score of 25 or higher at Baseline.\n* Are able to swallow pills.\n* Are willing to be driven home after the Dosing Session with a family member or caregiver or trusted transportation.\n* Are able to complete all protocol-required assessment tools without any assistance or alteration to the copyrighted assessments, and to comply with all study visits.\n* If able to become pregnant (i.e., with uterus and associated reproductive organs, fertile, following menarche and until becoming post-menopausal unless permanently sterile), must have a highly sensitive negative pregnancy test at study entry and prior to the Dosing Session, and must agree to use adequate birth control through 10 days after the Dosing Session if sexually active with a biologically male partner. Adequate birth control methods include intrauterine device (IUD), injected, implanted, intravaginal, or transdermal hormonal methods, abstinence, oral hormones plus a barrier contraception, vasectomized sole partner, or double barrier contraception. Two forms of contraception are required with any barrier method or oral hormones (i.e. condom plus diaphragm, condom or diaphragm plus spermicide, oral hormonal contraceptives plus spermicide or condom).\n* Must agree to inform the clinical investigators within 48 hours of any medical conditions and procedures.\n* Are proficient in speaking and reading English.\n* Agree to have all clinic visit sessions recorded to audio and\u002For video. Participants may opt out of the data analysis of the recordings.\n* Agree to the following lifestyle modifications: a light breakfast 2 to 3 hours before dosing is permitted, however, participants will refrain from caffeine and nicotine 2 hours prior to dosing sessions and at least 6 hours after dosing, abstain from alcohol for 24 hours prior to dosing, not enroll in any other interventional clinical studies during the duration of the study, be driven home after the Dosing Session, and commit to medication dosing, therapy, and study procedures.\n* Agree to refrain from beginning new medication and\u002For psychotherapy treatment.\n* Continued treatment with SSRIs will be permitted if participants have been on a stable dose for 3 months or longer prior to enrollment. However, participants must be tapered off of monoamine oxidase inhibitors (MAOIs) prior to dosing.\n\nIn addition, participants may remain in stable (\\> 3 months) psychotherapy.\n\n* May have well-controlled hypertension that has been successfully treated with anti-hypertensive medicines.\n* May have asymptomatic Hepatitis C virus (HCV) that has previously undergone evaluation and treatment as needed.\n* May have alcohol or substance use disorder if participant is not in withdrawal or requiring detox. Participants must have a plan, agreed upon by the principal investigator or designated physician, to reduce use of alcohol or other substances and to manage symptoms without self-medicating. Enrollment will require that, in the judgment of the principal investigator or designated physician, the plan for decreasing substance use is realistic and has a good chance of succeeding in order to prevent substance use from impacting the safety or efficacy of the investigational treatment.\n* May have a history of or current Diabetes Mellitus (Type 2) if additional screening measures rule out underlying cardiovascular disease, if the condition is judged to be stable on effective management, and with approval by the principal investigator or designated physician.\n* May have hypothyroidism if taking adequate and stable thyroid replacement medication.\n\nExclusion Criteria:\n\n* Male\n* Condition impairing oral intake or digestive absorption.\n* Are not able to give adequate informed consent.\n* Significant suicide risk as defined by suicidal ideation with intend and a plan as endorsed on items 5 on the C-SSRS within the past 3 months\n* Have any current problem which, in the opinion of the principal investigator or designated physician, might interfere with participation.\n* Would present a serious risk to others as established through clinical interview and contact with treating therapist.\n* Have a history of, or a current primary, schizophrenia, schizoaffective disorder or any form of psychotic disorder, major depressive disorder with psychotic features, bipolar affective disorder type 1, or personality disorders.\n* Require ongoing concomitant therapy with a psychiatric medication with exceptions described below (see Section 6.6).\n* Have received Electroconvulsive Therapy (ECT) within 12 weeks of enrollment.\n* Have evidence or history of recent stroke (\\\u003C 6 months from signing of ICF), recent myocardial infarction (\\\u003C 6 months from signing of ICF), or clinically significant arrhythmia within 1 year of signing the ICF.