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

Treatment Resistant Depression Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05624268
• Other study ID #: COMP 005
• Status: Recruiting
• Phase: Phase 3
• Start date: January 19, 2023
• Est. completion date: July 2025

Study information

• Verified date: June 2024
• Source: COMPASS Pathways
• Contact: Medical Director, MD
• Email: COMP005[@]compasspathways.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 255
• Est. completion date: July 2025
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder, Treatment-Resistant
• Treatment Resistant Depression

Intervention

Drug:
• Psilocybin
COMP360 Psilocybin administered under supportive conditions

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	Psych Atlanta	Atlanta	Georgia
United States	Sheppard Pratt Health System	Baltimore	Maryland
United States	Insight Clinical Trials, LLC	Beachwood	Ohio
United States	Uptown Research Institute, LLC	Chicago	Illinois
United States	University of Missouri	Columbia	Missouri
United States	ProScience Research Group	Culver City	California
United States	Cedar Clinical Research	Draper	Utah
United States	CBH Health, LLC	Gaithersburg	Maryland
United States	Collaborative Neuroscience Network, LLC	Garden Grove	California
United States	UT Health Science Center at Houston (UTHSC-H)	Houston	Texas
United States	Kadima Neuropsychiatry Institute	La Jolla	California
United States	University California San Diego	La Jolla	California
United States	Alivation Research, LLC.	Lincoln	Nebraska
United States	California Center for Psychedelic Therapy	Los Angeles	California
United States	CalNeuro Research Group, Inc	Los Angeles	California
United States	Clarity Clinical Research, LLC	Los Angeles	California
United States	University of Minnesota	Minneapolis	Minnesota
United States	Global Medical Institutes, LLC, Scranton Medical Institute	Moosic	Pennsylvania
United States	New York State Psychiatric Institute	New York	New York
United States	The Medical Research Network, LLC	New York	New York
United States	Neuro-Behaviroral Clinical Research, Inc.	North Canton	Ohio
United States	University of Massachusetts Medical School	North Worcester	Massachusetts
United States	Comprehensive Psychiatric Care	Norwich	Connecticut
United States	Rivus Wellness & Research Institute	Oklahoma City	Oklahoma
United States	ATP Clinical Research, Inc.	Orange	California
United States	APG Research, LLC	Orlando	Florida
United States	Clinical Neurosciecne Solutions, Inc. dba CNS Healthcare	Orlando	Florida
United States	Pharmasite Research, Inc	Pikesville	Maryland
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Artemis Institute for Clinical Research	San Diego	California
United States	Lumos Clinical Research Center	San Jose	California
United States	Stanford University	Stanford	California
United States	DMI Health Care Group, Inc	Tampa	Florida
United States	Meridien Research/Accel Research	Tampa	Florida
United States	ASCLEPES Research Centers	Thousand Oaks	California
United States	University of Arizona College of Medicine - Tuscon	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
COMPASS Pathways

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	COMP360 25 mg versus placebo 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	Week 6
Secondary	COMP360 25 mg versus placebo for the change from baseline in 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.	Week 6