EUCTR2007-006609-25-DE进行中（未招募）不适用
Effects of selective serotonin re-uptake inhibition on morbidity, mortality and mood in Depressed Heart Failure patients - MOOD-HF
Julius Maximilians Universität Würzburg0 个研究点开始时间: 2008年3月27日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients must meet ALL of the following criteria:
- •Age >= 18 years
- •Chronic systolic heart failure of any etiology with
- •- current NYHA class II-IV and
- •- at least one measurement of LVEF < 45% by echocardiography or laevocardio-graphy or cardio-MRT within the preceding three months
- •Diagnostic and Statistical Manual of Mental Disorders-IV diagnosis of current major DEP based on the Structured Clinical Interview for DSM-IV (SCID48).
- •Provision of written informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 274
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 140
排除标准
- •Recent history of acute myocardial infarction (<3 months)
- •Acute cardiac decompensation
- •Recent (< 3 months) or planned major cardiac surgery (<12 months)
- •Advanced renal failure (MDRD < 30ml/min)
- •Moderate or severe hepatic insufficiency (plasma levels of serum transaminases >threefold of the upper level of the normal range) or manifest hepatic failure
- •Thyreotoxicosis
- •Other medical contraindication against treatment with SSRI
- •Significantly reduced life expectancy due to other comorbidity (e.g. malignancy)
- •Use of any antidepressants including SSRI, lithium or anti-convulsants for mood disorder in adequate dosage, with sufficiently long duration of antidepressive treatment and clinical outcome
- •Currently undergoing any form of psychotherapy
- •Absence of response to a previous adequate trial of escitalopram treatment
- •Life time history of early termination (<8 weeks) of escitalopram treatment because of adverse events or side effects
- •Life time history of early termination (< 8 weeks) of other SSRI (e.g. sertraline, citalo-pram) treatment because of adverse events or side effects
- •SCID documented bipolar affective disorder
- •Major DEP with psychotic features
- •Evidence of substance abuse or dependency during the previous 12 months
- •Moderate and severe dementia (MMSE < 18)
- •Serious risk of imminent suicide based on clinical judgment
- •Participation in another clinical trial
- •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
- •Pregnancy or nursing period
- •Women with child bearing potential without effective contraception during the conduct of the trial
- •Expected low compliance with the visit schedule or telephone monitoring (e.g., due to comorbidity or travel distance to the trial site)
- •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
- •Patients with current treatment with drugs inducing QT prolongation, such as antiarrhythmic drugs class IA and III, anti-psychotics, tricyclic antidepressants
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