NCT00419471已完成4 期
Efficacy and Safety of Escitalopram in the Treatment of Depressive Patients With Acute Coronary Artery Syndrome: A Double-blind Placebo-controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Score on the Hamilton Depression Rating Scale-17 item
研究概览
简要总结
This study aimed to evaluate the efficacy and safety of escitalopram in the treatment of depressive patients with acute coronary artery syndrome (CAS).
详细描述
Depression is common in patients with acute CAS and increases cardiac morbidity and mortality. However, there are a few limited data available regarding the effects and safety of antidepressants for treating depression in patients with acute CAS. This study aims to investigate whether escitalopram might be an effective treatment option for these patients.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18~85
- •Diagnosed as acute CAS (unstable angina or acute myocardial infarction) and being conducted coronary angiography
- •Beck Depression Inventory > 10 and major or minor depressive disorder by the DSM-IV criteria
- •With ability to complete various questionnaires
- •Can understand the objective of the study and sign informed consent
排除标准
- •Occurrence of acute CAS while the patient was hospitalized for another reason, except for CAS
- •Current CAS developed less than 3 months after coronary artery bypass graft procedure
- •Uncontrolled hypertension (systolic BP > 180mmHg or diastolic BP > 100mmHg)
- •Resting heart rate < 40/min
- •Severe physical illnesses threatening life or interfering with the recovery from CAS
- •Persistent clinically significant laboratory abnormalities
- •Concomitant use of class I antiarrhythmic medications; reserpine, guanethidine, clonidine, or methyldopa; anticonvulsants or neuroleptics
- •History of neuropsychiatric illnesses such as dementia, Parkinson's disease, brain tumor, psychoses, alcoholism, and other substance dependence
- •Pregnancy
研究组 & 干预措施
Escitalopram
Experimental
干预措施: Escitalopram (Drug)
Placebo pill
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Score on the Hamilton Depression Rating Scale-17 item
时间窗: 24 weeks
次要结局
- Scores on the Beck Depression Inventory(24 weeks)
- Changes in electrocardiographic, echocardiographic, and angiographic variables(24 weeks)
- Scores on the Montgomery Asberg Depression Rating Scale(24 weeks)
- Scores on the World Health Organization Disability Assessment Schedule(24 weeks)
- Scores on the Clinical Global Impression scale(24 weeks)
- Scores on the Social and Occupational Functioning Assessment Scale(24 weeks)
- Scores on the World Health Organization Quality of Life scale(24 weeks)
研究者
Jae-Min Kim
Associate Professor
Chonnam National University Hospital
研究点 (1)
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