Major Depressive Disorder
Conditions
Brief summary
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.
Interventions
DRUGPsilocybin
Psilocybin administered with psychological support
Sponsors
National Institute of Mental Health (NIMH)
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MADRS (Montgomery-Asberg Depression Rating Scale) Change from Baseline | 3 weeks post-treatment | Depression severity rating scale, range 0-60 with higher scores indicating more severe symptoms |
| Adverse Events | Up to 12 weeks post-treatment | Rates of adverse events related to treatment, as determined by multiple data collection mechanisms |
| Study Retention and Completion | Throughout study participation (12-17 weeks) | Rates of successful attendance of study visits and completion of study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MADRS (Montgomery-Asberg Depression Rating Scale) Change from Baseline | 12 weeks post-treatment | Depression severity rating scale, range 0-60 with higher scores indicating more severe symptoms |
Outcome results
None listed