A Dose-Finding Study of MM-120 (LSD D-Tartrate) for the Treatment of Anxiety Symptoms
- Conditions
- Anxiety Generalized
- Interventions
- Other: PlaceboDrug: MM-120 (LSD D-Tartrate)
- Registration Number
- NCT05407064
- Lead Sponsor
- Mind Medicine, Inc.
- 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 anxiety symptoms in subjects diagnosed with generalized anxiety disorder (GAD).
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 198
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1- Placebo Placebo A substance that is designed to have no therapeutic value. Arm 3- 50 μg MM-120 (LSD D-Tartrate) MM-120 (LSD D-Tartrate) A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A). Arm 4- 100 μg MM-120 (LSD D-Tartrate) MM-120 (LSD D-Tartrate) A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A). Arm 2- 25 μg MM-120 (LSD D-Tartrate) MM-120 (LSD D-Tartrate) A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A). Arm 5- 200 μg MM-120 (LSD D-Tartrate) MM-120 (LSD D-Tartrate) A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A).
- Primary Outcome Measures
Name Time Method Dose Response 4 weeks To investigate the dose-response relationship for different doses of MM120 versus placebo in change from Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score at Week 4. The HAM-A consists of the following 14 items that encompass both psychological and somatic symptoms of anxiety: Anxious mood, Tension, Fears, Insomnia, Intellectual, Depressed mood, Somatic (muscular), Somatic (sensory), Cardiovascular symptoms, Respiratory symptoms, Gastrointestinal symptoms, Genitourinary symptoms, Autonomic symptoms, and Behavior at interview (general). The central rater assessed the extent to which the subject displayed each given criterion and gave a rating on a scale of 0-4, where 4 represents the most severe symptoms. Minimum score = 0, maximum score = 56. Scores are summed and the greater the total score, the more severe illness.
- Secondary Outcome Measures
Name Time Method Dose Response 8 weeks To investigate the dose-response relationship for different doses of MM120 versus placebo in change from Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score at Week 8. The HAM-A consists of the following 14 items that encompass both psychological and somatic symptoms of anxiety: Anxious mood, Tension, Fears, Insomnia, Intellectual, Depressed mood, Somatic (muscular), Somatic (sensory), Cardiovascular symptoms, Respiratory symptoms, Gastrointestinal symptoms, Genitourinary symptoms, Autonomic symptoms, and Behavior at interview (general). The central rater assessed the extent to which the subject displayed each given criterion and gave a rating on a scale of 0-4, where 4 represents the most severe symptoms. Minimum score = 0, maximum score = 56. Scores are summed and the greater the total score, the more severe illness.
Change From Baseline in HAM-A Total Score 4 weeks To determine the change from Baseline of 4 doses of MM120 (25, 50, 100 or 200 μg free base equivalent) compared to Placebo as measured by the change in HAM-A Total Score from Baseline to Week 4 Hamilton Anxiety Rating Scale (HAM-A) consists of the following 14 items that encompass both psychological and somatic symptoms of anxiety: Anxious mood, Tension, Fears, Insomnia, Intellectual, Depressed mood, Somatic (muscular), Somatic (sensory), Cardiovascular symptoms, Respiratory symptoms, Gastrointestinal symptoms, Genitourinary symptoms, Autonomic symptoms, and Behavior at interview (general). The central rater assessed the extent to which the subject displayed each given criterion and gave a rating on a scale of 0-4, where 4 represents the most severe symptoms. Minimum score = 0, maximum score = 56. Scores are summed and the greater the total score, the more severe illness. Data shown are change in HAM-A Total Score from Baseline to Week 4
Change From Baseline in HAM-A Total Scores 12 weeks To determine the change from Baseline in HAM-A total scores of 4 doses of MM120 (25, 50, 100 or 200 μg free base equivalent) compared with placebo from Baseline to End of Study (Week 12). Hamilton Anxiety Rating Scale (HAM-A) consists of the following 14 items that encompass both psychological and somatic symptoms of anxiety: Anxious mood, Tension, Fears, Insomnia, Intellectual, Depressed mood, Somatic (muscular), Somatic (sensory), Cardiovascular symptoms, Respiratory symptoms, Gastrointestinal symptoms, Genitourinary symptoms, Autonomic symptoms, and Behavior at interview (general). The central rater assessed the extent to which the subject displayed each given criterion and gave a rating on a scale of 0-4, where 4 represents the most severe symptoms. Minimum score = 0, maximum score = 56. Scores are summed and the greater the total score, the more severe illness. Data shown are change in HAM-A Total Score from Baseline to end of study (12 weeks)
Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Scores End of Study (Week 12) To determine whether MM120 (25, 50, 100, or 200 µg freebase-equivalent) improves functionality and quality of life measures in subjects with anxiety symptoms, including improvements in depressive symptoms measured via the MADRS. The Montgomery-Åsberg Depression Rating Scale (MADRS) - used to assess depression severity and to detect changes due to treatment. Questionnaire included 10 clinician-completed items. Each of 10 questions scored with a range of 0-6 points. An item score of 0 indicated item not present or normal, while an item score of 6 indicated severe or continuous presence of the symptoms. The total possible score was 60, and higher scores represented a more severe condition. A decrease in score by ≥ 50% indicated a response to treatment, and an actual score of ≤ 10 indicated a remission of symptoms.
