ISRCTN33128015已完成4 期
Effects of selective serotonin re-uptake inhibition on MOrbidity, mOrtality and mood in Depressed Heart Failure patients
German Federal Ministry of Education and Research (Bundesministerium Für Bildung und Forschung [BMBF]) (Germany)0 个研究点目标入组 414 人开始时间: 2007年5月10日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 414
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Aged more than 18 years
- •2. Stable systolic chronic heart failure (CHF) (New York Heart Association [NYHA] II to IV) with left ventricular ejection fraction (LVEF) less than 45%
- •3. Current comorbid episode of major depression confirmed by Structured Clinical Interview for Diagnostic and Statistical Manual for mental disorders - fourth edition (DSM-IV) (SCID)
- •4. Written informed consent
排除标准
- •Current inclusion criteria as of 15/04/2014:
- •1. Current treatment with a selective serotonin re-uptake inhibitor (SSRI)
- •2. Previous treatment failure with escitalopram
- •3. Acute myocardial infarction (less than three months), acute cardiac decompensation, recent (less than three months) or planned (less than 12 months) cardiac surgery
- •4. Advanced renal failure (Modification of Diet in Renal Disease [MDRD] less than 30 ml/min)
- •5. Thyreotoxicosis
- •6. Reduced life expectancy due to other co-morbidity (e.g. malignancy)
- •7. Moderate or severe hepatic insufficiency (plasma levels of hepatic enzymes more than threefold of the upper level of the normal range)
- •8. Known evidence of major psychiatric comorbidity:
- •8.1. Imminent risk for or history of attempted suicide
- •8.2. Schizophrenia and spectrum disorders
- •8.3. Bipolar affective disorder
- •8.4. Current substance disorder
- •8.5. Moderate and severe Dementia
- •8.6. Severe depressive episode with psychotic features
- •9. Other contraindications against therapy with escitalopram (according to product information)
- •10. Participation in another clinical trial
- •11. Inability to comply with PHQ-9 and/or SCID testing and/or telephone monitoring for mental or linguistic reasons or lack of access to telephone
- •12. Pregnancy or nursing period
- •13. Women with child bearing potential without effective contraception during the conduct of the trial
- •14. Expected low compliance with the visit schedule or telephone monitoring (e.g., due to comorbidity or travel distance to the trial site)
- •15. Patients with normal ventricular activation (no bundle branch block (total or incomplete), no other intraventricular conduction delay and no pacemaker) and known QTc* prolongation = 500 ms OR inborn long QT syndrome
- •16. Patients with current treatment with drugs inducing QT prolongation, such as antiarrhythmic drugs class IA and III, anti-psychotics, tricyclic antidepressants
- •Previous inclusion criteria:
- •1. Current treatment with a selective serotonin re-uptake inhibitor (SSRI)
- •2. Previous treatment failure with escitalopram
- •3. Acute myocardial infarction (less than 3 months), acute cardiac decompensation, recent (less than 3 months) or planned (less than 12 months) cardiac surgery
- •4. Advanced renal failure (Modification of Diet in Renal Disease [MDRD] less than 30 ml/min)
- •5. Thyreotoxicosis
- •6. Reduced life expectancy due to other co-morbidity (e.g. malignancy)
- •7. Moderate or severe hepatic insufficiency (plasma levels of hepatic enzymes more than threefold of the upper level of the normal range)
- •8. Known evidence of major psychiatric comorbidity:
- •8.1. Imminent risk for or history of attempted suicide
- •8.2. Schizophrenia and spectrum disorders
- •8.3. Bipolar affective disorder
- •8.4. Current substance disorder
- •8.5. Dementia
- •8.6. Severe depressive episode with psychotic features
- •8.7. Delirium
- •9. Other contraindications against therapy with escitalopram (according to product information)
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