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

Phase 2

Active, not recruiting

• Conditions: Treatment Resistant Depression
• Interventions: Drug: Psilocybin

• Registration Number: NCT04433845
• Lead Sponsor: Sheppard Pratt Health System

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-13
• Study First Submitted QC: 2020-06-13
• Study First Posted: 2020-06-16
• Study Start: 2021-03-01
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-24
• Last Update Posted: 2022-10-25
• Primary Completion: 2023-01-15
• Study Completion: 2023-04-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Diagnosis of Type 2 Bipolar Disorder (BP-II) Depression

Exclusion Criteria

• Comorbidities

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Psilocybin	Psilocybin	25mg of Psilocybin

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

Trial Locations

Locations (1)

Sheppard Pratt; 🇺🇸 Baltimore, Maryland, United States