Model for Early Prediction of Clinical Response in Patients With Major Depression Receiving Fluoxetine
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Stable response was defined as a reduction of 50% or more of the HAMD-17 score at week 4 and week 6 of treatment
研究概览
简要总结
The purpose of this study is to identify what degree of symptom changes during the early weeks could be used to predict eventual nonresponse at week 6 among depressive inpatients taking fluoxetine.
详细描述
Patients with major depressive disorder will receive 20 mg/day of fluoxetine for six weeks. Symptom severity was assessed by the 17-item Hamilton Depression Rating Scale (HAMD-17) at weeks 0, 1, 2, 3, 4 and 6. Stable response is defined as a reduction of 50% or more of the HAMD-17 score at week 4 and week 6 of treatment. Receiver operating characteristic curve will be used to determine the cutoff point of the percentage of HAMD-17 score reduction between stable responders and nonresponders at weeks 1, 2, 3 and 4.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of major depressive disorder
- •HAM-D-17 ≧17
- •written informed consent
排除标准
- •Comorbid of substance abuse/dependence
- •Comorbid with mental disorders due to general medical conditions
- •Past history of treatment-resistant depression
- •Severe physical problems
- •pregnant women
- •lactation
研究组 & 干预措施
fluoxetine
干预措施: fluoxetine (Drug)
结局指标
主要结局
Stable response was defined as a reduction of 50% or more of the HAMD-17 score at week 4 and week 6 of treatment
时间窗: 6 weeks after initiation of fluxetine
次要结局
- CGI, GAF, Zung's Depression Scale, Short-Form 36, auditory evoked potential, psychomotor speed(6 weeks after initiation of fluxetine)