Citalopram for Sx/Util in Acute Coronary Syndrome Patients
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Treatment usage
研究概览
简要总结
Symptoms (chest pain, shortness of breath, dizziness, etc.) and treatment usage (doctor or emergency room visits, testing, hospital days, etc.) in patients with Acute Coronary Syndromes are known to be related to emotional distress (Anxiety, Depression and Anger). In addition, behavioral treatment of emotional distress is known to decrease symptoms, and treatment usage. The present protocol tests whether the addition of a medication known to reduce emotional distress can also reduce symptoms and treatment usage.
This will done by recruiting patients with ACS during their hospital stay, randomizing them to receive citalopram or placebo, and then examining their symptoms and treatment usage at 6 months.
详细描述
Not applicable. Study not funded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, 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
- •Admission to hospital for chest pain/dyspnea, typical ECG changes plus positive tropinins
排除标准
- •age less than 18
- •cognitive impairment (per MMSE)
- •geographic unavailability for followup
- •unwillingness to participate
- •illiteracy
- •Hx cardiac transplant
- •untreated hypothyroidism
- •hepatic dysfunction
- •prior adverse reaction to citalopram
- •history of Bipolar Disorder
- •untreated Sleep Apnea
- •chronic steroid therapy
- •active substance abuse (e.g., within past year)
- •near term mortal illness
- •current mental health treatment
- •signitificant suicide risk
研究组 & 干预措施
Placebo
Placebo pill
干预措施: Citalopram (Drug)
Citalopram
Drug
干预措施: Citalopram (Drug)
结局指标
主要结局
Treatment usage
时间窗: 6 months
ER Visits, Hospital Days, Catheterizations, PTCAs/CABGs, Valve Surgery, AICD/Pacemaker, Treadmills, Echos, Nuclear Scans, Chest X-Rays
Frequency of ACS Symptoms
时间窗: 6 months
Frequency of episiodes of chest pain, presyncope, dyspnea, fatigue and palpitations
次要结局
- Emotional Distress(6 months)
研究者
Mark W. Ketterer, PhD
Senior Bioscientific Staff
Henry Ford Health System