Administration of Psilocybe Cubensis Mushrooms With or Without Fluoxetine for Refractory Depression: a Randomized Double-blind Controlled Clinical Trial - COGUNILA

Launched by FEDERAL UNIVERSITY OF LATIN AMERICAN INTEGRATION · Mar 20, 2025

Keywords

ClinConnect Summary

This clinical trial, called COGUNILA, is exploring a new way to help people who have severe depression that hasn't improved with standard treatments. It is looking at the effects of Psilocybe cubensis mushrooms, which contain a natural substance called psilocybin, when taken with or without the antidepressant fluoxetine. The study aims to see if combining these mushrooms with fluoxetine changes the way patients experience the treatment and whether it helps reduce their depressive symptoms. Participants will be assigned to one of two groups: one will receive fluoxetine along with psilocybin, while the other will receive a placebo (a sugar pill) with psilocybin.

To join this trial, individuals need to be between 25 and 65 years old and have tried at least one standard antidepressant without enough improvement in their symptoms. They should also have moderate to severe depression, as measured by a specific scale. Participants can expect to take part in psychotherapy sessions and will be monitored for six weeks to evaluate their depression symptoms. This research is important because it may offer new options for those who haven’t found relief with traditional treatments.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Who meet the following criteria for Treatment-Resistant Depression:
• • Over 25 years old and under 65 years old;
• • Having attempted Standard Treatment (at least one antidepressant at an adequate dose and duration);
• • Adequate treatment duration (for at least 6 to 12 weeks);
• • Incomplete responses to Standard Treatments (residual symptoms);
• • Moderate to Severe Depression according to the MADRS scale (MADRS ⩾20)
• Exclusion Criteria:
• • Individuals under 25 years of age or over 65 years of age;
• • Pregnant or breastfeeding women;
• • History of major psychiatric disorders, like bipolar, psychosis,or substance use. -Family history (first-degree relatives) of psychotic or bipolar disorders;
• • Subjects unwilling to withhold interacting pharmacotherapy
• • Patients with uncontrolled acute or chronic diseases;
• • Smokers who use more than 10 cigarettes per day;
• • Individuals who have used illicit drugs in the last 2 months (exception of THC).
• • Patients who report that they are currently experiencing suicidal ideation.