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Efficacy, Safety, and Tolerability of Two Administrations 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

NCT05711940
COMP 006

Details and patient eligibility

About

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

Full 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.

Enrollment

568 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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:

  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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

568 participants in 3 patient groups

25 mg COMP360 Psilocybin
Experimental group
Description:
25 mg COMP360 Psilocybin
Treatment:
Drug: Psilocybin
10 mg COMP360 Psilocybin
Experimental group
Description:
10 mg COMP360 Psilocybin
Treatment:
Drug: Psilocybin
1 mg COMP360 Psilocybin
Active Comparator group
Description:
1 mg COMP360 Psilocybin, active comparator
Treatment:
Drug: Psilocybin

Trial contacts and locations

53

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Central trial contact

Medical Director, MD

Data sourced from clinicaltrials.gov

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