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

NCT ID: NCT06741228

Last Updated: 2025-11-10

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-11

Study Completion Date

2026-11-30

Brief Summary

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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

Detailed Description

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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.

Conditions

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Generalized Anxiety Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
This study is double-blinded, which means that both the participants and the treating clinicians will be masked to treatment allocation, meaning neither party will know which participants are receiving the active drug and which are receiving the placebo. The placebo tablet is identical looking to the active drug

Study Groups

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Arm 1 - Placebo

A substance that is designed to have no therapeutic value

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

A substance that is designed to have no therapeutic value

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)

Group Type EXPERIMENTAL

MM120 (LSD D-Tartrate)

Intervention Type DRUG

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

Interventions

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Placebo

A substance that is designed to have no therapeutic value

Intervention Type OTHER

MM120 (LSD D-Tartrate)

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Diagnosis of GAD per DSM-5
2. Male or female aged 18 to 74
3. HAM-A Total Score ≥20

Exclusion Criteria

1. Certain psychiatric disorders (other than generalized anxiety 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mind Medicine, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Lighthouse Psychiatry

Gilbert, Arizona, United States

Site Status RECRUITING

Kadima Neuropsychiatry Institute

La Jolla, California, United States

Site Status RECRUITING

UCSF Department of Neurology

San Francisco, California, United States

Site Status RECRUITING

Psychedelic Science Institute

Santa Monica, California, United States

Site Status RECRUITING

Mountain View

Denver, Colorado, United States

Site Status RECRUITING

Clinical Neuroscience Solutions Inc.

Jacksonville, Florida, United States

Site Status RECRUITING

Accel Research Sites - Lakeland CRU

Lakeland, Florida, United States

Site Status ACTIVE_NOT_RECRUITING

Segal Trials

Lauderhill, Florida, United States

Site Status ACTIVE_NOT_RECRUITING

Atlanta Center for Medical Research

Atlanta, Georgia, United States

Site Status RECRUITING

iResearch Atlanta

Decatur, Georgia, United States

Site Status RECRUITING

CenExel iResearch, LLC

Savannah, Georgia, United States

Site Status RECRUITING

Uptown Research Institute

Chicago, Illinois, United States

Site Status RECRUITING

Adams Clinical Boston

Boston, Massachusetts, United States

Site Status RECRUITING

Adams Clinical Watertown

Watertown, Massachusetts, United States

Site Status ACTIVE_NOT_RECRUITING

University of Missouri Health Care

Columbia, Missouri, United States

Site Status RECRUITING

Hassman Research Institute

Marlton, New Jersey, United States

Site Status RECRUITING

Spectrum Neuroscience and Treatment Institute

New York, New York, United States

Site Status RECRUITING

Adams Clinical Harlem

New York, New York, United States

Site Status RECRUITING

New York State Psychiatric Institute (NYSPI)

New York, New York, United States

Site Status NOT_YET_RECRUITING

Adams Clinical Bronx

The Bronx, New York, United States

Site Status RECRUITING

Cleveland Clinic Lutheran Hospital

Cleveland, Ohio, United States

Site Status RECRUITING

Summit Headlands LLC

Portland, Oregon, United States

Site Status RECRUITING

Scranton Medical Institute

Moosic, Pennsylvania, United States

Site Status RECRUITING

Adams Clinical Philadelphia

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Coastal Carolina Research Center

North Charleston, South Carolina, United States

Site Status RECRUITING

Clinical Neuroscience Solutions, Inc.

Memphis, Tennessee, United States

Site Status RECRUITING

Dell Medical School, University of Texas at Austin

Austin, Texas, United States

Site Status RECRUITING

Austin Clinical Trial Partners

Austin, Texas, United States

Site Status NOT_YET_RECRUITING

BioBehavioral Research of Austin

Austin, Texas, United States

Site Status ACTIVE_NOT_RECRUITING

Cedar Clinical Research

Draper, Utah, United States

Site Status RECRUITING

Memory Clinic Inc.

Bennington, Vermont, United States

Site Status RECRUITING

Seattle Neuropsychiatric Treatment Center

Seattle, Washington, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Mind Medicine Clinical Trials Info Requests

Role: CONTACT

Phone: 332-282-0479

Email: [email protected]

Facility Contacts

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Matt Longson

Role: primary

Angelica Lau

Role: primary

Jennifer Mitchell, PhD

Role: primary

Keith Heinzerling

Role: primary

Kristen Johnson

Role: primary

Susan Angel

Role: primary

Katherine Prowse

Role: primary

Katie Prowse

Role: primary

Katie Prowse

Role: primary

Stephen Schneider

Role: primary

Allison Zadourian

Role: primary

Britlyn Brown

Role: primary

Lisa Speight

Role: primary

Simona Kobryn

Role: primary

Allison Zadourian

Role: primary

Adeen Izzathullah

Role: primary

Samantha Leonard

Role: backup

Allison Zadourian

Role: primary

Katelyn Schwesinger

Role: primary

Summit Research

Role: primary

Zoha Babar

Role: primary

Allison Zadourian

Role: primary

Brandy Dreyer

Role: primary

Charles Grandberry

Role: primary

Kelly Jackson

Role: primary

Cara Fonken

Role: primary

Janet Jimenez

Role: primary

Cynthia Murphy, PhD

Role: primary

Libby Kell

Role: primary

Other Identifiers

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MM120-300

Identifier Type: -

Identifier Source: org_study_id