RecruitingPhase 3LSD
A Phase 3 Trial of MM120 for Major Depressive Disorder (Emerge)
Sponsored by Definium Therapeutics US, Inc.
NCT ID
NCT06941844
Target Enrollment
140 participants
Start Date
2025-04-14
Est. Completion
2027-05
About This Study
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
Conditions Studied
Interventions
- •Placebo
- •MM120 (LSD D-Tartrate)
Eligibility
Age:18 Years - 74 Years
Healthy Volunteers:No
View full eligibility criteria
Inclusion Criteria: 1. Diagnosis of MDD per DSM-5 2. Male or female aged 18 to 74 3. Currently experiencing a major depressive episode (MDE) of ≥8 weeks and ≤24 months duration 4. MADRS Total Score ≥26 5. CGI-S Score ≥4 Exclusion Criteria: 1. Certain psychiatric disorders (other than major depressive disorder) 2. First degree relative with or lifetime history of a psychotic disorder or bipolar disorder 3. Current diagnosis of alcohol or substance use disorder (excluding nicotine and caffeine 4. Any clinically significant unstable illness
Study Locations (28)
Preferred Research Partner
Fayetteville, Arkansas, United States
Preferred Research Partners, Inc
Little Rock, Arkansas, United States
Kadima Neuropsychiatry Institute
La Jolla, California, United States
Psychedelic Science Institute
Santa Monica, California, United States
Mountain View Clinical Research, Inc
Denver, Colorado, United States
Clinical Neuroscience Solutions, Inc
Jacksonville, Florida, United States
Segal Trials- Center for Psychedelic Research
Lauderhill, Florida, United States
Clinical Neuroscience Solutions, Inc
Orlando, Florida, United States
Charter Research
Orlando, Florida, United States
Uptown Research
Chicago, Illinois, United States
+18 more locations