A Dose-Finding Study of MM120 (LSD D-Tartrate) for the Treatment of Anxiety Symptoms

A Phase 2, Multi-center, Randomized, Double-Blind, Parallel-Group, Dose-Finding Study to Assess the Effect of Four Doses of MM120 (LSD D-Tartrate) for the Treatment of Anxiety Symptoms

This is a Phase 2, multi-center, randomized, double-blind, parallel-group, dose-finding study to assess the effect of 4 doses of MM120 (25, 50, 100 or 200 μg freebase-equivalent) for the treatment of anxiety symptoms in subjects diagnosed with generalized anxiety disorder (GAD).

Study Overview

• Status: Completed
• Conditions: Anxiety Generalized
• Intervention / Treatment: Other: Placebo; Drug: MM120

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).

• Study Type: Interventional
• Enrollment (Actual): 198
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Preferred Research Partners
  • California
    • Irvine, California, United States, 92614
      • Irvine Center for Clinical Research
    • La Jolla, California, United States, 92037
      • Kadima Neuropsychiatry Institute
    • Santa Monica, California, United States, 90404
      • Pacific Neuroscience Institute
  • Colorado
    • Denver, Colorado, United States, 80209
      • Mountain View Clinical Research
    • Fort Collins, Colorado, United States, 80525
      • Wholeness Center
  • Florida
    • Lauderhill, Florida, United States, 33319
      • Segal Trials
    • Orlando, Florida, United States, 32801
      • CNS Healthcare - Orlando
  • Georgia
    • Decatur, Georgia, United States, 30030
      • iResearch Atlanta
  • Illinois
    • Chicago, Illinois, United States, 60640
      • Great Lakes Clinical Trials
    • Chicago, Illinois, United States, 60640
      • Uptown Research
  • Maryland
    • Rockville, Maryland, United States, 20850
      • Sunstone Therapies
  • Massachusetts
    • Springfield, Massachusetts, United States, 01103
      • SISU
    • Watertown, Massachusetts, United States, 02472
      • Adams Clinical
  • New Jersey
    • Berlin, New Jersey, United States, 08009
      • Hassman Research Institute
    • Princeton, New Jersey, United States, 08540
      • GMI - Princeton Medical Institute
  • Ohio
    • Cleveland, Ohio, United States, 44113
      • Lutheran Hospital - Cleveland Clinic
  • Texas
    • Austin, Texas, United States, 78759
      • BioBehavioral Research of Austin
    • Houston, Texas, United States, 77054
      • University of Texas Health Houston
  • Utah
    • Draper, Utah, United States, 84020
      • Cedar Clinical Research
    • Murray, Utah, United States, 84107
      • Cedar Clinical Research - Murray
  • Vermont
    • Woodstock, Vermont, United States, 05091
      • Woodstock Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 MM120; A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A).	Drug: MM120; A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A).; Other Names: MM-120; DT120; lysergide tartrate
Experimental: Arm 3- 50 μg MM120; A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A).	Drug: MM120; A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A).; Other Names: MM-120; DT120; lysergide tartrate
Experimental: Arm 4- 100 μg MM120; A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A).	Drug: MM120; A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A).; Other Names: MM-120; DT120; lysergide tartrate
Experimental: Arm 5- 200 μg MM120; A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A).	Drug: MM120; A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A).; Other Names: MM-120; DT120; lysergide tartrate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dose Response	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.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dose Response	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.	8 weeks
Change From Baseline in HAM-A Total Score	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	4 weeks
Change From Baseline in HAM-A Total Scores	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 Week 8. 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 8	8 weeks
Change From Baseline in HAM-A Total Scores	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)	12 weeks
Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Scores	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 as measured by 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.	Week 1
Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Scores	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.	Week 2
Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Scores	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.	Week 4
Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Scores	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.	Week 8
Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Scores	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.	End of Study (Week 12)
Change From Baseline in Clinical Global Impression - Severity (CGI-S) Total Scores	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)	Week 1
Change From Baseline in Clinical Global Impression - Severity (CGI-S) Total Scores	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)	Week 2
Change From Baseline in Clinical Global Impression - Severity (CGI-S) Total Scores	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)	Week 4
Change From Baseline in Clinical Global Impression - Severity (CGI-S) Total Scores	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)	Week 8
Change From Baseline in Clinical Global Impression - Severity (CGI-S) Total Scores	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)	End of Study (12 weeks)
Mean Clinical Global Impression - Improvement (CGI-I) Total Scores	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)	Week 1
Mean Clinical Global Impression - Improvement (CGI-I) Total Scores	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)	Week 2
Mean Clinical Global Impression - Improvement (CGI-I) Total Scores	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)	Week 4
Mean Clinical Global Impression - Improvement (CGI-I) Total Scores	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).	Week 8
Mean Clinical Global Impression - Improvement (CGI-I) Total Scores	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)	End of Study (Week 12)
Change From Baseline in Patient Global Impression - Severity (PGI-S) Total Scores	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)	Week 1
Change From Baseline in Patient Global Impression - Severity (PGI-S) Total Scores	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)	Week 2
Change From Baseline in Patient Global Impression - Severity (PGI-S) Total Scores	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)	Week 4
Change From Baseline in Patient Global Impression - Severity (PGI-S) Total Scores	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)	Week 8
Change From Baseline in Patient Global Impression - Severity (PGI-S) Total Scores	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)	End of study (Week 12)
Mean Patient Global Impression - Change (PGI-C) Total Scores	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)	Week 1
Mean Patient Global Impression - Change (PGI-C) Total Scores	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)	Week 2
Mean Patient Global Impression - Change (PGI-C) Total Scores	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)	Week 4
Mean Patient Global Impression - Change (PGI-C) Total Scores	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)	Week 8
Change From Baseline in Patient Global Impression - Change (PGI-C) Total Scores	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)	End of Study (Week 12)
Change From Baseline in Sheehan Disability Scale (SDS) Total Scores	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).	Week 1
Change From Baseline in Sheehan Disability Scale (SDS) Total Scores	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).	Week 2
Change From Baseline in Sheehan Disability Scale (SDS) Total Scores	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).	Week 4
Change From Baseline in Sheehan Disability Scale (SDS) Total Scores	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).	Week 8
Change From Baseline in Sheehan Disability Scale (SDS) Total Scores	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).	End of Study (Week 12)
Improved Quality of Life as Measured by EuroQol 5 Dimension 5 Level (EQ-5D-5L) Visual Analog Scale (VAS)	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.	Week 1
Improved Quality of Life as Measured by EuroQol 5 Dimension 5 Level (EQ-5D-5L) Visual Analog Scale (VAS)	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.	Week 2
Improved Quality of Life as Measured by EuroQol 5 Dimension 5 Level (EQ-5D-5L) Visual Analog Scale (VAS)	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.	Week 4
Improved Quality of Life as Measured by EuroQol 5 Dimension 5 Level (EQ-5D-5L) Visual Analog Scale (VAS)	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.	Week 8
Improved Quality of Life as Measured by EuroQol 5 Dimension 5 Level (EQ-5D-5L) Visual Analog Scale (VAS)	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.	End of Study (12 weeks)
Improved Sleep as Measured by Pittsburgh Sleep Quality Index (PSQI)	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.	Week 4
Improved Sleep as Measured by Pittsburgh Sleep Quality Index (PSQI)	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.	Week 8
Improved Sleep as Measured by Pittsburgh Sleep Quality Index (PSQI)	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.	End of Study (Week 12)
Improved Sexual Functioning as Measured by Arizona Sexual Experiences Questionnaire (ASEX) - Females	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.	Week 1
Improved Sexual Functioning as Measured by Arizona Sexual Experiences Questionnaire (ASEX) - Females	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.	Week 2
Improved Sexual Functioning as Measured by Arizona Sexual Experiences Questionnaire (ASEX) - Females	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.	Week 4
Improved Sexual Functioning as Measured by Arizona Sexual Experiences Questionnaire (ASEX) - Females	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.	Week 8
Improved Sexual Functioning as Measured by Arizona Sexual Experiences Questionnaire (ASEX) - Females	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.	End of Study (Week 12)
Improved Sexual Functioning as Measured by Arizona Sexual Experiences Questionnaire (ASEX) - Males	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.	Week 1
Improved Sexual Functioning as Measured by Arizona Sexual Experiences Questionnaire (ASEX) - Males	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.	Week 2
Improved Sexual Functioning as Measured by Arizona Sexual Experiences Questionnaire (ASEX) - Males	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.	Week 4
Improved Sexual Functioning as Measured by Arizona Sexual Experiences Questionnaire (ASEX) - Males	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.	Week 8
Improved Sexual Functioning as Measured by Arizona Sexual Experiences Questionnaire (ASEX) - Males	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.	End of Study (Week 12)
Summary of Sexual Dysfunction Rates (ASEX), Females, to 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.	Week 1
Summary of Sexual Dysfunction Rates (ASEX), Females, to 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.	Week 2
Summary of Sexual Dysfunction Rates (ASEX), Females, to 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.	Week 4
Summary of Sexual Dysfunction Rates (ASEX), Females, to 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.	Week 8
Summary of Sexual Dysfunction Rates (ASEX), Females, to 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.	End of Study (Week 12)
Summary of Sexual Dysfunction Rates (ASEX), Males, to 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.	Week 1
Summary of Sexual Dysfunction Rates (ASEX), Males, to 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.	Week 2
Summary of Sexual Dysfunction Rates (ASEX), Males, to 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.	Week 4
Summary of Sexual Dysfunction Rates (ASEX), Males, to 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.	Week 8
Summary of Sexual Dysfunction Rates (ASEX), Males, to 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.	Week 12

Collaborators and Investigators

• Sponsor: Definium Therapeutics US, Inc.

Publications and helpful links

General Publications

• Robison R, Barrow R, Conant C, Foster E, Freedman JM, Jacobsen PL, Jemison J, Karas SM, Karlin DR, Solomon TM, Halperin Wernli M, Fava M. Single Treatment With MM120 (Lysergide) in Generalized Anxiety Disorder: A Randomized Clinical Trial. JAMA. 2025 Oct 21;334(15):1358-1372. doi: 10.1001/jama.2025.13481.

Study record dates

Study Major Dates

• Study Start (Actual): August 24, 2022
• Primary Completion (Actual): October 6, 2023
• Study Completion (Actual): November 27, 2023

Study Registration Dates

• First Submitted: May 27, 2022
• First Submitted That Met QC Criteria: June 1, 2022
• First Posted (Actual): June 7, 2022

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 9, 2026
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Generalized Anxiety Disorder; Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs
• Other Study ID Numbers: MMED008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No