Efficacy, Safety, and Tolerability of COMP360 in Participants With TRD

Trial ID or NCT#

NCT05624268

Status

recruiting iconRECRUITING

Purpose

Efficacy, Safety, and Tolerability of a single administration of COMP360 in participants with treatment-resistant depression (TRD)

Official Title

A Phase III, Multicentre, Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy, Safety, and Tolerability of COMP360 in Participants With Treatment-resistant Depression

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. 1. Aged ≥18 years at Screening2. 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 Screening4. MADRS total score ≥20 at Screening and Baseline to ensure at least moderate severity of depression5. 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.
    1. Key
Exclusion Criteria:
  1. Psychiatric Exclusion Criteria:
    1. 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 judgement3. Borderline personality disorder as demonstrated by medical history or the Mini International Neuropsychiatric Interview Plus (MINI plus) - borderline personality disorder module4. 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 Screening6. Use of electroconvulsive therapy, deep brain stimulation, or vagus nerve stimulation during the current depressive episode7. Transcranial magnetic stimulation within the past six months prior to Screening8. 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 Screening9. Exposure to COMP360 psilocybin therapy prior to Screening
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Investigator(s)

Melanie Lean
Clinical Assistant Professor, Psychiatry and Behavioral Sciences
Jason Tucciarone, MD, PhD
Assistant Professor of Psychiatry and Behavioral Sciences (General Psychiatry and Psychology)

View on ClinicalTrials.gov