[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"post-traumatic-stress-disorder\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:post-traumatic-stress-disorder":374},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,121,0,25,[9,40,65,87,113,141,169,193,217,242,270,290,316,340,362,393,422,446,467,492,514,530,556,584,611],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100636705","phase-2-mdma-therapy-in-veterans-with-ptsd-100636705",false,"NCT07569159","MDMA Therapy in Veterans With PTSD","A Phase 2, Open-Label Study Investigating the Safety and Efficacy of MDMA-Assisted Therapy for Veterans With Posttraumatic Stress Disorder (PTSD)","Inclusion Criteria:\n\n* Veterans who are at least 18 years old\n* Are able to swallow pills\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* Proficient in speaking and reading English.\n\nExclusion Criteria:\n\n* Condition impairing oral intake or digestive absorption.\n* Unable to give adequate informed consent.\n* Significant suicide risk as defined by suicidal ideation with intend and plan as endorsed on items 5 on C-SSRS within the past 3 months\n* Cardiovascular disease, including, but not limited to, coronary artery disease (CAD) and chronic heart failure (CHF)\n* 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* 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* Current enrollment in any investigational drug or device study or participation in such within 30 days of screening.","ALL","18 Years",{"count":20,"type":21},52,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","A Phase 2, single-center, fixed-dose, open-label study will explore the efficacy, safety, and tolerability of a 120 mg dose of oral MDMA followed by a supplemental dose of 60 mg MDMA in conjunction with therapy in individual versus group settings for adult veterans diagnosed with PTSD.",[27],"Post Traumatic Stress Disorder","RECRUITING","2026-06-30",{"date":31,"type":32},"2026-07-01","ACTUAL",{"date":29,"type":21},{"date":35,"type":21},"2027-08",{"name":37,"class":38},"Sunstone Medical","OTHER",1,{"id":41,"slug":42,"hasResults":12,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":12,"sex":48,"minAge":18,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":52,"conditions":53,"keywords":55,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":59,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":39},"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).","FEMALE",{"count":50,"type":21},70,[24],"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).",[27,54],"PTSD",[54,56,57,58],"sexual assault","psilocybin","posttraumatic stress disorder",{"date":31,"type":32},{"date":61,"type":32},"2026-05-23",{"date":63,"type":21},"2028-05",{"name":37,"class":38},{"id":66,"slug":67,"hasResults":12,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":4,"eligibilityCriteria":71,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":72,"enrollmentInfo":73,"targetDuration":4,"studyType":22,"phases":75,"briefSummary":77,"conditions":78,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":39},"100538689","etms-for-veterans-and-first-responders-with-ptsd-100538689","NCT06294106","eTMS for Veterans and First Responders With PTSD","Electroencephalogram (EEG) Personalized Transcranial Magnetic Stimulation (eTMS) for Post-Traumatic Stress Disorder (PTSD)","Inclusion Criteria:\n\n* Veteran or first responder\n* diagnosed with post-traumatic stress disorder with PCL-5 cutoff of 31 or above\n\nExclusion Criteria:\n\n* Claustrophobia\n* Contraindications to MRI\n* Pregnant\n* Uncontrolled medical, psychological, or neurological conditions\n* Unable to calculate EEG alpha frequency\n* History of ECT or rTMS\n* History of intracranial lesion or increased intracranial pressure\n* History of stroke\n* History of other neurologic conditions\n* Family history of epilepsy\n* Personal history of epilepsy\n* certain medications","65 Years",{"count":74,"type":21},20,[76],"NA","A battery of physiological and behavioral data will be collected before and after application of eTMS. Participants will be veterans or first responders diagnosed with PTSD. Study will be a double-blind, sham-controlled, parallel group, randomized clinical trial.",[27],{"date":80,"type":32},"2026-07-02",{"date":82,"type":32},"2024-06-10",{"date":84,"type":21},"2028-09",{"name":86,"class":38},"Virginia Polytechnic Institute and State University",{"id":88,"slug":89,"hasResults":12,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":4,"eligibilityCriteria":93,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":94,"targetDuration":4,"studyType":22,"phases":96,"briefSummary":97,"conditions":98,"keywords":99,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":112},"100496994","reducing-posttraumatic-stress-disorder-ptsd-symptoms-in-first-responders-and-frontline-health-care-workers-100496994","NCT05751473","Reducing Posttraumatic Stress Disorder (PTSD) Symptoms in First Responders and Frontline Health Care Workers","Reducing PTSD Symptoms in First Responders and Frontline Healthcare Workers Through Trauma-focused Treatment in Employee Assistance Programs","Inclusion Criteria:\n\n* Are employees at an orginization served by a participating EAP\n* Have a Post-Traumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (PCL-5) score ≥33\n* Have had psychotropic medication stability for at least 4 weeks\n\nInclusion criteria for the qualitative portion of the study:\n\n\\- Enrolled into the randomized clinical trial and were a treatment responder or were a treatment non-responder\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: found in protocol)\n* Need for detoxification\n* Active psychosis or unmanaged bipolar disorder, as measured by items 12 and 13 of the cross cutting assessment\n* Currently 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":95,"type":21},410,[76],"This study addresses PTSD symptoms in First Responders and Healthcare workers. Specifically, it tests whether a brief PTSD treatment (talk therapy) effectively treats PTSD when provided to First Responders and Healthcare workers by counselors in Employee Assistance Programs (EAPs).\n\nThe central hypothesis is that the PTSD treatment, Prolonged Exposure for Primary Care (PE-PC), will reduce PTSD symptoms and improve functioning, compared to EAP Treatment as Usual (TAU).",[27],[100,101,102,103],"Employee Assistance Programs","Frontline Healthcare Workers","Prolonged Exposure for Primary Care","First Responders","2026-06-29",{"date":31,"type":32},{"date":107,"type":32},"2023-05-16",{"date":109,"type":21},"2027-07-30",{"name":111,"class":38},"University of Michigan",14,{"id":114,"slug":115,"hasResults":12,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":4,"eligibilityCriteria":119,"healthyVolunteers":12,"sex":17,"minAge":120,"maxAge":72,"enrollmentInfo":121,"targetDuration":4,"studyType":22,"phases":123,"briefSummary":124,"conditions":125,"keywords":127,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":136,"completionDateStruct":137,"leadSponsor":139,"locationsCount":39},"100601009","phase-2-mindfulness-based-psilocybin-therapy-for-ptsd-100601009","NCT07104916","Mindfulness-based Psilocybin Therapy for PTSD","A Pilot Mechanistic RCT of Psilocybin With Mindfulness-based Therapy vs Support for Posttraumatic Stress Disorder (PTSD)","Inclusion Criteria\n\nParticipants meeting the following criteria will be included in the study:\n\n1. Participant is assigned female or male at birth.\n2. Participant is aged between 21 to 65 years, inclusive, at Screening. This is to reduce variability in brain function and connectivity in this small pilot study that may be related to age \u002F developmental factors in persons under 21 and over 65.\n3. Participant has a BMI of 18 to 30 kg\u002Fm2, inclusive, at Screening.\n4. Participant has a diagnosis of PTSD (as defined in the Diagnostic and Statistical Manual of Mental Disorders, 5th edition \\[DSM-5\\] established through a clinician interview that includes the Mini-International Neuropsychiatric Interview \\[MINI\\]) and the Clinician Administered PTSD Scale for DSM-5 (CAPS-5).\n5. PTSD severity moderate to severe based on CAPS-5 score ≥25, and with moderate depression MADRS ≥20.\n6. Participants capable of producing sperm must use a condom during the trial and for 3 months after their dose of trial medication, if their partner is a person of childbearing potential. In addition, their partner of childbearing potential must also use a highly effective method of contraception (i.e., failure rate less than 1% when used consistently and correctly) from dosing until 3 months following dosing. Condoms alone and abstinence are not considered highly effective methods of contraception.\n7. Participants of childbearing potential must agree to use a highly effective method of contraception (i.e., failure rate less than 1% when used consistently and correctly) in combination with use of a condom by a partner who is capable of producing sperm, during the trial and for 3 months after dosing. Condoms alone and abstinence are not considered highly effective methods of contraception. Such participants must have a negative pregnancy test at Screening and Day 1.\n8. Participants of non-childbearing potential who are or were capable of producing eggs (ova) must be postmenopausal or permanently sterile following hysterectomy, bilateral salpingectomy or bilateral oophorectomy. Postmenopausal is defined as spontaneous amenorrhea for at least 12 months, and a serum follicle stimulating hormone (FSH) level in the menopausal range, unless the participant is taking hormone replacement therapy or is using hormonal contraception.\n9. Provision of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.\n\nIf appropriate, describe why certain populations may be excluded (e.g., non-English speaking individuals for studies involving informed consent).\n\nExclusion Criteria\n\nParticipants with the following will be excluded from study participation:\n\n1. Cardiovascular disease, including coronary artery disease (CAD) and congestive heart failure (CHF). This is an FDA requirement.\n2. Current or previously diagnosis of schizophrenia spectrum or other psychotic disorders, including schizophrenia, schizoaffective disorder, schizotypal disorder, schizophreniform disorder or brief psychotic disorder; current or previous history of bipolar disorder, or current personality disorder (as determined by MINI at Screening). This is an FDA requirement.\n3. Clinically significant risk of suicidality, as determined through a comprehensive psychiatric interview that incorporates the Columbia Suicide Severity Rating Scale (CSSRS); a score of 4 or higher on the suicidal ideation subscale of C-SSRS (past 6 months) or any suicidal behaviour (lifetime), would be exclusionary.\n4. History of substance use disorder within the 12 months, as assessed by a structured clinical interview (Mini International Neuropsychiatric Interview \\[MINI\\], Version 7.0.2) or determined by self-report, or intake of \\>21 units of alcohol weekly, and the inability to refrain from alcohol use from 48 hours before Screening and each scheduled visit until discharge from the study site. One unit is equivalent to a 285 mL glass of full-strength beer or 1 (30 mL) measure of spirits or 1 glass (100 mL) of wine.\n5. Currently receiving a monoamine oxidase inhibitor, tricyclic antidepressant, other non-SSRI or non-SNRI antidepressants (e.g. bupropion, mirtazapine, etc), an antipsychotic or a mood stabilizer.\n6. Exposure to psilocybin, or any other psychedelics, such as ayahuasca, mescaline, LSD or peyote more than 10 times in the last 10 years, or any psychedelic use within 6 months prior to Screening.\n7. Use of psychotropic medicine\u002Fsupplement (or medicine\u002Fsupplement that would interact with psilocybin) including buspirone and venlafaxine, during the 28 days before dosing. Participants may take a stable chronic dose of other SSRI antidepressant medication(s) and\u002For sedatives\u002Fhypnotics. The Investigator and study team may review medication on a case-by-case basis to determine if its use would compromise participant safety or interfere with study procedures or data interpretation.\n8. Family history of schizophrenia or schizoaffective disorder (first degree relatives), or bipolar disorder type 1 (first degree relatives).\n9. Clinically relevant history of abnormal physical health interfering with the study as determined by medical history and physical examinations obtained during Screening as judged by the Investigator (including \\[but not limited to\\], neurological, endocrine, cardiovascular, respiratory, gastrointestinal (including dyspepsia or gastroesophageal reflux disease), hepatic, or renal disorder).