Combination Therapy in Bipolar Rapid Cycling
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 49
- 主要终点
- The Proportion of Patients Who Experience a Marked and Persistent Bimodal Response
研究概览
简要总结
This study will compare triple and double drug regimens in the treatment of patients with depression, hypomania, or mania.
详细描述
Early studies have shown lithium to produce a high percentage of satisfactory clinical response in patients with bipolar disorders. These studies, however, do not include lithium-refractory subgroups, such as bipolar II disorder patients. When the wide spectrum of bipolar disorders is considered, the lithium response rate decreases significantly. More broadly effective regimens are needed.
Participants in this study will be randomly assigned to receive either lithium plus divalproex or lithium, divalproex, and lamotrigine for 7 months. Symptoms of depression and mania will be assessed with scales and patient questionnaires.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Bipolar I or II Disorder
- •Meet criteria for rapid cycling, defined as four or more episodes over the past 12 months
- •Meet criteria for a major depressive episode
排除标准
- •History of intolerability of lithium, divalproex, or lamotrigine
研究组 & 干预措施
Lithium + divalproex + lamotrigine
干预措施: Lithium (Drug)
Lithium + divalproex + lamotrigine
干预措施: Lamotrigine (Drug)
Lithium + divalproex + lamotrigine
干预措施: Divalproex (Drug)
Lithium + divalproex + placebo
干预措施: Lithium (Drug)
Lithium + divalproex + placebo
干预措施: Divalproex (Drug)
Lithium + divalproex + placebo
干预措施: Placebo (Drug)
结局指标
主要结局
The Proportion of Patients Who Experience a Marked and Persistent Bimodal Response
时间窗: Baseline and Week 28
A marked bimodal response is defined by the following three conditions over four consecutive weeks while on triple therapy and after three weeks of ltg: 1. Montgomery Asberg Depression Rating Scale (MADRS) total score of \<= 19 2. Young Mania Rating Scale (YMRS) total score of \<= 12.5 3. Global Assessment Scale (GAS) score \>= 51 The MADRS measures the severity of a subject's depression symptoms with a possible total score ranging from 0 - 60, with higher scores indicating more severe depression. The YMRS measures the severity of a subject's manic symptoms with a possible total score ranging from 0 - 60, with higher scores indicating more severe mania. The GAS measures a used to rate subjectively the social, occupational, and psychological functioning of a subject and ranges in score from 0-100, with a higher score indicating better social, occupational, and psychological functioning.
次要结局
未报告次要终点
研究者
Keming Gao
Director, Mood and Anxiety Clinic
University Hospitals Cleveland Medical Center