The Effects of Treatment With Sertraline for Panic Disorder and/or Depression Driven Chest Pain and/or Palpitations in a Double Blind, Care as Usual and Placebo Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- panic attacks
研究概览
简要总结
The purpose of this study is to determine whether care as usual or intervention (consisting of sertraline versus placebo), are effective in the treatment of panic disorder and/or depression driven noncardiac chest pain.
详细描述
Noncardiac chest pain remains an important problem in clinical cardiology. Often, panic disorder and/or depression are the underlying cause. However, this is largely underdiagnosed.
There are no clear existing treatment strategies/methods for this specific patient population.
In our double blind, placebo controlled care as usual versus sertraline study, we want to investigate whether intervention is more effective as care as usual for diminishing chest pain, and also if sertraline is more effective in this specific population compared to placebo.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •chest pain without a cardiac cause
- •diagnosed with panic disorder and or depression according to Diagnostic and statistical Manual (DSM) IV criteria
- •Living < 50 km from the hospital
- •informed consent
排除标准
- •other primary DSM IV diagnosis
- •known sensitivity to sertraline
- •using other anti-depressive agents
- •not speaking dutch language
- •living in a nursery home or having dementia
- •other severe, acute or progressive disease, kidney or liver-function disturbances, pregnancy or breastfeeding
研究组 & 干预措施
sertraline, panic education
treatment with sertraline after panic education
干预措施: sertraline (Drug)
placebo after panic education
treatment with placebo after panic education
干预措施: placebo (Drug)
结局指标
主要结局
panic attacks
时间窗: 24 weeks
reduction of panic attacks by more than or equal to 50%
17 items Hamilton depression (HAMD) rating scale score
时间窗: 24 weeks
reduction of HAMD score of \>50%
次要结局
- Hospital Anxiety and Depression Scale (HADS)reduction score(24 weeks)
- Clinical Global Impression (CGI) improvement(24 weeks)
- EuroQol (EQ-5D)score(24 weeks)
- Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) score(24 weeks)
- health care costs(24 weeks)