\n10. Participant has a presence or relevant history of any of the following medical conditions: organic brain disorders (e.g., epilepsy, seizure, intracranial hypertension, intracranial bleed and aneurysmal disease, brain tumor or other medical conditions associated with seizures or convulsions).\n11. Diagnosis of hypertension or arrhythmia.\n12. Clinically relevant abnormal heart rate (resting supine heart rate \\>100 bpm) or blood pressure (resting supine systolic blood pressure (SBP) above 140 mmHg or diastolic blood pressure (DBP) above 90 mmHg) at screening. Screening supine SBP, DBP and heart rate for evaluation will be the average of 3 readings obtained after at least 5 minutes rest. Participants with abnormal vital signs which are out of range and deemed clinically significant by the Investigator at Day 1, following triplicate readings.\n13. Presence of clinically significant ECG abnormalities at the Screening visit, as defined by medical judgement.\n14. QT interval corrected for heart rate using Fridericia's formula (QTcF) \\>450 msec at Screening, following triplicate ECG readings.\n15. Hypothyroidism and\u002For current abnormal thyroid function tests. In case of uncertain or questionable screening thyroid function test results, the TSH test may be repeated once during screening. The TSH test must be reviewed to ensure that it is within normal limits before randomizing a participant into the study.\n16. Clinically relevant abnormal laboratory results (including hepatic and renal panels, complete blood count, chemistry panel and urinalysis), 12-lead ECG and vital signs, or physical findings at Screening. In case of uncertain or questionable results, tests performed during Screening may be repeated once to confirm eligibility or judged to be clinically irrelevant.\n17. Other eligibility considerations (i.e., participant personal circumstances, behavior, and\u002For any current problem that might interfere with participation or that is incompatible with establishment of rapport or safe exposure to psilocin), as judged by the Investigator.\n18. History or clinical evidence of any disease and\u002For existence of any surgical or medical condition which might interfere with the absorption, distribution, metabolism or excretion (ADME) of the study drug.\n19. Any other concomitant disease or condition that could interfere with, or for which the treatment might interfere with, the conduct of the study as outlined in this Protocol, or that would, in the opinion of the Investigator, pose an unacceptable risk to the participant in this study.\n20. Participant is not fluent in English. Participants must be fluent in English because the consent form as well as all assessments are written and will be administered\u002Fcommunicated in English.\n21. Aspartate aminotransferase (AST), alanine transaminase (ALT), gamma-glutamyl transferase (GGT) or total bilirubin levels ≥1.5 x the upper limit of normal (ULN) at Screening. These laboratory evaluations may be repeated once at the discretion of the Investigator. If the repeat test is within the reference range, the participant may be included if the Investigator considers that the previous finding will not introduce additional risk factors.\n22. Positive urine test for drugs of abuse or alcohol breath test at Screening or Day 1. A positive test for cannabinoids (e.g., marijuana) at Screening may not exclude a participant if after discussion with and evaluation by the Investigator, the participant agrees not to use any marijuana or other cannabinoid products during the study, and if allowed to participate, the participant must test negative for cannabinoids on Day 1.\n23. Participant who consumes excessive amounts of caffeine (e.g., coffee, tea, caffeinated sodas) or (methyl) xanthines (e.g., chocolate) based on the Investigator's determination and discretion.\n24. The participant has participated in a clinical study and has received a medication or a new chemical entity within 3 months prior to dosing of current study medication.\n25. Known sensitivity to psilocybin, psilocin and\u002For any excipients present in the formulation.\n26. Participant is taking or has taken any drugs known to inhibit monoamine oxidase within 28 days prior to study drug administration.\n27. Participant is taking or has taken OTC doses of 5-hydroxytryptophan or St John's Wort within 28 days prior to study drug administration.\n28. Strenuous exercise within 48 hours prior to each visit, and while at the study site.\n29. Participants capable of producing sperm who will not abstain from sperm donation between first dosing and 3 months after final dosing.\n30. Participants of childbearing potential who are pregnant, breastfeeding or planning to conceive. This is an FDA requirement.","21 Years",{"count":122,"type":21},30,[24],"The goal of this study is to learn how psilocybin delivered with mindfulness-based therapy may help symptoms of posttraumatic stress disorder (PTSD). This is an assessor-blinded, randomized, controlled study in participants with PTSD. The study will investigate the changes in brain activity, connectivity, and microstructural neuroplasticity assessed using EEG\u002FEMG and multimodal MRI measures after administration of one oral dose of psilocybin, accompanied either with standard \"psychological support\" only; or with standard support plus Mindfulness-based Cognitive Therapy (MBCT).",[27,126],"Depression - Major Depressive Disorder",[128,129,130,131,132],"Psychedelic","functional MRI","Mindfulness-based Cognitive Therapy","Psilocybin","microstructural neuroplasticity","2026-06-24",{"date":135,"type":32},"2026-06-25",{"date":31,"type":21},{"date":138,"type":21},"2029-12",{"name":140,"class":38},"Anthony P King",{"id":142,"slug":143,"hasResults":12,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":147,"eligibilityCriteria":148,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":149,"enrollmentInfo":150,"targetDuration":4,"studyType":22,"phases":152,"briefSummary":153,"conditions":154,"keywords":158,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":161,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":39},"100552800","improving-sleep-in-veterans-with-the-polytrauma-clinical-triad-100552800","NCT06477796","Improving Sleep in Veterans With the Polytrauma Clinical Triad","A Sleep Intervention to Improve Quality of Life and Symptom Management in Veterans With the Polytrauma Clinical Triad","LIONv2","Inclusion Criteria:\n\n* Veteran\n* English speaking with phone and internet access\n* Current self-reported sleep disturbances\n* Clinical stable for current pharmacologic or behavioral health treatments for depression, anxiety, sleep and pain\n* Documented history of TBI\n\nExclusion Criteria:\n\n* Decisional impairment and\u002For dementia\n* Current usage of a lightbox or negative ion generator\n* Shift work\n* History of macular degeneration and\u002For bipolar disorder\n* Evidence for suicidal ideation\n* Cancer diagnosis within the past 6 months\n* Surgery within the past 6 months\n* Substance abuse within the past 6-12 months\n* Significant impairing post-stroke residual hemiparesis","89 Years",{"count":151,"type":21},96,[76],"The \"polytrauma clinical triad\" (PCT), a highly disabling constellation of factors, is defined by the coexistence of traumatic brain injury, post-traumatic stress disorder, and chronic pain. Veterans with the PCT are medically complex, often refractory to conventional therapies, and suffer from additional related chronic sequela. Notably, sleep disturbances and cognitive impairment, which the investigators hypothesize are significant contributing factors to these functional impairments and an impediment toward rehabilitation. Thus, the investigators' research aims to intervene \"at the level of sleep\", and by improving sleep, improve these interconnected, disabling, and difficult to treat enduring complexities associated with the PCT - ultimately to improve Veteran quality of life, functional independence, and restorative function. The investigators predict that the proposed intervention, morning bright light therapy, which is cost-effective, rapidly deployable and home-based, will be effective in improving sleep and overall PCT symptom management, thereby, resulting in a measurable and impactful improvement in quality of life.",[155,156,157],"Traumatic Brain Injury","Post-traumatic Stress Disorder","Chronic Pain",[159,160,54],"polytrauma clinical triad","TBI",{"date":104,"type":32},{"date":163,"type":32},"2025-05-01",{"date":165,"type":21},"2028-09-29",{"name":167,"class":168},"VA Office of Research and Development","FED",{"id":170,"slug":171,"hasResults":12,"nctId":172,"briefTitle":173,"officialTitle":174,"acronym":4,"eligibilityCriteria":175,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":72,"enrollmentInfo":176,"targetDuration":4,"studyType":22,"phases":178,"briefSummary":179,"conditions":180,"keywords":182,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":39},"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":177,"type":21},15,[24],"This is an open-label trial evaluating feasibility, tolerability, safety and efficacy of psilocybin assisted cognitive processing therapy for chronic Posttraumatic Stress Disorder (PTSD).",[27,54,181],"Chronic PTSD",[27,131,183],"Cognitive Processing Therapy","2026-06-22",{"date":186,"type":32},"2026-06-26",{"date":188,"type":21},"2026-06",{"date":190,"type":21},"2027-01",{"name":192,"class":38},"Unity Health Toronto",{"id":194,"slug":195,"hasResults":12,"nctId":196,"briefTitle":197,"officialTitle":197,"acronym":198,"eligibilityCriteria":199,"healthyVolunteers":200,"sex":17,"minAge":18,"maxAge":72,"enrollmentInfo":201,"targetDuration":4,"studyType":22,"phases":203,"briefSummary":205,"conditions":206,"keywords":4,"overallStatus":208,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":211,"completionDateStruct":213,"leadSponsor":215,"locationsCount":39},"100644304","phase-1-effects-of-stimulant-medications-in-ptsd-100644304","NCT07664631","Effects of Stimulant Medications in PTSD","SMP","Inclusion Criteria:\n\n* Age 18 - 65 years old\n* BMI 19-30 kg\u002Fm2\n* English fluency\n\nExclusion Criteria:\n\n* Individuals with current moderate or severe substance use disorder, no past stimulant or cocaine use disorder\n* Individuals with current acute or high risk of suicide or suicide attempt in past 6 months\n* Individuals with current psychotic or bipolar disorder\n* Individuals with past schizophrenia, schizoaffective disorder, psychotic bipolar disorder, stimulant or cocaine use disorder\n* Individuals with chronic (non-PRN) treatment with antipsychotic drug (except PRN quetiapine 25mg PO qHS) or D2 antagonist\n* Individuals with medications with significant PD or PK interactions\n* Individuals with current treatment with a stimulant medication\n* Individuals with court or legally mandated treatment\n* Individuals with unstable or untreated medical disorder that would increase the risk of serious side effects of study drug (unstable hypertension, tachycardia, cardiac arrhythmia, recent MI or stroke, clinically significant neuropsychiatric or neurological disorder)\n* Members of a vulnerable population\n* High blood pressure (\\>140\u002F90)\n* Women who are pregnant, breastfeeding, or planning to become pregnant",true,{"count":202,"type":21},40,[204],"PHASE1","While there have been advances in understanding post-traumatic stress disorder (PTSD) as a disorder and its biological features, unfortunately only one out of five traumatized persons with PTSD reach remission after cycling through evidence-based and\u002For FDA-approved medications. This is especially unfortunate given that people with PTSD are often from vulnerable populations, or those whose professions entail personal sacrifice. It is clear that new serotonergic antidepressants and atypical antipsychotics will not be sufficient to fix this gap, and new mechanisms of action need to be tested. In the current proposal, the investigators test the hypothesis that mixed amphetamine salts (brand name Adderall), FDA-approved for treating attention deficit hyperactivity disorder (ADHD), can improve PTSD outcomes.",[207,54,27],"Adderall","NOT_YET_RECRUITING","2026-06-18",{"date":133,"type":32},{"date":212,"type":21},"2026-09-15",{"date":214,"type":21},"2027-09-15",{"name":216,"class":38},"University of