Clinical TrialAnxiety DisordersPlaceboLSDRecruiting

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

This Phase III, multicenter, randomised, double-blind, placebo-controlled trial (n=200) will evaluate the efficacy and safety of oral MM120 (LSD D-Tartrate) compared to placebo in adults with Generalized Anxiety Disorder (GAD). The study aims to assess changes in anxiety levels, primarily measured by the Hamilton Anxiety Rating Scale (HAM-A), over a 12-week period, followed by a 40-week open-label extension. Participants aged 18 to 74 years with a confirmed diagnosis of GAD and a minimum HAM-A score of 20 will be enrolled. The trial consists of a 12-week treatment phase where participants will receive either a single dose of 100 µg MM120 or a placebo, followed by a 40-week extension phase allowing for open-label treatment based on safety and symptom severity criteria. The study will monitor participants for changes in anxiety symptoms and overall safety throughout the trial duration.

Target Enrollment
200 participants
Study Type
Phase III interventional
Design
Randomized, double Blind

Detailed Description

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

Study Arms & Interventions

Arm 1 - Placebo

inactive

A substance that is designed to have no therapeutic value

Interventions

  • Placebo other
    • single dose

Arm 2 - 100µg MM120 (LSD D-Tartrate)

experimental

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

Interventions

  • LSD100
    via Oral• single dose

Participants

Ages
18 – 74
Sexes
All

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

Study Details

  • Status
    Recruiting
  • Phase
    Phase III
  • Type
    interventional
  • Design
    Randomizeddouble Blind
  • Target Enrollment200 participants
  • Timeline
    Start: 2024-12-11
    End: 2026-11-01
  • Compounds
    PlaceboLSD
  • Topic
    Anxiety Disorders

Study Team

Sponsors & Collaborators

Locations

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

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