[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ptsd-post-traumatic-stress-disorder\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ptsd-post-traumatic-stress-disorder":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,51,85,114],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100536556","targeted-plasticity-therapy-for-ptsd-100536556",false,"NCT06266364","Targeted Plasticity Therapy for PTSD","Targeted Plasticity Therapy for the Treatment of Post-Traumatic Stress Disorder","Inclusion Criteria:\n\n1. Diagnosis of chronic PTSD for at least 3 months based on DSM-5 criteria\n2. In the medical opinion of the Principal Investigator (PI), failed at least one adequate course of first-line PTSD treatment per American Psychological Association (APA) guidelines\n3. PCL-5 score greater than 33\n4. Age 22-79 years\n5. Appropriate surgical candidate for VNS device implantation\n6. Willing and able to comply with study protocol\n7. Able to provide informed consent.\n\nExclusion Criteria:\n\n1. Currently undergoing prolonged exposure therapy elsewhere\n2. Concurrent participation in another interventional clinical trial\n3. Prior injury to vagus nerve\n4. Prior or current treatment with vagus nerve stimulation\n5. Psychiatric disorders and\u002For cognitive impairments that would interfere with study participation, as assessed by medical evaluation\n6. Moderate-High Risk of Suicide according to Columbia - Suicide Severity Rating Scale (C-SSRS) Screen Version\n7. Persons with a current or past: (a) medical (psychiatric, non-psychiatric) condition, disease, disorder, injury, or disability or (b) non-medical situation or circumstance that, in the opinion of the principal investigator, study participation:\n\n   * may pose a significant or undue risk to the person,\n   * make it unlikely the person will complete all the study requirements per protocol, or\n   * may adversely impact the integrity of the data or the validity of the study results\n8. Persons with a neck circumference larger than 18.5 inches\n9. Females of childbearing potential who are either pregnant or planning to become pregnant and who are not using, or will not agree to use medically acceptable birth control methods\n10. Non-English speaking\n11. As determined by the principal investigator, is under current incarceration or legal detention","ALL","22 Years","79 Years",{"count":20,"type":21},20,"ESTIMATED","INTERVENTIONAL",[24],"NA","Objectives of this study are to provide continued safety assessment for the ReStore system, and to gain further estimates of the effect size of Vagus Nerve Stimulation (VNS) therapy with Prolonged Exposure Therapy (PE) compared to PE with placebo (sham) stimulation in participants with posttraumatic stress disorder (PTSD)",[27],"PTSD, Post Traumatic Stress Disorder",[29,30,31,32,33,34,35,36,37],"PTSD, Post-Traumatic Stress Disorder","VNS, Vagus Nerve Stimulation","TPT, Targeted Plasticity Therapy","ReStore System","PE, Prolonged Exposure Therapy","Trauma and Stressor Related Disorders","Mental Disorders","Stress Disorders, Traumatic","Stress Disorders, Post-Traumatic","RECRUITING","2026-06-04",{"date":41,"type":42},"2026-06-08","ACTUAL",{"date":44,"type":42},"2024-12-30",{"date":46,"type":21},"2028-06",{"name":48,"class":49},"The University of Texas at Dallas","OTHER",3,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":16,"minAge":59,"maxAge":4,"enrollmentInfo":60,"targetDuration":4,"studyType":22,"phases":62,"briefSummary":65,"conditions":66,"keywords":70,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":4},"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","18 Years",{"count":61,"type":21},300,[63,64],"PHASE2","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.",[67,68,69,27],"PTSD - Post Traumatic Stress Disorder","PTSD","PTSD Symptoms",[71,72,57,68,73],"COMP360","psilocybin","trauma","NOT_YET_RECRUITING","2026-05-08",{"date":77,"type":42},"2026-05-12",{"date":79,"type":21},"2026-09",{"date":81,"type":21},"2029-09",{"name":83,"class":84},"COMPASS Pathways","INDUSTRY",{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":4,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":92,"minAge":4,"maxAge":4,"enrollmentInfo":93,"targetDuration":4,"studyType":22,"phases":95,"briefSummary":96,"conditions":97,"keywords":99,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":113},"100546388","phase-3-examining-34-methylenedioxymethamphetamine-mdma-effects-on-psychological-relational-and-hyperarousal-related-neural-reactivity-mechanisms-in-veterans-with-ptsd-and-moral-injury-100546388","NCT06394284","Examining 