LSD Therapy for Persons Suffering From Major Depression: A Randomised, Double-blind, Active-placebo Controlled Phase II Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in depressive symptoms assessed by questionnaire compared with active placebo
研究概览
简要总结
Background: Major Depressive Disorder is one of the most prevalent mental illnesses, leading to substantial personal distress and economical consequences. Pharmacological Treatment is limited and relapse is frequent.
Lysergic acid diethylamide (LSD) was extensively investigated in humans in the 1950s and 1960s and was shown to attenuate depressive symptoms. Clinical research with LSD ended in the 1970s due to regulatory restrictions but its use for personal and recreational purposes continued. In recent years, there has been a renewed interest in the use of hallucinogens in psychiatric research and practices, reconsidering LSD's antidepressant potential. Larger, well-designed and placebo-controlled studies are warranted. This study will evaluate the potential benefits of LSD-assisted psychotherapy in patients suffering from Major Depressive Disorder.
Objective: To test the efficacy of LSD in patients with Major Depressive Disorder.
Design: Randomised, double-blind, active-placebo-controlled trial using either two moderate to high doses of LSD (100 µg and 100 µg or 100 µg and 200 µg) as intervention and two low doses of LSD (25 µg and 25 µg) as active-placebo control.
Participants: 60 patients aged > 25 years with Major Depressive Disorder (according to DSM-V).
Main outcome measures: Change in depressive symptomatology (IDS, BDI), anxiety (STAI), and general psychopathology (SCL-90) compared with active-placebo-assisted psychotherapy.
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
- 25 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Major Depressive Disorder according to Diagnostic and Statistical Manual of Mental Disorders (DSM-V)
- •> 25 years
- •Sufficient understanding of the German language
排除标准
- •< 25 years
- •Concomitant diagnosis of past or present psychotic disorder
- •Concomitant diagnosis of past or present bipolar disorder
- •First degree relative with a psychotic disorder
- •Unable or unwilling to discontinue antidepressant medication
- •Pregnancy or breastfeeding
- •Known hypersensitivity to LSD
- •Somatic disorders including central nervous system (CNS) involvement
- •Known or suspected non-compliance, drug or alcohol abuse
- •Metal implants
- •Weight < 42 kg
- •Suicide risk or very likely to require psychiatric hospitalisation
研究组 & 干预措施
Treatment Arm
Subjects in the treatment arm will receive 100 μg LSD (first session) and 100 or 200 μg LSD (second session) per os.
干预措施: LSD (Drug)
Control Arm
Subjects in the control arm will receive 25 μg LSD (first session) and 25 μg LSD (second session) per os.
干预措施: LSD (Drug)
结局指标
主要结局
Change in depressive symptoms assessed by questionnaire compared with active placebo
时间窗: Baseline; 1 week before first intervention; 2 weeks after first intervention; 2, 6, and 12 weeks after LSD
Inventory of Depressive Symptomatology (IDS-SR, self-rated). Scores are obtained by summing responses to the items, with a total score ranging from 0 to 84 and higher scores indicating more and/or stronger depressive symptoms.
次要结局
未报告次要终点