NCT00292734已完成4 期
Additive Beneficial Effect of Zolpidem Onto the Antidepressant Therapy in Depressive and Dysthimic Patients in the Acute Phase of the Disease
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- To show that the combination of Stilnox+ antidepressant therapy is more effective in the treatment of the secondary insomnia of depressive and dysthimic patients than antidepressant therapy alone in the acute phase of the disease
研究概览
简要总结
Primary objective: To show that the combination of Zolpidem + antidepressant therapy is more effective in the treatment of the secondary insomnia of depressive and dysthimic patients than antidepressant therapy alone in the acute phase of the disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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
- •Depressive and dysthimic patients in acute phase of mild to moderate severity
- •Depressive and dysthimic patients suffering from secondary insomnia (DSM IV) recent antidepressant therapy (less than 1 week)
排除标准
- •Regularly use of sleeping pills in the last 2-3 month
- •Use of any sleeping pils in the last week
- •Insufficient hepatic
- •Myasthenia gravis
- •Proven hypersensivity to Zolpidem
- •Evidence of clinically relevant nervous system disorders (other neurologic/psychiatric diseases associated with depression)
- •History of evidence of alcohol or drug abuse
- •Evidence of clinically relevant cardiovascular, haematologic, hepatic, gastrointestinal, renal, pulmonary or endocrinologic diseases
- •Abnormal snore
- •Work an alternating shift
- •Suffering from periodic leg movement disorder and sleep apnea
结局指标
主要结局
To show that the combination of Stilnox+ antidepressant therapy is more effective in the treatment of the secondary insomnia of depressive and dysthimic patients than antidepressant therapy alone in the acute phase of the disease
次要结局
未报告次要终点
研究者
研究点 (1)
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