Status:
COMPLETED
A Dose-Finding Study of MM-120 (LSD D-Tartrate) for the Treatment of Anxiety Symptoms
Lead Sponsor:
Mind Medicine, Inc.
Conditions:
Anxiety Generalized
Eligibility:
All Genders
18-74 years
Phase:
PHASE2
Brief Summary
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...
Detailed Description
The study will enroll approximately 200 male and female subjects 18 years to \< 75 years of age who meet DSM-5 criteria for GAD and have a minimum HAM-A Total Score of 20. Subjects on contraindicated ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
August 24 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 27 2023
Estimated Enrollment :
198 Patients enrolled
Trial Details
Trial ID
NCT05407064
Start Date
August 24 2022
End Date
November 27 2023
Last Update
September 5 2025
Active Locations (22)
Enter a location and click search to find clinical trials sorted by distance.
1
Preferred Research Partners
Little Rock, Arkansas, United States, 72211
2
Irvine Center for Clinical Research
Irvine, California, United States, 92614
3
Kadima Neuropsychiatry Institute
La Jolla, California, United States, 92037
4
Pacific Neuroscience Institute
Santa Monica, California, United States, 90404