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Long Term Follow Up Study to COMP 001 And COMP 003 Trials (P-TRD LTFU)

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: NCT04519957
Recruitment Status : Recruiting
First Posted : August 20, 2020
Last Update Posted : March 3, 2021
Information provided by (Responsible Party):
COMPASS Pathways

Brief Summary:
The primary objective of this study is to assess the long-term efficacy of psilocybin with respect to use of new antidepressant treatment, hospitalisations for depression, suicidality, and depressive severity rated using the Montgomery and Asberg Depression Rating Scale (MADRS) over a total of 52 weeks (compared across the 1 mg, 10 mg and 25 mg psilocybin groups from COMP 001).

Condition or disease
Treatment Resistant Depression

Detailed Description:
In this present study (COMP 004), the aim is to follow up participants from COMP 001 and COMP 003 in a long-term follow up study, with both remote and digital assessments, to explore the long term efficacy and safety of the three different doses of psilocybin (1 mg, 10 mg, and 25 mg) administered to patients with TRD as a monotherapy in COMP 001 and 25 mg psilocybin administered as an adjunct to an SSRI in COMP 003. Patients previously treated in COMP001 will be followed for approximately 40 weeks and patients previosuly treated in COMP003 will be followed for approximately 49 weeks giving a total follow up period of 52 weeks from psilocybin dosing.

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Multicentre Study To Assess Safety And Efficacy Of Psilocybin In Patients With Treatment-Resistant Depression Following Completion Of COMP 001 And COMP 003 Trials (P-TRD LTFU)
Actual Study Start Date : July 20, 2020
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Long-term efficacy of psilocybin [ Time Frame: up to 52 weeks ]
    Use of new antidepressant treatment, hospitalisations for depression, suicidality, and depressive severity rated using the Montgomery and Asberg Depression Rating Scale (MADRS)

Secondary Outcome Measures :
  1. Response, sustained response, remission and change in depression severity [ Time Frame: Up to 52 weeks ]
    Montgomery Asberg Depression Rating Scale (MADRS)

  2. Psychosocial functioning and to predict durability of response to antidepressant treatment [ Time Frame: up to 52 weeks ]
    Work and Social Adjustment Scale (WSAS) score change from Baseline of the prior study

  3. Functional impairment in work/school, social life, and family life. [ Time Frame: Up to 52 weeks ]
    Sheehan Disability Scale (SDS) score change from Baseline of the prior study

  4. Safety of Psilocybin [ Time Frame: Up to 52 weeks ]
    Incidence and severity of Adverse Events (AEs) and Seroius Adverse Events (SAEs)

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 55 Years   (Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
TRD patients who completed COMP001 or COMP003

Inclusion Criteria:

Signed ICF Each participant having completed the final study visit of either COMP 001 or COMP 003 Ability to complete all protocol required assessment tools (including having access to the internet in order to complete the digital assessments) without any assistance or alteration to the copyrighted assessments, and to comply with all study visits

Exclusion Criteria:

Subject has any condition, for which in the opinion of the investigator, participation would not be in the interest of the subject eg participation could compromise the wellbeing of the participant or prevent, limit, or confound the protocol-specified assessments

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): NCT04519957

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Contact: Sue Stansfield +447780523013

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United States, California
Kadima Neuropsychiatry Institute Recruiting
La Jolla, California, United States, 92037
Contact: Olga Johnson   
Principal Investigator: David Feifel         
Altman Clinical and Translational Research Institute, University of California Recruiting
San Diego, California, United States, 92093
Contact: Lauren Cardoso   
Principal Investigator: Sidney Zisook         
United States, Georgia
Mood and Anxiety Disorders Program Emory University School of Medicine Recruiting
Atlanta, Georgia, United States, 30329
Contact: Tanja Mletzk    404-712-5063   
Principal Investigator: Boadie Dunlop         
United States, Texas
UT Center of Excellence on Mood Disorders, University of Texas Health Science Center Recruiting
Houston, Texas, United States, 77054
Contact: Daniel Chung   
Principal Investigator: Jair Soares         
National Institute of Mental Health Czech Republic Recruiting
Klecany, Czechia
Contact: Zusana Postranecka   
Contact: Alice Heuschneiderova         
Principal Investigator: Tomas Palenicek         
Sheaf House, Tallaght Hospital Recruiting
Dublin, Ireland
Contact: Annie Baker    00353867835422   
Principal Investigator: Veronica O'Keane         
Groningen University Medical Centre Recruiting
Groningen, Netherlands
Contact: Maurice Vischjager   
Principal Investigator: Robert Schoevers         
United Kingdom
Kings College London, Institute of Psychiatry, Psychology and Neurology Recruiting
London, United Kingdom
Contact: Catherine Bird   
Principal Investigator: Allan Young         
Sponsors and Collaborators
COMPASS Pathways
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Responsible Party: COMPASS Pathways Identifier: NCT04519957    
Other Study ID Numbers: COMP004
First Posted: August 20, 2020    Key Record Dates
Last Update Posted: March 3, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depressive Disorder, Treatment-Resistant
Behavioral Symptoms
Depressive Disorder
Mood Disorders
Mental Disorders