CompletedPhase 2LSD

A Dose-Finding Study of MM-120 (LSD D-Tartrate) for the Treatment of Anxiety Symptoms

Sponsored by Definium Therapeutics US, Inc.

NCT ID
NCT05407064
Target Enrollment
198 participants
Start Date
2022-08-24
Est. Completion
2023-11-27

About This Study

This is a Phase 2, multi-center, randomized, double-blind, parallel-group, dose-finding study to assess the effect of 4 doses of MM-120 (25, 50, 100 or 200 μg freebase-equivalent) for the treatment of anxiety symptoms in subjects diagnosed with generalized anxiety disorder (GAD).

Conditions Studied

Anxiety Generalized

Interventions

  • MM-120 (LSD D-Tartrate)
  • Placebo

Eligibility

Age:18 Years - 74 Years
Healthy Volunteers:No
View full eligibility criteria
Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Study Locations (22)

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

+12 more locations

This trial is not recruiting

This study has completed enrollment. Check back for results or find similar trials.

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Data Source
ClinicalTrials.gov

Last updated from source

A Dose-Finding Study of MM-120 (LSD D-Tartrate) for the Treatment of Anxiety Symptoms | Huxley