Psilocybin for depression after spinal cord injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.