Clinical TrialTreatment-Resistant Depression (TRD)PsilocybinPlaceboActive not recruiting

Efficacy, Safety, and Tolerability of COMP360 in Participants With TRD (COMP005)

Phase III randomised, double-blind, placebo-controlled trial (n=255) comparing a single 25 mg COMP360 psilocybin dose plus psychological support versus placebo in adults with treatment-resistant depression (Part A).

Target Enrollment
255 participants
Study Type
Phase III interventional
Design
Randomized, quadruple Blind

Detailed Description

This international, multi-centre, randomised (2:1), parallel-group, double-blind study evaluates the efficacy and safety of a single 25 mg COMP360 psilocybin dose versus matched placebo in adults with treatment-resistant depression. Part A comprises a 6‑week follow-up after the single administration; Parts B and C assess re-treatment durability and open‑label treatment respectively.

Primary outcome is reduction in depressive symptom severity (MADRS) at 6 weeks. Safety assessments include adverse events, vital signs, and standard clinical labs; psychological support is provided around dosing sessions.

Study Protocol

Preparation

sessions

Dosing

1 sessions

Integration

sessions

Therapeutic Protocol

support

Study Arms & Interventions

COMP360 25 mg

experimental

Single fixed 25 mg COMP360 (psilocybin) dose administered with psychological support (Part A).

Interventions

  • Psilocybin25 mg
    via Oral• single dose• 1 doses total

    COMP360 formulation administered under supportive conditions

Placebo

inactive

Matched placebo with psychological support.

Interventions

  • Placebo
    via Oral• single dose• 1 doses total

    Matched placebo comparator

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion Criteria

  • Key Inclusion Criteria:
  • 1. Aged ≥18 years at Screening
  • 2. Major depression without psychotic features (single or recurrent episode per DSM-5)
  • 3. If current episode is first lifetime episode, length must be ≥3 months and ≤2 years at Screening
  • 4. MADRS total score ≥20 at Screening and Baseline
  • 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 per MGH-ATRQ and supplementary advice
  • 6. Agreement to discontinue all prohibited medications at Screening

Exclusion Criteria

  • Key Exclusion Criteria:
  • 1. Prior or ongoing bipolar disorder, any psychotic disorder (including schizophrenia, schizoaffective disorder, brief psychotic disorder unless substance induced or due to medical condition), antisocial personality disorder
  • 2. Lifetime paranoid, schizoid, schizotypal, histrionic, narcissistic personality disorder, or any ongoing serious psychiatric comorbidity
  • 3. Borderline personality disorder as demonstrated by medical history or MINI plus
  • 4. Ongoing PTSD, OCD, or anorexia nervosa
  • 5. Psychiatric inpatient within past 12 months prior to Screening
  • 6. Use of ECT, DBS, or VNS during current depressive episode
  • 7. TMS within past six months prior to Screening
  • 8. Current enrolment in unstable psychological therapy; psychological therapies cannot have been initiated within 30 days prior to Screening
  • 9. Prior exposure to COMP360 psilocybin therapy prior to Screening

Study Details

Locations

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

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