Clinical TrialMajor Depressive Disorder (MDD)PlaceboLSDRecruiting

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

This randomised, double-blind, placebo-controlled Phase III trial (n=140) will evaluate the efficacy and safety of a single oral dose of MM120 (100 µg LSD D-tartrate) for the treatment of major depressive disorder (MDD).

Target Enrollment
140 participants
Study Type
Phase III interventional
Design
Randomized, triple Blind

Detailed Description

Randomised, triple-masked, parallel-group Phase III study comparing a single oral 100 µg dose of MM120 (LSD D‑tartrate) to placebo in adults with moderate to severe MDD; primary double-blind period is 12 weeks with a 40‑week open‑label extension.

Approximately 140 participants aged 18–74 with MADRS ≥26 and CGI‑S ≥4 will be enrolled; safety monitoring and pre-specified criteria determine eligibility for open‑label extension.

Study Protocol

Preparation

sessions

Dosing

1 sessions

Integration

sessions

Study Arms & Interventions

Placebo

inactive

Placebo comparator

Interventions

  • Placebo
    via Oral• single dose

    Placebo comparator, single oral administration

100 µg MM120

experimental

Single oral dose of MM120 (LSD D-tartrate) vs placebo

Interventions

  • LSD100 µg
    via Oral• single dose• 1 doses total

    Single oral 100 µg dose of MM120 (LSD D‑tartrate)

Participants

Ages
18 – 74
Sexes
Male & Female

Inclusion 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

  • 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 Details

Locations

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

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