NCT04433845Active, not recruitingPhase 2
The Safety and Efficacy of Psilocybin in Participants With Type 2 Bipolar Disorder (BP-II) Depression.
Sheppard Pratt Health System1 site in 1 country15 target enrollmentStarted: March 1, 2021Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Montgomery-Asberg Depression Rating Scale (MADRS)
Study Overview
Brief Summary
The primary objective of this study is to evaluate the efficacy of 25 mg of psilocybin under supportive conditions to adult participants with BP-II, current episode depressed, in improving depressive symptoms.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis of Type 2 Bipolar Disorder (BP-II) Depression
Exclusion Criteria
- •Comorbidities
Arms & Interventions
Psilocybin
Experimental
25mg of Psilocybin
Intervention: Psilocybin (Drug)
Outcomes
Primary Outcomes
Montgomery-Asberg Depression Rating Scale (MADRS)
Time Frame: 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 Outcomes
No secondary outcomes reported
Investigators
Scott T. Aaronson, M.D
Director, Clinical Research Programs
Sheppard Pratt Health System
Study Sites (1)
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