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Mushroom Retreats
RecruitingPhase 1 / Phase 2NCT06898606

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). (The sponsor's summary, shortened.)

Eligibility and contacts on ClinicalTrials.gov

The registry record

Status
Recruiting
Phase
Phase 1 / Phase 2
Conditions
Depressive Disorder
Intervention
Psilocybin and Psilocyn; Placebo; Psychotherapy-assisted session; Fluoxetine
Sponsor
Federal University of Latin American Integration
Ages
25 Years to 65 Years
Sex
All
Healthy volunteers
Accepted
Enrolment
24 people (planned)
Start
5 September 2024
Primary completion
20 August 2026
Registry last updated
27 March 2026

Sites (1)

  • Federal University of Latin American Integration, Foz do Iguaçu, Paraná, Brazil (recruiting)

How joining a trial works

Free to take part
Trials generally cost participants nothing for the study drug and the study visits, and some pay for travel or time. Check what a study covers on its registry page.
Screened first
Every study screens volunteers with questionnaires, medical history and often a physical and psychiatric check. Many people who apply are not enrolled.
Eligibility is strict
Common exclusions include a personal or family history of psychosis or bipolar disorder, some heart conditions, pregnancy and certain medications, which you may be asked to stop under medical supervision. Never stop a medication on your own to qualify.
You may get a placebo
Many trials compare psilocybin with a placebo or a low dose, and you may not be told which you had until the study ends.
Contact the study team through the registry
Each registry record lists the study contacts and sites. We do not republish personal emails or phone numbers; use the link on each trial page.
Not medical advice
This is a list of registry records, not a recommendation. Talk to your doctor before applying. Disclaimer · Safety and medications

Source: ClinicalTrials.gov API v2, U.S. National Library of Medicine, read 28 October 2026. Filter: overall status RECRUITING or NOT_YET_RECRUITING; an intervention named psilocybin, psilocin, COMP360 or CYB003. Refreshed weekly; a study's own registry page is always the current record.

Record read from ClinicalTrials.gov API v2, U.S. National Library of Medicine on 28 October 2026. All psilocybin trials