\n* Have evidence or history of significant (controlled or uncontrolled) hematological, endocrine, cerebrovascular, cardiovascular, coronary, pulmonary, renal, gastrointestinal, immunocompromising, or neurological disease, including seizure disorder, or any other medical disorder judged by the investigator to significantly increase the risk of psilocybin administration.\n* Have uncontrolled hypertension using the standard criteria of the American Heart Association (values of 140\u002F90 milligrams of Mercury \\[mmHg\\] or higher).\n* Abnormal and clinically significant results on vital signs, ECG, or laboratory tests at screening and baseline\n* Have symptomatic liver disease.\n* Are pregnant, nursing, or able to become pregnant and are not practicing an effective means of birth control if sexually active with a biologically male partner.\n* Have hypersensitivity to any ingredient of the study drug.\n* Positive urine drug screen for illicit drugs or drugs of abuse prior to the Dosing Session. Any positive urine drug test will be reviewed with participants to determine the pattern of use and eligibility will be determined at the investigator's discretion.\n* Current enrollment in any investigational drug or device study or participation in such within 30 days of screening.\n* Other personal circumstances and behavior judged to be incompatible with establishment of rapport or safe exposure to psilocybin or completion of clinical study procedures (e.g., active participation in legal proceedings).",{"count":539,"type":22},70,[85],"A Phase 2, Open-Label Study to explore the efficacy, safety, and tolerability of psilocybin-assisted therapy in women with sexual assault-related Posttraumatic Stress Disorder (PTSD).",[174,30],[30,544,123,545],"sexual assault","posttraumatic stress disorder","2026-06-30",{"date":521,"type":41},{"date":549,"type":41},"2026-05-23",{"date":551,"type":22},"2028-05",{"name":553,"class":48},"Sunstone Medical",{"id":555,"slug":556,"hasResults":12,"nctId":557,"briefTitle":558,"officialTitle":559,"acronym":4,"eligibilityCriteria":560,"healthyVolunteers":12,"sex":57,"minAge":19,"maxAge":4,"enrollmentInfo":561,"targetDuration":4,"studyType":23,"phases":563,"briefSummary":564,"conditions":565,"keywords":566,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":572,"lastUpdatePostDateStruct":573,"startDateStruct":574,"completionDateStruct":576,"leadSponsor":577,"locationsCount":578},"100474444","testing-adaptive-interventions-to-improve-posttraumatic-stress-disorder-treatment-outcomes-in-federally-qualified-health-centers-100474444","NCT05457985","Testing Adaptive Interventions to Improve Posttraumatic Stress Disorder Treatment Outcomes in Federally Qualified Health Centers","Testing Adaptive Interventions to Improve Posttraumatic Stress Disorder (PTSD) Treatment Outcomes in Federally Qualified Health Centers","Inclusion Criteria:\n\n* Receive care at a participating federally qualified health center (FQHC)\n* Have a Posttraumatic Stress Disorder checklist (PCL-5) score greater or equal (≥) to 33\n* Own a mobile device that can be used for the PTSD Coach App\n* Have had psychotropic medication stability for at least 4 weeks\n\nExclusion Criteria:\n\n* Severe cognitive impairment that in the judgment of the investigators makes it unlikely that the participant can adhere to the study regimen (as evidenced by confusion, inability to track discussion or answer questions, or other clear and significant indicators of cognitive impairment)\n* High risk of suicide (defined as meeting criteria for Action Step 3 on the Participant Suicide Risk Screening form\n* Severe alcohol or substance use disorder (moderate-severe alcohol use disorder on Alcohol Use Disorders Identification Test (AUDIT) (scores ≥ 15) or high risk on National Institute on Drug Abuse Quick Screen (scores ≥ 27))\n* Active psychosis or unmanaged bipolar disorder\n* Unstable housing\n* Current engagement in a trauma-focused behavioral treatment (such as Prolonged Exposure or Cognitive Processing Therapy).\n* Patients who do not speak English will be excluded for logistical reasons.",{"count":562,"type":22},430,[25],"This trial is being completed to develop a stepped-care talk therapy model for patients with PTSD. Specifically, this study is testing whether beginning with one type of therapy is better than beginning with another type of therapy, and whether moving to a different therapy after four sessions is more helpful than staying with the same therapy, depending on how well it is working.