Evaluating MM120 for Major Depressive Disorder
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
This study is testing a new treatment called MM120 to see if it can help adults with Major Depressive Disorder feel better compared to a placebo.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years to 74 Years |
| Sex | All |
| Sponsor | Mind Medicine, Inc. Industry-sponsored |
| Locations | 26 sites (Fayetteville, Arkansas and 25 other locations) |
| Trial ID | NCT06941844 on ClinicalTrials.gov |
What this trial studies
This Phase 3 trial aims to assess the efficacy of MM120, a compound derived from LSD, in treating Major Depressive Disorder (MDD) compared to a placebo. The study will enroll around 140 adults aged 18 to 74 who meet specific diagnostic criteria for MDD. Participants will undergo a 12-week double-blind period followed by a 40-week open-label extension, where they will be monitored for safety and symptom improvement. The trial seeks to provide insights into the potential benefits of MM120 in managing depressive symptoms.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 74 with a confirmed diagnosis of Major Depressive Disorder experiencing a major depressive episode.
Not a fit: Patients with other significant psychiatric disorders or unstable medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a novel therapeutic option for patients suffering from Major Depressive Disorder.
How similar studies have performed: Previous studies exploring psychedelic compounds for depression have shown promising results, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Fayetteville, Arkansas and 25 other locations
- Preferred Research Partner — Fayetteville, Arkansas, United States (Not_yet_recruiting)
- Preferred Research Partners, Inc — Little Rock, Arkansas, United States (Recruiting)
- Kadima Neuropsychiatry Institute — La Jolla, California, United States (Not_yet_recruiting)
- Pacific Neuroscience Institute at Providence Saint John's — Santa Monica, California, United States (Not_yet_recruiting)
- Mountain View Clinical Research, Inc — Denver, Colorado, United States (Recruiting)
- Clinical Neuroscience Solutions, Inc — Jacksonville, Florida, United States (Recruiting)
- Segal Trials- Center for Psychedelic Research — Lauderhill, Florida, United States (Withdrawn)
- Clinical Neuroscience Solutions, Inc — Orlando, Florida, United States (Recruiting)
- Charter Research — Orlando, Florida, United States (Not_yet_recruiting)
- Uptown Research — Chicago, Illinois, United States (Recruiting)
- Sheppard Pratt — Baltimore, Maryland, United States (Not_yet_recruiting)
- Copley Clinical — Boston, Massachusetts, United States (Not_yet_recruiting)
- Adams Clinical — Boston, Massachusetts, United States (Recruiting)
- University of Missouri — Columbia, Missouri, United States (Not_yet_recruiting)
- Cenexel HRI — Berlin, New Jersey, United States (Not_yet_recruiting)
- Berman Clinical — New York, New York, United States (Not_yet_recruiting)
- Columbia - New York State Psychiatric Institute — New York, New York, United States (Not_yet_recruiting)
- Neuro-Behavioral Clinical Research — Canton, Ohio, United States (Not_yet_recruiting)
- University of Cincinnati — Cincinnati, Ohio, United States (Recruiting)
- Adams Clinical — Philadelphia, Pennsylvania, United States (Not_yet_recruiting)
- Clinical Neuroscience Solutions, Inc — Memphis, Tennessee, United States (Not_yet_recruiting)
- Dell Medical School, University of Texas at Austin — Austin, Texas, United States (Not_yet_recruiting)
- Austin Clinical Trial Partners — Austin, Texas, United States (Recruiting)
- FutureSearch Trials of Dallas — Dallas, Texas, United States (Not_yet_recruiting)
- Cedar Clinical Research — Murray, Utah, United States (Recruiting)
- Memory Clinic, Inc — Bennington, Vermont, United States (Recruiting)
Study contacts
- Study coordinator: Mind Medicine, Inc.
- Email: ClinicalTrials@Mindmed.co
- Phone: 1-332-282-0479
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.