NCT00566150已完成不适用
Levetiracetam in the Management of Bipolar Depression
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Change in Hamilton Depression Rating Scale (HDRS-21) Total Score From Baseline at Week 6.
研究概览
简要总结
A 6-week outpatient, double-blind, placebo-controlled, add-on trial to investigate the effects of levetiracetam on depressive symptoms in bipolar depressed patients.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DSM-IV diagnosis of bipolar disorder
- •Presence of a current major depressive episode on the SCID
- •Score of 17 or great on the HDRS
- •Capable of giving voluntary written consent
排除标准
- •Significant current substance dependence/abuse within 3 months preceding the trial
- •Active suicidal ideation
- •Pregnant/lactating mothers
- •Significant medical history
研究组 & 干预措施
Levetiracetam
Active Comparator
干预措施: Levetiracetam (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Hamilton Depression Rating Scale (HDRS-21) Total Score From Baseline at Week 6.
时间窗: Baseline to week 6
Change is observed value at each visit minus baseline value. HDRS-21 is a 21-item instrument measuring depression. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 60.
次要结局
- Number of Subjects Who Achieve Remission.(Week 6)
- Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline at Week 6.(Baseline to week 6)
- Change in Clinical Global Impressions Scale for Bipolar Disorder (CGI-BP) Depression Severity Rating From Baseline at Week 6.(Baseline to week 6)
研究者
研究点 (1)
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