Status:
RECRUITING
A Phase 3 Trial of MM120 for Major Depressive Disorder (Emerge)
Lead Sponsor:
Mind Medicine, Inc.
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-74 years
Phase:
PHASE3
Brief 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
Detailed Description
The study will enroll approximately 140 adult men and women aged 18 to 74 years, inclusive with a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) confirmed primary diagnos...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Certain psychiatric disorders (other than major depressive disorder)
- First degree relative with or lifetime history of a psychotic disorder or bipolar disorder
- Current diagnosis of alcohol or substance use disorder (excluding nicotine and caffeine
- Any clinically significant unstable illness
Key Trial Info
Start Date :
April 14 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2027
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT06941844
Start Date
April 14 2025
End Date
May 1 2027
Last Update
December 17 2025
Active Locations (28)
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1
Preferred Research Partner
Fayetteville, Arkansas, United States, 72703
2
Preferred Research Partners, Inc
Little Rock, Arkansas, United States, 72211
3
Kadima Neuropsychiatry Institute
La Jolla, California, United States, 92037
4
Psychedelic Science Institute
Santa Monica, California, United States, 90404