Administration of Psilocybe Cubensis Mushrooms with or Without Fluoxetine with or Without Fluoxetine for Refractory Depression: a Randomized Double-blind Controlled Trial Controlled Clinical Trial – COGUNILA (COGUNILA)
This randomised, quadruple-blind, placebo-controlled Phase I/II trial (n=50) will investigate the antidepressant, psychedelic, and adverse effects of Psilocybe cubensis mushrooms (equivalent to 30 mg of psilocybin) with or without daily fluoxetine (20mg) in adults with treatment-resistant depression.
Details
Randomized, quadruple-blind, parallel-group Phase 2a pilot in adults with treatment-resistant major depressive disorder comparing concurrent fluoxetine 20 mg/day versus matching placebo around a single 3 g Psilocybe mushroom dosing session with manualized psychotherapeutic support.
Primary outcome is change in MADRS from baseline to Week 4; secondary outcomes include response and remission rates at Week 4 and durability to Week 6, plus measures of the acute psychedelic experience (5D-ASC, SOCQ), psychological flexibility (AAQ-10), and safety/tolerability (UKU, adverse events).