A Dose-Finding Study of MM120 (LSD D-Tartrate) for the Treatment of Anxiety Symptoms

Completed · Phase 2 · Has a placebo group

Conditions studied: Anxiety Generalized

In brief

This is a Phase 2, multi-center, randomized, double-blind, parallel-group, dose-finding study to assess the effect of 4 doses of MM120 (25, 50, 100 or 200 μg freebase-equivalent) for the treatment of anxiety symptoms in subjects diagnosed with generalized anxiety disorder (GAD).

Key facts

Study ID

NCT05407064

Run by

Definium Therapeutics US, Inc.

People needed

198

Starts

2022-08-24

Expected to finish

2023-11-27

Last updated by the study team

2026-02-27

Who can join

Age: 18 and older, up to 74. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Bodyweight of ≥ 50 kg
• 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

You may not qualify if…

• Women of childbearing potential (WOCBP) (i.e., physiologically capable of becoming pregnant) who are unwilling or unable to use a highly effective method of contraception for the duration of the study, OR Men physiologically capable of fathering a child who are sexually active with WOCBP but are unwilling or unable to use barrier contraception (e.g., condom with or without spermicidal cream or jelly) for the duration of the study
• 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)

Where it is running

• 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

Full record on ClinicalTrials.gov

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