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Efficacy, Safety, and Tolerability of COMP360 in Participants With 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. Identifier: NCT05624268
Recruitment Status : Recruiting
First Posted : November 22, 2022
Last Update Posted : June 12, 2024
Information provided by (Responsible Party):
COMPASS Pathways

Brief Summary:
Efficacy, Safety, and Tolerability of a single administration of COMP360 in participants with treatment-resistant depression (TRD)

Condition or disease Intervention/treatment Phase
Treatment Resistant Depression Drug: Psilocybin Phase 3

Detailed Description:

This is a phase III, international, multi-centre, randomised, parallel group, fixed single-dose, double-blind, placebo-controlled study. The study population will include participants aged ≥18 years with TRD.

Overall, 255 participants will be randomised in a 2:1 ratio to receive COMP360 25 mg or placebo.

The study comprises three parts (A, B, and C) and will last approximately 62 weeks including a three- to ten-week Screening Period.

Part A will include a six-week follow-up from initial investigational product (IP) administration.

In this study, the primary aim is to assess the efficacy and safety of a single dose of COMP360 25 mg versus placebo for reducing symptom severity in TRD, when administered with psychological support. This will be assessed in a 6-week, single-dose, double-blind, placebo-controlled part of the study (Part A). Durability of efficacy and long-term safety, and the efficacy and safety of re-treatment will be assessed in a 20-week single-dose, double-blind re-treatment part (Part B), and a 26-week open-label treatment part (Part C).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 255 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III, Multicentre, Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy, Safety, and Tolerability of COMP360 in Participants With Treatment-resistant Depression
Actual Study Start Date : January 19, 2023
Estimated Primary Completion Date : October 2024
Estimated Study Completion Date : July 2025

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 25 mg COMP360 Psilocybin
25 mg COMP360 Psilocybin
Drug: Psilocybin
COMP360 Psilocybin administered under supportive conditions
Other Name: COMP360

Placebo Comparator: Placebo
Matched placebo
Drug: Psilocybin
COMP360 Psilocybin administered under supportive conditions
Other Name: COMP360

Primary Outcome Measures :
  1. COMP360 25 mg versus placebo for the change from baseline in MADRS total score [ Time Frame: Week 6 ]
    Montgomery-Åsberg Depression Rating Scale (MADRS) is a 10-item clinician rated scale measuring depression severity

Secondary Outcome Measures :
  1. COMP360 25 mg versus placebo for the change from baseline in SDS total score [ Time Frame: Week 6 ]
    Sheehan Disability Scale (SDS) is a brief, five-item self report inventory that assesses functional impairment in work/school, social life, and family life.

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 and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Key Inclusion Criteria:

  1. Aged ≥18 years at Screening
  2. Major depression without psychotic features (single or recurrent episode as informed by the Diagnostic and Statistical Manual of Mental Disorders, 5th edition [DSM-5])
  3. If the current major depressive episode is the participant's first lifetime episode of depression, the length of the current episode must be ≥3 months and ≤2 years at Screening
  4. MADRS total score ≥20 at Screening and Baseline to ensure at least moderate severity of depression
  5. TRD, defined as failure to respond to an adequate dose and duration of two, three, or four different pharmacological treatments for the current episode as determined through the Massachusetts General Hospital Antidepressant Treatment Response Questionnaire (MGH-ATRQ) and using the supplementary advice on additional antidepressants not included in MGH-ATRQ.
  6. At Screening, agreement to discontinue all prohibited medications.

Key Exclusion Criteria:

Psychiatric Exclusion Criteria:

  1. Prior or ongoing bipolar disorder, any psychotic disorder, including schizophrenia, schizophreniform disorder, schizoaffective disorder, brief psychotic disorder (unless substance induced or due to a medical condition), antisocial personality disorder as assessed by a structured clinical interview (MINI 7.0.2)
  2. Lifetime paranoid, schizoid, schizotypal, histrionic, narcissistic personality disorder, or any ongoing serious psychiatric comorbidity based on medical history and clinical judgement
  3. Borderline personality disorder as demonstrated by medical history or the Mini International Neuropsychiatric Interview Plus (MINI plus) - borderline personality disorder module
  4. Ongoing post-traumatic stress disorder, obsessive-compulsive disorder, or anorexia nervosa as assessed by medical history and a structured clinical interview (MINI 7.0.2)
  5. Psychiatric inpatient within the past 12 months prior to Screening
  6. Use of electroconvulsive therapy, deep brain stimulation, or vagus nerve stimulation during the current depressive episode
  7. Transcranial magnetic stimulation within the past six months prior to Screening
  8. Current enrolment in a psychological therapy programme that will not remain stable for the duration of the study. Psychological therapies cannot have been initiated within 30 days prior to Screening
  9. Exposure to COMP360 psilocybin therapy prior to Screening

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): NCT05624268

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Contact: Medical Director, MD

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Sponsors and Collaborators
COMPASS Pathways
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Responsible Party: COMPASS Pathways Identifier: NCT05624268    
Other Study ID Numbers: COMP 005
First Posted: November 22, 2022    Key Record Dates
Last Update Posted: June 12, 2024
Last Verified: June 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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, Treatment-Resistant
Behavioral Symptoms
Depressive Disorder
Mood Disorders
Mental Disorders
Physiological Effects of Drugs
Psychotropic Drugs