Acute Treatment of Bipolar II Depression
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Change in depression symptoms, as measured by the Hamilton Rating Scale for Depression
研究概览
简要总结
This study will compare the medications lithium and lamotrigine (Lamictal®) in treating depression in individuals with bipolar II disorder.
详细描述
Bipolar II disorder (BDII) is a serious condition characterized by depressive and hypomanic episodes. The disability and suicide risk associated with BDII is equal to bipolar I disorder. However, there are no clinical trials for BDII, nor is the treatment of BDII addressed in current treatment guidelines. Data suggest that Li and LTG may be effective treatment options for BDII. This study will determine the safety, effectiveness, and tolerability of the two drugs in people with BDII.
Participants in this study will be randomly assigned to receive either Li or LTG for 16 weeks. Participants will be assessed every 2 weeks. One week after study completion, participants will have a follow-up visit. Measures of depression, mania, quality of life, functioning, and participant satisfaction will be taken.
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
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Current diagnosis of bipolar II disorder
排除标准
- •Use of lithium or lamotrigine
- •Intolerance to lithium or lamotrigine
- •Substance abuse or dependence within the last month
- •Suicidal thoughts
- •Unstable medical conditions
- •Pregnancy or breast-feeding
- •Stable on current medications
- •Use of fluoxetine (Prozac) within 2 weeks of study
- •Require an antipsychotic medication
- •Do not speak or read English
研究组 & 干预措施
1 Lithium
干预措施: Lithium (Drug)
2 Lamotrigine
干预措施: Lamotrigine (Drug)
结局指标
主要结局
Change in depression symptoms, as measured by the Hamilton Rating Scale for Depression
时间窗: Measured at baseline and Week 16
次要结局
- Incidence and severity of hypomanic and depressive symptoms(Measured at baseline and Week 16)
- Medication tolerability, response (defined as a 50% reduction on the Ham-D), and remission (defined as Ham-D or MADRS score less than 12)(Measured at baseline and Week 16)
- Switch into hypomania, defined as a CGI-BP Mania severity score of 4 or greater(Measured at baseline and Week 16)