search
Back to results

Efficacy, Safety, and Tolerability of Two Administrations of COMP360 in Participants With TRD

Primary Purpose

Treatment Resistant Depression

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Psilocybin
Sponsored by
COMPASS Pathways
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Treatment Resistant Depression focused on measuring psilocybin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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 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

Sites / Locations

  • Catalina Research Institute, LLCRecruiting
  • Pacific Clinical Research Management Group, LLCRecruiting
  • Innovative Clinical Research, Inc.Recruiting
  • Behavioral Clinical Research, Inc.Recruiting
  • Health Synergy Clinical ResearchRecruiting
  • University South FloridaRecruiting
  • Atlanta Center for Medical ResearchRecruiting
  • iResearch AtlantaRecruiting
  • Hassman Research InstituteRecruiting
  • Princeton Medical InstituteRecruiting
  • University of Cincinnati, Department of Psychiatry & Behavirol NeuroscienceRecruiting
  • The Ohio State UniversityRecruiting
  • Suburban Research AssociatesRecruiting
  • The University of Texas at Austin - Dell Medical SchoolRecruiting
  • Seattle Neuropsychiatric Treatment CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

25 mg COMP360 Psilocybin

10 mg COMP360 Psilocybin

1 mg COMP360 Psilocybin

Arm Description

25 mg COMP360 Psilocybin

10 mg COMP360 Psilocybin

1 mg COMP360 Psilocybin, active comparator

Outcomes

Primary Outcome Measures

COMP360 25 mg versus COMP360 1 mg for the change from baseline in MADRS total score.
Montgomery-Åsberg Depression Rating Scale (MADRS) is a 10-item clinician rated scale measuring depression severity

Secondary Outcome Measures

COMP360 25 mg versus COMP360 1 mg for the change from baseline in Sheehan Disability Scale (SDS) total score.
Sheehan Disability Scale (SDS) is a brief, five-item self report inventory that assesses functional impairment in work/school, social life, and family life.
COMP360 25 mg versus COMP360 10 mg for the change from baseline in MADRS total score.
Montgomery-Åsberg Depression Rating Scale (MADRS) is a 10-item clinician rated scale measuring depression severity
COMP360 25 mg versus COMP360 10 mg for the change from baseline in Sheehan Disability Scale (SDS) total score.
Sheehan Disability Scale (SDS) is a brief, five-item self report inventory that assesses functional impairment in work/school, social life, and family life.

Full Information

First Posted
January 25, 2023
Last Updated
September 29, 2023
Sponsor
COMPASS Pathways
search

1. Study Identification

Unique Protocol Identification Number
NCT05711940
Brief Title
Efficacy, Safety, and Tolerability of Two Administrations of COMP360 in Participants With TRD
Official Title
A Phase III, Multicentre, Randomised, Double-blind, Controlled Study to Investigate the Efficacy, Safety, and Tolerability of Two Administrations of COMP360 in Participants With Treatment-resistant Depression
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 14, 2023 (Actual)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
May 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
COMPASS Pathways

