An Open-label, 8- Week, Flexible Dose Trial of Escitalopram (Lexapro®) in Comorbid Major Depression With Amyotrophic Lateral Sclerosis and Multiple Sclerosis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Hamilton Depression Scale (HAM-D 17).
研究概览
简要总结
The purpose of this study is to see if escitalopram (Lexapro) improves symptoms of major depressive disorder in patients who have ALS or MS.
详细描述
This eight-week study aims to assess the effectiveness and tolerability of escitalopram in improving symptoms of Major Depression in patients with Amyotrophic Lateral Sclerosis (ALS) or Multiple Sclerosis (MS) as measured by the HAM-D. In addition, the study will assess improvement in the quality of life in patients with Major Depression and ALS or MS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between 18 and 70 years of age with documented ALS or MS,
- •DSM-IV episode of non-psychotic Major Depression,
- •≥14 score on the 17-item HAM-D,
- •Ability to give informed consent.
排除标准
- •History of psychotic disorders,
- •Psychotic depression,
- •Bipolar depression,
- •Suicide risk,
- •History of substance abuse in the previous 6 months,
- •History of unstable medical disorders,
- •Pregnancy or planning for pregnancy,
- •Severity of ALS or MS that limits participating in the study protocol.
研究组 & 干预措施
Escitalopram
All patients will receive escitalopram 20 mg daily.
干预措施: escitalopram (Drug)
结局指标
主要结局
Hamilton Depression Scale (HAM-D 17).
时间窗: 8 weeks
Hamilton Depression Rating Scale-17 (HAM-D) is a 17-item observer rated scale that measures depressive symptoms. Items are rated 0 (no symptoms)-4 ( most severe symptoms. Possible minimum and maximum scores range is 0-50. total score indications: 0-7 = Normal; 8-13 = Mild Depression; 14-18 = Moderate Depression; 19-22 = Severe Depression and ≥ 23 = Very Severe Depression.
次要结局
- McGill Quality of Life Scale (MQOL)(8 weeks)
研究者
Meera Narasimhan
Professor
University of South Carolina