Psilocybin molecule:

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Psilocybin Clinical Trials

A Randomized, Double-Blind, Support-of-Concept Phase 2 Study of Single-Dose Psilocybin for Major Depressive Disorder (MDD)

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Id: NCT03866174

Organisation Name: Usona Institute

Overal Status: Active, not recruiting

Start Date: October 15, 2019

Last Update: December 2, 2022

Lead Sponsor: Usona Institute

Brief Summary: One hundred participants, ages 21 to 65, who meet Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for major depressive disorder (MDD) will be stratified by study site and randomized with a 1-to-1 allocation under double-blind conditions to receive a single 25 mg oral dose of psilocybin or a single 100 mg oral dose of niacin. Niacin will serve as an active placebo.

The purpose of this study is to evaluate the potential efficacy of a single 25 mg oral dose of psilocybin for MDD compared to the active placebo in otherwise medically-healthy participants, assessed as the difference between groups in changes in depressive symptoms from Baseline to Day 43 post-dose.

  • Depressive Disorder, Major

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