NCT00046241已完成3 期
A 7 Month, Multicenter, Randomized, Double-blind, Placebo-controlled Comparison of 150-300mg/Day of Extended-release Bupropion Hydrochloride and Placebo for the Prevention of Seasonal Affective Disorder in Subjects With a History of Seasonal Affective Disorder Followed by an 8-week Observational Follow-up Phase
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 52
- 主要终点
- Time between randomization and onset of a seasonal depressive episode. Proportion of depression-free subjects.
研究概览
简要总结
This is a placebo controlled study evaluating the effectiveness of medication in preventing depressive episodes in subjects with a history of Seasonal Affective Disorder (SAD).
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
- •Patient has a history of Major Depressive Disorder (MDD) with a seasonal pattern.
排除标准
- •Patient has a current or past history of seizure disorder or brain injury.
- •Patient has a history or current diagnosis of anorexia nervosa or bulimia.
- •Patient has recurrent summer depression more frequently than winter depression.
- •Patient has primary diagnosis of panic disorder, Obsessive Compulsive Disorder (OCD), Posttraumatic Stress Disorder (PTSD), acute distress disorder, bipolar II disorder or other psychotic disorders.
- •Patient has initiated psychotherapy within the last 3 months.
结局指标
主要结局
Time between randomization and onset of a seasonal depressive episode. Proportion of depression-free subjects.
次要结局
- Change in HAMD-24 and -17 total score. Change in pain score.
研究者
研究点 (52)
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