Chicago",{"id":218,"slug":219,"hasResults":12,"nctId":220,"briefTitle":221,"officialTitle":222,"acronym":4,"eligibilityCriteria":223,"healthyVolunteers":200,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":224,"targetDuration":4,"studyType":22,"phases":226,"briefSummary":227,"conditions":228,"keywords":230,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":234,"lastUpdatePostDateStruct":235,"startDateStruct":236,"completionDateStruct":238,"leadSponsor":240,"locationsCount":39},"100410556","general-psychological-distress-ptsd-and-co-morbidities-in-healthcare-workers-consequent-to-occupational-trauma-100410556","NCT04626050","General Psychological Distress, PTSD, and Co-Morbidities in Healthcare Workers Consequent to Occupational Trauma","A Brief Phased Two-Step Intervention for Treating General Psychological Distress, PTSD, and Co-Morbidities in Healthcare Workers Consequent to Occupational Trauma","Inclusion Criteria:\n\n* Any healthcare worker providing medical care or support who has experienced occupational-related trauma\n* English-speaking\n* Age \\>18\n* Medically stable\n* Able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments\n* If on psychotropic medication stable for prior 60 days\n\nFor phase II additional inclusion criteria:\n\n\\- Current diagnosis of PTSD\n\nExclusion Criteria:\n\n* Current significant unstable medical illness precluding regular session attendance or assessment completion\n* Participants who in the investigator's judgment pose a current homicidal, suicidal, or other risk\n* Lifetime or current diagnosis of schizophrenia or other psychotic disorder\n* Participation in a clinical trial or concurrent evidence-based treatment for psychiatric conditions or PTSD during the previous 3 months.",{"count":225,"type":21},120,[76],"It is expected that large numbers of healthcare workers experience a broad range of psychological reactions and symptoms including anxiety, depression, moral distress, and trauma symptoms that will cause both significant suffering as well as occupational and social impairment. The purpose of this study is to find interventions which are helpful in treating psychological distress in healthcare workers adversely affected by occupational-related trauma.\n\nThere are two phases of the study. All participants will take part in Phase I, which consists of 4 sessions over a two-week period of either a narrative writing intervention or a medical music intervention. Participants will be randomly assigned to the narrative writing intervention or medical music intervention.\n\nAfter Phase I, participants will be re-assessed. Healthcare workers who meet criteria for PTSD will be given the option to participate in Phase II of the study, in which they will be offered a choice between one of two evidence-based treatments for PTSD: Interpersonal Therapy (IPT) or Exposure Therapy (ET). Both treatments are comprised of ten 75-minute sessions scheduled twice weekly. Participants will be allowed to choose a preferred treatment in Phase II. After Phase II participants will complete a final assessment concluding the study. All interventions will be offered using distance technology.",[156,229],"Moral Injury",[54,229,231,232,233],"Psychological Distress","Healthcare Workers","Occupational Trauma","2026-06-17",{"date":184,"type":32},{"date":237,"type":32},"2022-01-20",{"date":239,"type":21},"2028-04",{"name":241,"class":38},"Weill Medical College of Cornell University",{"id":243,"slug":244,"hasResults":12,"nctId":245,"briefTitle":246,"officialTitle":247,"acronym":248,"eligibilityCriteria":249,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":250,"targetDuration":4,"studyType":22,"phases":252,"briefSummary":254,"conditions":255,"keywords":256,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":261,"startDateStruct":263,"completionDateStruct":265,"leadSponsor":267,"locationsCount":269},"100628058","phase-3-an-evaluation-of-the-safety-and-efficacy-of-tsnd-201-for-the-treatment-of-ptsd-empower-1-100628058","NCT07456696","An Evaluation of the Safety and Efficacy of TSND-201 for the Treatment of PTSD (EMPOWER-1)","A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Evaluation of the Safety and Efficacy of TSND-201 for the Treatment of PTSD","EMPOWER-1","Inclusion Criteria:\n\n* Meets the DSM-5 criteria for current PTSD diagnosis, with a symptom duration of at least 6 months.\n* Tried at least one pharmacological treatment for PTSD or trauma-focused psychotherapy.\n* Proficient in communication (verbal and reading) to complete interviews and written questionnaires.\n* Free from any other clinically significant illness or disease.\n\nExclusion Criteria:\n\n* Primary diagnosis of any other DSM-5 disorder.\n* Body mass index (BMI) \\\u003C18 kg\u002Fm2 or ≥40 kg\u002Fm2.\n* Unable to refrain from nicotine use for at least 8 hours.\n* Use of prohibited concomitant medications or therapies.\n* Current or previous history of clinically significant cardiovascular (including current uncontrolled hypertension) \u002F cerebrovascular conditions.",{"count":251,"type":21},300,[253],"PHASE3","This study is evaluating the safety and efficacy of TSND-201 in adults with PTSD.\n\nEligible participants will enter a 4-week Treatment Period where they will be randomized 1:1:1 to receive one of two doses of TSND-201 or placebo, once per week. Following the Treatment Period, participants will enter an 8-week Follow-up Period.",[27],[54,248,257,258,259],"Transcend Therapeutics","TSND-201","Neuroplastogen","2026-06-10",{"date":262,"type":32},"2026-06-12",{"date":264,"type":32},"2026-04-02",{"date":266,"type":21},"2027-12",{"name":257,"class":268},"INDUSTRY",32,{"id":271,"slug":272,"hasResults":12,"nctId":273,"briefTitle":274,"officialTitle":275,"acronym":276,"eligibilityCriteria":277,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":72,"enrollmentInfo":278,"targetDuration":4,"studyType":22,"phases":280,"briefSummary":281,"conditions":282,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":283,"startDateStruct":284,"completionDateStruct":286,"leadSponsor":288,"locationsCount":39},"100506436","people-bereaved-by-violent-death--negative-event-biases-and-temporal-perception-100506436","NCT05874362","People Bereaved by Violent Death : Negative Event Biases and Temporal Perception","People Bereaved by Violent Death : a Negative Event Biases and Temporal Perception Study","PrEVENT","Inclusion Criteria:\n\n* An age between 18 and 65 years old\n* Recent bereavement by violent death of a relative in first and second degree\n\nExclusion Criteria:\n\n* Protected adults\n* Lack of mastering French language\n* History of neurodegenerative disorder\n* History of psychiatric disorder treated pharmacologically with modification of the basic treatment in the month preceding the death\n* The take of an benzodiazepine treatment in the 24th hours before the first visit (T0)",{"count":279,"type":21},61,[76],"A violent death is defined by its brutality, unexpectedness and is secondary to an external cause (suicide, homicide, accident). Bereavement following a violent death constitutes a particular clinical situation, at risk of complications. Research on bereavement after a violent death shows higher risks of psychiatric and somatic complications than in bereavement by non-violent death. These complications, sometimes comorbid, take the form of depressive episodes, post-traumatic stress disorders, suicidal behavior and prolonged grief disorders after 12 months, precociously mediated by ruminations.\n\nProcesses responsible for this increased risk of complications are poorly documented. Current literature relates mainly to socio-demographic and epidemiological factors which, alone, do not explain this difference in risks. Further research is needed exploring other kinds of data and processes. To our knowledge, there is no description of early neurocognitive functioning in people bereaved after violent death. This study aims at exploring early neurocognitive processes which can lead to complications in people bereaved by violent death.",[27],{"date":262,"type":32},{"date":285,"type":32},"2023-09-19",{"date":287,"type":21},"2026-12-19",{"name":289,"class":38},"Hôpital le Vinatier",{"id":291,"slug":292,"hasResults":12,"nctId":293,"briefTitle":294,"officialTitle":295,"acronym":4,"eligibilityCriteria":296,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":297,"enrollmentInfo":298,"targetDuration":4,"studyType":22,"phases":300,"briefSummary":301,"conditions":302,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":307,"lastUpdatePostDateStruct":308,"startDateStruct":309,"completionDateStruct":311,"leadSponsor":313,"locationsCount":315},"100475189","co2-reactivity-as-a-biomarker-of-non-response-to-exposure-based-therapy-100475189","NCT05467683","CO2 Reactivity as a Biomarker of Non-Response to Exposure-Based Therapy","Carbon Dioxide (CO2) Reactivity as a Biomarker of Non-Response to Exposure-Based Therapy","Inclusion Criteria:\n\n* A primary DSM-5 diagnosis of panic disorder (with or without an agoraphobia diagnosis), social anxiety disorder, generalized anxiety disorder, obsessive-compulsive disorder, or post-traumatic stress disorder as assessed by the Structured Clinical Interview for the DSM-5 (SCID-5)\n* A score of 8 or greater on the Overall Anxiety Severity and Impairment Scale (OASIS)\n* Ages 18 to 70\n* Willingness and ability to provide informed consent and comply with the requirements of the study protocol.\n* Proficiency in English (because assessment instruments have only been validated in English)\n\nExclusion Criteria:\n\n* A lifetime history of bipolar or psychotic disorders, substance use disorders (other than nicotine) or eating disorder in the past 6 months; serious cognitive impairment.\n* Active suicidal ideation with at least some intent to act with or without specific plan (a rating of 4 for suicidal ideation on the Columbia-Suicide Severity Rating Scale) or suicidal behaviors (actual attempt, interrupted attempt, aborted or self-interrupted attempt, or preparatory acts or behavior) within the past 6 months.\n* Medical conditions contraindicating CO2 inhalation or hyperventilation challenge (e.g., cardiac arrhythmia, cardiac failure, asthma, lung fibrosis, high blood pressure, epilepsy, or stroke).\n* Pregnancy or lactation\n* Ongoing psychotherapy directed toward the primary disorder.\n* Pharmacological treatment started within 8 weeks prior to the screen (patients \"stable\" on their medication regimen will be included and their medication status will be included as a variable in the model)","70 Years",{"count":299,"type":21},600,[76],"Anxiety-, obsessive-compulsive and trauma- and stressor-related disorders reflect a significant public health problem. This study is designed to evaluate the predictive power of a novel biomarker based on a CO2 challenge, thus addressing the central question \"can this easy-to-administer assay aid clinicians in deciding whether or not to initiate exposure-based therapy?\"",[303,27,304,305,306],"Obsessive-Compulsive Disorder","Generalized Anxiety Disorder","Social Anxiety Disorder","Panic Disorder","2026-06-08",{"date":260,"type":32},{"date":310,"type":32},"2022-11-02",{"date":312,"type":21},"2027-02-28",{"name":314,"class":38},"Jasper A. Smits",2,{"id":317,"slug":318,"hasResults":12,"nctId":319,"briefTitle":320,"officialTitle":320,"acronym":321,"eligibilityCriteria":322,"healthyVolunteers":200,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":323,"targetDuration":325,"studyType":326,"phases":4,"briefSummary":327,"conditions":328,"keywords":329,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":330,"lastUpdatePostDateStruct":331,"startDateStruct":333,"completionDateStruct":335,"leadSponsor":337,"locationsCount":339},"100466771","predictability-of-the-clinical-global-impression-scale-cgi-in-post-immediate-in-psychotraumatic-impact-100466771","NCT05358067","Predictability of the Clinical Global Impression Scale (CGI) in Post Immediate in Psychotraumatic Impact","PRECLIP","Inclusion Criteria:\n\n* Patient who has experienced a traumatic event in the last 48 hours;\n* Patient speaking French;\n\nExclusion Criteria:\n\n* Patient participating in another clinical trial on the treatment of his psychotraumatic experience.