RecruitingPhase 3NCT06741228

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

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 Generalized Anxiety Disorder - Voyage

Sponsor

Definium Therapeutics US, Inc.

Enrollment

200 participants

Start Date

Dec 11, 2024

Study Type

INTERVENTIONAL

Conditions

Generalized Anxiety Disorder

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

Min Age: 18 YearsMax Age: 74 Years

Plain Language Summary

Simplified for easier understanding

This Phase 3 trial tests MM120 — a proprietary formulation of lysergide (LSD) — as a treatment for generalized anxiety disorder (GAD). It is one of the first large-scale trials of a psychedelic-assisted therapy approach for anxiety. The study compares MM120 against a placebo to see if it significantly reduces anxiety symptoms. **You may be eligible if...** - You are between 18 and 74 years old - You have a confirmed diagnosis of generalized anxiety disorder (GAD) based on DSM-5 criteria - Your anxiety severity score on a standard rating scale (HAM-A) is at least 20, indicating moderate to severe anxiety **You may NOT be eligible if...** - You have certain other psychiatric disorders (beyond GAD) - You or a first-degree family member has a history of psychotic disorder or bipolar disorder - You have a current alcohol or substance use disorder (excluding nicotine and caffeine) - You have an unstable or significant medical condition Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERPlacebo

A substance that is designed to have no therapeutic value

DRUGMM120 (LSD D-Tartrate)

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

Locations(36)

Lighthouse Psychiatry

Gilbert, Arizona, United States

Scottsdale Research Institute

Scottsdale, Arizona, United States

Kadima Neuropsychiatry Institute

La Jolla, California, United States

UCSF Department of Neurology

San Francisco, California, United States

Psychedelic Science Institute

Santa Monica, California, United States

Mountain View

Denver, Colorado, United States

Clinical Neuroscience Solutions Inc.

Jacksonville, Florida, United States

Accel Research Sites - Lakeland CRU

Lakeland, Florida, United States

Segal Trials

Lauderhill, Florida, United States

Atlanta Center for Medical Research

Atlanta, Georgia, United States

iResearch Atlanta

Decatur, Georgia, United States

CenExel iResearch, LLC

Savannah, Georgia, United States

Uptown Research Institute

Chicago, Illinois, United States

Adams Clinical Boston

Boston, Massachusetts, United States

Adams Clinical Watertown

Watertown, Massachusetts, United States

University of Missouri Health Care

Columbia, Missouri, United States

Hassman Research Institute

Marlton, New Jersey, United States

Spectrum Neuroscience and Treatment Institute

New York, New York, United States

Adams Clinical Harlem

New York, New York, United States

New York State Psychiatric Institute (NYSPI)

New York, New York, United States

Adams Clinical Bronx

The Bronx, New York, United States

Cleveland Clinic Lutheran Hospital

Cleveland, Ohio, United States

Summit Headlands LLC

Portland, Oregon, United States

Scranton Medical Institute

Moosic, Pennsylvania, United States

Adams Clinical Philadelphia

Philadelphia, Pennsylvania, United States

Coastal Carolina Research Center

North Charleston, South Carolina, United States

Clinical Neuroscience Solutions, Inc.

Memphis, Tennessee, United States

University of Texas at Austin

Austin, Texas, United States

Austin Clinical Trial Partners

Austin, Texas, United States

BioBehavioral Research of Austin

Austin, Texas, United States

FutureSearch Trials of Dallas, LLC

Dallas, Texas, United States

Adams Clinical Dallas

DeSoto, Texas, United States

Cedar Clinical Research

Draper, Utah, United States

Inner Space Research

Orem, Utah, United States

Memory Clinic Inc.

Bennington, Vermont, United States

Seattle Neuropsychiatric Treatment Center

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06741228

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