Does Pregabalin Improve Symptoms of Anxiety in Patients With Epilepsy? A Comparison With Sertraline
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Improvement of anxiety symptoms measured with the changes of the total scores of GAD-7 & HAM-A.
研究概览
简要总结
The aim of the study is to compare the safety & efficacy of sertraline (up to a dose of 200mg/day) & pregabalin (up to a dose of 300mg/day) for the treatment of symptoms of anxiety in patients with epilepsy.
详细描述
Patients with epilepsy will be treated with either sertraline (up to a dose of 200mg/day) or pregabalin (up to a dose of 300mg/day) for the treatment of symptoms of anxiety. Outcome measures will include changes in the anxiety severity scales.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •GAD-7 total score above
- •Have a diagnosis of a Partial Seizure Disorder.
- •Have a Hamilton-A total score 20 and above.
- •18-80 years of age.
- •Able to read at a fourth grade level.
- •If a woman of childbearing age, agrees to use an acceptable means of birth control.
排除标准
- •Unable to understand and sign a consent.
- •Unable to follow instructions for the study.
- •Displaying current suicidal ideation
- •Having psychogenic non-epileptic seizures
- •Have a history of drug or alcohol abuse.
- •Use of any investigational drug within the last 30 days.
- •Hypersensitivity reaction or other serious adverse event to PGB in prior trials.
研究组 & 干预措施
Pregabalin
Pregabalin is an antiepileptic medication which has been found in double blind placebo controlled trials to be effective and safe in the treatment of primary generalized anxiety disorder. It has an indication for the treatment of this condition in Europe & Canada but not in the US.
干预措施: Pregabalin-Lyrica (Drug)
Sertraline
Sertraline is an SSRI found to be an effective treatment of generalized anxiety disorder in controlled trials. It does not have an indication for this in this country.
干预措施: Sertraline (Drug)
结局指标
主要结局
Improvement of anxiety symptoms measured with the changes of the total scores of GAD-7 & HAM-A.
时间窗: 27 weeks
Change in severity of symptoms \&/o remission of symptoms of anxiety between visit 0 \& the end of treatment phase.
次要结局
- Change in Quality of life measures assessed with the QOLIE-89.(27 weeks.)