RecruitingPhase 2NCT06378229

Psilocybin for Hospitalized Patients with Treatment-resistant Depression

Psilocybin-assisted Psychotherapy in the Treatment of Patients Hospitalized for Treatment-resistant Depression: an Open-label Feasibility Study with an Experiential and Systemic Focus


Sponsor

University Hospital, Ghent

Enrollment

100 participants

Start Date

May 21, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to determine the safety and feasibility of performing psilocybin-assisted psychotherapy in patients hospitalized for treatment-resistant depression.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether psilocybin (an active compound found in certain mushrooms) can help treat severe, treatment-resistant depression in people who are currently hospitalized and have not responded to multiple antidepressant medications. **You may be eligible if...** - You are 18 or older - You have a diagnosis of moderate-to-severe major depressive disorder (without psychotic features), confirmed using DSM-5 criteria - You have tried at least 2 antidepressants at adequate doses for at least 6 weeks each, without improvement - You are not currently using alcohol (verified by breathalyzer) and provide a negative drug screen on the dosing day - You are not pregnant (verified by test on dosing day) **You may NOT be eligible if...** - You have psychotic features with your depression - You have a personal or family history of psychosis or schizophrenia - You are unable to abstain from alcohol before your dosing session - You have medical conditions that make psilocybin unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPsilocybin

A psychedelic drug found in certain mushrooms. It will be in a capsule of 25mg psilocybin (PEX010).


Locations(1)

Ghent University Hospital

Ghent, Oost-Vlaanderen, Belgium

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NCT06378229


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