A Dose-Finding Study of MM-120 (LSD D-Tartrate) for the Treatment of Anxiety Symptoms
Anxiety Generalized
About this trial
This is an interventional treatment trial for Anxiety Generalized
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) 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)
Sites / Locations
- Preferred Research Partners
- Irvine Center for Clinical Research
- Kadima Neuropsychiatry Institute
- Pacific Neuroscience Institute
- Mountain View Clinical Research
- Wholeness Center
- Segal Trials
- CNS Healthcare - Orlando
- iResearch Atlanta
- Great Lakes Clinical Trials
- Uptown Research
- Sunstone Therapies
- SISU BHR
- Hassman Research Institute
- GMI - Princeton Medical Institute
- Nautilus Sanctuary
- Lutheran Hospital - Cleveland Clinic
- BioBehavioral Research of Austin
- University of Texas Health Houston
- Cedar Clinical Research
- Murray
- Woodstock Research Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Placebo Comparator
Experimental
Experimental
Experimental
Experimental
Arm 1- Placebo
Arm 2- 25 μg MM-120 (LSD D-Tartrate)
Arm 3- 50 μg MM-120 (LSD D-Tartrate)
Arm 4- 100 μg MM-120 (LSD D-Tartrate)
Arm 5- 200 μg MM-120 (LSD D-Tartrate)
A substance that is designed to have no therapeutic value.
A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A).
A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A).
A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A).
A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A).