The trial is taking place at:
A

APG Research, LLC | Orlando, FL

Veeva-enabled site

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

C

COMPASS Pathways

Status and phase

Enrolling
Phase 3

Conditions

Treatment Resistant Depression

Treatments

Drug: Psilocybin

Study type

Interventional

Funder types

Industry

Identifiers

NCT05624268
COMP 005

Details and patient eligibility

About

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

Full 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).

Enrollment

255 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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:

Psychiatric 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

255 participants in 2 patient groups, including a placebo group

25 mg COMP360 Psilocybin
Experimental group
Description:
25 mg COMP360 Psilocybin
Treatment:
Drug: Psilocybin
Placebo
Placebo Comparator group
Description:
Matched placebo
Treatment:
Drug: Psilocybin

Trial contacts and locations

38

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Central trial contact

Medical Director, MD

Data sourced from clinicaltrials.gov

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