\n* Person deprived of liberty (prisoners, defendants);\n* Persons under legal protection (protected adults: under guardianship, curatorship, etc.);\n* Opposition of the patient to participate in the research.",{"count":324,"type":21},241,"6 Months","OBSERVATIONAL","The objective of this study is to evaluate correlation between Clinical Global Impression Scale (CGI) score immediately in patients who have experienced psychotrauma and occurrence of posttraumatic stress disorder at distance from traumatic event. This could allow, in future, implementation of a systematic telephone reminder of psychotraumatized patients when they have a high score on the CGI scale, and thus detect onset of a stress disorder as early as possible, post-traumatic and orientation of these patients on specialized care.",[156],[156],"2026-06-04",{"date":332,"type":32},"2026-06-05",{"date":334,"type":32},"2022-10-24",{"date":336,"type":21},"2027-04-23",{"name":338,"class":38},"Centre Hospitalier Arras",5,{"id":341,"slug":342,"hasResults":12,"nctId":343,"briefTitle":344,"officialTitle":345,"acronym":346,"eligibilityCriteria":347,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":348,"targetDuration":4,"studyType":22,"phases":350,"briefSummary":351,"conditions":352,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":354,"lastUpdatePostDateStruct":355,"startDateStruct":357,"completionDateStruct":359,"leadSponsor":361,"locationsCount":315},"100602079","phase-2-mdma-assisted-therapy-for-veterans-with-ptsd-and-alcohol-use-disorder-100602079","NCT07118839","MDMA-Assisted Therapy for Veterans With PTSD and Alcohol Use Disorder","MDMA-Assisted Therapy for Veterans With PTSD and Alcohol Use Disorder: A Randomized Controlled Trial","MAP VETS","Inclusion Criteria:\n\nParticipants are eligible to be included in the study if all the following criteria apply:\n\nAge\n\n1. Are at least 18 years old at the time of signing the informed consent.\n\n   Type of Participant and Disease Characteristics\n2. Are currently enrolled in VA care.\n3. Veterans must have initiated and discontinued (or completed) at least one first-line evidence-based treatment (EBT) for PTSD alone, for PTSD and AUD together, or for a dual-diagnosis condition, as documented in CPRS.\n4. Are fluent in speaking and reading English.\n5. At Screening, Veterans must meet past 3-month criteria for Alcohol Use Disorder as measured by the SCID-5.\n6. Must have a desire to abstain or reduce alcohol use, per Veteran report.\n7. Able to safely abstain from alcohol for at least 48 hours without requiring medical detox.\n8. At Screening (V0) have a confirmed diagnosis of PTSD with symptom duration of at least 6 months and a total severity score of \\>28 per the CAPS-5.\n\n   a.At Baseline (V3) must continue to have a confirmed diagnosis of PTSD per CAPS-5.\n9. Are able to swallow pills.\n10. Agree to have study visits recorded, including Experimental Sessions, assessments, and non-drug therapy sessions.\n11. Able to 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.\n12. Able to identify an appropriate support person to stay with the participant on the evenings of the Experimental Sessions.\n\n    Weight\n13. Body Mass Index (BMI) in the range of 18-35.\n\n    Sex and Contraceptive\u002F Barrier Requirements\n14. For participants assigned female sex at birth:\n\n    -A participant is eligible to participate if not pregnant, not planning to become pregnant, or is not breastfeeding and one of the following conditions applies: oIs not able to become pregnant OR oIs a person able to be pregnant (PABP) and using a contraceptive method that is highly effective, with a failure rate of \\\u003C1%. The investigator will evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated) in relationship to the first does of study intervention.\n\n    -A PABP must have a highly sensitive negative urine pregnancy test at study entry and prior to each Experimental Session, see Schedule of Activities.\n\n    Informed Consent\n15. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.\n\n    Other Inclusions\n16. Agree to inform the investigators within 48 hours of any medical conditions and procedures.\n17. May have asymptomatic Hepatitis C virus (HCV) that has previously undergone evaluation and treatment as needed.\n18. May have a history of or current Diabetes Mellitus (Type 2) if additional screening measures of Hemoglobin A1c levels are less than 7, identifying that the Type 2 diabetes is well controlled, if the condition is judged to be stable on effective management, and with approval by the study clinician.\n19. May have hypothyroidism if taking adequate and stable thyroid replacement medication.\n20. May have a history of, or current, glaucoma if approval for study participation is received from an ophthalmologist.\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\nMedical Conditions\n\n1. Have symptomatic liver disease or have significant liver enzyme elevations.\n\n   1. Alanine transaminase (ALT) or aspartate transaminase (AST) \\> 3 x upper limit of normal (ULN).\n   2. Total bilirubin \\> 1.5 x ULN or direct bilirubin \\\u003C 35%.\n2. 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   a)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.\n3. Moderate or severe chronic kidney disease, defined as Estimated Glomerular Filtration Rate (eGFR)\\\u003C60 mL\u002Fmin at screening or end stage renal disease on dialysis.\n4. Have a history of seizures or delirium tremens.\n5. Significant alcohol withdrawal symptoms, defined as a Clinical Institute Withdrawal Assessment of alcohol scale, revised (CIWA-Ar) \\>10.\n6. Have a recent history of clinically significant hyponatremia or hyperthermia.\n7. Have a marked Screening QTcF interval \\>450 ms demonstrated on repeated ECG 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.\n\n   a)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.\n8. 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   1. Participants with other mild, stable chronic medical problems may be enrolled if the study physician and principal investigators 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 the study drug.\n   2. Examples of stable medical conditions that could be allowed include, but are not limited to, Diabetes Mellitus (Type 2), 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).\n9. Acute Retention History (e.g., have needed a catheter in the last 6-12 months) or \"Stage 4\" BPH (kidney damage or chronic high residual urine)\n\n   a.Note: BPH Stage 1-2 (Mild\u002FModerate) and BPH on Alpha Blockers could be included if study physician and principal investigator agree the condition would not significantly increase the risk of worsening the BPH symptoms.\n10. Have a diagnosis of uncontrolled hypertension, defined as repeated blood pressure readings of 140 millimeters of Mercury \\[mmHg\\] systolic or 90 mmHg diastolic. The diagnosis may be confirmed by repeated clinic measurements or home blood pressure monitoring if clinically indicated.\n11. Have a history of ventricular arrhythmia at any time, other than occasional premature ventricular contractions (PVCs) in the absence of ischemic heart disease.\n12. Have Wolff-Parkinson-White syndrome or any other accessory pathway that has not been successfully eliminated by ablation.\n13. 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    a)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 or are under adequate and stable pharmacologic treatment for atrial fibrillation for at least a year, as confirmed by a cardiologist.\n14. 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\n15. 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.\n16. Are currently prescribed antidepressant medication (antidepressant pharmacotherapy use considered if assessed by physician and titrated down to 5 half-lives + 1 week washout).\n17. Are currently prescribed antipsychotic medications. Note: off-label use of low dose quetiapine (\\\u003C100 mg) for insomnia is not exclusionary. Quetiapine should be replaced by other treatment to control insomnia such as non-benzodiazepine sedative hypnotics (e.g., Zopiclone, Eszopiclone, Zolpidem).\n18. 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 directly during the study.\n19. 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 cannabis use disorder within the 12 months prior to enrollment (meets at least 6 of 11 diagnostic criteria per DSM-5).\n\n    a)May have current mild cannabis use disorder (meets 3 of 11 diagnostic criteria per DSM-5) or moderate cannabis use disorder in early remission for the 3 months prior to enrollment (meets 4 or 5 of 11 diagnostic criteria per DSM-5).\n20. Have an active substance use disorder (other than cannabis) at any severity within 12 months prior to enrollment.\n21. Have used MDMA or Ecstasy (material represented as containing MDMA) more than 10 times within the last 10 years or at least once within 12 months of the first Experimental Session\n22. Any participant presenting current serious suicide risk, as determined through psychiatric interview, responses to 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 Screening C-SSRS will be excluded:\n\n    1. Suicidal ideation score of 4 or greater within the last 6 months of the assessment at a frequency of once a week or more\n    2. Suicidal ideation score of 5 within the last 6 months of the assessment\n    3. 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 physician.\n23. Would present a serious risk to others as established through clinical interview and contact with treating providers.\n\n    Prior\u002FConcomitant Therapy\n24. Require ongoing concomitant therapy with a psychiatric medication with exceptions described in protocol section on Concomitant Medications (refer to Appendix 3: Permitted and Prohibited Medications).\n25. Current use of pharmacotherapies (i.e., naltrexone, acamprosate, or disulfiram) to treat alcohol use.\n26. Require use of concomitant medications that could prolong the QT interval during Experimental Sessions.\n27. Are currently engaged in trauma-focused psychotherapy or are currently in a treatment program for SUD (self-help programs are not an exclusion).\n\n    Prior\u002FConcurrent Clinical Study Experience\n28. Current enrollment in any other clinical study involving an investigational study treatment or any other type of medical research, unless approved by the study team.\n\n    Diagnostic Assessments\n29. Have a history of or a current Schizophrenia Spectrum and other Psychotic Disorder according to the DSM-5, or a bipolar disorder type I or II, or DSM-5 category of Dissociative Identity Disorder, assessed via the DDIS and clinical interview.\n30. Have a current eating disorder with compensatory behaviors.\n31. Have current major depressive disorder with psychotic features.\n32. Have current Personality Disorders (Cluster A or Cluster B) assessed via the SCID-5-PD. Diagnoses will be confirmed by clinical interview.\n\n    Other Exclusions\n33. Are not able to provide adequate informed consent.\n34. Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Principal Investigator or study physician, contraindicates participation in the study.\n35. Lack of social support or lack of a stable living situation since the inclusion of a support person to assist the participant following Experimental Sessions is important for ensuring participant safety. If a participant is not able to identify a support person whom the research team may contact, they will not be enrolled.\n36. Previous participation in a MAPS\u002FLykos-sponsored MDMA clinical trial.\n37. Employees (and their immediate family members) of MAPS, Lykos, or MAPS Europe B.V; or individuals in a personal relationship with the sponsor investigator.