{ "data": { "asOf": "2026-10-30T22:24:26.957Z", "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only", "byRegistry": { "clinicaltrials_gov": 1 }, "canonicalTrial": { "canonicalId": "NCT07226232", "title": "Psilocybin Intervention for Veterans Overcoming Treatment-Resistant Depression", "scientificTitle": "A Multi-site Randomized Controlled Trial of Psilocybin for Treatment-Resistant Depression (TRD) in Veterans", "status": "recruiting", "studyType": "interventional", "phase": [ "PHASE3" ], "conditions": [ "Major Depression" ], "interventions": [ { "name": "Psilocybin", "type": "DRUG", "description": "Psilocybin comparator dose" }, { "name": "Psilocybin", "type": "DRUG", "description": "Psilocybin Intervention Dose" } ], "sponsor": { "name": "VA Office of Research and Development", "type": "FED" }, "locations": [ { "city": "Birmingham", "country": "United States", "facility": "Birmingham VA Medical Center, Birmingham, AL" }, { "city": "Tuscaloosa", "country": "United States", "facility": "Tuscaloosa VA Medical Center, Tuscaloosa, AL" }, { "city": "Portland", "country": "United States", "facility": "VA Portland Health Care System, Portland, OR" }, { "city": "Philadelphia", "country": "United States", "facility": "Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA" }, { "city": "Seattle", "country": "United States", "facility": "VA Puget Sound Health Care System Seattle Division, Seattle, WA" } ], "outcomes": { "other": [ "Clinician-Administered PTSD Scale for DSM-5 - Revised", "Hamilton Depression Rating Scale", "Patient Health Questionnaire 9", "PTSD Checklist for DSM-5" ], "primary": [ "Montgomery-Asberg Rating Scale (MADRS)" ], "secondary": [ "Swiss Psychedelic Side Effects Inventory Overall Score" ] }, "eligibility": { "sex": "ALL", "criteria": "Inclusion Criteria:\n\n* Veteran of the U.S. military who is English-speaking\n* Signed informed consent and Health Insurance Portability and Accountability Act (HIPAA)\n* Adults \\/= 20 at baseline\n* Failure to respond satisfactorily to \\>/= 2 antidepressant treatments for \\>/= 8 weeks, including \\>/= 2 weeks at an adequate dose (\\>/= 50% of the FDA-approved uppermost dose) for major depression. Augmentation with a medication for depression (e.g., neuroleptics, lithium, levothyroxine) is considered a separate course of treatment.\n* If applicable, concurrent \\& permitted antidepressants must be at stable doses for \\>/= 4 weeks prior to baseline (see allowed \\& prohibited medication list)\n* Participants of child-bearing potential must have negative pregnancy test \\& agree to adhere to a medically acceptable method of birth control during the study\n* Has a responsible adult who will provide transportation to the participant's home or place of lodging on the days of psilocybin administration\n\nExclusion Criteria:\n\n* Lifetime bipolar, schizophrenia spectrum, or other psychotic disorders\n* First-degree relative with history of bipolar I, schizophrenia spectrum or other psychotic disorder\n* Presence of psychotic symptoms (e.g., MDE with psychotic symptoms)\n* Sedative-hypnotic, stimulant, inhalant and/or opioid use disorder within past 6 months (lifetime substance use disorder is allowed at the discretion of the LSI)\n* Severe alcohol and/or cannabis use disorder within the past 6 months (mild or moderate alcohol and/or cannabis use is allowed at the discretion of the LSI)\n* Lifetime hallucinogen persisting perception or hallucinogen use disorders\n* Use of psilocybin, ayahuasca, mescaline, lysergic acid diethylamide (LSD), dimethyltryptamine (DMT), 5-Methoxy-N,N-dimethyltryptamine (5-MeO-DMT), peyote, or 3,4-methylenedioxymethamphetamine (MDMA) within past XX months\n* Participant agrees to not use psychedelics (listed above) during the study, except as prescribed by the study protocol\n* Taking prohibited