Foz Do Iguacu

Researchers are evaluating whether taking fluoxetine alongside a psychedelic-assisted psychotherapy session changes the antidepressant effects, the psychedelic experience, or safety in adults with treatment-resistant major depressive disorder (TRD). This Phase 2a pilot, exploratory, randomized, double-blind, placebo-controlled trial includes adults aged 25 to 64 with moderate to severe depression who have had only partial improvement from previous antidepressant treatments. The study aims to understand how fluoxetine, started two weeks before and continued two weeks after the psychedelic session, affects outcomes compared to placebo. All participants receive a single psychotherapy session assisted by 3 grams of standardized Psilocybe cubensis mushrooms, with preparation and integration sessions before and after dosing. Participants are randomly assigned to receive either fluoxetine 20 mg daily or matching placebo for four weeks, beginning two weeks prior to the psychedelic session and continuing for two weeks after. The study uses quadruple blinding to ensure unbiased results, and the mushroom material is tested to standardize the active compounds. During the study, depression symptoms are assessed at multiple time points up to six weeks, mainly using the Montgomery-Åsberg Depression Rating Scale (MADRS). The psychedelic experience is measured with specific questionnaires shortly after dosing, and psychological flexibility is also evaluated. Safety is closely monitored through side effect ratings and adverse event tracking throughout the study. The main goal is to measure changes in depression severity at four weeks and to explore how fluoxetine influences the psychedelic session's effects and tolerability.