Change From Baseline in Clinical Global Impression - Severity (CGI-S) Total Scores End of Study (12 weeks) To determine whether MM120 (25, 50, 100, or 200 µg freebase-equivalent) improves functionality and quality of life measures in subjects with anxiety symptoms, including improvements in anxiety symptoms measured via the CGI-S. The Clinical Global Impression - Severity (CGI-S) was used to assess the subject's current severity of illness at the time of the assessment relative to the clinician's past experience with patients who have the same diagnosis. The CGI-S comprises 1 Investigator-completed (or trained rater-completed) item with 7 possible ratings (1-7 points), where a higher score indicates more severe illness. (minimum score 1, maximum score 7)
Mean Clinical Global Impression - Improvement (CGI-I) Total Scores End of Study (Week 12) To determine whether MM120 (25, 50, 100, or 200 µg freebase-equivalent) improves functionality and quality of life measures in subjects with anxiety symptoms, including improvements in anxiety symptoms measured via the CGI-I. The Clinical Global Impression - Improvement (CGI-I) was used to measure the clinician's assessment of how much the subject's illness has improved or worsened relative to Baseline (Visit 2). The CGI-I comprises 1 Investigator-completed (or trained rater-completed) item with 7 possible ratings (1-7 points), where a lower score indicates improvement, and a higher score indicates worsening. (minimum score 1, maximum score 7)
Change From Baseline in Patient Global Impression - Severity (PGI-S) Total Scores End of study (Week 12) To determine whether MM120 (25, 50, 100, or 200 µg freebase-equivalent) improves functionality and quality of life measures in subjects with anxiety symptoms, including improvements in anxiety symptoms measured via the PGI-S. The Patient Global Impression - Severity (PGI-S) is the patient-reported outcome counterpart to the CGI scale. The PGI is adapted to the patient population and can be used to measure disease severity (PGI-S). The PGI-S comprises 1 subject-completed item with 5 possible ratings (1-5). A higher score indicates more severe illness. (minimum score 1, maximum score 5)
Mean Patient Global Impression - Change (PGI-C) Total Scores Week 8 To determine whether MM120 (25, 50, 100, or 200 µg freebase-equivalent) improves functionality and quality of life measures in subjects with anxiety symptoms, including improvements in anxiety symptoms measured via the PGI-C. The Patient Global Impression - Change (PGI-C) is the patient-reported outcome counterpart to the CGI scale. The PGI is adapted to the patient population and can be used to measure changes in disease severity (PGI-C). The PGI-C comprises 1 subject-completed item with 5 possible ratings (1-5). A higher score indicates change for the worse (worsening symptoms). (minimum score 1, maximum score 5)
Change From Baseline in Patient Global Impression - Change (PGI-C) Total Scores End of Study (Week 12) To determine whether MM120 (25, 50, 100, or 200 µg freebase-equivalent) improves functionality and quality of life measures in subjects with anxiety symptoms, including improvements in anxiety symptoms measured via the PGI-C. The Patient Global Impression - Change (PGI-C) is the patient-reported outcome counterpart to the CGI scale. The PGI is adapted to the patient population and can be used to measure changes in disease severity (PGI-C). The PGI-C comprises 1 subject-completed item with 5 possible ratings (1-5). A higher score indicates change for the worse (worsening symptoms). (minimum score 1, maximum score 5)
Change From Baseline in Sheehan Disability Scale (SDS) Total Scores End of Study (Week 12) To determine whether MM120 (25, 50, 100, or 200 µg freebase-equivalent) improves functionality and quality of life measures in subjects with anxiety symptoms, including improvements in functional disability symptoms measured via the SDS. The Sheehan Disability Scale (SDS) is a composite of 3 self-rated items designed to measure the extent to which 3 major domains in the patient's life (work, social life/leisure activities and family life/home responsibilities) are functionally impaired by psychiatric or medical symptoms. Total score 0-30 (0 unimpaired, 30 highly impaired). Work/school (0-10); Social life (0-10); Family life/home responsibilities (0-10).
