Effects of an antidepressant drug on morbidity, mortality and mood in Depressed Heart Failure patients

• Conditions: To investigate the effects of selective serotonin re-uptake inhibition with the SSRI escitalopram on morbidity and mortality in depressed patients with CHF. The primary endpoint is the time to a first clinical event, either death or unplanned hospitalisation, whichever occurs first, for any reasons.; MedDRA version: 16.1Level: LLTClassification code 10008908Term: Chronic heart failureSystem Organ Class: 100000004849; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2007-006609-25-DE
• Lead Sponsor: Julius Maximilians Universität Würzburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03-27
• Last Update Posted: 6 January 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

• 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified