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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Psilocybin administered with psychological support
MADRS (Montgomery-Asberg Depression Rating Scale) Change from Baseline
Depression severity rating scale, range 0-60 with higher scores indicating more severe symptoms
Time frame: 3 weeks post-treatment
Adverse Events
Rates of adverse events related to treatment, as determined by multiple data collection mechanisms
Time frame: Up to 12 weeks post-treatment
Study Retention and Completion
Rates of successful attendance of study visits and completion of study
Time frame: Throughout study participation (12-17 weeks)
MADRS (Montgomery-Asberg Depression Rating Scale) Change from Baseline
Depression severity rating scale, range 0-60 with higher scores indicating more severe symptoms
Time frame: 12 weeks post-treatment
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