Clinical trial NCT05624268: Efficacy, Safety, and Tolerability of COMP360 in Participants With TRD
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Treatment Resistant Depression
Lead sponsor: COMPASS Pathways
Sponsor class: INDUSTRY
First posted: 2022-11-22
Enrollment: 255
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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).

Eligibility criteria: 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

Primary outcomes:
measure: COMP360 25 mg versus placebo for the change from baseline in MADRS total score
timeFrame: Week 6
Secondary outcomes:
measure: COMP360 25 mg versus placebo for the change from baseline in SDS total score
timeFrame: Week 6
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona College of Medicine - Tuscon
state: Arizona
city: Culver City
country: United States
facility: ProScience Research Group
state: California
city: Garden Grove
country: United States
facility: Collaborative Neuroscience Network, LLC
state: California
city: La Jolla
country: United States
facility: Kadima Neuropsychiatry Institute
state: California
city: La Jolla
country: United States
facility: University California San Diego
state: California
city: Los Angeles
country: United States
facility: California Center for Psychedelic Therapy
state: California
city: Los Angeles
country: United States
facility: CalNeuro Research Group, Inc
state: California
city: Los Angeles
country: United States
facility: Clarity Clinical Research, LLC
state: California
city: Orange
country: United States
facility: ATP Clinical Research, Inc.
state: California
city: San Diego
country: United States
facility: Artemis Institute for Clinical Research
state: California
city: San Jose
country: United States
facility: Lumos Clinical Research Center
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
city: Thousand Oaks
country: United States
facility: ASCLEPES Research Centers
state: California
city: Norwich
country: United States
facility: Comprehensive Psychiatric Care
state: Connecticut
city: Orlando
country: United States
facility: Clinical Neurosciecne Solutions, Inc. dba CNS Healthcare
state: Florida
city: Orlando
country: United States
facility: APG Research, LLC
state: Florida
city: Tampa
country: United States
facility: DMI Health Care Group, Inc
state: Florida
city: Tampa
country: United States
facility: Meridien Research/Accel Research
state: Florida
city: Atlanta
country: United States
facility: Psych Atlanta
state: Georgia
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Chicago
country: United States
facility: Uptown Research Institute, LLC
state: Illinois
city: Baltimore
country: United States
facility: Sheppard Pratt Health System
state: Maryland
city: Gaithersburg
country: United States
facility: CBH Health, LLC
state: Maryland
city: Pikesville
country: United States
facility: Pharmasite Research, Inc
state: Maryland
city: North Worcester
country: United States
facility: University of Massachusetts Medical School
state: Massachusetts
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Columbia
country: United States
facility: University of Missouri
state: Missouri
city: Saint Charles
country: United States
facility: Midwest Research Group
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Lincoln
country: United States
facility: Alivation Research, LLC.
state: Nebraska
city: Toms River
country: United States
facility: Bio Behavioral Health
state: New Jersey
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
city: New York
country: United States
facility: The Medical Research Network, LLC
state: New York
city: Beachwood
country: United States
facility: Insight Clinical Trials, LLC
state: Ohio
city: North Canton
country: United States
facility: Neuro-Behaviroral Clinical Research, Inc.
state: Ohio
city: Oklahoma City
country: United States
facility: Rivus Wellness & Research Institute
state: Oklahoma
city: Moosic
country: United States
facility: Global Medical Institutes, LLC, Scranton Medical Institute
state: Pennsylvania
city: Houston
country: United States
facility: UT Health Science Center at Houston (UTHSC-H)
state: Texas
city: Draper
country: United States
facility: Cedar Clinical Research
state: Utah
city: Everett
country: United States
facility: Core Clinical Research
state: Washington
Study officials:
References: