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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04433845
Recruitment Status : Active, not recruiting
First Posted : June 16, 2020
Last Update Posted : October 25, 2022
COMPASS Pathways
Information provided by (Responsible Party):
Scott T. Aaronson, M.D, 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.

Condition or disease Intervention/treatment Phase
Treatment Resistant Depression Drug: Psilocybin Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Safety and Efficacy of Psilocybin in Participants With Type 2 Bipolar Disorder (BP-II) Depression.
Actual Study Start Date : March 1, 2021
Estimated Primary Completion Date : January 15, 2023
Estimated Study Completion Date : April 15, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

Arm Intervention/treatment
Experimental: Psilocybin
25mg of Psilocybin
Drug: Psilocybin

Primary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • Comorbidities

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04433845

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United States, Maryland
Sheppard Pratt
Baltimore, Maryland, United States, 21204
Sponsors and Collaborators
Sheppard Pratt Health System
COMPASS Pathways
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Principal Investigator: Scott Aaronson, MD Sheppard Pratt Health System
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Responsible Party: Scott T. Aaronson, M.D, Director, Clinical Research Programs, Sheppard Pratt Health System
ClinicalTrials.gov Identifier: NCT04433845    
Other Study ID Numbers: 14947483
First Posted: June 16, 2020    Key Record Dates
Last Update Posted: October 25, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depressive Disorder
Bipolar Disorder
Depressive Disorder, Treatment-Resistant
Behavioral Symptoms
Mood Disorders
Mental Disorders
Bipolar and Related Disorders
Physiological Effects of Drugs
Psychotropic Drugs