Efficacy of melatonin, low-dose quetiapine, or placebo in patients with psychiatric disorders and comorbid insomnia: a randomized clinical trial

Region Hovedstadens Psykiatriske0 个研究点目标入组 255 人开始时间: 2023年4月28日最近更新: 2024年8月21日

适应症

试验速览

暂无简介。

•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

•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

发起方

Region Hovedstadens Psykiatriske