NCT07251491RecruitingPhase 1/2
Psilocybin to Treat Depression in Spinal Cord Injury
Safety, Tolerability, Outcomes of Psilocybin for Depression (STOP Depression) in Veterans With Spinal Cord Injury
Source: ClinicalTrials.gov · Last updated 10 Aug 2026
Brief summary (registry, in English)
The main goal of this study is to determine if psilocybin is safe for use in people with SCI. The study will measure how people with SCI respond to three psilocybin doses: low (5mg), medium (10mg), and high (25mg). The main question the study aims to answer is: does psilocybin increase the number and severity of adverse (bad) events reported by people with SCI? These may include pain, muscle spasms, symptoms of depression, and symptoms of low or high blood pressure. The investigators will also measure how well people with SCI tolerate the psychedelic experience, and compare responses between the low (5mg), medium (10mg), and high (25mg) doses. Participants will: * Agree to be enrolled in the study for up to 13 months. * Agree to complete the seven (7) visits that are included in the psilocybin-assisted therapy. * Agree to complete follow-up study visits, including in-person visits to the James J Peters VA Medical Center, located in the Bronx, New York and remote visits. * Agree to keep a log of how they are feeling and any change in the frequency or severity of adverse events.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 30 Sept 2025
- Start date
- 6 Aug 2026
- Primary completion date
- 1 Mar 2028
- Lead sponsor
- James J. Peters Veterans Affairs Medical Center
- Diseases
- Depression
- NCT number
- NCT07251491
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 30
- From 6 Aug 2026 to the primary completion date, 1 Mar 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Have received Electroconvulsive Therapy (ECT) within 12 weeks
Other illness
- 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
- History of heart attack, aneurysm, or stroke
- Uncontrolled hypertension
Other
- Are not able to give adequate informed consent
- Have used psilocybin or another psychedelic within 6 months
- Have used ketamine within 12 weeks
- Current serious suicide risk
- Are pregnant or nursing
Who the study is looking for
- 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
Age in the registry: 22 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| James J. Peters Department of Veterans Affairs Medical Center Coordinator of this site? Confirm its status | The Bronx | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.