Status:
ACTIVE_NOT_RECRUITING
An Open Label Study of the Safety and Efficacy of Psilocybin in Participants With Treatment-Resistant Depression (P-TRD)
Lead Sponsor:
Sheppard Pratt Health System
Collaborating Sponsors:
COMPASS Pathways
Conditions:
Treatment Resistant Depression
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
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
Inclusion
- Diagnosis of at least moderate Major Depressive Disorder (MDD)
Exclusion
- Comorbidities
- Note for CA site: Only Veterans are Eligible
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2026
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT04433858
Start Date
March 1 2021
End Date
May 1 2026
Last Update
August 9 2024
Active Locations (2)
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1
VA Palo Alto Healthcare System/Stanford Medicine
Palo Alto, California, United States, 94304
2
Sheppard Pratt Health System
Baltimore, Maryland, United States, 21204