A Dose-Finding Study of MM-120 for the Treatment of Anxiety Symptoms
This is a Phase II, multi-centre, randomized, double-blind, parallel-group, dose-finding study to assess the effect of four doses of MM-120 (25, 50, 100 or 200 μg LSD freebase-equivalent) for the treatment of anxiety symptoms in subjects diagnosed with generalized anxiety disorder (GAD).
Detailed Description
Multi-centre, randomised, quadruple-blind, parallel-group Phase II trial in approximately 198 participants with DSM-5 GAD and HAM-A ≥20 comparing placebo and four ascending single doses of MM-120 (25–200 µg, oral capsule).
Primary aim is treatment of anxiety symptoms; participants on contraindicated medications will undergo tapering prior to baseline. Safety and tolerability, and standard anxiety outcome measures (including HAM-A) will be assessed.
Study Arms & Interventions
Placebo
inactivePlacebo comparator (capsule).
Interventions
- Placebovia Oral• single dose• 1 doses total
Placebo capsule
MM-120 25 µg
experimentalMM-120 (LSD D‑tartrate) 25 µg capsule.
Interventions
- LSD25 µgvia Oral• single dose• 1 doses total
MM-120 (LSD D‑tartrate)
MM-120 50 µg
experimentalMM-120 (LSD D‑tartrate) 50 µg capsule.
Interventions
- LSD50 µgvia Oral• single dose• 1 doses total
MM-120 (LSD D‑tartrate)
MM-120 100 µg
experimentalMM-120 (LSD D‑tartrate) 100 µg capsule.
Interventions
- LSD100 µgvia Oral• single dose• 1 doses total
MM-120 (LSD D‑tartrate)
MM-120 200 µg
experimentalMM-120 (LSD D‑tartrate) 200 µg capsule.
Interventions
- LSD200 µgvia Oral• single dose• 1 doses total
MM-120 (LSD D‑tartrate)
Participants
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
- Minimum HAM-A Total Score of 20
- Subjects on contraindicated concomitant medications, supplements or other therapeutics at Screening will undergo a medication taper prior to advancing to Baseline.
Exclusion Criteria
- Women of childbearing potential 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 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) 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 Details
- StatusCompleted
- PhasePhase II
- Typeinterventional
- DesignRandomizedquadruple Blind
- Target Enrollment198 participants
- TimelineStart: 2022-06-27End: 2023-11-30
- Compounds
- Topic