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NCT04433845 Clinical Trial

The Safety and Efficacy of Psilocybin in Participants With Type 2 Bipolar Disorder (BP-II) Depression.

Treatment Resistant Depression Clinical Trial

Official title:
The Safety and Efficacy of Psilocybin in Participants With Type 2 Bipolar Disorder (BP-II) Depression.

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04433845
Other study ID # 14947483
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date March 1, 2021
Est. completion date April 15, 2023

Study information
Verified date October 2022
Source Sheppard Pratt Health System
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 15
Est. completion date April 15, 2023
Est. primary completion date January 15, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Diagnosis of Type 2 Bipolar Disorder (BP-II) Depression Exclusion Criteria: - Comorbidities

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Psilocybin
Open-label

Locations
Country Name City State
United States Sheppard Pratt Baltimore Maryland

Sponsors (2)
Lead Sponsor Collaborator
Sheppard Pratt Health System COMPASS Pathways

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Montgomery-Asberg Depression Rating Scale (MADRS) 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 From Baseline (Day -1) to three weeks post-dose.
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