\n38. Have any current problem which, in the opinion of the Principal Investigator or study clinician, might interfere with study participation.",{"count":349,"type":21},80,[24,253],"The study investigators are conducting the first randomized placebo-controlled trial of MDMA-assisted therapy with a comorbid sample of military Veterans with a co-occurring diagnosis of Alcohol Use Disorder (AUD) and Post-Traumatic Stress Disorder (PTSD). This novel experimental treatment package consists of three once-monthly Experimental Sessions of therapy combined with a divided-dose of MDMA HCl, along with non-drug preparatory and integrative therapy. The primary objective of the proposed project is to evaluate safety and clinical outcomes of MDMA-assisted therapy compared to identical psychotherapy with low dose (\"active placebo\") MDMA for the treatment of PTSD-AUD in military Veterans. The Primary Outcome measures, the Clinician Administered PTSD Scale (CAPS-5) and Inventory of Psychosocial Functioning (IPF), will evaluate changes in PTSD symptoms and psychosocial outcomes over time. Changes in drinking outcomes will also be evaluated (via the Timeline Followback, TLFB).",[27,353],"Alcohol Use Disorder","2026-06-01",{"date":356,"type":32},"2026-06-02",{"date":358,"type":32},"2026-05-18",{"date":360,"type":21},"2030-05-30",{"name":167,"class":168},{"id":363,"slug":364,"hasResults":12,"nctId":365,"briefTitle":366,"officialTitle":367,"acronym":368,"eligibilityCriteria":369,"healthyVolunteers":12,"sex":17,"minAge":370,"maxAge":72,"enrollmentInfo":371,"targetDuration":4,"studyType":326,"phases":4,"briefSummary":372,"conditions":373,"keywords":375,"overallStatus":208,"whyStopped":4,"lastUpdateSubmitDate":384,"lastUpdatePostDateStruct":385,"startDateStruct":387,"completionDateStruct":389,"leadSponsor":391,"locationsCount":39},"100640217","intra-sessional-autonomic-arc-detection-in-ketamine-assisted-therapy-for-ptsd-a-signal-characterisation-pilot-study-100640217","NCT07614581","Intra-Sessional Autonomic Arc Detection in Ketamine-Assisted Therapy for PTSD: A Signal Characterisation Pilot Study","Intra-Sessional Autonomic Arc Detection Using Continuous HRV and EDA Monitoring in Adults Undergoing Ketamine-Assisted Therapy for PTSD: A Prospective Observational Signal Characterisation Pilot Study","OMS-KAT","Inclusion Criteria:\n\n1. Adults aged 19 to 65 years\n2. Currently enrolled in or referred for equine-assisted therapy at the study facility\n3. No prior relationship with the therapy horse assigned to their study sessions\n4. Able to wear a chest-strap heart rate monitor comfortably for 35 minutes\n5. Able to provide written informed consent in English\n6. Willing to have sessions video recorded for research purposes\n\nExclusion Criteria:\n\n1. Diagnosed cardiac arrhythmia of any type\n2. Implanted cardiac device including pacemaker or implantable cardioverter-defibrillator\n3. Current use of beta-blockers, calcium channel blockers, digoxin, or any other medication known to suppress or significantly alter heart rate variability\n4. Active psychosis or acute psychiatric crisis at time of enrolment\n5. Inability to provide written informed consent\n6. Pregnancy\n7. Prior participation in this study under a different horse pairing","19 Years",{"count":339,"type":21},"This study examines whether a continuous wearable biosensor and a proprietary signal detection algorithm (JungleCODE, Open Medicine Studio) can detect and characterise the autonomic nervous system arc - a trajectory from a state of high physiological arousal (aporia) to a state of regulated calm (ataraxia) - during ketamine-assisted therapy (KAT) sessions in adults with post-traumatic stress disorder (PTSD).\n\nParticipants independently arrange their own ketamine-assisted therapy sessions with a licensed British Columbia provider. The researcher does not administer ketamine or any other substance. The researcher's role is continuous physiological monitoring via a wrist-worn biosensor (EmbracePlus, Empatica) and a structured post-session interview only.\n\nThe primary purpose is to determine whether the JungleCODE arc-position detection algorithm can identify a consistent, characterisable autonomic trajectory within KAT sessions, and to assess the feasibility of this monitoring protocol. This is a pilot signal characterisation study (N=2-6); no therapeutic outcomes are assessed and no clinical claims are made.",[374],"Post-Traumatic Stress Disorder",[376,377,378,379,380,381,382,383],"Heart Rate Variability","Autonomic Nervous System","Neuroplasticity","Physiological Synchrony","Electrodermal Activity","Ketamine-Assisted Therapy","Signal Characterization","Wearable Biosensor","2026-05-28",{"date":386,"type":32},"2026-05-29",{"date":388,"type":21},"2026-07-15",{"date":390,"type":21},"2026-09-30",{"name":392,"class":38},"Adriaan Dirk van der Wart",{"id":394,"slug":395,"hasResults":12,"nctId":396,"briefTitle":397,"officialTitle":398,"acronym":4,"eligibilityCriteria":399,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":400,"targetDuration":4,"studyType":22,"phases":402,"briefSummary":403,"conditions":404,"keywords":407,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":414,"lastUpdatePostDateStruct":415,"startDateStruct":416,"completionDateStruct":418,"leadSponsor":420,"locationsCount":39},"100564923","improving-mental-health-in-forcibly-displaced-populations-100564923","NCT06635486","Improving Mental Health in Forcibly Displaced Populations","Adaptation of an Open Source Cognitive Behavioral Treatment Protocol Designed to Improve Mental Health in Forcibly Displaced Populations","Inclusion Criteria:\n\nTo be eligible to participate in this study, an individual must meet all of the following criteria:\n\n* have Venezuelan nationality\n* have arrived in Lima in years 2014 to the present\n* be 18 years of age or older\n\nIn addition, in order to be eligible to participate in this study, an individual must meet one of the following criteria:\n\n* score 10 points or more at the Patient Health Questionnaire (PHQ-9) or\n* score 10 points or more at the General Anxiety Disorder (GAD-7) or\n* have a history of trauma exposure as listed in the Life Events Checklist (LEC-5) and score 31 points or more in the PTSD Checklist (PCL-5)\n\nExclusion Criteria:\n\nAn individual is excluded from the study if they respond positively to one or more of the following questions during screening:\n\n* Suicidal ideation: \"When someone feels as upset as you do, they may have thoughts that life isn't worth living. What thoughts have you had like this?\"\n* Homicidal ideation: \"When someone feels as upset as you do, they may have thoughts about hurting the person who has upset or hurt them. What thoughts have you had like this?\"\n* Psychosis: \"Do you have a diagnosis of psychosis or schizophrenia?\"",{"count":401,"type":21},90,[76],"This project aims to improve mental health support for Venezuelan migrants living in Lima, Peru, who often face challenges like anxiety, depression, and post-traumatic stress disorder (PTSD). Since 2015, millions of Venezuelans have fled their country due to a severe humanitarian crisis, including extreme inflation, food shortages, and political unrest. Many of these individuals now live in Peru, where they struggle to access mental health services.\n\nA new type of intervention that is both evidence-based and culturally adapted to meet the specific needs of Venezuelan migrants is the focus of this research. The intervention is designed to be delivered by trained lay providers-people from the community who have received special training but are not professional mental health workers. The intervention consists of 6 to 12 weekly online sessions, each lasting about an hour. These sessions will cover various therapeutic techniques, including cognitive restructuring (changing negative thought patterns), behavioral activation (encouraging positive activities), and emotional regulation (managing feelings). The sessions will be conducted remotely, allowing participants to join from the comfort of their homes.This approach is intended to make mental health care more accessible and relatable for migrants, who may feel more comfortable receiving help from someone who understands their cultural background and experiences.",[405,27,406],"Anxiety","Depression",[408,409,410,411,412,413],"Venezuelan migrants","Cognitive behavioral intervention (CBT)","Culturally adapted","Lay providers","Feasibility","Acceptability","2026-05-27",{"date":384,"type":32},{"date":417,"type":32},"2025-04-15",{"date":419,"type":21},"2027-06",{"name":421,"class":38},"Boston Medical Center",{"id":423,"slug":424,"hasResults":12,"nctId":425,"briefTitle":426,"officialTitle":427,"acronym":428,"eligibilityCriteria":429,"healthyVolunteers":200,"sex":48,"minAge":18,"maxAge":430,"enrollmentInfo":431,"targetDuration":4,"studyType":22,"phases":432,"briefSummary":433,"conditions":434,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":414,"lastUpdatePostDateStruct":439,"startDateStruct":440,"completionDateStruct":442,"leadSponsor":444,"locationsCount":39},"100482574","exploring-virtual-reality-adventure-training-exergaming-100482574","NCT05563805","Exploring Virtual Reality Adventure Training Exergaming","Exploring Virtual Reality Adventure Training Exergaming (V-RATE) on Veterans' Health Outcomes","V-RATE","Inclusion Criteria:\n\n1. Are between the ages of 18 and 45\n2. Identify as a U.S. military veteran\n\n4\\. Normal vision (no colorblindness)\n\nExclusion Criteria:\n\n1. Unable to walk independently (e.g., use of any mobility assistive device such as brace, wheelchair, cane, crutch, walker, knee scooter)\n2. Self-reported joint problem that limits mobility (e.g., arthritis or other condition that would prevent participation) or ongoing orthopedic injury\n3. Self-reported pregnancy or suspicion of pregnancy\n4. Self-reported motor disorder or impaired sense of motion or balance (such as Parkinsonism)\n5. Self-reported color blindness\n6. Self-reported neurological or cognitive disorder (e.g., TBI, history of seizure)\n7. Self-reported cardiac surgery or any ongoing cardiovascular issues preventing participation or physical activity.","45 Years",{"count":202,"type":21},[76],"The current project aims to design and implement an 8-week Virtual Reality Adventure Therapy Exergaming (V-RATE) intervention focused on women veterans. A randomized controlled trial using a repeated measure design with a 1-month follow-up assessment will be employed to examine effects on physical and mental health outcomes.",[435,436,406,437,27,438,405],"Physical Activity","Sedentary Behavior","Cognitive Function","Quality of Life",{"date":354,"type":32},{"date":441,"type":32},"2022-09-07",{"date":443,"type":21},"2027-08-31",{"name":445,"class":38},"The University of Texas at Arlington",{"id":447,"slug":448,"hasResults":12,"nctId":449,"briefTitle":450,"officialTitle":451,"acronym":4,"eligibilityCriteria":452,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":453,"enrollmentInfo":454,"targetDuration":4,"studyType":22,"phases":456,"briefSummary":457,"conditions":458,"keywords":4,"overallStatus":208,"whyStopped":4,"lastUpdateSubmitDate":459,"lastUpdatePostDateStruct":460,"startDateStruct":461,"completionDateStruct":463,"leadSponsor":465,"locationsCount":39},"100637485","identification-of-physiological-sleep-indices-that-reflect-clinical-improvement-and-reduction-in-stress-biomarkers-after-stellate-ganglion-block-in-patients-with-posttraumatic-stress-disorder-ptsd-100637485","NCT07618611","Identification of Physiological Sleep Indices That Reflect Clinical Improvement and Reduction in Stress Biomarkers After Stellate Ganglion Block in Patients With Posttraumatic Stress Disorder (PTSD)","Dentification of Physiological Sleep Indices That Reflect Clinical Improvement and Reduction in Stress Biomarkers After Stellate Ganglion Block in Patients With Posttraumatic Stress Disorder (PTSD)","Inclusion Criteria:The study will include adults (age ≥18) with a confirmed diagnosis of post-traumatic stress disorder (PCL-5), who are capable of providing informed consent and are willing to continuously wear a smart device (ring and\u002For watch) throughout the study period.\n\n\\-\n\nExclusion Criteria:Allergy to local anesthetics, psychosis (active or past), active suicidality in the past 2 months, treatment with anticoagulants or P2Y12 antiplatelet agents, significant arrhythmias, pregnancy, clinical contraindication to SGB (such as infection limiting the procedure), as well as inability to wear a monitoring device or baldness preventing hair sampling. Patients who report data equal to 25% of what is expected for the follow-up period will be excluded from the study.