A Phase II, Multicentre, Randomised, Double-blind, Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of COMP360 in Participants With Recurrent Major Depressive Disorder

April 9, 2024 updated by: COMPASS Pathways
Safety, Tolerability, pharmacokinetics and efficacy of a single administration of COMP360 in participants with recurrent Major Depressive Disorder.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a phase II, multi-centre, randomised, double-blind, controlled study. The study population will include participants aged ≥18 years with recurrent Major Depressive Disorder (MDD) with up to four prior treatment failures of an antidepressant in their current depressive episode.

Overall, 102 participants will be randomised in a 1:1:1 ratio to receive COMP360 25 mg, COMP360 10mg or COMP360 1 mg.

In this study the aim is to investigate the safety and tolerability of COMP360, administered with psychological support, in adult participants with MDD with one prior treatment failure. In addition, pharmacokinetics and efficacy of COMP360 will be investigated.

The study will last up to 16 weeks including a three- to ten-week Screening Period and a six-week follow-up from investigational product (IP) administration.

Study Type

Interventional

Enrollment (Estimated)

102

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92037
        • Recruiting
        • Kadima Neuropsychiatry Institute
        • Principal Investigator:
          • David Feifel, MD
        • Contact:
    • Florida
      • Jacksonville, Florida, United States, 32256
        • Recruiting
        • Clinical NeuroScience Solutions Inc
        • Contact:
        • Principal Investigator:
          • Mark Joyce, MD
    • Maryland
      • Rockville, Maryland, United States, 20850
        • Recruiting
        • Sunstone Therapies
        • Contact:
          • Heather Honstein
        • Contact:
        • Principal Investigator:
          • Manish Agrawak, MD
    • Massachusetts
      • Springfield, Massachusetts, United States, 01103
        • Recruiting
        • Elixia MA, LLC
        • Contact:
        • Principal Investigator:
          • Adnan Dahdul, MD
    • Texas
      • Plano, Texas, United States, 75093
        • Recruiting
        • Aims Trial
        • Contact:
        • Principal Investigator:
          • Sejal Mehta, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • Aged ≥18 years at Screening
  • Major depression without psychotic features (single or recurrent episode as informed by the Diagnostic and Statistical Manual of Mental Disorders, 5th edition [DSM-5])
  • 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
  • MADRS total score ≥20 at Screening and Baseline to ensure at least moderate severity of depression.
  • Failure to respond to an adequate dose and duration of up to four pharmacological treatment 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.
  • At Screening, agreement to discontinue all prohibited medications.

Key Exclusion Criteria:

  • 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)
  • Lifetime paranoid, schizoid, schizotypal, histrionic, narcissistic personality disorder, or any ongoing serious psychiatric comorbidity based on medical history and clinical judgement
  • Borderline personality disorder as demonstrated by medical history or the Mini International Neuropsychiatric Interview Plus (MINI plus) - borderline personality disorder module
  • 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) Psychiatric inpatient within the past 12 months prior to Screening
  • Use of electroconvulsive therapy, deep brain stimulation, or vagus nerve stimulation during the current depressive episode
  • Transcranial magnetic stimulation within the past six months prior to Screening
  • 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
  • Exposure to COMP360 psilocybin therapy prior to Screening

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 25 mg COMP360 Psilocybin
Drug: Psilocybin
COMP360 Psilocybin administered under supportive conditions
Other Names:
  • COMP360
Active Comparator: 1 mg COMP360 Psilocybin
Drug: Psilocybin
COMP360 Psilocybin administered under supportive conditions
Other Names:
  • COMP360
Experimental: 10 mg COMP360 Psilocybin
Drug: Psilocybin
COMP360 Psilocybin administered under supportive conditions
Other Names:
  • COMP360

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and tolerability of COMP360 Psilocybin
Time Frame: Up to Week 6
Proportion of patients with adverse events (AEs)
Up to Week 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetics of COMP360 Psilocybin
Time Frame: Day 1
Plasma concentrations of psilocybin, psilocin, 4-hydroxyindoleacetic acid (4-HIAA) and psilocin-O-glucuronide post-COMP360 administration on Day 1
Day 1
Change from baseline in MADRS total score at Week 3 and Week 6 for COMP360 25 mg versus COMP360 1 mg
Time Frame: Week 3 and Week 6
Montgomery-Åsberg Depression Rating Scale (MADRS) is a 10-item clinician rated scale measuring depression severity
Week 3 and Week 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

COMPASS Pathways

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 30, 2023

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

November 1, 2024

Study Registration Dates

First Submitted

February 8, 2023

First Submitted That Met QC Criteria

February 8, 2023

First Posted (Actual)

February 17, 2023

Study Record Updates

Last Update Posted (Actual)

April 10, 2024

Last Update Submitted That Met QC Criteria

April 9, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COMP 104

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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