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Efficacy, Safety, and Tolerability of two administrations of COMP360 in participants with treatment-resistant depression (TRD)
Detailed Description
This is a phase III, international, multi-centre, randomised, parallel group, fixed repeat dose, double-blind, controlled study. The study population will include participants aged ≥18 years with TRD. Overall, 568 participants are to be randomised in a 2:1:1 ratio to receive COMP360 25 mg, 10 mg or 1 mg. The study will last up to 16 weeks including a three- to ten-week Screening Period and six-week follow-up from investigational product (IP) administration. In this study, the aim is to assess the efficacy of COMP360, administered with psychological support in adult participants with TRD, in improving symptoms of depression.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Treatment Resistant Depression
Keywords
psilocybin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
568 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
25 mg COMP360 Psilocybin
Arm Type
Experimental
Arm Description
25 mg COMP360 Psilocybin
Arm Title
10 mg COMP360 Psilocybin
Arm Type
Experimental
Arm Description
10 mg COMP360 Psilocybin
Arm Title
1 mg COMP360 Psilocybin
Arm Type
Active Comparator
Arm Description
1 mg COMP360 Psilocybin, active comparator
Intervention Type
Drug
Intervention Name(s)
Psilocybin
Other Intervention Name(s)
COMP360
Intervention Description
COMP360 Psilocybin administered under supportive conditions
Primary Outcome Measure Information:
Title
COMP360 25 mg versus COMP360 1 mg for the change from baseline in MADRS total score.
Description
Montgomery-Åsberg Depression Rating Scale (MADRS) is a 10-item clinician rated scale measuring depression severity
Time Frame
Week 6
Secondary Outcome Measure Information:
Title
COMP360 25 mg versus COMP360 1 mg for the change from baseline in Sheehan Disability Scale (SDS) total score.
Description
Sheehan Disability Scale (SDS) is a brief, five-item self report inventory that assesses functional impairment in work/school, social life, and family life.
Time Frame
Week 6
Title
COMP360 25 mg versus COMP360 10 mg for the change from baseline in MADRS total score.
Description
Montgomery-Åsberg Depression Rating Scale (MADRS) is a 10-item clinician rated scale measuring depression severity
Time Frame
Week 6
Title
COMP360 25 mg versus COMP360 10 mg for the change from baseline in Sheehan Disability Scale (SDS) total score.
Description
Sheehan Disability Scale (SDS) is a brief, five-item self report inventory that assesses functional impairment in work/school, social life, and family life.
Time Frame
Week 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Medical Director, MD
Email
COMP006@compasspathways.com
Facility Information:
Facility Name
Catalina Research Institute, LLC
City
Montclair
State/Province
California
ZIP/Postal Code
91763
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Arriaga
Phone
909-590-6324
Email
aarriaga@catalinari.com
First Name & Middle Initial & Last Name & Degree
Stephen Volk, MD
Facility Name
Pacific Clinical Research Management Group, LLC
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Casey Rosas
Phone
909-920-3000
Ext
3
Email
crosas@pcrmg.com
First Name & Middle Initial & Last Name & Degree
Rebecca Kornbluh, MD
Facility Name
Innovative Clinical Research, Inc.
City
Lauderhill
State/Province
Florida
ZIP/Postal Code
33319
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Segal Trials
Phone
954-990-6326
Email
psychedelics@segaltrials.com
First Name & Middle Initial & Last Name & Degree
Rishi Kakar, MD
Facility Name
Behavioral Clinical Research, Inc.
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Segal Trials
Email
psychedelics@segaltrials.com
First Name & Middle Initial & Last Name & Degree
Olga Lapeyra, MD
Facility Name
Health Synergy Clinical Research
City
Okeechobee
State/Province
Florida
ZIP/Postal Code
34972
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melissa Corzo
Phone
863-824-7989
Email
mcorzo@healthsynergyclinicalresearch.com
First Name & Middle Initial & Last Name & Degree
Mohammad Nisar, MD
Facility Name
University South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613-4788
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yvonne Bannon
Phone
813-974-2832
Email
ybannon@usf.edu
First Name & Middle Initial & Last Name & Degree
Glenn Currier, MD
Facility Name
Atlanta Center for Medical Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30331
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amber Tannahill
Email
a.tannahill@cenexel.com
First Name & Middle Initial & Last Name & Degree
Robert Riesenberg, MD
Facility Name
iResearch Atlanta
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amber Tannahill
Email
a.tannahill@cenexel.com
First Name & Middle Initial & Last Name & Degree
Saundra Maass-Robinson, MD
Facility Name
Hassman Research Institute
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
HRI Recruitment Team
Phone
888-449-5080
First Name & Middle Initial & Last Name & Degree
Steven Glass, MD
Facility Name
Princeton Medical Institute
City
Princeton
State/Province
New Jersey
ZIP/Postal Code
08540
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kaylee White
Phone
609-921-3555
Ext
110
Email
kwhite@gminstitutes.com
First Name & Middle Initial & Last Name & Degree
James Wolberg, MD
Facility Name
University of Cincinnati, Department of Psychiatry & Behavirol Neuroscience
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Colette Mueller
Email
muellec5@ucmail.uc.edu
First Name & Middle Initial & Last Name & Degree
Fabiano Nery, MD
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne-Marie Duchemin
Email
anne-marie.duchemin@osumc.edu
First Name & Middle Initial & Last Name & Degree
Subhdeep Virk, MD
Facility Name
Suburban Research Associates
City
Media
State/Province
Pennsylvania
ZIP/Postal Code
19063
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suburban Research Associates
Phone
610-891-9024
First Name & Middle Initial & Last Name & Degree
Shivkumar Hatti, MD
Facility Name
The University of Texas at Austin - Dell Medical School
City
Austin
State/Province
Texas
ZIP/Postal Code
78712
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julie Farrington, MD
Facility Name
Seattle Neuropsychiatric Treatment Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adrian Cufley
Email
research@seattlentc.com
First Name & Middle Initial & Last Name & Degree
Rebecca Allen, MD

12. IPD Sharing Statement

Learn more about this trial

Efficacy, Safety, and Tolerability of Two Administrations of COMP360 in Participants With TRD

We'll reach out to this number within 24 hrs