Lithium Versus Lamotrigine in Bipolar Disorder, Type II - a Single Blinded Randomized Controlled Trial (the LiLa-Bipolar RCT)
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
研究概览
简要总结
The investigators want in a 6-month randomized controlled trial (RCT) to compare effects of lithium versus lamotrigine on mood stabilization and other critical patient outcomes in patients with BDII.
详细描述
Although BDII is more prevalent and with a higher disease burden, including more and longer depressive episodes and lower functioning, than bipolar disorder, type I (BDI), effects of pharmacological treatment including the most frequently used drugs in clinical practice lithium and lamotrigine, is substantially understudied. The investigators want in a 6-month randomized controlled trial (RCT) to compare effects of lithium versus lamotrigine on mood stabilization and other critical patient outcomes in patients with BDII.
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
- Single (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, type II with diagnosis confirmed by SCAN interview
- •Age 18-70 years
- •Habile (i.e., able to give informed consent)
排除标准
- •Past non-response or intolerance to lamotrigine or lithium with > 6 weeks treatment at an adequate dosage
- •Currently taking mood stabilizers at enrollment in CADIC
- •Severe chronic kidney disease
- •Severe cardiac insufficiency
- •Brugadas syndrome
- •Severe hypothyroidism despite treatment
- •Women who are pregnant, breastfeeding or planning pregnancy in near future.
研究组 & 干预措施
Lithium
tablet
干预措施: Lithium Carbonate (Drug)
Lamotrigine
tablet
干预措施: Lamotrigine (Drug)
结局指标
主要结局
Mood stabilization
时间窗: 6 (possibility of 12) months follow-up
Mood Stabilization will be measured by a mood instability score reflecting the daily variability in self-monitored mood collected via the Monsenso app. 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
- Non-response(6 (possibility of 12) months follow-up)
- Depression(6 months)
研究者
Lars Vedel Kessing
professor, MD, DMSc.
University Hospital Bispebjerg and Frederiksberg