Eight-Month Maintenance Treatment of Bipolar Depression With Lamotrigine or Lamotrigine Plus Divalproex Combination
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 86
- 主要终点
- Mania Rating Scale
研究概览
简要总结
This study will compare two different antidepressant treatment regimens to determine which is more effective in reducing symptoms of bipolar depression.
详细描述
Depression is a serious condition that is often difficult to diagnosis and treat. Bipolar disorder-related depression is especially complex because of the presence of mania symptoms. Lamotrigine and divalproex are commonly prescribed medications for depression. However, their effectiveness in treating bipolar depression has not been thoroughly evaluated. Studies have shown that combining lamotrigine with another antidepressant may be more effective in reducing depressive symptoms than lamotrigine alone. This study will provide participants with either lamotrigine alone or in combination with divalproex and will determine which regimen is more effective in reducing symptoms of bipolar depression.
Participants will be randomly assigned to a daily regimen of either lamotrigine and divalproex or lamotrigine and placebo for 8 months. Participants will be assessed at study entry, at two unspecified times during the study, and at the end of the study. During each assessment, participants will undergo a brief interview and complete a questionnaire about their depressive symptoms, any physical manifestations of their depression, and their overall level of functioning in daily activities.
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 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of bipolar disorder I or II
- •Experiencing symptoms of depression at study entry OR have experienced symptoms of depression within 6 months prior to study entry
- •Willing to use acceptable methods of contraception
- •Parent or guardian willing to provide informed consent, if applicable
排除标准
- •History of liver disease
- •History of substance abuse
- •Previous treatment with lamotrigine or divalproex
- •Lamotrigine or divalproex intolerance
研究组 & 干预措施
lamotrigine plus divalproex ER
Participants will take active lamotrigine and active divalproex ER
干预措施: Lamotrigine (Drug)
lamotrigine plus divalproex ER
Participants will take active lamotrigine and active divalproex ER
干预措施: Divalproex (DIV) ER (Drug)
lamotrigine plus placebo divalproex ER
Participants will take active lamotrigine and placebo
干预措施: Lamotrigine (Drug)
lamotrigine plus placebo divalproex ER
Participants will take active lamotrigine and placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Mania Rating Scale
时间窗: up to 8 months
Severity of the illness and psychopathological features will be measured by the increase in the SADS Mania Rating Scale, with higher scores representing worse mania. The range of this scale is 0-75.
次要结局
未报告次要终点
研究者
Charles L. Bowden
Professor
The University of Texas Health Science Center at San Antonio
