Psilocybin to Treat Depression in Spinal Cord Injury

Recruiting Phase 1 Phase 2 Interventional Study
Spinal Cord Injury Depression - Major Depressive Disorder Veteran
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
22 and older
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
30 (estimated)
Sponsor
James J. Peters Veterans Affairs Medical Center · Federal
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About This Trial
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 spas…
Trial Locations
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Eligibility 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…
Contacts

Thomas W Sutor, PhD

718-584-9000

Thomas.Sutor@mountsinai.org

CONTACT

Dylan C Arnero, MS

718-584-9000

Dylan.Arnero@va.gov

CONTACT