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) 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 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

ArmDescriptionAssigned Intervention
Placebo Comparator
Arm 1- Placebo 		A substance that is designed to have no therapeutic value.
  • Other: 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).
  • Drug: 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).
  • Drug: 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).
  • Drug: 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).
  • Drug: MM-120 (LSD D-Tartrate)
    A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A).

More Details

Status
Completed
Sponsor
Mind Medicine, Inc.

Study Contact

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).