3,4-methylenedioxymethamphetamine (MDMA) Effects on Psychological, Relational and Hyperarousal-Related Neural Reactivity Mechanisms in Veterans With PTSD and Moral Injury","IISPT2: Examining 3,4-methylenedioxymethamphetamine (MDMA) Effects on Psychological, Relational and Hyperarousal-Related Neural Reactivity Mechanisms in Veterans With PTSD and MI","Inclusion Criteria:\n\n* 1\\. Were assigned male sex at birth and currently identify as a male (e.g. are not transgender nor taking hormone replacement therapy) 2. Are veterans of the Israeli military 3. Are at least 18 years old. 4. Are fluent in speaking and reading Hebrew 5. Are able to swallow pills. 6. Agree to have EEG (three times) and salivary monitoring (during experimental sessions) at multiple occasions throughout the study.\n\n  7\\. Agree to have study visits recorded, including Experimental Sessions, Independent Rater assessments, and non-drug therapy sessions.\n\n  8\\. Must provide a contact (relative, spouse, close friend or other support person) who is willing and able to be reached by the investigators in the event of a participant becoming unwell or unreachable.\n\n  8\\. Must agree to inform the investigators within 48 hours of any medical conditions and procedures.\n\n  9\\. Agree to the following lifestyle modifications: comply with requirements for fasting and refraining from certain medications prior to experimental sessions, not enroll in any other interventional clinical trials during the duration of the study, remain overnight at the study site after each experimental Session and be driven home after, and commit to medication dosing, therapy, and study procedures.\n\nMedical History\n\n10\\. At Screening, meet diagnostic criteria (Diagnostic Statisticians Manual, 5th version, DSM-5) for current military-based PTSD with a symptom duration of 6 months or longer with a history of at least one attempt at psychiatric or psychological treatment.\n\n11\\. At Screening, have a PCL-5 total score of 33 or greater and at Screening\u002FBaseline a confirmed diagnosis of PTSD per CAPS-5 and a total severity score of 28 or greater.\n\n12\\. Have a body weight of at least 45 kilograms. Participants with a body weight of 45 to 48 kg must also have a body mass index (BMI) within the range of 18 to 30 kg\u002Fm2.\n\n13\\. Capable of giving signed informed consent.\n\nExclusion Criteria:\n\n\\- Medical Conditions\n\n1. Alanine transaminase (ALT) \\[or aspartate transaminase (AST)\\]higher than 2 x upper limit of normal (ULN).\n2. Total bilirubin higher than 1.5 x ULN (isolated bilirubin higher than; 1.5 x ULN is acceptable if total bilirubin is fractionated and direct bilirubin less than; 35%).\n3. Current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis.\n\n   • Note: Stable chronic liver disease (including Gilbert's syndrome, asymptomatic gallstones, and chronic stable hepatitis B (e.g., the presence of hepatitis B surface antigen or positive hepatitis C antibody test result without evidence of active infection at screening or within 3 months prior to starting study intervention) is acceptable if the participant otherwise meets entry criteria.\n4. Have a recent history of clinically significant hyponatremia or hyperthermia.\n5. Have a marked baseline QTcF (QT interval corrected for heart rate ) interval higher than 450 ms demonstrated on repeated ECG (electrocardiogram) assessments. Participants whose QTcF exceeds this value during screening may be initially enrolled if a pre-study concomitant medication is suspected to be prolonging the QT-interval. ECGs should be repeated after initial enrollment and tapering off the pre-study concomitant medication to ensure the participant meets eligibility criteria prior to enrolment confirmation and to IMP dosing.\n\n   • Note: The QTcF is the QT interval corrected for heart rate according to Fridericia's formula. It is either machine-read or manually over-read.\n6. Have a 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 myocardial infarction, cerebrovascular accident, heart failure, severe coronary artery disease, or aneurysm.\n\n   * Participants with other mild, stable chronic medical problems may be enrolled if the study clinician and Sponsor Investigator (S-I) agree the condition would not significantly increase the risk of MDMA administration or be likely to produce significant symptoms during the study that could interfere with study participation or be confused with side effects of MDMA.