Clinical TrialMajor Depressive Disorder (MDD)PsilocybinPsilocybinPsilocybinActive not recruiting

A Phase II, Multicentre, Randomised, Double-blind, Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of COMP360 in Participants With Major Depressive Disorder With One Prior Treatment Failure

This Phase II interventional trial (n=102) randomises adults with MDD and up to four prior treatment failures to single-dose COMP360 (25 mg, 10 mg or 1 mg) with psychological support to assess safety, tolerability, pharmacokinetics and efficacy.

Target Enrollment
102 participants
Study Type
Phase II interventional
Design
Randomized, quadruple Blind

Detailed Description

Multi-centre, randomised, double-blind, parallel-group Phase II study comparing single oral doses of COMP360 (25 mg, 10 mg, 1 mg) in adults with major depressive disorder administered with psychological support.

Primary aims are safety and tolerability; secondary assessments include pharmacokinetics and efficacy measures (MADRS) with follow-up to six weeks post‑dosing.

The study randomises 102 participants 1:1:1 and follows participants for up to 16 weeks including screening and a six‑week follow‑up.

Study Protocol

Preparation

sessions

Dosing

sessions

Integration

sessions

Therapeutic Protocol

Manualized psychotherapy included

Study Arms & Interventions

COMP360 25 mg

experimental

Single oral 25 mg COMP360 (psilocybin) with psychological support.

Interventions

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

    COMP360 administered with psychological support

COMP360 10 mg

experimental

Single oral 10 mg COMP360 (psilocybin) with psychological support.

Interventions

  • Psilocybin10 mg
    via Oral• single dose• 1 doses total

    COMP360 administered with psychological support

COMP360 1 mg

active comparator

Single oral 1 mg COMP360 (low-dose comparator) with psychological support.

Interventions

  • Psilocybin1 mg
    via Oral• single dose• 1 doses total

    Low-dose COMP360 active comparator

Participants

Ages
18 – 99
Sexes
Male & Female

Inclusion Criteria

  • Key Inclusion Criteria:
  • Aged ≥18 years at Screening
  • Major depression without psychotic features (single or recurrent episode as defined by DSM-5)
  • If the current major depressive episode is the participant's first lifetime episode, the length of the current episode must be ≥3 months and ≤2 years at Screening
  • MADRS total score ≥20 at Screening and Baseline
  • Failure to respond to an adequate dose and duration of up to four pharmacological treatments for the current episode as determined through the MGH-ATRQ
  • At Screening, agreement to discontinue all prohibited medications.

Exclusion Criteria

  • Key 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) or antisocial personality disorder
  • Lifetime paranoid, schizoid, schizotypal, histrionic, narcissistic personality disorder, or any ongoing serious psychiatric comorbidity
  • Borderline personality disorder as demonstrated by medical history or MINI plus
  • Ongoing post-traumatic stress disorder, obsessive-compulsive disorder, or anorexia nervosa
  • 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 psychological therapy that will not remain stable for the duration of the study
  • Exposure to COMP360 psilocybin therapy prior to Screening

Study Details

Locations

Kadima Neuropsychiatry Institute — La Jolla, California, United States
Clinical Neuroscience Solutions Inc — Jacksonville, Florida, United States
Sunstone Therapies — Rockville, Maryland, United States
Elixia MA, LLC — Springfield, Massachusetts, United States
Aims Trial — Plano, Texas, United States

Your Library