2023-504728-24-00招募中3 期
Efficacy of melatonin, low-dose quetiapine, or placebo in patients with psychiatric disorders and comorbid insomnia: a randomized clinical trial
Region Hovedstadens Psykiatriske, Psykiatrisk Center Kobenhavn1 个研究点 分布在 1 个国家目标入组 255 人开始时间: 2023年7月31日最近更新:
试验速览
- 阶段
- 3 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 using the Insomnia Severity Index (ISI)
研究概览
简要总结
The objective of the trial is to examine the efficacy of melatonin versus low-dose quetiapine versus placebo as augmentation to treatment as usual in patients with psychiatric disorders and comorbid chronic insomnia.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •18 to 64 years of age
- •ICD-10 diagnosis of a current or previous mental or behavioral disorder (F20-F69, F84, F90-F95)
- •For the diagnoses F84 and F90 a previous period of treatment with melatonin is required
- •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 (F1X.2) 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
结局指标
主要结局
Insomnia severity using the Insomnia Severity Index (ISI)
Insomnia severity using the Insomnia Severity Index (ISI)
次要结局
- Clinical global impression (CGI)
- Subjective sleep quality using the Pittsburgh Sleep Quality Index (PSQI)
- Psychosocial functioning using the Personal and Social Performance Scale (PSP)
- Patient-reported subjective well-being using the WHO-5 well-being index
研究者
Lone Baandrup
Scientific
Region Hovedstadens Psykiatriske
研究点 (1)
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