A Study of Psilocybin for Major Depressive Disorder (MDD)

PHASE2CompletedINTERVENTIONAL
Enrollment

104

Participants

Timeline

Start Date

October 15, 2019

Primary Completion Date

June 28, 2022

Study Completion Date

June 28, 2022

Conditions
Depressive Disorder, Major
Interventions
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.

OTHER

Set and Setting (SaS) Protocol

The SaS Protocol prescribes 6-8 hours of preparatory meetings with two facilitators prior to dosing, a 7-10 hour dosing session in a comfortable room under the supervision of the same two facilitators, and 4 hours of post-dose integration sessions with facilitators. During the dosing session participants are encouraged to wear eyeshades and listen to a curated playlist on headphones.

Trial Locations (11)

10016

New York University School of Medicine, New York

21229

Johns Hopkins University, Baltimore

30322

Emory University, Atlanta

33319

Segal Trials, Lauderhill

53706

University of Wisconsin - Madison, Madison

60640

Great Lakes Clinical Trials, Chicago

84020

Cedar Clinical Research, Draper

91404

Pacific Neuroscience Institute, Santa Monica

94121

University of California, San Francisco, San Francisco

06520

Yale University, New Haven

08009

Hassman Research Institute, Berlin

All Listed Sponsors
collaborator

The Emmes Company, LLC

INDUSTRY

lead

Usona Institute

OTHER

NCT03866174 - A Study of Psilocybin for Major Depressive Disorder (MDD) | Biotech Hunter | Biotech Hunter