NCT00071695已完成4 期
Duloxetine Versus Venlafaxine Extended Release in the Treatment of Major Depressive Disorder
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- The linear measure of global benefit-risk assessment. Benefit defined as remission at endpoint (HAMD 17 total score less than or equal to 7), a virtually symptom-free state.
研究概览
简要总结
How duloxetine compares to a medication currently available for the treatment of patients diagnosed with depression
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
- Double
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
- •Must be at least 18 years of age
- •Must be diagnosed with depression
- •Must sign informed consent
- •Women who can become pregnant must be using birth control
排除标准
- •Previous diagnosis of bipolar disorder, schizophrenia, or other psychotic disorder
- •History of substance abuse or dependence in the last year
- •Patients who are suicidal
- •Frequent or severe allergic reactions with multiple medications
结局指标
主要结局
The linear measure of global benefit-risk assessment. Benefit defined as remission at endpoint (HAMD 17 total score less than or equal to 7), a virtually symptom-free state.
次要结局
- HAMD17 Response Rates defined as greater than or equal to 50% reduction in HAMD17 total score from baseline to endpoint.
- HAMD17 Time-to-First Response defined as the visit where a sustained greater than or equal to 30% reduction in the Maier subscale of the HAMD17.
- HAMD17 Remission Rates defined as HAMD17 total score of less than or equal to 7 at endpoint.
- Hamilton Anxiety Rating Scale measures the presence and severity of anxiety.
- Clinical Global Impressions of Severity scale to record severity of illness at the time of assessment.
- Patient's Global Impressions of Improvement scale measures improvement of the patient's symptoms.
- HAMD17 Subscales evaluate severity of psychic and somatic manifestations of anxiety as well as agitation and evaluate dysfunction in mood, work, and sexual activity, as well as overall motor retardation and evaluate initial, middle, and late insomnia.
研究者
研究点 (1)
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