A Dose-Finding Study of MM-120 (LSD D-Tartrate) for the Treatment of Anxiety Symptoms
Purpose
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).
Condition
- Anxiety Generalized
Eligibility
- Eligible Ages
- Between 18 Years and 74 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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) or known first-degree relative (i.e., mother/father/full siblings) with a lifetime diagnosis of schizophrenia spectrum, posttraumatic stress disorder 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 Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Placebo Comparator Arm 1- Placebo |
A substance that is designed to have no therapeutic value. |
|
|
Experimental 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). |
|
|
Experimental 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). |
|
|
Experimental 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). |
|
|
Experimental 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). |
|
Recruiting Locations
University of Texas Health Houston
Houston, Texas 77054
Houston, Texas 77054
More Details
- Status
- Recruiting
- Sponsor
- Mind Medicine, Inc.
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 concomitant medications, supplements or other therapeutics at Screening (Visit 1) will undergo a medication taper prior to advancing to Baseline (Visit 2).