A Phase 3 Trial of MM120 for Major Depressive Disorder (Emerge)
NCT ID: NCT06941844
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
140 participants
INTERVENTIONAL
2025-04-14
2027-05-31
Brief Summary
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Detailed Description
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The study consists of a 12-week randomized, double-blind, single-dose administration period evaluating MM120 versus placebo, followed by a 40-week extension phase with the opportunity for open-label treatment. During this phase, participants will be monitored and evaluated for potential treatment with MM120 based on pre-specified safety and symptom severity criteria.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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)
MM120 (LSD D-Tartrate)
A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A)
Arm 1 - Placebo
A substance that is designed to have no therapeutic value
Placebo
A substance that is designed to have no therapeutic value
Interventions
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Placebo
A substance that is designed to have no therapeutic value
MM120 (LSD D-Tartrate)
A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A)
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
74 Years
ALL
No
Sponsors
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Mind Medicine, Inc.
INDUSTRY
Responsible Party
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Locations
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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
Sheppard Pratt
Baltimore, Maryland, United States
Adams Clinical Boston
Boston, Massachusetts, United States
Adams Clinical
Watertown, Massachusetts, United States
University of Missouri
Columbia, Missouri, United States
Cenexel HRI
Berlin, New Jersey, United States
Spectrum Neuroscience and Treatment Institute
New York, New York, United States
Adams Clinical Harlem
New York, New York, United States
Columbia - New York State Psychiatric Institute
New York, New York, United States
Neuro-Behavioral Clinical Research
Canton, Ohio, United States
University of Cincinnati
Cincinnati, Ohio, United States
Adams Clinical Philadelphia
Philadelphia, Pennsylvania, United States
Scranton Medical Institute, LLC
Scranton, Pennsylvania, United States
Clinical Neuroscience Solutions, Inc
Memphis, Tennessee, United States
Dell Medical School, University of Texas at Austin
Austin, Texas, United States
Austin Clinical Trial Partners
Austin, Texas, United States
FutureSearch Trials of Dallas
Dallas, Texas, United States
Cedar Clinical Research
Murray, Utah, United States
Memory Clinic, Inc
Bennington, Vermont, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MM120-310
Identifier Type: -
Identifier Source: org_study_id