A Phase 3 Trial of MM120 for Generalized Anxiety Disorder (Voyage)

Last updated: May 14, 2025
Sponsor: Mind Medicine, Inc.
Overall Status: Active - Recruiting

Phase

3

Condition

Anxiety Disorders

Panic Disorders

Mood Disorders

Treatment

Placebo

MM120 (LSD D-Tartrate)

Clinical Study ID

NCT06741228
MM120-300
  • Ages 18-74
  • All Genders

Study Summary

A Phase 3 Double-blind, Placebo-controlled Study (Part A) with an Open-label Extension (Part B) Evaluating MM120 Compared to Placebo in Generalized Anxiety Disorder - Voyage

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Diagnosis of GAD per DSM-5

  2. Male or female aged 18 to 74

  3. HAM-A Total Score ≥20

Exclusion

Exclusion Criteria:

  1. Certain psychiatric disorders (other than generalized anxiety disorder)

  2. First degree relative with or lifetime history of a psychotic disorder or bipolardisorder

  3. Current diagnosis of alcohol or substance use disorder (excluding nicotine andcaffeine)

  4. Any clinically significant unstable illness

Study Design

Total Participants: 200
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
December 11, 2024
Estimated Completion Date:
November 30, 2026

Study Description

The study will enroll up to 200 participants aged 18 to 74 years, inclusive with a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) confirmed primary diagnosis of GAD and a minimum HAM-A total score of at least 20 at Screening and Baseline without clinically relevant medical or psychiatric history.

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.

Connect with a study center

  • Lighthouse Psychiatry

    Gilbert, Arizona 85234
    United States

    Active - Recruiting

  • Kadima Neuropsychiatry Institute

    La Jolla, California 92037
    United States

    Active - Recruiting

  • UCSF Department of Neurology

    San Francisco, California 94158
    United States

    Site Not Available

  • Pacific Neuroscience Institute

    Santa Monica, California 90404
    United States

    Site Not Available

  • Mountain View

    Denver, Colorado 80209
    United States

    Active - Recruiting

  • Clinical Neuroscience Solutions Inc.

    Jacksonville, Florida 32256
    United States

    Active - Recruiting

  • Accel Research Sites - Lakeland CRU

    Lakeland, Florida 33803
    United States

    Active - Recruiting

  • Segal Trials

    Lauderhill, Florida 33319
    United States

    Active - Recruiting

  • Atlanta Center for Medical Research

    Atlanta, Georgia 30331
    United States

    Site Not Available

  • iResearch Atlanta

    Decatur, Georgia 30030
    United States

    Active - Recruiting

  • CenExel iResearch, LLC

    Savannah, Georgia 31405
    United States

    Site Not Available

  • Kendall.chaves@accelclinical.com

    Savannah, Georgia 31405
    United States

    Site Not Available

  • Uptown Research Institute

    Chicago, Illinois 60640
    United States

    Active - Recruiting

  • DelRicht Research

    Baton Rouge, Louisiana 70810
    United States

    Site Not Available

  • DelRicht Research

    New Orleans, Louisiana 70115
    United States

    Site Not Available

  • Copley Clinical

    Boston, Massachusetts 02116
    United States

    Site Not Available

  • Adams Clinical

    Watertown, Massachusetts 02472
    United States

    Active - Recruiting

  • University of Missouri Health Care

    Columbia, Missouri 65212
    United States

    Active - Recruiting

  • Hassman Research Institute

    Marlton, New Jersey 08053
    United States

    Site Not Available

  • New York State Psychiatric Institute (NYSPI)

    New York, New York 10032
    United States

    Site Not Available

  • Spectrum Neuroscience and Treatment Institute

    New York, New York 10021
    United States

    Site Not Available

  • Cleveland Clinic Lutheran Hospital

    Cleveland, Ohio 44113
    United States

    Site Not Available

  • Summit Headlands LLC

    Portland, Oregon 97210
    United States

    Active - Recruiting

  • Scranton Medical Institute

    Moosic, Pennsylvania 18507
    United States

    Active - Recruiting

  • Coastal Carolina Research Center

    North Charleston, South Carolina 29405
    United States

    Active - Recruiting

  • Clinical Neuroscience Solutions, Inc.

    Memphis, Tennessee 38119
    United States

    Active - Recruiting

  • BioBehavioral Research of Austin

    Austin, Texas 78759
    United States

    Site Not Available

  • Dell Medical School, University of Texas at Austin

    Austin, Texas 78712
    United States

    Active - Recruiting

  • Cedar Clinical Research

    Draper, Utah 84020
    United States

    Active - Recruiting

  • Memory Clinic Inc.

    Bennington, Vermont 05201
    United States

    Active - Recruiting

  • Seattle Neuropsychiatric Treatment Center

    Seattle, Washington 98104
    United States

    Active - Recruiting

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