NCT00191399已完成4 期
Bipolar Depression Assessment Study on Tx Response
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 11
- 主要终点
- MADRS is a rating scale for severity of depressive mood symptoms.
研究概览
简要总结
The primary objective of this study is to assess the efficacy of olanzapine and fluoxetine combined on all the visits as compared with the baseline visit in patients with bipolar disorder, measured by the total score of the Montgomery-Asberg Depression Rating Scale (MADRS).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet criteria for bipolar depression, in the opinion of the investigator, according to the Diagnostic and Statistical Manual of Mental Disorders [Text Revision] (DSM-IV-TR) disease diagnostic criteria.
- •Patients must have experienced, in the opinion of the investigator, at least one previous hypomanic, manic or mixed episode as defined in DSM-IV-TR.
- •Subjects must have an initial score at Visit 1 of at least 20 on the MADRS.
排除标准
- •Any patient currently meeting DSM-IV-TR criteria rapid-cycling course.
- •A CGI-Severity - Mania score of at least 3.
结局指标
主要结局
MADRS is a rating scale for severity of depressive mood symptoms.
次要结局
- Clinical Global Impression - Bipolar Version (CGI-BP) Severity - Depression is used by the clinician to record the severity of depression illness at the time of assessment
- CGI-BP Severity - Mania is used by the clinician to record the severity of mania illness at the time of assessment
- Short Form-12 (SF-12) Questionnaire was developed from the SF-36 Health Survey for use in monitoring outcomes for general and specific populations.
研究者
研究点 (11)
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