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Trial record 3 of 20 for:    psilocybin | Phase 2

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04433845
Recruitment Status : Not yet recruiting
First Posted : June 16, 2020
Last Update Posted : October 12, 2020
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)
Estimated Enrollment : 12 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.
Estimated Study Start Date : November 1, 2020
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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 identifier (NCT number): NCT04433845

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Contact: Tammy Miller 410-938-3000

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 Identifier: NCT04433845    
Other Study ID Numbers: 14947483
First Posted: June 16, 2020    Key Record Dates
Last Update Posted: October 12, 2020
Last Verified: October 2020
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