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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: NCT03775200
Recruitment Status : Not yet recruiting
First Posted : December 13, 2018
Last Update Posted : December 14, 2018
Sponsor:
Information provided by (Responsible Party):
COMPASS Pathways

Brief Summary:
The Safety and Efficacy of Psilocybin in Participants with Treatment Resistant Depression

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

Detailed Description:
The Safety and Efficacy of Psilocybin in Participants with Treatment Resistant Depression - a dose-ranging study

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 216 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Safety and Efficacy of Psilocybin in Participants With Treatment Resistant Depression
Estimated Study Start Date : December 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Low dose
Low dose Psilocybin
Drug: Psilocybin
Dose-ranging

Experimental: Medium dose
Medium dose Psilocybin
Drug: Psilocybin
Dose-ranging

Experimental: High dose
High dose Psilocybin
Drug: Psilocybin
Dose-ranging




Primary Outcome Measures :
  1. Montgomery Asberg Depression Rating Scale [ Time Frame: Up to 12 weeks ]
    MADRS



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of TRD

Exclusion Criteria:

  • Other 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): NCT03775200


Contacts
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Contact: Susan Stansfield, PhD +44-7780-523013 sue@compasspathways.com

Locations
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United Kingdom
Wolfson Research Centre, Campus for Ageing and Vitality Recruiting
Newcastle Upon Tyne, Tyne And Wear, United Kingdom, NE4 5PL
Contact: Wendy Hall    +44(0)191 208 1362    Wendy.Hall@ntw.nhs.uk   
Sponsors and Collaborators
COMPASS Pathways

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Responsible Party: COMPASS Pathways
ClinicalTrials.gov Identifier: NCT03775200     History of Changes
Other Study ID Numbers: COMP001
First Posted: December 13, 2018    Key Record Dates
Last Update Posted: December 14, 2018
Last Verified: December 2018

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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