medication within 2 weeks of baseline (see allowed and prohibited concomitant medication list)\n* History of severe traumatic brain injury (TBI)\n* Diagnosis of dementia or related progressive neurocognitive disorder\n* Suicidal ideation/behavior Type 4 or Type 5 intensity on C-SSRS within past 6 months of baseline\n* Psychiatric inpatient treatment within past 3 months of baseline\n* Treatment with electroconvulsive therapy, deep brain stimulation, vagus nerve stimulation, or transcranial magnetic stimulation within 3 months of baseline\n* Implanted central nervous system device\n* Treatment with evidence-based psychotherapy (EBP) for MDD or PTSD within 2 weeks prior to baseline. If receiving EBP therapy, he/she must complete treatment at least 2 weeks prior to baseline. Other forms of non-EBP psychotherapy for MDD or PTSD are allowed to continue during the study period.\n* Pregnancy or lactation, or anticipated pregnancy or breastfeeding during the active treatment phase\n* History of myocardial infarction, congestive heart failure, diabetic ketoacidosis, brain cancer, stroke and/or severe cardiac disease\n* Clinically significant cardiac, pulmonary, renal, liver and/or other medical disease that, in the opinion of the investigator, may contraindicate the use of psilocybin, interfere with the interpretation of study results and/or constitute a health risk for the participant if they take part in the study\n* Seizure disorder, except for seizures due to fever or withdrawal from a substance\n* Clinically significant hypertension (\\>160/95 mmHg), hypotension (\\<90/60 mmHg) tachycardia (\\>100 bpm at rest), QTc prolongation (\\>450 msec men; \\>470 msec women) or clinically significant arrhythmia on ECG\n* Clinically significant abnormal laboratory results on chemistry panel, liver function tests, complete blood count, and/or thyroid stimulating hormone\n* Positive urine drug screen for illicit drugs of abuse (except for THC) at screening or baseline\n* Prior allergic, adverse reaction or adverse experience to a psilocybin formulation\n* Litigating for disability income for a mental disorder outside the VA compensation and pension process", "maximumAge": "75 Years", "minimumAge": "18 Years", "healthyVolunteers": false }, "enrollment": { "type": "ESTIMATED", "count": 240 }, "startDate": "2026-08-03", "completionDate": "2031-06-30", "lastUpdated": "2026-10-23T00:00:00.000Z", "firstPosted": "2025-11-10T00:00:00.000Z", "resultsAvailable": false, "sourceRegistries": [ "clinicaltrials_gov" ], "sourceUrls": [ "https://clinicaltrials.gov/study/NCT07226232" ] }, "identifiers": [ { "idType": "nct", "idValue": "NCT07226232", "declaredBy": "clinicaltrials_gov" } ], "sourceRecords": [ { "registry": "clinicaltrials_gov", "registryName": "ClinicalTrials.gov", "license": "public-domain", "sourceId": "NCT07226232", "sourceUrl": "https://clinicaltrials.gov/study/NCT07226232", "sourceStatus": "RECRUITING", "retrievedAt": "2026-10-28T04:33:21.764Z", "payloadSha256": "b736f5385d0efd401a1a8389dc16af588f63ce0a3220c0ed4963a2483f910a77", "piiRedacted": true } ], "citation": { "canonicalId": "NCT07226232", "sources": [ { "registry": "clinicaltrials_gov", "registryName": "ClinicalTrials.gov", "license": "public-domain", "sourceId": "NCT07226232", "verifyAt": "https://clinicaltrials.gov/study/NCT07226232", "retrievedAt": "2026-10-28T04:33:21.764Z", "payloadSha256": "b736f5385d0efd401a1a8389dc16af588f63ce0a3220c0ed4963a2483f910a77", "text": "ClinicalTrials.gov, record NCT07226232 (https://clinicaltrials.gov/study/NCT07226232), retrieved 2026-10-28, licence: public-domain." } ], "crossRegistry": false, "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only", "text": "Trial NCT07226232, registered in ClinicalTrials.gov, retrieved 2026-10-28. 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