Effect of SSRIs on Response to Psilocybin Therapy
This open-label, single-arm trial (n=30) aimed to evaluate the effect of length of time on selective serotonin reuptake inhibitors (SSRIs) on the response to psilocybin-assisted therapy in individuals with mild-moderate Major Depressive Disorder (MDD).
Details
Open-label, single-arm within-subject feasibility study enrolling 30 participants with mild–moderate MDD to receive a single 25 mg dose of psilocybin (PEX010) with pre- and post-dose therapy sessions; participants stratified by duration of SSRI exposure into four groups (≤1 yr; 1–≤5 yrs; 5–≤10 yrs; >10 yrs).
Rationale: most psilocybin trials exclude or taper SSRIs; this study evaluates safety and clinical response when psilocybin is administered to participants maintained on SSRIs. Follow-up is 12 weeks; PEX010 supplied by Filament Health.