\n\n\\-","99 Years",{"count":455,"type":21},60,[76],"Post-traumatic stress disorder (PTSD) is a chronic disorder that develops following exposure to trauma, and is characterized by intrusive experiences, avoidance, cognitive-emotional changes, and hyperarousal. It is based on a complex noradrenergic dysregulation. The amygdala activates the hypothalamus to release excessive corticotropin releasing factor (CRF), which activates the hypothalamic-pituitary-adrenal (HPA) axis and leads to high nocturnal cortisol levels with EEG changes and increased arousals. At the same time, the Locus Coeruleus (LC) releases excess norepinephrine (NE), which interferes with the transition to Non-REM sleep and suppresses the stability of REM sleep, a stage essential for emotional processing and the extinction of conditioned fear. Sleep disturbances occur in 70-90% of PTSD patients, leading to fragmented sleep that impairs conditioned fear extinction, reinforces hyperarousal, and perpetuates the disorder as a protective-morbidity mechanism \\[1,2\\]. Beyond the clinical implications, sleep disturbances mediate the relationship between PTSD and functional disability and occupational disability, with 74% of the economic burden of PTSD in Israel attributed to loss of employment and productivity (3,4). The Stellate Ganglion (SG), located between the C6-C7 vertebrae, is a central sympathetic junction between the central nervous system and the periphery. This connection is expressed in descending pathways from the amygdala and prefrontal cortex (PFC) and ascending pathways from the periphery through the SG that feed the LC, which in turn secretes NE to the amygdala and other limbic areas and affects fear and memory processing. Subganglionic ganglion block (SGB) using local anesthetic injection reduces sympathetic tone, reduces Nerve Growth Factor (NGF) and NE levels, and \"breaks\" the pathological feedback loop. This effect was found to reduce conditioned fear memory and was accompanied by a significant decrease in NE concentration in the amygdala (5,6). A multicenter RCT showed that SGB led to an improvement in PTSD symptoms, with sleep disturbances and hyperarousal being the most responsive symptoms \\[7\\]. This finding was supported by a recent meta-analysis that confirmed a significant improvement in key sleep measures, including total sleep time and overall sleep quality (8). A RCT that included a sleep laboratory and neurotransmitter measurements in anxiety patients with sleep disorders found that SGB led to a decrease in NE and an increase in Serotonin- and NPY-, along with an objective improvement in quality and time of wakefulness \\[9\\]. Initial findings in primary insomnia patients without PTSD also showed significant improvement, and combining SGB with CBT-I (cognitive-behavioral therapy) yielded stable results over time \\[10\\]. These findings strengthen the rationale for using SGB as a treatment for disorders resulting from sympathetic overactivity and HPA axis dysregulation. Despite this promising evidence, there is a knowledge gap: the effect of SGB on objective and continuous sleep measures in a natural setting has not yet been examined, and cortisol levels have not been measured concurrently with changes in sleep. Polysomnography (PSG)-the standard test for diagnosing sleep disorders-is not suitable for continuous monitoring due to discomfort. Wearable devices, in particular the Oura Ring Gen3, have been shown to be a valid alternative to PSG for sleep monitoring in a natural setting. The ring, which demonstrated the highest PSG compliance among consumer monitoring devices, combines accelerometry and photoplethysmography (PPG) to continuously measure WASO (Wake After Sleep Onset), Sleep efficiency (SE), Heart rate variability (HRV), sleep stages, and nocturnal heart rate (11,12). The proposed study aims to bridge this gap, to monitor for the first time objective physiological sleep measures and cortisol levels over time in PTSD patients after SGB. In addition to its contribution to understanding the mechanism of action of SGB, this study will isolate the physiological measures associated with clinical improvement and may serve as a gateway for further research and treatments in the field and for therapeutic success in PTSD and autonomic dysregulation.",[27],"2026-05-24",{"date":354,"type":32},{"date":462,"type":21},"2026-08-01",{"date":464,"type":21},"2031-08-01",{"name":466,"class":38},"sara dichtwald",{"id":468,"slug":469,"hasResults":12,"nctId":470,"briefTitle":471,"officialTitle":471,"acronym":4,"eligibilityCriteria":472,"healthyVolunteers":12,"sex":17,"minAge":120,"maxAge":297,"enrollmentInfo":473,"targetDuration":4,"studyType":22,"phases":475,"briefSummary":476,"conditions":477,"keywords":478,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":483,"lastUpdatePostDateStruct":484,"startDateStruct":486,"completionDateStruct":488,"leadSponsor":490,"locationsCount":39},"100615095","phase-2-mdma-assisted-massed-exposure-therapy-for-ptsd-100615095","NCT07288151","MDMA-Assisted Massed Exposure Therapy for PTSD","Inclusion Criteria:\n\n* PTSD diagnosis as assessed by Clinician-Administered Posttraumatic Stress Scale for DSM-5 - Revised (CAPS-5-R).\n* Able to speak and read English (due to standardization of outcome measures).\n* Willing to sign a release for the investigators to communicate with their primary care or mental health providers if indicated.\n* Able to swallow pills.\n* Agree to have study visits video and\u002For audio recorded, including Experimental Session, assessments, and non-drug therapy sessions.\n* Willing to provide a contact (relative, spouse, close friend, or another support person) who is willing and able to be contacted by the investigators.\n* Agree to inform the investigators within 48 hours of any medical conditions and procedures.\n* If able to become pregnant, must have a negative pregnancy test before study entry, at study entry, and before the Medicine Session. Must agree to use adequate birth control for a month before the Medicine session and through 10 days after the Medicine Session.\n* Agree to the following lifestyle modifications: comply with requirements for fasting and refraining from certain medications before the Medicine Session, and not participating in any other interventional clinical trials during the duration of the study, are driven home or to a hotel after the Medicine Session, and commit to medication dosing, therapy, and study procedures\n\nExclusion Criteria:\n\n* Are not able to give adequate informed consent.\n* Have previously participated in a Multidisciplinary Association for Psychedelic Studies (MAPS) sponsored MDMA clinical trial.\n* Have any current problem which, in the opinion of the investigator or study physician, might interfere with participation.\n* Have hypersensitivity to any ingredient of the Investigational Medicinal Product (IMP).\n* Upon review of medical or psychiatric history and psychiatric assessment, have any current or past diagnosis that would be considered a risk to participating in the study\n* Requires ongoing psychiatric medication use with certain exceptions. Individuals may decide to taper psychiatric medications under the guidance of their local provider.\n* Have a history of any medical condition that could make receiving MDMA dangerous because of increases in blood pressure and heart rate or any medical condition the study physician believes would pose a safety risk or interfere with the effects of the treatment. Any medical disorder judged by the investigator to significantly increase the risk of MDMA administration by any mechanism is exclusionary.\n* Have any unstable medical condition that would interfere with participation.\n* Have uncontrolled hypertension) documented on three separate occasions.\n* Have Wolff-Parkinson-White syndrome or any other accessory pathway that has not been successfully eliminated by ablation.\n* Have a history of ever having ventricular arrhythmia or any other abnormal heart rhythm that the study physician believes would pose a significant risk of participation.\n* Have an abnormal finding on electrocardiogram\n* Have a history of additional risk factors for Torsade de Pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome).\n* Require the use of concomitant medications that could impact the effects or safety of MDMA during the Medicine Session.\n* Have symptomatic liver disease or significant liver enzyme elevations.\n* Have a history of hyponatremia or hyperthermia.\n* Weigh less than 48 kilograms (105 lbs.).\n* Are pregnant or nursing\n* Have engaged in ketamine-assisted therapy or used ketamine within 12 weeks of enrollment",{"count":474,"type":21},200,[24],"The goal of this clinical trial is to investigate the efficacy of 3,4-methylenedioxy-methamphetamine hydrochloride (MDMA) combined with Massed Prolonged Exposure (PE) therapy for the treatment of posttraumatic stress disorder (PTSD) in adult participants diagnosed with PTSD. This randomized, placebo-controlled trial will enroll 95 participants.\n\nThe main questions it aims to answer are:\n\n* Does the combination of PE + MDMA lead to greater reduction in PTSD symptom severity from pre-treatment to one-month follow-up compared to PE + placebo?\n* Does PE + MDMA improve response efficiency and durability of PTSD symptom improvement compared to PE + placebo?\n* Does MDMA + PE enhance extinction retention and reduce amygdala threat reactivity, and are these changes associated with improved PTSD outcomes?\n\nParticipants will:\n\n* Receive 10 sessions of Massed Prolonged Exposure therapy over two weeks\n* Be administered either 100 mg of MDMA or a placebo at Visit 2\n* Undergo blinded independent evaluator assessments using the Clinician-Administered PTSD Scale for DSM-5-R (CAPS-5-R) at the one-month posttreatment follow-up",[27],[479,480,481,482],"MDMA","3,4-Methylenedioxymethamphetamine","Massed prolonged exposure therapy","Pos traumatic stress disorder","2026-05-21",{"date":485,"type":32},"2026-05-26",{"date":487,"type":21},"2026-07",{"date":489,"type":21},"2030-01",{"name":491,"class":38},"Emory University",{"id":493,"slug":494,"hasResults":12,"nctId":495,"briefTitle":496,"officialTitle":496,"acronym":4,"eligibilityCriteria":497,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":72,"enrollmentInfo":498,"targetDuration":4,"studyType":22,"phases":500,"briefSummary":501,"conditions":502,"keywords":503,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":358,"lastUpdatePostDateStruct":506,"startDateStruct":508,"completionDateStruct":510,"leadSponsor":512,"locationsCount":39},"100557922","rapid-treatment-of-ptsd-with-accelerated-non-invasive-brain-stimulation-100557922","NCT06544408","Rapid Treatment of PTSD With Accelerated Non-Invasive Brain Stimulation","Inclusion:\n\n1. Adults age 18 years to 65 years old.\n2. Meets DSM-5 criteria for PTSD with a PCL-5 score \\> 33\n3. No changes in psychotropic medication (if taking psychotropic medication) and\u002For changes in supportive psychotherapy for 1 month prior to initial visit; and clinically appropriate to maintain stable treatment regimen for duration of trial.\n4. Clinically competent to give informed written consent and ability to understand study procedures and to comply with them for the entire length of the study\n\nExclusion:\n\n1. Medical contraindication for neuromodulation (e.g., ferrous metal in head, seizure disorder, brain tumor, stroke, aneurysm, multiple sclerosis, etc.).\n2. Active substance use disorder in last 3 months or any current substance use that puts the participant at increased risk or significant impairment.\n3. Dementia or other cognitive disorder making unable to engage in treatment.\n4. Any history or diagnosis of Schizophrenia, Schizoaffective Disorder, Delusional Disorder or other psychotic illness that precludes safe participation in trial.\n5. Suicidal risk that precludes safe participation defined as clinical impression that the participant is at significant risk for suicide.\n6. OCD cannot be the primary disorder but can have OCD symptoms.\n7. Inability to stop taking any medication that significantly lowers the seizure threshold (e.g., tricyclic antidepressants, clozapine, etc.)\n8. Current, planned, or suspected pregnancy\n9. Unstable medical conditions or any current medical condition that could preclude being able to safely participate in TMS treatment (e.g., unstable metabolic abnormality, unstable angina, etc.)\n10. Severe Traumatic Brain Injury\n11. We will exclude non-English speakers because of the need for rapid communication during the delivery of treatments.\n12. Significant ongoing litigation or claims that impact research activities, as determined by the research study team. (Research may especially be impacted when mental health or pain is being evaluated for litigation or claims, such as civil and criminal cases, disability claims and worker's compensation).\n13. Prior known active TMS of dorsolateral prefrontal cortex or dorsomedial prefrontal cortex or electroconvulsive therapy (ECT) -",{"count":499,"type":21},132,[76],"This study will test the clinical efficacy of an accelerated TMS (accel-TMS) protocol that rapidly addresses PTSD symptoms with 1 week (25 sessions over 5 days) of condensed treatment.",[27,155],[54,504,505],"TMS","Transcranial Magnetic Stimulation",{"date":507,"type":32},"2026-05-20",{"date":509,"type":32},"2024-11-06",{"date":511,"type":21},"2028-12-30",{"name":513,"class":38},"Florida State University",{"id":515,"slug":516,"hasResults":12,"nctId":517,"briefTitle":518,"officialTitle":519,"acronym":4,"eligibilityCriteria":520,"healthyVolunteers":200,"sex":17,"minAge":18,"maxAge":72,"enrollmentInfo":521,"targetDuration":4,"studyType":22,"phases":522,"briefSummary":523,"conditions":524,"keywords":4,"overallStatus":208,"whyStopped":4,"lastUpdateSubmitDate":358,"lastUpdatePostDateStruct":525,"startDateStruct":526,"completionDateStruct":527,"leadSponsor":528,"locationsCount":4},"100512140","phase-2-department-of-defense-ptsd-adaptive-platform-trial---intervention-b---vilazodone-100512140","NCT05948579","Department of Defense PTSD Adaptive Platform Trial - Intervention B - Vilazodone","A Phase 2, Multi-center, Multi-arm, Randomized, Placebo-controlled, Double-blind, Adaptive Platform Study to Evaluate the Safety, Tolerability, and Efficacy of Potential Pharmacotherapeutic Interventions in Active-Duty Service Members, Veterans, and Non-Veteran Civilians With PTSD","Inclusion Criteria:\n\nNo additional inclusion criteria beyond the inclusion criteria specified in the Master Protocol (NCT05422612).