An Open Label Study of the Safety and Efficacy of Psilocybin in Participants With Treatment-Resistant Depression (P-TRD)
- Registration Number
- NCT04433858
- Lead Sponsor
- Sheppard Pratt Health System
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 27
Inclusion Criteria
- Diagnosis of at least moderate Major Depressive Disorder (MDD)
Exclusion Criteria
- Comorbidities
Note for CA site: Only Veterans are Eligible
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Psilocybin Psilocybin 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.
- Primary Outcome Measures
Name Time Method Montgomery Asberg Depression Rating Scale (MADRS) From Baseline (Day -1) to three weeks post-dose. MADRS is a clinician-rated scale measuring depression severity, consisting of 10 items, each scored from 0 (normal) to 6 (severe), for a total possible score of 60; higher scores denote greater severity. Response = \>50% decrease and Remission =\< 10 actual score.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
VA Palo Alto Healthcare System/Stanford Medicine
🇺🇸Palo Alto, California, United States
Sheppard Pratt Health System
🇺🇸Baltimore, Maryland, United States