Purpose

Efficacy, Safety, and Tolerability of two administrations of COMP360 in participants with treatment-resistant depression (TRD)

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
25 mg COMP360 Psilocybin
25 mg COMP360 Psilocybin
  • Drug: Psilocybin
    COMP360 Psilocybin administered under supportive conditions
    Other names:
    • COMP360
Experimental
10 mg COMP360 Psilocybin
10 mg COMP360 Psilocybin
  • Drug: Psilocybin
    COMP360 Psilocybin administered under supportive conditions
    Other names:
    • COMP360
Active Comparator
1 mg COMP360 Psilocybin
1 mg COMP360 Psilocybin, active comparator
  • Drug: Psilocybin
    COMP360 Psilocybin administered under supportive conditions
    Other names:
    • COMP360

Recruiting Locations

More Details

Status
Recruiting
Sponsor
COMPASS Pathways

Study Contact

Medical Director, MD
COMP006@compasspathways.com

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.