Melatonin Versus Placebo for Bipolar Disorder - a Double Blinded Randomised Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Mood stabilization
研究概览
简要总结
The objective with this study is to conduct a 6-month RCT comparing effects of add-on melatonin versus add-on placebo on mood stabilisation and other critical patient outcomes in patients with BD and to test whether principal effects are antimanic, antidepressant and/or prophylactic against relapse
详细描述
Sleep abnormalities are common in all phases of bipolar disorder (BD) and constitute core symptoms of both depression and mania also during remitted phases and despite treatment.
Melatonin is a key circadian hormone, that expresses a robust circadian rhythm and acts as an important endogenous modulator of the circadian timing system of sleep and may thus improve sleep and stabilize BD per se. Nevertheless, sleep in general and melatonin specifically is critically understudied in BD reflecting a central key knowledge gap within psychiatry. The investigators want in a 6-month randomized placebo-controlled trial (RCT) to compare effects of add on melatonin versus add on placebo on mood stabilisation and other critical patient outcomes in patients with BD.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Bipolar disorder with diagnosis confirmed by SCAN interview
- •Age 18 - 70 years
- •The participants must be able to read and understand the participant information in their native language and consent (English and Danish)
- •Habile (i.e able to give informed consent)
排除标准
- •Past intolerance to melatonin (allergic reactions)
- •Impaired renal or hepatic function (defined by GFR <60 ml/min and/or ALAT over allowed reference value)
- •Women who are pregnant, breastfeeding or planning pregnancy in near future.
研究组 & 干预措施
Placebo
100 BD patients will receive placebo. Patients, clinicians and researchers will be blinded.
干预措施: Placebo (Drug)
Melatonin
100 BD patients will receive 6 mg melatonin every evening. Patients, clinicians and researchers will be blinded.
干预措施: Melatonin (Drug)
结局指标
主要结局
Mood stabilization
时间窗: 6 months
Mood stabilization will be measured by a mood instability score reflecting the daily variability in self-monitored mood collected via the Monsenso system. Patients score their daily mood on a 9-point scale (-3 to +3); scores between -0.5 to 0.5 reflect normal variations, whereas scores of +1, +2 or +3 correspond to mildly, moderately, and severely increased mood and scores of -1, -2 or -3 correspond to mildly, moderately, and severely decreased mood. According to our established methodology, for each participant, we will estimate a mood instability score. Estimates of instability will be based on reading obtained via the Monsenso system which will prompt patients to complete daily mood ratings.
次要结局
- Sleep(6 months)
- Depression(Changes between baseline, 3 months and 6 months)
研究者
Lars Vedel Kessing
Professor
University Hospital Bispebjerg and Frederiksberg