2025-523549-92-00招募中4 期
Melatonin versus placebo for bipolar disorder - a double blinded randomised controlled trial (The M-bipolar RCT)
Region Hovedstaden1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2026年1月16日最近更新:
适应症
试验速览
- 阶段
- 4 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 will be measured by a mood instability score reflecting the daily variability in self-monitored mood collected via the Monsenso system
研究概览
简要总结
To conduct a 6-month RCT comparing effects of melatonin versus placebo on mood stabilisation and other critical patient outcomes in patients with bipolar disorder and to test whether principal effects are antimanic, antidepressant and/or prophylactic against relapse. Primary hypotheses: Add on melatonin improves mood stabilization compared with add on placebo.
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
- •Bipolar disorder with diagnosis confirmed by SCAN interview
- •Age 18-70 years
- •Speaks and writes danish or english at a level equal to mothers tongue
- •Habile (i.e., able to give informed consent)
排除标准
- •Past intolerance to melatonin
- •Impaired renal or hepatic function
- •Women who are pregnant, breastfeeding or planning pregnancy in near future
结局指标
主要结局
Mood stabilization will be measured by a mood instability score reflecting the daily variability in self-monitored mood collected via the Monsenso system
Mood stabilization will be measured by a mood instability score reflecting the daily variability in self-monitored mood collected via the Monsenso system
次要结局
- Hamilton D6, Pittsburgh Sleep Quality, Young Mania Rating Scale, Functioning Assessment Short Test (FAST), internet-based Cognition Assessment Tool (ICAT) and bloodbased inflammation markers in bloodsamples, hair cortisol and urine oxidative stress markers
研究者
Lars Vedel Kessing
Scientific
Region Hovedstaden
研究点 (1)
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