Clinical Trial

A Study of Psilocybin for Major Depressive Disorder (MDD)

Study Description

A Study of Psilocybin for Major Depressive Disorder (MDD)

Eighty 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 8 post-dose.

Location

Locations Selected Location

Methods

Pharmaceutical medication involved Pharmaceutical medication involved
Patients and healthy individuals accepted Patients and healthy individuals accepted

Drug - Psilocybin

The psilocybin used in this study is synthetically manufactured in a laboratory and meets quality specifications suitable for human research use. The active drug is encapsulated using a hydroxypropyl methylcellulose (HPMC) capsule and contains 25 mg of psilocybin.

Drug - Niacin

The active placebo is encapsulated using a HPMC capsule and contains 100 mg of pharmaceutical grade niacin.

Additional Information

Official Study Title

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

Clinical Trial ID

NCT03866174

ParticipAid ID

epYnXa