A Double-Blind, Placebo-Controlled Investigation Into the Safety and Efficacy of Escitalopram for Depression in Multiple Sclerosis
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Escitalopram-treated MS patients will have greater reductions in their depressive symptom scores than patients randomized to placebo
研究概览
简要总结
Emotionally labile, depressed participants with multiple sclerosis treated with escitalopram will have a greater reduction in emotional lability scores and in their psychological distress scores than those who are randomized to receive placebo.
详细描述
Patients with multiple sclerosis who are experiencing mood lability and symptoms of depression will be randomized to receive either escitalopram 10mg/day or placebo tablets for a period of 6 weeks. It is hypothesized that patients receiving medication will experience a greater normalization of their emotional instability and a greater reduction in their depressive symptoms at the end of the six-week trial than those who are not receiving medication.
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
- •Clinical diagnosis of multiple sclerosis
- •Having mild to moderate depressive symptoms, with or without emotional lability
- •Experiencing psychological distress
排除标准
- •Meeting DSM-IV diagnostic criteria for Major Depressive Disorder or another Axis 1 diagnosis
- •Cognitive impairment
- •The presence of an unstable medical illness that might preclude completion of the study -
结局指标
主要结局
Escitalopram-treated MS patients will have greater reductions in their depressive symptom scores than patients randomized to placebo
Adverse events for both groups will be similar
次要结局
- Escitalopram-treated emotionally labile patients with MS will have a greater reduction in emotional lability scores than those randomized to placebo.