NCT06062953招募中2 期
Efficacy of Melatonin, Low-dose Quetiapine, or Placebo in Patients With Psychiatric Disorders and Comorbid Insomnia: a Randomized Clinical Trial
Lone Baandrup1 个研究点 分布在 1 个国家目标入组 255 人开始时间: 2023年9月18日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 255
- 试验地点
- 1
- 主要终点
- Insomnia severity
研究概览
简要总结
The goal of this investigator-initiated, randomized, blinded, 3-armed placebo-controlled, pragmatic, clinical superiority trial is to examine the efficacy of melatonin or low-dose quetiapine versus placebo for treatment of insomnia in patients with psychiatric disorders. The aims of the study are:
- To examine the efficacy of melatonin or low-dose quetiapine versus placebo for treatment of insomnia
- To examine how melatonin or low-dose quetiapine affects global symptom severity, sleep quality, psychosocial functioning and subjective well-being.
Participants will receive six weeks of treatment with either melatonin, quetiapine or placebo followed by a brief taper off.
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
- 16 Years 至 64 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •16 to 64 years of age
- •ICD-10 diagnosis of a current or previous mental or behavioral disorder (F20-F69, F84, F90-95)
- •For the diagnoses F84 and F90 a previous period of treatment with melatonin is required
- •For the 16-17 years old: Non-pharmacological treatment options including sleep hygiene education, weighted blanket or other gravity products have been tested with insufficient effect
- •Self-reported sleep difficulties at least three times per week in the preceding 3 months
- •Insomnia Severity Index score ≥11
- •Women of childbearing potential: negative pregnancy test at baseline and use of highly effective contraception measures
- •Informed consent
排除标准
- •Current treatment with melatonin or quetiapine
- •Severe somatic comorbidity
- •BMI ≥ 35 kg/m2
- •Breastfeeding
- •Alcohol and/or substance dependency within the last 3 months
- •Inadequate Danish language skills
- •Not able to make an informed consent
- •Increased cardiac risk as assessed by presence of cardiac risk factors, cardiac symptoms, or prolonged QT-interval at baseline ECG
研究组 & 干预措施
Melatonin
Experimental
干预措施: Melatonin (Drug)
Quetiapine
Experimental
干预措施: Quetiapine (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Insomnia severity
时间窗: 6 weeks
Insomnia Severity Index, range 0-28, higher is worse
次要结局
- Clinical global impression (CGI)(6 weeks)
- Patient-reported subjective well-being(6 weeks)
- Subjective sleep quality(6 weeks)
- Psychosocial functioning(6 weeks)
研究者
Lone Baandrup
Sponsor-investigator
University of Copenhagen
研究点 (1)
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