A Phase 3 Trial of MM120 for Major Depressive Disorder (Emerge)

NCT06941844 | Active Not Recruiting Phase 3 FDA Drug

• 1 other identifier: MM120-310
• Study Type: interventional
• Target: 149
• Locations: 1 country
• Sites: 25

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

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Week 6

  The MADRS is used to assess depression severity and to detect changes due to antidepressant treatment. The MADRS includes 10 clinician-completed items. Each of the 10 questions is scored with a range of 0-6 points. An item score of 0 indicates item not present or normal, while an item score of 6 indicates severe or continuous presence of the symptoms. The total possible score is 60, and higher scores represent a more severe condition.

  Baseline to Week 6

Secondary Outcomes (26)

• Change from Baseline in the MADRS total score at Week 12, Week 4, Week 2, and Week 1

  Week 12, Week 4, Week 2, and Week 1

• MADRS response (reduction from Baseline score of ≥50%) at each timepoint assessed during the 12-week double-blind period

  Baseline to Week 12

• MADRS remission (total score ≤10) at each timepoint assessed during the 12-week double-blind treatment period

  Baseline to Week 12

• Clinical Global Impression - Improvement (CGI-I) Scale score at each timepoint assessed during the 12-week double-blind period

  Day 2 to Week 12

• Change from Baseline throughout the 12-week double-blind period at each timepoint assessed in Clinical Global Impression - Severity (CGI-S) Scale score

  Baseline to Week 12

Study Arms (2)

Arm 1 - Placebo

PLACEBO COMPARATOR

A substance that is designed to have no therapeutic value

Other: Placebo

Arm 2 - 100µg MM120 (LSD D-Tartrate)

EXPERIMENTAL

A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A)

Drug: MM120 (LSD D-Tartrate)

Interventions

Placebo OTHER

A substance that is designed to have no therapeutic value

Arm 1 - Placebo

MM120 (LSD D-Tartrate) DRUG

A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A)

Arm 2 - 100µg MM120 (LSD D-Tartrate)

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Definium Therapeutics US, Inc.: lead

Study Sites (25)

Preferred Research Partner

Fayetteville, Arkansas, 72703, United States

Location

Preferred Research Partners, Inc

Little Rock, Arkansas, 72211, United States

Location

Kadima Neuropsychiatry Institute

La Jolla, California, 92037, United States

Location

Psychedelic Science Institute

Santa Monica, California, 90404, United States

Location

Mountain View Clinical Research, Inc

Denver, Colorado, 80209, United States

Location

Clinical Neuroscience Solutions, Inc

Jacksonville, Florida, 32256, United States

Location

Clinical Neuroscience Solutions, Inc

Orlando, Florida, 32801, United States

Location

Charter Research

Orlando, Florida, 32803, United States

Location

Uptown Research

Chicago, Illinois, 60640, United States

Location

Sheppard Pratt

Baltimore, Maryland, 21204, United States

Location

Adams Clinical Boston

Boston, Massachusetts, 02116, United States

Location

Adams Clinical

Watertown, Massachusetts, 02472, United States

Location

University of Missouri

Columbia, Missouri, 65212, United States

Location

Cenexel HRI

Berlin, New Jersey, 08053, United States

Location

Adams Clinical Harlem

New York, New York, 10029, United States

Location

Columbia - New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Neuro-Behavioral Clinical Research

Canton, Ohio, 44720, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45219, United States

Location

Adams Clinical Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Clinical Neuroscience Solutions, Inc

Memphis, Tennessee, 38119, United States

Location

Dell Medical School, University of Texas at Austin

Austin, Texas, 78712, United States

Location

Austin Clinical Trial Partners

Austin, Texas, 78737, United States

Location

FutureSearch Trials of Dallas

Dallas, Texas, 75231, United States

Location

Cedar Clinical Research

Murray, Utah, 84020, United States

Location

Memory Clinic, Inc

Bennington, Vermont, 05201, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2025
• First Posted: April 24, 2025
• Study Start: April 14, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: March 13, 2026

Record last verified: 2025-05

Locations

US (25)