\n   * Examples of stable medical conditions that could be allowed include but are not limited to human immunodeficiency virus (HIV) infection, gastroesophageal reflux disease (GERD), hypothyroidism (if taking adequate and stable thyroid replacement medication), glaucoma (if approval for study participation is received from an ophthalmologist). Any medical disorder judged by the investigator to significantly increase the risk of harm from MDMA exposure by any mechanism would require exclusion.\n7. Have a diagnosis of uncontrolled hypertension, defined as repeated blood pressure readings of ≥140 mmHg systolic or ≥90 mmHg diastolic. The diagnosis may be confirmed by repeated clinic measurements or home blood pressure monitoring if clinically indicated.\n\n   • Participants with well-controlled hypertension that has been successfully treated with anti-hypertensive medicines may be enrolled if they pass a risk assessment and potentially additional screening to rule out underlying cardiovascular disease.\n8. Have a history of ventricular arrhythmia at any time, other than occasional premature ventricular contractions (PVCs) in the absence of ischemic heart disease.\n9. Have Wolff-Parkinson-White syndrome or any other accessory pathway that has not been successfully eliminated by ablation.\n10. Have a history of arrhythmia, other than premature atrial contractions (PACs) or occasional PVCs in the absence of ischemic heart disease, within 12 months of screening.\n\n    • Participants with a history of atrial fibrillation, atrial tachycardia, atrial flutter or paroxysmal supraventricular tachycardia or any other arrhythmia associated with a bypass tract may be enrolled only if they have been successfully treated with ablation and have not had recurrent arrhythmia for at least one year off all antiarrhythmic drugs, as confirmed by a cardiologist.\n11. Have a history of additional risk factors for Torsade de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome).\n\n    Psychiatric Conditions (for MDMA-AT and somatic-based arms)\n12. Have engaged in a new form of psychiatric or mental health care within 12 weeks of enrollment, including Electroconvulsive Therapy (ECT), and ketamine-assisted therapy.\n13. Are likely, in the investigator's opinion and via observation during the Preparatory Period, to be re-exposed to their index trauma or other significant trauma during the study.\n14. Have a current moderate (not in early remission in the 3 months prior to enrollment and meets at least 5 of 11 diagnostic criteria per DSM-5) or severe alcohol or cannabis use disorder within the 12 months prior to enrollment (meets at least 6 of 11 diagnostic criteria per DSM-5).\n\n    • May have current mild alcohol or cannabis use disorder (meets 3 of 11 diagnostic criteria per DSM-5) or moderate alcohol or cannabis use disorder in early remission for the 3 months prior to enrollment (meets 4 or 5 of 11 diagnostic criteria per DSM-5).\n15. Have an active illicit drug (other than cannabis) or prescription drug substance use disorder at any severity within 12 months prior to enrollment.\n16. Any participant presenting current serious suicide risk, as determined through psychiatric interview, responses to Columbia Suicide Severity Rating Scale (C-SSRS), and clinical judgment of the investigator will be excluded; however, history of suicide attempts is not an exclusion. Any participant who is likely to require hospitalization related to suicidal ideation and behavior, in the judgment of the investigator, will not be enrolled. Any participant presenting with the following on the Baseline\u002FScreening C-SSRS will be excluded:\n\n    * Suicidal ideation score of 4 or greater within the last month of the assessment at a frequency of once a week or more.\n    * Suicidal ideation score of 5 within the last 6 months of the assessment.\n    * Any suicidal behavior, including suicide attempts or preparatory acts, within the last 6 months of the assessment. Participants with non-suicidal self-injurious behavior may be included if approved by the study clinician.\n\n    Prior\u002FConcomitant Therapy\n17. Unable or unwilling to safely taper-off prohibited psychiatric medication with exceptions described in section on Concomitant Medications in study protocol or require use of prohibited medications during experimental sessions.\n18. Require use of concomitant medications that could prolong the QT interval during Experimental Sessions.\n19. Have used Ecstasy (unregulated material represented as containing MDMA) more than 10 times within the last 10 years, or at least once within 6 months of the first Experimental Session.