Safety and Efficacy of Repeated Low Dose d-Lysergic Acid Diethylamide (LSD) D-tartrate (MM-120) as Treatment for ADHD in Adults: a Multi-center, Randomized, Double-blind, Placebo-controlled Phase 2a Proof of Concept Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- Change in Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Symptoms
研究概览
简要总结
This study measures the safety and efficacy of repeated low dose MM-120 as treatment for ADHD in adults: a multi-center, randomized, double-blind, placebo-controlled
详细描述
This study is a multi-center, randomized, double-blind, placebo-controlled Phase 2a study of low dose MM-120 (20 μg) compared with a placebo administered for 6 weeks (twice a week on a 3/4-day schedule).
Low dose MM-120 (20 μg) is about 20% of the dose typically consumed for recreational psychedelic purposes.
There will be a 1:1 randomization, double-blind, to MM-120 or placebo with the aim to reach 26 evaluable patients in each of the 2 arms at Week 6.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female outpatients ≥ 18 and ≤ 65 years of age at Screening
- •Patients with the diagnosis of Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) ADHD, as determined by clinical evaluation and confirmed by structured interview (MINI).
- •Adequate organ function.
- •Able to understand the study procedures and understand risks associated with the study, and sign written informed consent to participate in the study.
- •Must be willing to refrain from more than 6 standard alcoholic drinks a week, more than 10 cigarettes a day, and more than 2 cups of coffee a day throughout the study treatment period (6 weeks) and until the last study visit is complete.
排除标准
- •Past or present diagnosis of a primary psychotic disorder or first degree relative with a psychotic disorder.
- •Past or present bipolar disorder (DSM-5).
- •Any lifetime history of suicide attempt.
- •Once Informed Consent form is signed, not willing or able to stop any prescription or non-prescription ADHD medications.
- •Use of investigational medication/treatment in the past 30 days.
- •Patients with a positive urine drug screen with the exception of THC or its metabolites.
- •Pregnant or nursing females.
研究组 & 干预措施
Arm 1- Placebo
A total of 26 patients will receive a placebo identical in appearance to the investigational medicinal product (IMP) administered orally twice weekly (e.g., Tuesday/Friday) for 6 weeks.
干预措施: Placebo (Other)
Arm 2- MM-120
A total of 26 patients will receive 20 μg of MM-120 administered orally twice weekly for 6 weeks.
干预措施: MM-120 (Drug)
结局指标
主要结局
Change in Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Symptoms
时间窗: 6 weeks
The Adult ADHD investigator symptom rating scale (AISRS) total score consists of 18 items from the original Attention-deficit/hyperactivity Disorder Rating Scale (ADHD-RS). The ADHD-RS includes 9 items that address symptoms of inattention, and 9 items that address symptoms of impulsivity and hyperactivity. Each item is rated from 0 to 3. The AISRS total score can range from 0 to 54. A higher score corresponds to a worse severity of ADHD.
次要结局
- Changes in Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Investigator Symptom Rating Scale (AISRS) Symptoms(Week 2)
- Number of Patients Who Experience a Decrease in the Clinical Global Impressions Scale (CGI-S)(Baseline, Week 2, Week 6, Week 10)
- Adult Attention-deficit/Hyperactivity Disorder Self-reporting Rating Scale (ASRS)(6 weeks)
- Mystical Experience Questionnaire 30 Items (MEQ30)(6 weeks)
- Summary of Drug Effects Visual Analog Scale (VAS)(6 hours)
- Change From Baseline in in Clinical Global Impressions Scale (CGI-S)(Baseline, Week 2, Week 6)
- Change From Baseline in Connors' Adult ADHD Rating Scale (CAARS)(6 weeks)
- 5 Dimensions of Altered States of Consciousness Questionnaire (5D-ASC) Scores(6 weeks)