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临床试验/NCT00183469
NCT00183469已完成4 期

Eight-Month Maintenance Treatment of Bipolar Depression With Lamotrigine or Lamotrigine Plus Divalproex Combination

The University of Texas Health Science Center at San Antonio0 个研究点目标入组 86 人开始时间: 2004年12月最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

Participants will take active lamotrigine and active divalproex ER

干预措施: Lamotrigine (Drug)

lamotrigine plus divalproex ER

Active Comparator

Participants will take active lamotrigine and active divalproex ER

干预措施: Divalproex (DIV) ER (Drug)

lamotrigine plus placebo divalproex ER

Placebo Comparator

Participants will take active lamotrigine and placebo

干预措施: Lamotrigine (Drug)

lamotrigine plus placebo divalproex ER

Placebo Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Charles L. Bowden

Professor

The University of Texas Health Science Center at San Antonio

相似试验

Maintenance Treatment of Bipolar Depression | 临床试验