Improved Quality of Life as Measured by EuroQol 5 Dimension 5 Level (EQ-5D-5L) Visual Analog Scale (VAS) End of Study (12 weeks) To determine whether MM120 (25, 50, 100, or 200 µg freebase-equivalent) improves functionality and quality of life measures in subjects with anxiety symptoms, including improvements in quality of life. The EuroQol 5 Dimension 5 Level (EQ-5D-5L) was used to evaluate health outcomes over a wide range of health conditions and treatments. The EQ-5D consists of the EQ-5D descriptive system and the EQ visual analogue scale (VAS). The VAS for the subject's health status scored as ranging from 0 = worst health you can imagine, to 100 = best health you can imagine.
Improved Sleep as Measured by Pittsburgh Sleep Quality Index (PSQI) End of Study (Week 12) To determine whether MM120 (25, 50, 100, or 200 µg freebase-equivalent) improves functionality and quality of life measures in subjects with anxiety symptoms, including improvements in sleep measured via the PSQI. The Pittsburgh Sleep Quality Index (PSQI) was used to assess sleep quality and disturbances over the preceding month. The questionnaire had a Component Score for each of these with a range of 0-3 points: Subjective sleep quality, Sleep latency, Sleep duration, Habitual sleep efficiency, Sleep disturbance, Use of sleeping medication, and Daytime dysfunction. The sum of the Component Scores = a Global Score. Global Score of 0 indicated no difficulty and a Global Score of 21 indicated severe difficulty in all areas.
Improved Sexual Functioning as Measured by Arizona Sexual Experiences Questionnaire (ASEX) - Females End of Study (Week 12) To determine whether MM120 (25, 50, 100, or 200 µg freebase-equivalent) improves functionality and quality of life measures in female subjects with anxiety symptoms, including improvements in sexual function measured via the ASEX. The Arizona Sexual Experiences Questionnaire (ASEX) is a 5-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm over the past week. Possible total scores on the ASEX range of 5-30, with a higher score indicating more sexual dysfunction.
Improved Sexual Functioning as Measured by Arizona Sexual Experiences Questionnaire (ASEX) - Males End of Study (Week 12) To determine whether MM120 (25, 50, 100, or 200 µg freebase-equivalent) improves functionality and quality of life measures in male subjects with anxiety symptoms, including improvements in sexual function measured via the ASEX. The Arizona Sexual Experiences Questionnaire (ASEX) is a 5-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm over the past week. Possible total scores on the ASEX range of 5-30, with a higher score indicating more sexual dysfunction.
Summary of Sexual Dysfunction Rates (ASEX), Females, to Week 1 Week 1 Number of Participants with sexual dysfunction n (%) vs Number of Participants without sexual dysfunction n (%). The Arizona Sexual Experiences Questionnaire (ASEX) is a 5-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm over the past week. Possible total scores on the ASEX range of 5-30, with a higher score indicating more sexual dysfunction.
Summary of Sexual Dysfunction Rates (ASEX), Females, to Week 2 Week 2 Number of Participants with sexual dysfunction n (%) vs Number of Participants without sexual dysfunction n (%). The Arizona Sexual Experiences Questionnaire (ASEX) is a 5-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm over the past week. Possible total scores on the ASEX range of 5-30, with a higher score indicating more sexual dysfunction.
Summary of Sexual Dysfunction Rates (ASEX), Females, to Week 4 Week 4 Number of Participants with sexual dysfunction n (%) vs Number of Participants without sexual dysfunction n (%). The Arizona Sexual Experiences Questionnaire (ASEX) is a 5-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm over the past week. Possible total scores on the ASEX range of 5-30, with a higher score indicating more sexual dysfunction.
