Psilocybin for Major Depressive Disorder

Study Overview
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Brief Summary
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The goal of this study is to assess the effectiveness of psilocybin for the treatment of Major Depressive Disorder and potential therapeutic mechanisms. Enrolled participants will receive a single active dose of psilocybin, or a dose considered high enough to treat depression, administered orally with accompanying psychological support.

Official Title
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Psilocybin for the Treatment of Major Depressive Disorder

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Drug: Psilocybin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Currently meeting DSM-V Criteria for a Major Depressive Episode of at least mild-moderate severity Aged 18-85 Ability and willingness to attend study visits and complete study assessments Exclusion Criteria: Presence of medical conditions at screening that may affect the safe administration of psilocybin (including, but not limited to: AST/ALT > 150, QTc > 450ms, MELD > 9) Depression deemed secondary to a severe medical condition Recent use of any classical psychedelic drug or MDMA Recent use of any interventional psychiatric treatment (including: ECT, ketamine, esketamine, TMS) Intention to begin any new treatment for depression prior to primary outcome determination Use of any excluded medication Active substance use disorder Presence of any psychiatric condition that may interfere with the safe administration of psilocybin Active suicidal ideation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Psilocybin Active Dose Treatment A<br>Psilocybin | Drug: Psilocybin<br>* Psilocybin administered with psychological support<br>|
| Experimental: Psilocybin Active Dose Treatment B<br>Psilocybin | Drug: Psilocybin<br>* Psilocybin administered with psychological support<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MADRS (Montgomery-Asberg Depression Rating Scale) Change from Baseline | Depression severity rating scale, range 0-60 with higher scores indicating more severe symptoms | 3 weeks post-treatment | 
| Adverse Events | Rates of adverse events related to treatment, as determined by multiple data collection mechanisms | Up to 12 weeks post-treatment | 
| Study Retention and Completion | Rates of successful attendance of study visits and completion of study | Throughout study participation (12-17 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MADRS (Montgomery-Asberg Depression Rating Scale) Change from Baseline | Depression severity rating scale, range 0-60 with higher scores indicating more severe symptoms | 12 weeks post-treatment |