NCT00069459已完成1 期
A 7 Month, Multicenter, Parallel, Double-Blind, Placebo-Controlled Comparison of 150-300 mg/Day of Extended-Release Bupropion Hydrochloride and Placebo for the Prevention of Seasonal Depressive Episodes in Subjects With a History of Seasonal Affective Disorder Followed by an 8-week Observational Follow-up Phase
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- End of season depression-free rate.
研究概览
简要总结
A placebo controlled study evaluating the effectiveness of medication in preventing winter depressive episodes in patients with a history of Seasonal Affective Disorder
详细描述
A 7-Month Multicenter, Parallel, Double-Blind, Placebo-Controlled Comparison of 150-300mg/day of Extended-release Bupropion Hydrochloride and Placebo for the Prevention of Seasonal Depressive Episodes in Subjects with a History of Seasonal Affective Disorder Followed by an 8-week Observational Follow-up Phase
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 (Participant, Investigator)
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
- •History of Major Depressive Disorder (MDD) with a seasonal pattern.
排除标准
- •Current or past history of seizure disorder or brain injury.
- •History or current diagnosis of anorexia nervosa or bulimia.
- •Recurrent summer depression more frequently than winter depression.
- •Primary diagnosis of panic disorder, Obsessive Compulsive Disorder (OCD), Post-traumatic Stress Disorder(PTSD), acute distress disorder, bipolar II disorder or other psychotic disorders.
- •Initiated psychotherapy within the last 3 months.
研究组 & 干预措施
Extended-release Bupropion Hydrochloride
Other
Extended-release Bupropion Hydrochloride
干预措施: Extended-release Bupropion Hydrochloride (Drug)
结局指标
主要结局
End of season depression-free rate.
时间窗: 7 months
次要结局
- Time to onset of a seasonal depressive episode.Change from randomization on SIGH-SAD and HAMD-17.(7 months)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Prevention of Seasonal Affective DisorderSeasonal Affective DisorderNCT00046241GlaxoSmithKline300
已完成
3 期
Prevention of Seasonal Affective DisorderSeasonal Affective Disorder (SAD)NCT00046449GlaxoSmithKline
已完成
2 期
A Study Of A New Medicine (GW597599B) For The Treatment Of Major Depressive DisorderDepressive Disorder, MajorNCT00048204GlaxoSmithKline372
已完成
3 期
Depression And Bipolar DisorderBipolar DisorderNCT00274677GlaxoSmithKline221
已完成
2 期
An Eight-Week Study Evaluating the Efficacy of Two Fixed Doses (250 mg Twice Daily and 100 mg Twice Daily) of SSR149415 in Patients With Major Depressive DisorderDepressive DisorderNCT00361491Sanofi324