Back to resultsThe Safety and Efficacy of Psilocybin in Participants With Type 2 Bipolar Disorder (BP-II) Depression.
Primary Purpose
Treatment Resistant Depression
Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Psilocybin
Sponsored by
About this trial
This is an interventional treatment trial for Treatment Resistant Depression
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of Type 2 Bipolar Disorder (BP-II) Depression
Exclusion Criteria:
- Comorbidities
Sites / Locations
- Sheppard Pratt
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Psilocybin
Arm Description
25mg of Psilocybin
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT04433845
First Posted
June 13, 2020
Last Updated
October 24, 2022
Sponsor
Sheppard Pratt Health System
Collaborators
COMPASS Pathways
1. Study Identification
Unique Protocol Identification Number
NCT04433845
Brief Title
The Safety and Efficacy of Psilocybin in Participants With Type 2 Bipolar Disorder (BP-II) Depression.
Official Title
The Safety and Efficacy of Psilocybin in Participants With Type 2 Bipolar Disorder (BP-II) Depression.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
January 15, 2023 (Anticipated)
Study Completion Date
April 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sheppard Pratt Health System
Collaborators
COMPASS Pathways
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Treatment Resistant Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Psilocybin
Arm Type
Experimental
Arm Description
25mg of Psilocybin
Intervention Type
Drug
Intervention Name(s)
Psilocybin
Intervention Description
Open-label
Primary Outcome Measure Information:
Title
Montgomery-Asberg Depression Rating Scale (MADRS)
Description
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
Time Frame
From Baseline (Day -1) to three weeks post-dose.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of Type 2 Bipolar Disorder (BP-II) Depression
Exclusion Criteria:
Comorbidities
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott Aaronson, MD
Organizational Affiliation
Sheppard Pratt Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sheppard Pratt
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Safety and Efficacy of Psilocybin in Participants With Type 2 Bipolar Disorder (BP-II) Depression.
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