Safety and Efficacy of Sertraline for Depression CHF
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 469
- 试验地点
- 1
- 主要终点
- Symptoms of Depression in Congestive Heart Failure Patients With Clinical Depression After Treatment With Sertraline or Placebo
研究概览
简要总结
This study will examine the effect of antidepressant medication on rates of death and disease in depressed people with chronic heart failure.
详细描述
Comorbid depression in people with chronic medical illness is a serious public health concern. Depressive disorders lead to increased morbidity, mortality, and poorer outcomes in ischemic heart disease, a leading cause of chronic heart failure (CHF). Evidence suggests that a relationship exists between depression and CHF; studies that examine the way CHF is affected by depression treatments are needed.
Participants in this study will be randomly assigned to receive either sertraline or placebo for 12 weeks. Assessments will be made at Weeks 2, 4, 6, 8, 10, and 12. Participants who do not respond to their treatment will have their medication dose adjusted following assessment. Interviews and rating scales will be used to assess depressive symptoms, cognitive status, psychiatric comorbidity, daily and chronic stress, and social support. A follow-up visit will take place 6 months, 1 year, 2 years, and 3 years after study completion.
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
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic heart failure
- •Diagnostic and Statistical Manual- Fourth Edition (DSM-IV) criteria for major depression
- •Current use of any antipsychotic medication at study entry
排除标准
- •Life-threatening comorbidity with a 50% or higher likelihood of death within 1 year
- •History of psychoses, bipolar disorder, or severe personality disorder
- •History of alcohol or drug dependence in the last year
- •Severe physical disability that may interfere with the study
- •Neurological impairment
- •Active suicidal ideations
- •Current use of antidepressant medication(s) at the start of study medication
研究组 & 干预措施
Sertraline
Participants will take sertraline for 12 weeks
干预措施: Sertraline (Drug)
Placebo
Participants will take placebo for 12 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Symptoms of Depression in Congestive Heart Failure Patients With Clinical Depression After Treatment With Sertraline or Placebo
时间窗: Measured at Week 12
Symptoms of depression (as measured by the Hamilton Depression Rating Scale, HDRS) in congestive heart failure patients with clinical depression after treatment with sertraline or placebo. The 17-item Hamilton Depression Rating Scale (HDRS) is a rater-administered assessment of depression severity, with total score ranges from 0 (not at all depressed) to 52 (most severely depressed). Change in depression was measured as the difference between the 12-week HDRS scores and the baseline HDRS scores. Thus, a negative value reflects an improvement in depressive symptoms over the 12-week period.
次要结局
- Percentage of Cardiac Events and Morbidity / Mortality, Including Rehospitalization, in Congestive Heart Failure Patients With Depression After Treatment With Sertraline or Placebo.(Measured at Week 12)