\n\n    Prior\u002FConcurrent Clinical Study Experience\n20. Current enrollment in any other clinical study involving an investigational study treatment or any other type of medical research, unless approved by the study clinician.\n\n    Diagnostic Assessments\n21. Have current Personality Disorders assessed via psychiatric assessment (by consultant psychiatrist).\n22. Have a current eating disorder with compensatory behaviors\n23. Have current major depressive disorder with psychotic features\n24. Have a history of, or a current primary psychotic disorder, bipolar affective disorder type 1 or dissociative identity disorder.\n\n    Other Exclusions\n25. Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the sponsor-investigator or study clinician, contraindicates participation in the study.\n26. Are currently engaged in compensation litigation whereby financial gain would be achieved from prolonged symptoms of PTSD or any other psychiatric disorders.\n27. Lack social support or lack a stable living situation.\n28. Previous participation in a MAPS-sponsored MDMA clinical trial.\n29. Employees (and their immediate family members) of MAPS, MAPS Public Benefit Corporation, or MAPS Europe B.V; or individuals in a personal relationship with the site investigator.\n30. Have any current problem which, in the opinion of the sponsor-investigator or study clinician, might interfere with study participation.\n\nSecurity Criteria\n\nThe current study dealing with intensive treatment of military veterans suffering from PTSD, requires an environment of physical and emotional security for the patients. Safety is critical in the success of the treatment. Since October 7, 2023, we have been in a continuous state of war, which we do not know when it will end. Therefore, we are required at this time to define what security is as a criterion for conducting research at this time, and in relation to the normative reality in the world and in the State of Israel in particular. Therefore:\n\n1. The research will be carried out in Jerusalem and long sessions will not take place when there is a high risk of rocket attack or sirens during the previous day\u002Fnight.\n2. The participants in the study will be military veterans who do not participate or have taken an operational part in the war in the three months prior to the start of their participation in the study.\n3. The participants in the study do not have first degree relatives or a partner who are actively serving in a war zone at the time of their participation in the study.\n4. The participants live in a permanent and safe place and are not expected to change their place of residence during their participation in the study.","MALE",{"count":94,"type":21},60,[64],"Despite being exposed to a high level of potentially traumatic experiences due to exposure to combat, military veterans have poor response rates to traditional PTSD treatments, in some reports, just 1\u002F3 of veterans recover using traditional treatments. In recent years 3,4-methylenedioxymethamphetamine (MDMA), a psychedelic drug has demonstrated a significant treatment potential for severe and treatment resistant PTSD though not specifically in a veteran population. Additionally, even in groups where participants receive a placebo, the effect of the psychedelic treatment formulation, intensive, focused and respectful structure, appears to have promising effects. Indeed, in the current psychedelic literature, the setting and mind with which participant approach psychedelic therapy, significantly contributes to the treatment effect.\n\nThe current study proposes to address the major gaps in the theoretical literature by examining the proposed mechanisms by which MDMA enhances the \"window of tolerance\" for PTSD therapy, specifically in those with comorbid symptoms of moral injury; namely by reducing hyperarousal and enhancing connection (to self and others) and whether MDMA assisted therapy is more successful in reducing PTSD in veterans compared to a matched somatic experiential PTSD treatment, Somatic Experiental Acceptance Intensive Trauma-based therapy, (SEA-IT) which builds upon the promising placebo results, enhancing them with somatic and acceptance based treatment protocols.",[27,98],"Moral Injury",[100,68,98,101,102,103],"MDMA","Oxytocin","veterans","Hyperarousal","2024-04-30",{"date":106,"type":42},"2024-05-01",{"date":108,"type":42},"2024-02-18",{"date":110,"type":21},"2028-12-31",{"name":112,"class":49},"Herzog