CLINICAL TRIAL

Psilocybe Cubensis Mushrooms With or Without Fluoxetine for Refractory Depression

This Phase 2a pilot, exploratory, randomized, double-blind, placebo-controlled, parallel-group trial will estimate whether concurrent fluoxetine alters the antidepressant effect, acute psychedelic experience, or safety of a psychedelic-assisted psychotherapy session in adults with treatment-resistant major depressive disorder (TRD). Eligible participants (ages 25-64) have DSM-5-TR MDD, moderate-severe, MADRS ≥20, and partial response in the current episode (≥1 adequate antidepressant trial of 6-12 weeks with \

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Bibliographic context

Journal: ClinicalTrials.gov
Date: 2026-03-26
Source: ClinicalTrials.gov
DOI: Unavailable
PubMed: Unavailable

Authors

Federal University of Latin American Integration

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Topics and keywords

psilocybin Depression Clinical Trial Treatment-Resistant Depression Safety Clinical Trial Depressive Disorder Psilocybin and Psilocyn Placebo Psychotherapy-assisted session Fluoxetine RECRUITING

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