Depression and Health Outcomes in Refractory Epilepsy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- MINI
研究概览
简要总结
To define the benefits of antidepressant treatment or cognitive behavior therapy on mood, function, and quality of life in persons with depression and refractory epilepsy.
详细描述
This randomized clinical trial will be conducted to compare the drug sertraline to cognitive behavioral therapy on symptoms of depression, antiepileptic medication compliance, seizure frequency, and quality of life outcomes in persons with depression and a seizure disorder or epilepsy. Approximately 140 persons will be enrolled in this study over a period of five years. Individual participation will last approximately 16 weeks. Study participants will be chosen randomly to receive either the study medication (sertraline) or cognitive behavior therapy for 16 weeks. Sertraline is approved by the Food and Drug Administration (FDA). Subjects who receive cognitive behavior therapy will be provided with a one-hour individual session with a licensed clinical psychologist each week for 15 weeks. All study participants will attend scheduled clinic visits every 4 weeks for 16 weeks.
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
- None
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Sertraline
干预措施: sertraline (Drug)
CBT
干预措施: cognitive behavior therapy (Behavioral)
结局指标
主要结局
MINI
时间窗: completed at screen and 16 weeks
次要结局
- Depression as measured by the CES-D(completed every 2 weeks during the 16 week intervention period and at 6 month and 1 year follow ups)
- antiepileptic medication toxicity as measured by the AEP(assessed every 2 weeks during the 16 week intervention period)
- seizure frequency and seizure severity(assessed every 2 weeks during the 16 week intervention period)
- Health Related Quality of life as measured by the QOILIE-89(completed every 4 weeks during the 16 week intervention period and at 6 month and 1 year follow ups)
- antiepileptic medication compliance(assessed at 16 weeks)