NCT06898606View on ClinicalTrials.gov

Psilocybe Cubensis Mushrooms With or Without Fluoxetine for Refractory Depression: a Phase 2a Pilot Randomized Clinical Trial (COGUNILA)

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

September 5, 2024

Primary Completion Date

August 20, 2026

Study Completion Date

November 20, 2026

Conditions
Depressive Disorder
Interventions
DRUG

Psilocybin and Psilocyn

Oral dose administered via Psilocybe mushrooms material batch-assayed by LC-MS to standardize psilocybin and psilocyn content.

DRUG

Placebo

Matching capsules, once daily for 4 weeks (-14 to +14 days).

BEHAVIORAL

Psychotherapy-assisted session

Same manualized procedures as Arm 1.

DRUG

Fluoxetine

20 mg/day for 4 weeks (-14 to +14 days relative to dosing day).

Trial Locations (1)

85870-650

RECRUITING

Federal University of Latin American Integration, Foz do Iguaçu

All Listed Sponsors
lead

Federal University of Latin American Integration

OTHER