\n\nExclusion Criteria:\n\nThe following exclusion criteria are in addition to the exclusion criteria specified in the Master Protocol (NCT05422612).\n\n1\\. History of treatment for PTSD with vilazodone at doses of 20 to 40 mg daily, for at least 4 weeks.",{"count":474,"type":21},[24],"This is a Phase 2 randomized, double-blinded, placebo-controlled study that will evaluate multiple potential pharmacotherapeutic interventions for PTSD utilizing an adaptive platform trial design.\n\nIntervention B - Vilazodone will assess the safety and efficacy of vilzodone in participants with PTSD.\n\nPlease see NCT05422612 for information on the S-21-02 Master Protocol.",[27],{"date":507,"type":32},{"date":35,"type":21},{"date":63,"type":21},{"name":529,"class":38},"Global Coalition for Adaptive Research",{"id":531,"slug":532,"hasResults":12,"nctId":533,"briefTitle":534,"officialTitle":534,"acronym":535,"eligibilityCriteria":536,"healthyVolunteers":12,"sex":48,"minAge":370,"maxAge":4,"enrollmentInfo":537,"targetDuration":4,"studyType":326,"phases":4,"briefSummary":539,"conditions":540,"keywords":543,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":548,"lastUpdatePostDateStruct":549,"startDateStruct":551,"completionDateStruct":553,"leadSponsor":554,"locationsCount":39},"100636126","predictive-value-of-early-peritraumatic-distress-screening-for-childbirth-ptsd-following-unplanned-cesarean-delivery-100636126","NCT07561632","Predictive Value of Early Peritraumatic Distress Screening for Childbirth-PTSD Following Unplanned Cesarean Delivery","PREDICT","Inclusion Criteria:\n\n* Age ≥19 years\n* Underwent unplanned cesarean delivery\n* Able to provide informed consent\n* Able to read and understand English questionnaires\n\nExclusion Criteria:\n\n* Fetal or neonatal demise\n* Unable to complete study questionnaires or provide informed consent",{"count":538,"type":21},420,"The goal of this observational study is to learn whether early postpartum screening tools can predict the development of childbirth-related post-traumatic stress symptoms in individuals who undergo unplanned cesarean delivery.\n\nThe main questions it aims to answer are:\n\n* Do scores on the Peritraumatic Distress Inventory (PDI) collected 24-48 hours after delivery predict childbirth-related PTSD symptoms at 6 weeks postpartum?\n* Do scores on the City Birth Trauma Scale - Short Form (CityBiTS-SF) collected 24-48 hours after delivery predict childbirth-related PTSD symptoms at 6 weeks postpartum?\n\nParticipants will:\n\n* Complete questionnaires within 24-48 hours after delivery, including the PDI, CityBiTS-SF, and Edinburgh Postnatal Depression Scale (EPDS).\n* Complete follow-up questionnaires at 6 weeks and 3 months postpartum, including measures of PTSD symptoms (PTSD Checklist for DSM-5, PCL-5) and depressive symptoms.\n\nResearchers will evaluate whether early screening scores are associated with later symptoms of childbirth-related PTSD and postpartum depression, and will assess the feasibility and acceptability of implementing routine inpatient screening for psychological birth trauma.",[27,541,542],"Post Partum Depression","Acute Stress Symptoms",[544,545,546,547],"Childbirth Related PTSD","Psychological birth trauma","Peritraumatic Distress Inventory","City Birth Trauma Scale","2026-05-15",{"date":550,"type":32},"2026-05-19",{"date":552,"type":32},"2026-05-08",{"date":239,"type":21},{"name":555,"class":38},"University of British Columbia",{"id":557,"slug":558,"hasResults":12,"nctId":559,"briefTitle":560,"officialTitle":561,"acronym":562,"eligibilityCriteria":563,"healthyVolunteers":12,"sex":48,"minAge":18,"maxAge":4,"enrollmentInfo":564,"targetDuration":4,"studyType":22,"phases":566,"briefSummary":567,"conditions":568,"keywords":570,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":575,"lastUpdatePostDateStruct":576,"startDateStruct":578,"completionDateStruct":580,"leadSponsor":581,"locationsCount":583},"100435672","a-case-management-algorithm-for-women-victims-of-violence-100435672","NCT04953273","A Case Management Algorithm for Women Victims of Violence","Effectiveness of a Case Management Algorithm on Clinical Outcome After Consultations Requested in a Clinical Forensic Medicine Unit by Female Victims of Violence","VIGITRAUMA","Inclusion Criteria:\n\n* Women\n* 18 years and older\n* Consultation requested in a clinical forensic medicine unit after being victim of violence\n* The person was exposed to: death, threatened death, actual or threatened serious injury, or actual or threatened sexual violence (PTSD criterion A - DSM -5)\n* With social insurance\n* Consent to participate to the study\n\nExclusion Criteria:\n\n* Do no consent to participate to the study\n* Intrafamilial or intimate partner violence\n* Do not speak french",{"count":565,"type":21},756,[76],"A considerable body of research has demonstrated that women who are victims of interpersonal violence are at substantially elevated risk for the development of post-traumatic stress disorder (PTSD). In France, victims can request a medico-legal examination in a clinical forensic medicine unit. Although these units are also a place for initial psychological examination, women often don't attend future scheduled appointments. Decision-making algorithm using phone contact are effective in suicide prevention. Our aim is to assess the effectiveness of case management algorithm using early phone contact compared to a control group treated as usual on clinical outcome after consultation requested in a clinical forensic medicine unit by female victims of violence.\n\nMethod: Prospective, multicenter, open-label, randomized controlled clinical trial, for women victims of violence. Victims randomized in VIGITRAUMA group will be contacted by phone at 3 weeks after the consultation in a clinical forensic medicine unit, and a second phone call can be done. If the subject is not contacted after the second phone call, he will receive a postcard.\n\nControl group will benefit from usual follow-up.\n\nAll the subjects included will be then evaluated at 3 months, 6 months and 1 year during a phone call.",[374,569],"Violence-Related Symptom",[374,571,572,573,574],"Women Health","Physical Abuse","Forensic Medicine","Case-Management Algorithm","2026-05-11",{"date":577,"type":32},"2026-05-14",{"date":579,"type":32},"2021-07-06",{"date":487,"type":21},{"name":582,"class":38},"University Hospital, Lille",8,{"id":585,"slug":586,"hasResults":12,"nctId":587,"briefTitle":588,"officialTitle":588,"acronym":4,"eligibilityCriteria":589,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":590,"enrollmentInfo":591,"targetDuration":4,"studyType":22,"phases":593,"briefSummary":594,"conditions":595,"keywords":597,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":602,"lastUpdatePostDateStruct":603,"startDateStruct":605,"completionDateStruct":607,"leadSponsor":609,"locationsCount":39},"100509560","phase-1-alpha-amino-3-hydroxy-5-methyl-4--isoxazole-propionic-acid-receptor-components-of-the-anti-depressant-ketamine-response-100509560","NCT05915013","Alpha-Amino-3-Hydroxy-5-Methyl-4- Isoxazole Propionic Acid Receptor Components of the Anti-Depressant Ketamine Response","Inclusion Criteria Substudy #2:\n\n* Right-handed as determined by the Edinburgh Handedness Inventory\n* Current depression as indicated by a score greater than 17 on the full Hamilton Depression Rating Scale\n* Anti-depressant resistant depressive symptoms, defined by a history of failure of one or more adequate anti-depressant trials\n* Individuals who have previously received ketamine must have had a positive response. Individuals who report reduced depressive symptoms will be treated as ketamine responders and entered directly into the closed label trial.\n* Participants will meet DSM-5 Criteria for MDD as determined by the SCID-5\n* All participants given ketamine must be engaged in treatment outside of the research protocol. Those who are not currently in treatment may be referred for treatment.\n* Individuals who are receiving pharmacotherapy for depression must have been receiving the current medication and dose for 4 weeks before randomization. In addition, they should have a plan to continue the current regime of pharmacotherapy for the duration of the trial.\n* Individuals who are receiving psychotherapy must have been in treatment for four weeks and should have a plan to continue the current regime of psychotherapy for the duration of the trial.\n* Willing to refrain from caffeine, drug and alcohol use for one week prior to each MRI session\n* Females will be included if they are not pregnant or breastfeeding and agree to utilize a medically accepted birth control method (to include oral, injectable, or implant birth control, condom, diaphragm with spermicide, intrauterine device, tubal ligation, abstinence, or partner with vasectomy). Women who are surgically sterile or post-menopausal with cessation of menses for at least one year are not required to use birth control. If a woman should become pregnant during the study, she will be excluded from the trial.\n* Females will receive ketamine during the follicular phase, i.e., in the first week after the start of the menstrual period, if at all possible. If a prospective participant typically has significant menstrual cramps during this entire follicular phase, she will be studied during another part of her cycle. She will be studied during the same part of her cycle for each scan, if possible.\n* Able to read and write English\n* Have at least a 12th grade education level or equivalent\n\nExclusion Criteria Substudy #2:\n\n* A score on the Columbia Suicide Severity Rating Scale in the \"intent\" or \"intent with plan\" categories or judged by Dr. Krystal or Dr. Driesen to be at serious risk for suicide.\n* Neurological disorder excluding migraine headaches or more than mild head injury. Individuals with migraines will not complete any ketamine infusion visits within 24 hours of a migraine. More than mild head injury is indicated by the presence of any of the following:\n\n  * More than half hour unconsciousness after trauma\n  * More than one hour post-traumatic amnesia\n  * Concussive symptoms such as headache, memory problems, nausea\u002Fvomiting, irritability, ringing in the ears, dizziness, balance problems, difficulty concentrating or visual disturbances lasting more than one week after injury.\n  * Concussive symptoms as defined above in the first week after injury causing more than one day impairment in typical duties.\n  * Four or more concussive events of less severity than the above will also be grounds for exclusion. These events would include post-trauma symptoms such as the individual being dazed, seeing stars, unconscious for less than one half hour, or post-traumatic amnesia of less than an hour.\n* Current therapeutic treatment with ketamine\n* Current treatment with topiramate, memantine, or barbiturates within two weeks of randomization\n* Daytime use of benzodiazepines\n* Current treatment with monoamine oxidase inhibitors within 4 weeks of randomization\n* Treatment with a vagal nerve stimulator, ECT or deep brain stimulation within two weeks of randomization\n* Psychosis other than psychotic experiences congruent with depressed mood during a period of depression\n* Insulin-dependent diabetes or non-insulin dependent diabetes that is poorly controlled\n* Other major medical disorder unless cleared by a study physician\n* History of violence unless cleared by Dr. Driesen or Dr. Krystal because of extenuating circumstances. For example, an individual whose violent behavior was always coupled with substance abuse and had obtained stable sobriety with no violent incidents or an individual who had received successful pharmacotherapy for impulse control difficulties may be included.