Hospital",1,{"id":115,"slug":116,"hasResults":11,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":4,"eligibilityCriteria":120,"healthyVolunteers":11,"sex":16,"minAge":59,"maxAge":121,"enrollmentInfo":122,"targetDuration":4,"studyType":22,"phases":124,"briefSummary":125,"conditions":126,"keywords":129,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":113},"100533636","phase-2-ketamine-treatment-for-ptsd-and-mdd-in-tbi-100533636","NCT06228391","Ketamine Treatment for PTSD and MDD in TBI","Examining the Efficacy and Safety of Subanesthetic Ketamine on Depression and Post-traumatic Stress Among Veterans With Mild and Moderate Traumatic Brain Injury","Inclusion Criteria:\n\n* Willingness\u002Fable to sign informed consent.\n* Able to read and write in English.\n* Male or female Veterans aged 18-55 years old.\n* Remote history of TBI mild-moderate that is ≥12 weeks post-injury (chronic period) that met at minimum the 2021 VA\u002FDoD Clinical Practice Guideline for the Management and Rehabilitation of Post-Acute Mild Traumatic Brain Injury (i.e., new onset or worsening of at least one of the following clinical signs immediately following the event: loss or decreased of consciousness, period of posttraumatic amnesia, period of being dazed and confused, and neurologic deficits).\n* Lifetime history of treatment resistance to at least one adequate trial of an antidepressant as determined by the Massachusetts General Hospital Antidepressant Treatment History Questionnaire (MGH-ATRQ).\n* FDA-approved antidepressant, trazodone, atypical neuroleptic, prazosin, or clonidine with stable treatment, as determined by the study clinician, for at least 4 weeks prior to randomization. Following randomization, changes to doses may be allowable at the investigator's discretion\n\nExclusion Criteria:\n\n* Ketamine treatment within the last 6 months\n\n  * Lifetime history of psychosis-related disorder, current episode of mania\u002Fhypomania\u002Fmixed assessed by the Mini-International Neuropsychiatric Interview (MINI 7.0 for DSM-5).\n  * History of penetrating head wounds or severe traumatic brain injury (Glasgow Coma Scale \\<9; loss of consciousness \\>24hr; post-traumatic amnesia\\>7 days).\n  * Severe substance and\u002For alcohol use disorder (DSM-5-TR) within six months of initial assessment; presence of illicit drugs (except cannabis) by positive urine toxicology at screening.\n  * Intellectual disability or pervasive developmental disorder; dementia of any type.\n  * Any disorder that, based on the Principal Investigator\\'s judgement, would increase risk (e.g., unstable cardiac conditions) or protocol adherence (e.g., severe personality disorder).\n  * For women: pregnancy (confirmed by lab test), initiation of female hormonal treatments within 3 months of screening, or inability\u002F unwillingness to use a medically accepted contraceptive method during the study. Women who are surgically sterile or have been post-menopausal for at least 1 year will not be excluded\n  * At screening, resting blood pressure (sitting or supine) lower than 90\u002F60 or higher than 150\u002F90, or resting heart rate lower than 45\u002Fmin or higher than 100\u002Fmin.\n  * Imminent risk of suicidal\u002Fhomicidal ideation and\u002For behavior with intent and\u002For plan.\n  * Concurrent participation in a cognitive rehabilitation program, however patient will have a TBI clinician involved in directed services.\n  * Subjects on a prohibited medication: monoamine oxidase inhibitors, memantine, long acting benzodiazepines (i.e., Chlordiazepoxide, Diazepam, Flurazepam)","75 Years",{"count":123,"type":21},40,[63],"The goal of this clinical trial is to examine the use of sedative ketamine to treat depression and post-traumatic stress disorder (PTSD) in Veterans with mild to moderate traumatic brain injury (TBI). The main questions it aims to answer are:\n\n* Efficacy of ketamine to reduce symptoms of depression and\u002For PTSD\n* Safety of ketamine to treat depression and\u002For PTSD in TBI Participants will be randomly assigned to receive either ketamine or midazolam (active placebo) twice a week for 3 weeks. During participation, subjects will be interviewed, have lab tests, and complete rating scales, and questionnaires.",[27,127,128],"Major Depressive Disorder","Traumatic Brain Injury",[130,131,68,132,133],"Veteran","Ketamine","Depression","TBI","2024-01-26",{"date":136,"type":42},"2024-01-29",{"date":138,"type":21},"2024-03",{"date":140,"type":21},"2027-03",{"name":142,"class":143},"Minneapolis Veterans Affairs Medical Center","FED"]