A Phase II, Multicentre, Randomised,... — Clinical Trial Details

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.

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.

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

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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

Detailed Description

Study Protocol

Preparation

Dosing

Locations

Integration

Therapeutic Protocol

Study Arms & Interventions

COMP360 25 mg

Interventions

COMP360 10 mg

Interventions

COMP360 1 mg

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details

Study Team

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