\n* Individual meets criteria for a diagnosis of substance or alcohol use disorder within the three months prior to screening date. Individuals who meet criteria for mild alcohol use disorder within three months prior to screening date may be included in the study at investigator discretion. The diagnosis of mild alcohol use disorder shall be per DSM-5 and involve 2-3 symptoms. The PI's discretion will be based on the symptoms that are reported. The purpose of including individuals with mild alcohol use disorder is to extend recruitment to more individuals who can participate safely in the trial.\n* A positive on screening urine drug test or, at the study physicians' discretion, on any drug screens given before the scans.\n* A positive screening breathalyzer test or, at the study physicians' discretion, on any breathalyzer test given before the scans. This applies to all subjects, including those who make criteria for current mild alcohol use disorder.\n* A 12-lead ECG at screening has clinically significant abnormalities as determined by the physician reading the ECG.\n* Abnormality on clinical chemistry or hematology examination at the pre-study medical screening. Subjects with laboratory parameters outside the reference range for this age group will only be included if the study physician considers that such findings will not introduce additional risk factors.\n* History of positive HIV or Hepatitis B\n* Has received either prescribed or over-the-counter (OTC) centrally active medicine or herbal supplements within the week prior to the MRI scan. Subjects who have taken OTC medication or herbal supplements may still be entered into the study, if, in the opinions of the Principal\u002FCo-Investigator, the medication received will not interfere with the study procedures or compromise safety.\n* Known sensitivity to ketamine or heparin\n* Resting blood pressure lower than 85\u002F55 or higher than 140\u002F90, or resting heart rate lower than 45\u002Fmin or higher than 100\u002Fmin, unless cleared by study physician. If a subject meets these blood pressure entrance criteria, but is being treated for high blood pressure, the study team will check with the subject's primary care physician or treatment provider to confirm that the subject is stable and normotensive on their current treatment plan.\n* History of general intellectual disability\n* History of claustrophobia\n* Any clinically significant impairment of color vision or visual acuity after correction available in the scanner\n* Presence of cardiac pacemaker or other electronic device or ferromagnetic metal foreign bodies in vulnerable positions as assessed by a Yale Magnetic Resonance Research Center standard pre-MRI screening questionnaire\n* Subjects will be advised not to drive or operate heavy machinery for at least 24 hours after completing the infusion.\n* Donation of blood in excess of 500 mL within 56 days prior to dosing or similar loss of blood due to other causes.\n* Potential participants may be eliminated at the discretion of Dr. Krystal, Dr. Driesen, or the study physician.","60 Years",{"count":592,"type":21},50,[204],"The proposed study will assess the combined effect of perampanel and ketamine on the anti-depressant response in individuals with treatment resistant depression. The purpose of this study is to test the hypothesis that stimulation of Alpha-Amino-3-Hydroxy-5-Methyl-4- Isoxazole Propionic Acid receptors (AMPAR) is critical to the anti-depressant response of ketamine.",[596,27],"Depressive Disorder, Major",[598,599,27,600,601],"Ketamine","Major Depression","AMPA Receptor","Magnetic Resonance Imaging","2026-05-05",{"date":604,"type":32},"2026-05-06",{"date":606,"type":32},"2023-09-07",{"date":608,"type":21},"2032-12",{"name":610,"class":38},"Yale University",{"id":612,"slug":613,"hasResults":12,"nctId":614,"briefTitle":615,"officialTitle":615,"acronym":4,"eligibilityCriteria":616,"healthyVolunteers":12,"sex":17,"minAge":120,"maxAge":72,"enrollmentInfo":617,"targetDuration":4,"studyType":22,"phases":618,"briefSummary":619,"conditions":620,"keywords":625,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":602,"lastUpdatePostDateStruct":627,"startDateStruct":628,"completionDateStruct":630,"leadSponsor":632,"locationsCount":39},"100499654","phase-2-the-impact-of-ampa-receptor-blockade-on-ketamines-anti-suicidal-effects-100499654","NCT05786066","The Impact of AMPA Receptor Blockade on Ketamine's Anti-Suicidal Effects","Inclusion Criteria:\n\n* Current depression as indicated by a score greater than 17 on the full Hamilton Depression Rating Scale (HDRS-17) AND current major depressive episode as determined by structured clinical interview (SCID-5)\n* Current suicidal ideation as indicated by a score ≥ 2 on the HDRS-17 Item #3 (\"wishes to be dead (or any thoughts of possible death to self)\")\n* Anti-depressant resistant depressive symptoms, defined by a history of failure of one or more adequate anti-depressant trials\n* Participants will meet DSM-5 Criteria for MDD, PTSD or Bipolar Disorder as determined by the SCID-5\n* All participants given Ketamine must be engaged in mental health treatment outside of the research protocol. Those who are not receiving treatment with a mental health provider at the time of the phone screen may be referred for treatment and will have their admission to the protocol deferred until they are receiving treatment with a mental health provider for at least 4 weeks, at which time they may re-apply for admission to the protocol.\n* Individuals who are receiving pharmacotherapy for depression must have been receiving the current medication and dose for 4 weeks before randomization. Those who are not stable on their current medication and dose for 4 weeks at the time of the phone screen may have their admission to the protocol deferred until they are stable on their current psychopharmacotherapy. In addition, all individuals admitted to the protocol should have a plan to continue the current regime of pharmacotherapy for the duration of the trial.\n* Individuals who are receiving psychotherapy must have been in treatment for four weeks and should have a plan to continue the current regime of psychotherapy for the duration of the trial. Those who are not stable on their current regime of psychotherapy for 4 weeks at the time of the phone screen may have their admission to the protocol deferred until they are stable on their current regime of psychotherapy.\n* Willing to refrain from caffeine, drug, and alcohol use for one week prior to each Ketamine infusion\n* Females will be included if they are not pregnant or breastfeeding and agree to utilize a medically accepted birth control method (to include oral, injectable, or implant birth control, condom, diaphragm with spermicide, intrauterine device, tubal ligation, abstinence, or partner with vasectomy). Women who are surgically sterile or post-menopausal with cessation of menses for at least one year are not required to use birth control. If a woman should become pregnant during the study, she will be excluded from the trial.\n* Females will receive Ketamine during the follicular phase, i.e., in the first week after the start of the menstrual period, if at all possible. If a prospective participant typically has significant menstrual cramps during this entire follicular phase, she will be studied during another part of her cycle. She will be studied during the same part of her cycle for each scan, if possible.\n* Able to read and write English\n* Have at least a 12th grade education level or equivalent\n\nExclusion Criteria:\n\n* A score on the Columbia-Suicide Severity Rating Scale \\[43\\] in the \"intent\" or \"intent with plan\" categories within the last 3 months or judged by Dr. Krystal or Dr. Driesen to be at serious risk for suicide.\n* Psychiatric hospitalization in the past two months\n* Suicide attempt in the past two months\n* Neurological disorder excluding migraine headaches or mild head injury. More than mild head injury is indicated by the presence of any of the following:\n\n  * More than half hour unconsciousness after trauma\n  * More than one hour post-traumatic amnesia\n  * Concussive symptoms such as headache, memory problems, nausea\u002Fvomiting, irritability, ringing in the ears, dizziness, balance problems, difficulty concentrating or visual disturbances lasting more than one week after injury.\n  * Concussive symptoms as defined above in the first week after injury causing more than one day impairment in typical duties.\n  * Four or more concussive events of less severity than the above will also be grounds for exclusion. These events would include post-trauma symptoms such as the individual being dazed, seeing stars, unconscious for less than one half hour, or post-traumatic amnesia of less than an hour.\n* Current therapeutic treatment with Ketamine\n* Previous trial of Ketamine without therapeutic benefit\n* Current treatment with topiramate, memantine, or barbiturates within two weeks of randomization\n* Daytime use of benzodiazepines\n* Current treatment with monoamine oxidase inhibitors within 4 weeks of randomization\n* Treatment with a vagal nerve stimulator, ECT or deep brain stimulation within two weeks of randomization\n* Psychosis other than psychotic experiences congruent with depressed mood during a period of depression. Individuals experiencing psychosis during the current depressive episode will be excluded.\n* Other major medical disorder unless cleared by a study physician\n* History of violence unless cleared by Dr. Driesen or Dr. Krystal because of extenuating circumstances. For example, an individual whose violent behavior was always coupled with substance abuse and had obtained stable sobriety with no violent incidents or an individual who had received successful pharmacotherapy for impulse control difficulties may be included.\n* Individual meets criteria for a diagnosis of substance or alcohol use disorder within the three months prior to screening date. Individuals who meet criteria for mild alcohol use disorder within three months prior to screening date may be included in the study at investigator discretion. The diagnosis of mild alcohol use disorder shall be per DSM-5 and involve 2-3 symptoms. The PI's discretion will be based on the symptoms that are reported and the judged consistency and accuracy of the subjects' self-report.\n* A positive on screening urine drug test or, at the study physicians' discretion, on any drug screens given before the infusion visits.\n* A positive screening alcohol breathalyzer or alcohol saliva test or, at the study physicians' discretion, on any alcohol breathalyzer or alcohol saliva test given before the infusion visits.\n* A 12-lead ECG at screening has clinically significant abnormalities as determined by the physician reading the ECG.\n* Abnormality on clinical chemistry or hematology examination at the pre-study medical screening. Subjects with laboratory parameters outside the reference range for this age group will only be included if the study physician considers that such findings will not introduce additional risk factors.\n* History of positive HIV or Hepatitis B\n* Has received either prescribed or over-the-counter (OTC) centrally active medicine or herbal supplements within the week prior to the Ketamine infusion visit. Subjects who have taken OTC medication or herbal supplements may still be entered into the study, if, in the opinions of the Principal\u002FCo-Investigator, the medication received will not interfere with the study procedures or compromise safety.\n* Known sensitivity to Ketamine or heparin\n* Resting blood pressure lower than 85\u002F55 or higher than 140\u002F90, or resting heart rate lower than 45\u002Fmin or higher than 100\u002Fmin, unless cleared by study physician. If a subject meets these blood pressure entrance criteria, but is being treated for high blood pressure, the study team will check with the subject's primary care physician or treatment provider to confirm that the subject is stable and normotensive on their current treatment plan.\n* History of general intellectual disability\n* Donation of blood in excess of 500 mL within 56 days prior to dosing or similar loss of blood due to other causes.\n* Potential participants may be eliminated at the discretion of Dr. Krystal, Dr. Driesen, or the study physician.",{"count":122,"type":21},[24],"The purpose of this study is to test the hypothesis that the anti-depressant and anti-suicidal effects of the N-methyl-D-aspartate receptor (NMDAR) antagonist Ketamine is critically dependent on stimulation of Alpha-Amino-3-Hydroxy-5-Methyl-4-Isoxazole Propionic Acid receptors (AMPAR).",[621,622,623,27,624],"Depressive Disorder","Major Depressive Disorder","Bipolar Disorder","Suicidal Ideation",[598,626],"Suicide",{"date":604,"type":32},{"date":629,"type":32},"2023-04-03",{"date":631,"type":21},"2033-03",{"name":610,"class":38}]