A DOUBLE-BLIND PILOT STUDY TO EVALUATE THE SAFETY AND EFFICACY OF PROVIGIL® (MODAFINIL) AT FIXED/FLEXIBLE DOSES, IN CONJUNCTION WITH IDENTIFIED SSRIs FOR THE TREATMENT OF EXCESSIVE SLEEPINESS IN PATIENTS WITH MILD TO MODERATE DEPRESSION WITH ATTENDANT SYMPTOMS OF SLEEPINESS AND FATIGUE
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 7
- 主要终点
- Epworth Sleepiness Scale (ESS)
研究概览
简要总结
The main purpose of this study is to determine if Provigil® (modafinil) at a dose of 200 mg once daily is safe and effective for treating symptoms of sleepiness and fatigue associated with Major Depressive Disorder when added to a SSRI.
详细描述
Approximately 100 male and female outpatients, who are between the ages of 18 and 65, will be enrolled at four sites in the United States. This study consists of two parts. The first part consists of 6 weeks of open label treatment with a selected SSRI & double blind treatment with Provigil or placebo (inactive medication).
After the six week double blind treatment phase all patients will enter a four week open label treatment phase with Provigil. The dose of Provigil is not to exceed 400 mg and cannot be less than 100 mg per day. They will continue taking the prescribed SSRI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Major Depressive Disorder
- •MADRS score ≥ 15 at both screen & baseline.
- •Significant fatigue as evidenced by FSS ≥4 at both screen & baseline.
- •Excessive sleepiness as evidenced by ESS ≥ 10 at both screen & baseline.
排除标准
- •Treatment refractory depression
- •Serious or unstable medical condition.
- •Pregnancy
- •Primary diagnosis of another Axis I or II disorder
- •Alcohol or substance abuse or dependence within the past 12 months.
结局指标
主要结局
Epworth Sleepiness Scale (ESS)
次要结局
- Hamilton Depression Scale (HAM-D 31 item)