Summary of Sexual Dysfunction Rates (ASEX), Females, to Week 8 Week 8 Number of Participants with sexual dysfunction n (%) vs. Number of Participants without sexual dysfunction n (%). The Arizona Sexual Experiences Questionnaire (ASEX) is a 5-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm over the past week. Possible total scores on the ASEX range of 5-30, with a higher score indicating more sexual dysfunction.
Summary of Sexual Dysfunction Rates (ASEX), Females, to Week 12 End of Study (Week 12) Number of Participants with sexual dysfunction n (%) vs. Number of Participants without sexual dysfunction n (%). The Arizona Sexual Experiences Questionnaire (ASEX) is a 5-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm over the past week. Possible total scores on the ASEX range of 5-30, with a higher score indicating more sexual dysfunction.
Summary of Sexual Dysfunction Rates (ASEX), Males, to Week 1 Week 1 Number of Participants with sexual dysfunction n (%) vs. Number of Participants without sexual dysfunction n (%). The Arizona Sexual Experiences Questionnaire (ASEX) is a 5-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm over the past week. Possible total scores on the ASEX range of 5-30, with a higher score indicating more sexual dysfunction.
Summary of Sexual Dysfunction Rates (ASEX), Males, to Week 2 Week 2 Number of Participants with sexual dysfunction n (%) vs. Number of Participants without sexual dysfunction n (%). The Arizona Sexual Experiences Questionnaire (ASEX) is a 5-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm over the past week. Possible total scores on the ASEX range of 5-30, with a higher score indicating more sexual dysfunction.
Summary of Sexual Dysfunction Rates (ASEX), Males, to Week 4 Week 4 Number of Participants with sexual dysfunction n (%) vs. Number of Participants without sexual dysfunction n (%). The Arizona Sexual Experiences Questionnaire (ASEX) is a 5-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm over the past week. Possible total scores on the ASEX range of 5-30, with a higher score indicating more sexual dysfunction.
Summary of Sexual Dysfunction Rates (ASEX), Males, to Week 8 Week 8 Number of Participants with sexual dysfunction n (%) vs. Number of Participants without sexual dysfunction n (%). The Arizona Sexual Experiences Questionnaire (ASEX) is a 5-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm over the past week. Possible total scores on the ASEX range of 5-30, with a higher score indicating more sexual dysfunction.
Summary of Sexual Dysfunction Rates (ASEX), Males, to Week 12 Week 12 Number of Participants with sexual dysfunction n (%) vs. Number of Participants without sexual dysfunction n (%). The Arizona Sexual Experiences Questionnaire (ASEX) is a 5-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm over the past week. Possible total scores on the ASEX range of 5-30, with a higher score indicating more sexual dysfunction.
Trial Locations
- Locations (20)
Irvine Center for Clinical Research
🇺🇸Irvine, California, United States
Lutheran Hospital - Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
iResearch Atlanta
🇺🇸Decatur, Georgia, United States
Great Lakes Clinical Trials
🇺🇸Chicago, Illinois, United States
Segal Trials
🇺🇸Lauderhill, Florida, United States
Cedar Clinical Research
🇺🇸Draper, Utah, United States
Sunstone Therapies
🇺🇸Rockville, Maryland, United States
Cedar Clinical Research - Murray
🇺🇸Murray, Utah, United States
GMI - Princeton Medical Institute
🇺🇸Princeton, New Jersey, United States
Hassman Research Institute
🇺🇸Berlin, New Jersey, United States
Pacific Neuroscience Institute
🇺🇸Santa Monica, California, United States
Kadima Neuropsychiatry Institute
🇺🇸La Jolla, California, United States
Uptown Research
🇺🇸Chicago, Illinois, United States
University of Texas Health Houston
🇺🇸Houston, Texas, United States
Wholeness Center
🇺🇸Fort Collins, Colorado, United States
Mountain View Clinical Research
🇺🇸Denver, Colorado, United States
Woodstock Research Center
🇺🇸Woodstock, Vermont, United States
Preferred Research Partners
🇺🇸Little Rock, Arkansas, United States
CNS Healthcare - Orlando
🇺🇸Orlando, Florida, United States
BioBehavioral Research of Austin
🇺🇸Austin, Texas, United States