Psilocybin for Depression
Recruiting in Palo Alto (17 mi)
+2 other locations
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: Sheppard Pratt Health System
No Placebo Group
Prior Safety Data
Approved in 2 jurisdictions
Trial Summary
What is the purpose of this trial?The primary objective of this study is to evaluate the efficacy of psilocybin (25 mg) administered under supportive conditions to adult participants with severe TRD, in improving depressive symptoms.
Eligibility Criteria
This trial is specifically for veterans who have been diagnosed with moderate to severe Major Depressive Disorder (MDD) and haven't found relief from standard treatments. It's not suitable for individuals with other significant health conditions.Participant Groups
The study is testing the effects of a single dose of psilocybin (25 mg), given in a supportive setting, on improving symptoms in participants with treatment-resistant depression.
1Treatment groups
Experimental Treatment
Group I: PsilocybinExperimental Treatment1 Intervention
25mg of Psilocybin
Note: CA site only is re-dosing participants with an exacerbation in depressive symptoms at a minimum of 12 months post-initial dosing.
Psilocybin is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Psilocybin for:
- Treatment-resistant depression (TRD) under Breakthrough Therapy designation
🇪🇺 Approved in European Union as Psilocybin for:
- Treatment-resistant depression (TRD) under PRIME designation
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Stanford Exploratory Therapeutics LaboatoryPalo Alto, CA
VA Palo Alto Healthcare System/Stanford MedicinePalo Alto, CA
Sheppard Pratt Health SystemBaltimore, MD
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Who is running the clinical trial?
Sheppard Pratt Health SystemLead Sponsor
COMPASS PathwaysIndustry Sponsor