Psilocybin for Depression

Recruiting in Palo Alto (17 mi)

+4 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: COMPASS Pathways

No Placebo Group

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

Safety, Tolerability, pharmacokinetics and efficacy of a single administration of COMP360 in participants with recurrent Major Depressive Disorder.

Eligibility Criteria

Adults with Major Depressive Disorder who haven't improved after one antidepressant treatment, as verified by a specific questionnaire. They must have moderate depression severity and agree to stop taking certain medications. Excluded are those with certain personality disorders, recent psychiatric hospitalization, bipolar or psychotic disorders, ongoing serious mental health issues, or recent use of intensive psychiatric treatments.

Inclusion Criteria

My depression didn't improve after trying a recommended medication.

At Screening, agreement to discontinue all prohibited medications

MADRS total score ≥20 at Screening and Baseline to ensure at least moderate severity of depression

Exclusion Criteria

Lifetime paranoid, schizoid, schizotypal, histrionic, narcissistic personality disorder, or any ongoing serious psychiatric comorbidity based on medical history and clinical judgement

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)

I have not used electroconvulsive, deep brain, or vagus nerve stimulation for my current depression.

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Treatment Details

Interventions

Psilocybin (Psychedelic)

Trial OverviewThe trial is testing the safety and effectiveness of a single dose of COMP360 psilocybin for people with depression who didn't respond well to their first treatment. It's a controlled study where some participants will receive the actual medication while others may receive a placebo without knowing which one they're getting.

Participant Groups

3Treatment groups

Experimental Treatment

Active Control

Group I: 25 mg COMP360 PsilocybinExperimental Treatment1 Intervention

25 mg COMP360 Psilocybin

Group II: 10 mg COMP360 PsilocybinExperimental Treatment1 Intervention

10 mg COMP360 Psilocybin

Group III: 1 mg COMP360 PsilocybinActive Control1 Intervention

1 mg COMP360 Psilocybin

Psilocybin is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Psilocybin for: