A Phase 2, Multi-center, Randomized, Double-Blind, Parallel-Group, Dose-Finding Study to Assess the Effect of Four Doses of MM-120 (LSD D-Tartrate) for the Treatment of Anxiety Symptoms
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 198
- 试验地点
- 22
- 主要终点
- Dose Response
研究概览
简要总结
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).
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Arm 1- Placebo
A substance that is designed to have no therapeutic value.
干预措施: Placebo (Other)
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).
干预措施: MM-120 (LSD D-Tartrate) (Drug)
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).
干预措施: MM-120 (LSD D-Tartrate) (Drug)
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).
干预措施: MM-120 (LSD D-Tartrate) (Drug)
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).
干预措施: MM-120 (LSD D-Tartrate) (Drug)
结局指标
主要结局
Dose Response
时间窗: 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.
次要结局
- Dose Response(8 weeks)
- Change From Baseline in HAM-A Total Score(4 weeks)
- Change From Baseline in HAM-A Total Scores(12 weeks)
- Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Scores(End of Study (Week 12))
- Change From Baseline in Clinical Global Impression - Severity (CGI-S) Total Scores(End of Study (12 weeks))
- Mean Clinical Global Impression - Improvement (CGI-I) Total Scores(End of Study (Week 12))
- Change From Baseline in Patient Global Impression - Severity (PGI-S) Total Scores(End of study (Week 12))
- Mean Patient Global Impression - Change (PGI-C) Total Scores(Week 8)
- Change From Baseline in Patient Global Impression - Change (PGI-C) Total Scores(End of Study (Week 12))
- Change From Baseline in Sheehan Disability Scale (SDS) Total Scores(End of Study (Week 12))
- Improved Quality of Life as Measured by EuroQol 5 Dimension 5 Level (EQ-5D-5L) Visual Analog Scale (VAS)(End of Study (12 weeks))
- Improved Sleep as Measured by Pittsburgh Sleep Quality Index (PSQI)(End of Study (Week 12))
- Improved Sexual Functioning as Measured by Arizona Sexual Experiences Questionnaire (ASEX) - Females(End of Study (Week 12))
- Improved Sexual Functioning as Measured by Arizona Sexual Experiences Questionnaire (ASEX) - Males(End of Study (Week 12))
- Summary of Sexual Dysfunction Rates (ASEX), Females, to Week 1(Week 1)
- Summary of Sexual Dysfunction Rates (ASEX), Females, to Week 2(Week 2)
- Summary of Sexual Dysfunction Rates (ASEX), Females, to Week 4(Week 4)
- Summary of Sexual Dysfunction Rates (ASEX), Females, to Week 8(Week 8)
- Summary of Sexual Dysfunction Rates (ASEX), Females, to Week 12(End of Study (Week 12))
- Summary of Sexual Dysfunction Rates (ASEX), Males, to Week 1(Week 1)
- Summary of Sexual Dysfunction Rates (ASEX), Males, to Week 2(Week 2)
- Summary of Sexual Dysfunction Rates (ASEX), Males, to Week 4(Week 4)
- Summary of Sexual Dysfunction Rates (ASEX), Males, to Week 8(Week 8)
- Summary of Sexual Dysfunction Rates (ASEX), Males, to Week 12(Week 12)