\n\nThe central hypothesis is that beginning with a low- or medium-intensity PTSD intervention and then titrating intensity based on early indications of response will result in clinically significant PTSD symptom reduction with parsimony of resources.",[30],[567,568,569,570,571],"Prolonged Exposure for Primary Care","Mobile device","Clinician Supported PTSD Coach App","PTSD symptoms","Prolonged Exposure\u002FPE","2026-06-29",{"date":521,"type":41},{"date":575,"type":41},"2022-06-23",{"date":156,"type":22},{"name":47,"class":48},13,{"id":580,"slug":581,"hasResults":12,"nctId":582,"briefTitle":583,"officialTitle":583,"acronym":4,"eligibilityCriteria":584,"healthyVolunteers":12,"sex":57,"minAge":19,"maxAge":4,"enrollmentInfo":585,"targetDuration":4,"studyType":23,"phases":586,"briefSummary":587,"conditions":588,"keywords":590,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":593,"lastUpdatePostDateStruct":594,"startDateStruct":596,"completionDateStruct":598,"leadSponsor":600,"locationsCount":49},"100645264","examining-the-efficacy-of-short-term-intensive-ptsd-treatment-on-psychological-and-cognitive-impairment-symptoms-100645264","NCT07680517","Examining the Efficacy of Short-Term Intensive PTSD Treatment on Psychological and Cognitive Impairment Symptoms","Inclusion Criteria:\n\n-Treatment-seeking military personnel (i.e., any assigned or aligned JSOC personnel) who meet diagnostic criteria for PTSD or subthreshold PTSD (i.e., meeting diagnostic threshold for 3 of 4 symptom criteria who are (1) 18 years of age or older; (2) current diagnosis of PTSD or subthreshold PTSD (i.e. meeting diagnostic criteria for 3 of 4 symptom criteria, assessed using the DIAMOND); (3) current military personnel; (4) ability to speak and understand the English language; and (5) ability to complete the informed consent process\n\nExclusion Criteria:\n\n* (1) substance use disorder requiring medical management; (2) imminent suicide risk warranting inpatient hospitalization or suicide-focused treatment; and (3) impaired mental status that precludes the ability to provide informed consent (e.g., intoxication, psychosis, mania).",{"count":140,"type":22},[25],"Our long-term goal is to provide rapid and sustained reductions of trauma and cognitive-related symptoms among Special Operations personnel with PTSD or subthreshold PTSD. The primary objective of this project is to examine the effectiveness of massed PTSD treatment (i.e., CPT and EMDR) in \"real-world\" military settings. CPT and EMDR are both empirically supported psychotherapies for PTSD. To accomplish this objective, we will enroll military personnel meeting diagnostic criteria for PTSD or subthreshold PTSD (i.e., meeting threshold levels for 3 of 4 symptom criteria).",[30,589],"Cognitive Performance",[30,591,592],"CPT","Military","2026-06-25",{"date":595,"type":41},"2026-07-02",{"date":597,"type":41},"2026-04-01",{"date":599,"type":22},"2028-08",{"name":601,"class":48},"Ohio State University",{"id":603,"slug":604,"hasResults":12,"nctId":605,"briefTitle":606,"officialTitle":606,"acronym":4,"eligibilityCriteria":607,"healthyVolunteers":12,"sex":57,"minAge":19,"maxAge":4,"enrollmentInfo":608,"targetDuration":4,"studyType":23,"phases":609,"briefSummary":610,"conditions":611,"keywords":4,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":614,"lastUpdatePostDateStruct":615,"startDateStruct":616,"completionDateStruct":618,"leadSponsor":620,"locationsCount":49},"100538044","enhancing-the-effectiveness-of-prolonged-exposure-among-suicidal-individuals-with-ptsd-100538044","NCT06285708","Enhancing the Effectiveness of Prolonged Exposure Among Suicidal Individuals With PTSD","Inclusion Criteria:\n\n* Current diagnosis of PTSD or subthreshold PTSD; ability to speak and understand the English language; and ability to complete the informed consent process.\n\nExclusion Criteria:\n\n* Substance use disorder requiring medical management; imminent suicide risk warranting inpatient hospitalization or suicide-focused treatment; and impaired mental status that precludes the ability to provide informed consent (e.g., intoxication, psychosis, mania).",{"count":301,"type":22},[25],"The long-term goal of this study is to reduce suicidal thoughts and behaviors among treatment-seeking individuals who also have posttraumatic stress disorder (PTSD). Prolonged exposure (PE) and crisis response plan (CRP) have demonstrated empirical support for reducing suicide attempts as compared to treatment as usual. However, no studies to date have assessed their effectiveness when used in combination. In light of this knowledge gap, the primary objective of this study will be to test the effectiveness of PE augmented with CRP as compared to PE with care as usual (self-guided treatment plan), an active comparator, for the reduction of suicide ideations and attempts for individuals with comorbid