A Phase 3 Trial of MM120 for Generalized Anxiety Disorder (Voyage)
NCT ID: NCT06741228
Last Updated: 2026-02-09
Study Results
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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RECRUITING
PHASE3
200 participants
INTERVENTIONAL
2024-12-11
2026-11-30
Brief Summary
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Arm 1 - Placebo
A substance that is designed to have no therapeutic value
Placebo
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)
MM120 (LSD D-Tartrate)
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
MM120 (LSD D-Tartrate)
A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A)
Eligibility Criteria
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Inclusion Criteria
2. Male or female aged 18 to 74
3. HAM-A Total Score ≥20
Exclusion Criteria
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
18 Years
74 Years
ALL
No
Sponsors
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Definium Therapeutics
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MM120-300
Identifier Type: -
Identifier Source: org_study_id
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