NCT00067912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
- 480
- 试验地点
- 1
- 主要终点
- Linear measure of global benefit-risk assessment. Benefit is defined as remission at endpoint (HMAD17 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 depression in the treatment of patients with major depressive disorder.
The safety of duloxetine and any side effects that might be associated with it.
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
排除标准
- •women who can become pregnant must be using birth control
- •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
Linear measure of global benefit-risk assessment. Benefit is defined as remission at endpoint (HMAD17 total score less than or equal to 7, a virtually symptom-free state.
次要结局
- HAMD17 Response Rates: Response is defined as a greater or equal to 50% reduction in HAMD17 total score from baseline to endpoint.
- HAMD17 Time to First Response: Time to first response is defined as the visit where a sustained greater than or equal to 30% reduction in the Maier subscale of the HAMD17.
- HAMD17 Remission Rates: Remission is defined as a HAMD17 total score of less than or equal to 7 at endpoint.
- Hamilton Anxiety Rating Scale (HAMA) that measures the presence and severity of anxiety. The 14-item version of this scale will be used to assess the severity of anxiety and its improvement during the course of therapy.
- Clinical Global Impressions of Severity (CGI-Severity) Scale to record the severity of illness at the time of assessment.
- Patient's Global Impressions of Improvement (PGI Improvement) Scale is a patient-rated instrument that measures the improvement of the patient's symptoms.
- HAMD17 Subscales to evaluate severity of psychic and somatic manifestations of anxiety, as well as agitation; evaluate dysfunction in mood, work, and sexual activity, as well as overall motor retardation; evaluate initial, middle and late insomnia.
研究者
研究点 (1)
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