PTSD.",[30,31,612,613],"Suicide, Attempted","Trauma, Psychological","2026-06-24",{"date":572,"type":41},{"date":617,"type":41},"2024-02-26",{"date":619,"type":22},"2027-06",{"name":601,"class":48},{"id":622,"slug":623,"hasResults":12,"nctId":624,"briefTitle":625,"officialTitle":626,"acronym":4,"eligibilityCriteria":627,"healthyVolunteers":12,"sex":57,"minAge":19,"maxAge":167,"enrollmentInfo":628,"targetDuration":4,"studyType":23,"phases":629,"briefSummary":630,"conditions":631,"keywords":633,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":636,"lastUpdatePostDateStruct":637,"startDateStruct":639,"completionDateStruct":640,"leadSponsor":642,"locationsCount":49},"100545753","phase-2-psilocybin-assisted-cognitive-processing-therapy-for-chronic-ptsd-100545753","NCT06386003","Psilocybin-Assisted Cognitive Processing Therapy for Chronic PTSD","Psilocybin-Assisted Massed Cognitive Processing Therapy for Chronic Posttraumatic Stress Disorder: An Open-label Trial","Inclusion Criteria:\n\n1. Meet Diagnostic and Statistical Manual-5th edition (DSM-5) criteria for current PTSD with a duration of 6 months or longer assessed by study psychiatrist;\n2. Have a Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) score of 50 or higher, indicating moderate to severe PTSD symptoms;\n3. Are willing to refrain from taking any psychiatric medications during the study period.\n\nExclusion Criteria:\n\n1. Are pregnant or nursing, or are women of child bearing potential who are not practicing an effective means of birth control;\n2. Have a history of or a current primary diagnosis of psychotic disorder, schizophrenia, delusional disorder, borderline personality disorder, schizoaffective disorder, bipolar disorder or, dissociative identity disorder;\n3. Have evidence or history of coronary artery disease or cerebral or peripheral vascular disease, hepatic disease with abnormal liver enzymes, or any other medical disorder judged by the investigator to significantly increase the risk of psilocybin administration;\n4. Have hypertension using the standard criteria of the American Heart Association (values of 140\u002F90 or higher assessed on three separate occasions;\n5. History of seizure disorder;\n6. Uncontrolled insulin-dependent diabetes;\n7. Recent stroke, intracranial or subarachnoid hemorrhage (\\\u003C 1 year from signing of informed consent form \\[ICF\\]), recent myocardial infarction (\\\u003C 1 year from signing of ICF), clinically significant arrhythmia (\\\u003C 1 year from signing of ICF);\n8. Have liver disease with the exception of asymptomatic subjects with Hepatitis C who have previously undergone evaluation and successful treatment;\n9. Lifetime history of substance-induced psychosis;\n10. Lifetime history of substance use disorder with a hallucinogen;\n11. History of alcohol use disorder in the past 3 months.",{"count":353,"type":22},[85],"This is an open-label trial evaluating feasibility, tolerability, safety and efficacy of psilocybin assisted cognitive processing therapy for chronic Posttraumatic Stress Disorder (PTSD).",[174,30,632],"Chronic PTSD",[174,634,635],"Psilocybin","Cognitive Processing Therapy","2026-06-22",{"date":638,"type":41},"2026-06-26",{"date":525,"type":22},{"date":641,"type":22},"2027-01",{"name":643,"class":48},"Unity Health Toronto",{"id":645,"slug":646,"hasResults":12,"nctId":647,"briefTitle":648,"officialTitle":648,"acronym":4,"eligibilityCriteria":649,"healthyVolunteers":12,"sex":57,"minAge":19,"maxAge":81,"enrollmentInfo":650,"targetDuration":4,"studyType":23,"phases":652,"briefSummary":653,"conditions":654,"keywords":4,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":655,"lastUpdatePostDateStruct":656,"startDateStruct":657,"completionDateStruct":659,"leadSponsor":660,"locationsCount":49},"100641178","exposure-by-assessment-effects-of-daily-amq-based-ema-of-an-intrusive-trauma-memory-in-ptsd-100641178","NCT07658157","Exposure by Assessment: Effects of Daily AMQ-Based EMA of an Intrusive Trauma Memory in PTSD","Inclusion Criteria:\n\n* Adults aged 18-70\n* Posttraumatic stress disorder\n* intrusive symptoms.\n\nExclusion Criteria:\n\n* Psychotic or bipolar disorder\n* Heavy use of drugs or alcohol\n* Prominent personality disorder\n* Significant risk of harm to self or others\n* Current trauma-focused treatment\n* Reporting intrusions as thoughts only rather than as memories",{"count":651,"type":22},50,[25],"Intrusive re-experiencing is a hallmark of PTSD. The study applies ecological momentary assessment (EMA) of participants' trauma memories (active group) vs. EMA of a neutral memory (control group) to test whether the active intervention can reduce intrusive symptoms severity and overal PTSD symptom severity in general.",[30],"2026-06-20",{"date":593,"type":41},{"date":658,"type":41},"2026-06-14",{"date":619,"type":22},{"name":661,"class":48},"Tel Aviv University"]