Investigating the effects of COMP360 on recurrent major depressive disorder
A Phase II, Multicentre, Randomised, Double-blind, Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of COMP360 in Participants With Recurrent Major Depressive Disorder
This study is testing a new psilocybin-based treatment called COMP360 to see if it can help adults with recurring major depression who haven't found relief from other medications.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 102 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | COMPASS Pathways Industry-sponsored |
| Locations | 5 sites (La Jolla, California and 4 other locations) |
| Trial ID | NCT05733546 on ClinicalTrials.gov |
What this trial studies
This phase II, multicentre, randomised, double-blind, controlled study aims to evaluate the safety, tolerability, pharmacokinetics, and efficacy of COMP360, a psilocybin-based treatment, in adults with recurrent Major Depressive Disorder (MDD). Participants aged 18 and older, who have experienced up to four treatment failures with antidepressants, will be randomly assigned to receive one of three doses of COMP360. The study will last up to 16 weeks, including a screening period and follow-up, with psychological support provided alongside the treatment. The primary focus is to assess the impact of COMP360 on depressive symptoms and overall patient well-being.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with recurrent major depressive disorder and a history of treatment failure with antidepressants.
Not a fit: Patients with bipolar disorder, psychotic disorders, or those who have not experienced treatment failure may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with recurrent major depressive disorder who have not responded to traditional antidepressants.
How similar studies have performed: Other studies have shown promising results with psilocybin in treating depression, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Key Inclusion Criteria: * Aged ≥18 years at Screening * Major depression without psychotic features (single or recurrent episode as informed by the Diagnostic and Statistical Manual of Mental Disorders, 5th edition \[DSM-5\]) * 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 * MADRS total score ≥20 at Screening and Baseline to ensure at least moderate severity of depression. * Failure to respond to an adequate dose and duration of up to four pharmacological treatment 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. * 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), antisocial personality disorder as assessed by a structured clinical interview (MINI 7.0.2) * Lifetime paranoid, schizoid, schizotypal, histrionic, narcissistic personality disorder, or any ongoing serious psychiatric comorbidity based on medical history and clinical judgement * Borderline personality disorder as demonstrated by medical history or the Mini International Neuropsychiatric Interview Plus (MINI plus) - borderline personality disorder module * 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) 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 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 * Exposure to COMP360 psilocybin therapy prior to Screening
Where this trial is running
La Jolla, California and 4 other locations
- Kadima Neuropsychiatry Institute — La Jolla, California, United States (Recruiting)
- Clinical Neuroscience Solutions Inc — Jacksonville, Florida, United States (Recruiting)
- Sunstone Therapies — Rockville, Maryland, United States (Recruiting)
- Elixia MA, LLC — Springfield, Massachusetts, United States (Recruiting)
- Aims Trial — Plano, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Medical Director, MD
- Email: info@compasspathways.com
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.