Psilocybin for depression after spinal cord injury
Safety, Tolerability, Outcomes of Psilocybin for Depression (STOP Depression) in Veterans With Spinal Cord Injury
This trial will test whether three doses of psilocybin (5 mg, 10 mg, and 25 mg) are safe and tolerable for adults with chronic spinal cord injury who have major depression.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 22 Years and up |
| Sex | All |
| Sponsor | James J. Peters Veterans Affairs Medical Center Federal |
| Locations | 1 site (The Bronx, New York) |
| Trial ID | NCT07251491 on ClinicalTrials.gov |
What this trial studies
The study enrolls 30 adults with chronic spinal cord injury and diagnosed major depressive disorder, split between paraplegia and tetraplegia, and assigns participants in a stepwise design to low (5 mg), medium (10 mg), or high (25 mg) psilocybin doses. Participants complete seven psilocybin-assisted therapy visits plus follow-up visits over about 12 months, with both in-person visits at the James J. Peters VA Medical Center in the Bronx and remote check-ins. Primary outcomes track the number and severity of adverse events (including pain, muscle spasms, blood pressure changes) and tolerability of the psychedelic experience, while secondary outcomes include changes in depression severity, neuropathic pain, spasms, and quality of life. The protocol requires supervised tapering of antidepressants and uses audio/video recording and medical record release for safety monitoring.
Who should consider this trial
Good fit: Ideal candidates are adults (≥22 years) with a spinal cord injury at least one year old, a confirmed diagnosis of major depressive disorder, able to taper antidepressants under supervision, weigh at least 50 kg, and able to attend in-person visits in the Bronx and complete study procedures in English.
Not a fit: People with a history of Bipolar I disorder, recent use of psychedelics or ketamine, recent ECT, active severe substance or eating disorders, ventilator dependence, inability to give informed consent, or inability to taper antidepressants are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If safe and effective, psilocybin could offer a new treatment option to reduce depressive symptoms and improve wellbeing for people living with chronic spinal cord injury.
How similar studies have performed: Previous psilocybin trials have shown promising antidepressant effects in general populations, but people with spinal cord injury have not been previously included and safety in this group is untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Able and willing to provide informed consent * Spinal cord injury for at least 1 year * Confirmed diagnosis of depression * At least 22 years of age at time of consent * At least 50 kg (110 lbs.) body weight * Fully independent from ventilatory support (ventilator or diaphragm pacer) * Fluent in speaking and reading English * Able to swallow pills * Agree to have study visits recorded with audio and video * Agree to release outside medical and psychiatric records * Able and willing to taper off antidepressant, under clinician supervision * Agree to use adequate contraceptive methods Exclusion Criteria: * Are not able to give adequate informed consent * Have used psilocybin or another psychedelic within 6 months * Have received Electroconvulsive Therapy (ECT) within 12 weeks * Have used ketamine within 12 weeks * Have a history of Bipolar I Disorder * Have a current eating disorder * Have a current severe alcohol or cannabis use disorder within the 6 months * Have an illicit drug or prescription drug substance use disorder within 12 months * Current serious suicide risk * History of heart attack, aneurysm, or stroke * Uncontrolled hypertension * Are pregnant or nursing
Where this trial is running
The Bronx, New York
- James J. Peters Department of Veterans Affairs Medical Center — The Bronx, New York, United States (Recruiting)
Study contacts
- Principal investigator: Jill M Wecht, EdD — James J Peters VA Medical Center
- Study coordinator: Thomas W Sutor, PhD
- Email: Thomas.Sutor@mountsinai.org
- Phone: 718-584-9000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.