Major Depression study: Psilocybin
Official title Psilocybin Intervention for Veterans Overcoming Treatment-Resistant Depression
ClinicalTrials.gov ID: NCT07226232
What this study is testing
What is Psilocybin?
An investigational oral psychedelic being studied as a potential treatment for major depression in U.S. military Veterans. Psilocybin is designed to act as a serotonin 5‑HT2A receptor agonist, which may alter brain signaling related to mood.
Also referred to as COMP360.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether psilocybin helps depression in veterans.
- Who it's for
- You may be able to join if you are a U.S. veteran with major depression, with or without PTSD.
- What's involved
- You would receive a dose of psilocybin in a clinic and then have follow‑up visits to see how you feel.
- Time commitment
- The study lasts several weeks and includes a few clinic visits.
- Phase 3: a large, late-stage study
- Time commitment: about 6 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Veteran of the U.S. military who is English-speaking
- Signed informed consent and Health Insurance Portability and Accountability Act (HIPAA)
- Adults \</= 75 years of age
- Meets DSM-5 criteria for current major depressive episode (MDE)
- Montgomery-Asberg Rating Scale (MADRS)\>/= 20 at baseline
You likely can't join if
- Lifetime bipolar, schizophrenia spectrum, or other psychotic disorders
- First-degree relative with history of bipolar I, schizophrenia spectrum or other psychotic disorder
- Presence of psychotic symptoms (e.g., MDE with psychotic symptoms)
- Sedative-hypnotic, stimulant, inhalant and/or opioid use disorder within past 6 months (lifetime substance use disorder is allowed at the discretion...
- 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...
- Lifetime hallucinogen persisting perception or hallucinogen use disorders
See the full eligibility criteria
- Veteran of the U.S. military who is English-speaking
- Signed informed consent and Health Insurance Portability and Accountability Act (HIPAA)
- Adults \</= 75 years of age
- Meets DSM-5 criteria for current major depressive episode (MDE)
- Montgomery-Asberg Rating Scale (MADRS)\>/= 20 at baseline
- 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.
- If applicable, concurrent \& permitted antidepressants must be at stable doses for \>/= 4 weeks prior to baseline (see allowed \& prohibited medication list)
- Participants of child-bearing potential must have negative pregnancy test \& agree to adhere to a medically acceptable method of birth control during the study
- Has a responsible adult who will provide transportation to the participant's home or place of lodging on the days of psilocybin administration
- Lifetime bipolar, schizophrenia spectrum, or other psychotic disorders
- First-degree relative with history of bipolar I, schizophrenia spectrum or other psychotic disorder
- Presence of psychotic symptoms (e.g., MDE with psychotic symptoms)
- 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)
- 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)
- Lifetime hallucinogen persisting perception or hallucinogen use disorders
- 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
- Participant agrees to not use psychedelics (listed above) during the study, except as prescribed by the study protocol
- Taking prohibited medication within 2 weeks of baseline (see allowed and prohibited concomitant medication list)
- History of severe traumatic brain injury (TBI)
- Diagnosis of dementia or related progressive neurocognitive disorder
- Suicidal ideation/behavior Type 4 or Type 5 intensity on C-SSRS within past 6 months of baseline
- Psychiatric inpatient treatment within past 3 months of baseline
- Treatment with electroconvulsive therapy, deep brain stimulation, vagus nerve stimulation, or transcranial magnetic stimulation within 3 months of baseline
- Implanted central nervous system device
- 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.
- Pregnancy or lactation, or anticipated pregnancy or breastfeeding during the active treatment phase
- History of myocardial infarction, congestive heart failure, diabetic ketoacidosis, brain cancer, stroke and/or severe cardiac disease
- 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...
- Seizure disorder, except for seizures due to fever or withdrawal from a substance
- Clinically significant hypertension (\>160/95 mmHg), hypotension (\ 100 bpm at rest), QTc prolongation (\>450 msec men; \>470 msec women) or clinically significant arrhythmia on ECG
- Clinically significant abnormal laboratory results on chemistry panel, liver function tests, complete blood count, and/or thyroid stimulating hormone
- Positive urine drug screen for illicit drugs of abuse (except for THC) at screening or baseline
- Prior allergic, adverse reaction or adverse experience to a psilocybin formulation
- Litigating for disability income for a mental disorder outside the VA compensation and pension process
The study team makes the final eligibility decision.
Where it is enrolling
- Birmingham, Alabama, United States
- Tuscaloosa, Alabama, United States
- Portland, Oregon, United States
- Philadelphia, Pennsylvania, United States
- Seattle, Washington, United States
Compensation & support
This study's listing mentions compensation or reimbursement.
No amount is published here because ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team, so confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 6 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Birmingham, Alabama, United States; Tuscaloosa, Alabama, United States; Portland, Oregon, United States; Philadelphia, Pennsylvania, United States; Seattle, Washington, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.