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An Open Label Study of the Safety and Efficacy of Psilocybin in Participants With Treatment-Resistant Depression (P-TRD)

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.
 
ClinicalTrials.gov Identifier: NCT04433858
Recruitment Status : Recruiting
First Posted : June 16, 2020
Last Update Posted : December 21, 2021
Sponsor:
Collaborator:
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 psilocybin (25 mg) administered under supportive conditions to adult participants with severe TRD, 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 : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Study of the Safety and Efficacy of Psilocybin in Participants With Treatment-Resistant Depression (P-TRD)
Actual Study Start Date : March 1, 2021
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Psilocybin
25mg of Psilocybin
Drug: Psilocybin
open-label




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
Criteria

Inclusion Criteria:

  • Diagnosis of at least moderate Major Depressive Disorder (MDD)

Exclusion Criteria:

  • Comorbidities

Note for CA sites: Only Veterans are Eligible


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): NCT04433858


Contacts
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Contact: Sam Rudow 410-938-3126 srudow@sheppardpratt.org
Contact: Tammy Miller TMiller1@sheppardpratt.org

Locations
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United States, California
Stanford Exploratory Therapeutics Laboatory Recruiting
Palo Alto, California, United States, 94304
Contact: Grace Fischer    650-849-0161    grace.fischer@stanford.edu   
Principal Investigator: Trisha Suppes, MD, PhD         
VA Palo Alto Healthcare System/Stanford Medicine Recruiting
Palo Alto, California, United States, 94304
Contact: Grace Fischer    650-849-0161    grace.fischer@stanford.edu   
Principal Investigator: Trisha Suppes, MD, PhD         
United States, Maryland
Sheppard Pratt Health System Active, not recruiting
Baltimore, Maryland, United States, 21204
Sponsors and Collaborators
Sheppard Pratt Health System
COMPASS Pathways
Investigators
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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: NCT04433858    
Other Study ID Numbers: 14947563
First Posted: June 16, 2020    Key Record Dates
Last Update Posted: December 21, 2021
Last Verified: December 2021
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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Depression
Depressive Disorder
Depressive Disorder, Treatment-Resistant
Behavioral Symptoms
Mood Disorders
Mental Disorders
Psilocybin
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs