A Dose-Finding Study of MM-120 (LSD D-Tartrate) for the Treatment of Anxiety Symptoms
NCT ID: NCT05407064
Last Updated: 2025-09-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
198 participants
INTERVENTIONAL
2022-08-24
2023-11-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
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- 25 μg MM-120 (LSD D-Tartrate)
A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A).
MM-120 (LSD D-Tartrate)
A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A).
Arm 3- 50 μg MM-120 (LSD D-Tartrate)
A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A).
MM-120 (LSD D-Tartrate)
A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A).
Arm 4- 100 μg MM-120 (LSD D-Tartrate)
A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A).
MM-120 (LSD D-Tartrate)
A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A).
Arm 5- 200 μg MM-120 (LSD D-Tartrate)
A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A).
MM-120 (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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MM-120 (LSD D-Tartrate)
A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A).
Placebo
A substance that is designed to have no therapeutic value.
Eligibility Criteria
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Inclusion Criteria
* Body mass index \[BMI\] ≥ 18 to ≤ 38 mg/kg2
* Diagnosis of DSM-5 generalized anxiety disorder
* Acceptable overall medical condition to be safely enrolled into and to complete the study
* Ability to swallow capsules
* Ability to provide informed consent
Exclusion Criteria
* Women who are currently pregnant or breastfeeding or plan to become pregnant or breastfeed during the study
* Men who plan to donate sperm during the study
* Prior history (lifetime diagnosis) with a lifetime diagnosis of schizophrenia spectrum, or other psychotic disorders or bipolar disorder
* Has a significant risk of suicide attempt based upon medical history or has active suicidal ideation
* Unwillingness or inability to discontinue prohibited concomitant medications, supplements or other therapeutics (prescription or over-the-counter)
18 Years
74 Years
ALL
No
Sponsors
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Mind Medicine, Inc.
INDUSTRY
Responsible Party
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Locations
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Preferred Research Partners
Little Rock, Arkansas, United States
Irvine Center for Clinical Research
Irvine, California, United States
Kadima Neuropsychiatry Institute
La Jolla, California, United States
Pacific Neuroscience Institute
Santa Monica, California, United States
Mountain View Clinical Research
Denver, Colorado, United States
Wholeness Center
Fort Collins, Colorado, United States
Segal Trials
Lauderhill, Florida, United States
CNS Healthcare - Orlando
Orlando, Florida, United States
iResearch Atlanta
Decatur, Georgia, United States
Great Lakes Clinical Trials
Chicago, Illinois, United States
Uptown Research
Chicago, Illinois, United States
Sunstone Therapies
Rockville, Maryland, United States
SISU
Springfield, Massachusetts, United States
Adams Clinical
Watertown, Massachusetts, United States
Hassman Research Institute
Berlin, New Jersey, United States
GMI - Princeton Medical Institute
Princeton, New Jersey, United States
Lutheran Hospital - Cleveland Clinic
Cleveland, Ohio, United States
BioBehavioral Research of Austin
Austin, Texas, United States
University of Texas Health Houston
Houston, Texas, United States
Cedar Clinical Research
Draper, Utah, United States
Cedar Clinical Research - Murray
Murray, Utah, United States
Woodstock Research Center
Woodstock, Vermont, United States
Countries
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References
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Robison R, Barrow R, Conant C, Foster E, Freedman JM, Jacobsen PL, Jemison J, Karas SM, Karlin DR, Solomon TM, Halperin Wernli M, Fava M. Single Treatment With MM120 (Lysergide) in Generalized Anxiety Disorder: A Randomized Clinical Trial. JAMA. 2025 Sep 4:e2513481. doi: 10.1001/jama.2025.13481. Online ahead of print.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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MMED008
Identifier Type: -
Identifier Source: org_study_id
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