A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled, 12-Week Study (Part A) With a 40-Week Open-label Extension (Part B) Evaluating the Efficacy and Safety of Oral MM120 Compared to Placebo in the Treatment of Adults With Major Depressive Disorder - Emerge
Status: Recruiting
Location: See all (28) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
A Phase 3 Double-blind, Placebo-controlled Study (Part A) with an Open-label Extension (Part B) Evaluating MM120 Compared to Placebo in Major Depressive Disorder - Emerge
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 74
Healthy Volunteers: f
View:
• Diagnosis of MDD per DSM-5
• Male or female aged 18 to 74
• Currently experiencing a major depressive episode (MDE) of ≥8 weeks and ≤24 months duration
• MADRS Total Score ≥26
• CGI-S Score ≥4
Locations
United States
Arkansas
Preferred Research Partner
ACTIVE_NOT_RECRUITING
Fayetteville
Preferred Research Partners, Inc
RECRUITING
Little Rock
California
Kadima Neuropsychiatry Institute
RECRUITING
La Jolla
Psychedelic Science Institute
RECRUITING
Santa Monica
Colorado
Mountain View Clinical Research, Inc
RECRUITING
Denver
Florida
Clinical Neuroscience Solutions, Inc
RECRUITING
Jacksonville
Segal Trials- Center for Psychedelic Research
WITHDRAWN
Lauderhill
Charter Research
RECRUITING
Orlando
Clinical Neuroscience Solutions, Inc
RECRUITING
Orlando
Illinois
Uptown Research
RECRUITING
Chicago
Massachusetts
Adams Clinical Boston
RECRUITING
Boston
Adams Clinical
RECRUITING
Watertown
Maryland
Sheppard Pratt
RECRUITING
Baltimore
Missouri
University of Missouri
ACTIVE_NOT_RECRUITING
Columbia
New Jersey
Cenexel HRI
RECRUITING
Berlin
New York
Adams Clinical Harlem
RECRUITING
New York
Columbia - New York State Psychiatric Institute
NOT_YET_RECRUITING
New York
Spectrum Neuroscience and Treatment Institute
WITHDRAWN
New York
Ohio
Neuro-Behavioral Clinical Research
RECRUITING
Canton
University of Cincinnati
RECRUITING
Cincinnati
Pennsylvania
Adams Clinical Philadelphia
RECRUITING
Philadelphia
Scranton Medical Institute, LLC
WITHDRAWN
Scranton
Tennessee
Clinical Neuroscience Solutions, Inc
RECRUITING
Memphis
Texas
Austin Clinical Trial Partners
RECRUITING
Austin
Dell Medical School, University of Texas at Austin
RECRUITING
Austin
FutureSearch Trials of Dallas
RECRUITING
Dallas
Utah
Cedar Clinical Research
RECRUITING
Murray
Vermont
Memory Clinic, Inc
RECRUITING
Bennington
Contact Information
Primary
Mind Medicine, Inc.
ClinicalTrials@Mindmed.co
1-332-282-0479
Time Frame
Start Date: 2025-04-14
Estimated Completion Date: 2027-05
Participants
Target number of participants: 140
Treatments
Placebo_comparator: Arm 1 - Placebo
A substance that is designed to have no therapeutic value
Experimental: Arm 2 - 100µg MM120 (LSD D-Tartrate)
A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A)
Related Therapeutic Areas
Sponsors
Leads: Mind Medicine, Inc.