Mood Effects of Serotonin Agonists
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Change From Baseline in Profile of Mood States (POMS)
研究概览
简要总结
The purpose of this study is to determine the effects of very low doses of serotonergic agonists on depressed mood in human volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •English fluency
- •High school level education
- •BMI between 19 and 30
排除标准
- •Diagnosed medical condition
- •women who are nursing, pregnant, or plan to become pregnant within 3 months
- •History of psychotic disorder or family history of psychotic disorder
研究组 & 干预措施
Placebo
Placebo
干预措施: Lysergic Acid Diethylamide (Drug)
low dose MDMA
6.5ug dose of serotonin agonist
干预措施: Lysergic Acid Diethylamide (Drug)
medium dose
13ug dose of serotonin agonist
干预措施: Lysergic Acid Diethylamide (Drug)
high dose
26ug dose of serotonin agonist
干预措施: Lysergic Acid Diethylamide (Drug)
结局指标
主要结局
Change From Baseline in Profile of Mood States (POMS)
时间窗: End of study (Baseline - time 0 and approximately 8 weeks later)
The POMS measures individuals' mood states. This is a validated scale to measure positive and negative mood states. The POMS contains 30 items and assesses six identified mood factors: Tension-Anxiety, Depression-Ejection, Anger- Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment. Scoring of the instrument provides a global score of 0 to 120 or individual domain scores. Lower scores indicate better mood state. The POMS brief form is a simple self-rating instrument.
次要结局
未报告次要终点