NCT01035073已完成4 期
Functional Change and Efficacy of Duloxetine in Patients With Major Depression and Co-Morbid Soft Tissue Discomfort Symptoms
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
- 22
- 试验地点
- 1
- 主要终点
- 24-hour Activity Level
研究概览
简要总结
The objective of this study is to determine the time course of duloxetine efficacy on the symptoms of Major Depressive Disorder (MDD)and on the symptoms of Soft Tissue Discomfort Syndrome(STDS) via use of 24-hour Actigraph™ measures.
We hypothesize that there will be a reduction in both MDD and STDS symptoms in MDD patients with co-morbid STDS symptoms. We further hypothesize that there will be a rapid improvement in functional outcome ratings and 24-hour activity in MDD patients with co-morbid STDS symptoms which may occur even before the antidepressant effect is observed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •> 17 years old
- •All races and ethnicity
- •DSM IV-TR Axis I diagnosis of MDD
- •Co-morbid STDS
- •Baseline 17-item Hamilton Depression Rating > 13
排除标准
- •Primary Axis I disorder other than MDD
- •History of mania or psychosis
- •Actively suicidal
- •Required hospitalization
- •A alcohol or substance abuse or dependence within the preceding 3 months
- •Pregnant or nursing
- •Unstable medical condition (other than STDS)
- •Narrow-angle glaucoma
- •Sensitivity to duloxetine, concurrent antidepressant, tranquilizer, or mood stabilizer use
- •Hepatic or renal insufficiency
研究组 & 干预措施
Duloxetine
Experimental
干预措施: Duloxetine (Drug)
结局指标
主要结局
24-hour Activity Level
时间窗: Baseline and Week One of Treatment
次要结局
- Functional Symptom Questionnaire(Baseline; Week 6 and Week 8 of Treatment)
研究者
研究点 (1)
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