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Clinical Trials/EUCTR2007-006609-25-DE
EUCTR2007-006609-25-DE
Active, not recruiting
Not Applicable

Effects of selective serotonin re-uptake inhibition on morbidity, mortality and mood in Depressed Heart Failure patients - MOOD-HF

Julius Maximilians Universität Würzburg0 sitesMarch 27, 2008

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Julius Maximilians Universität Würzburg
Status
Active, not recruiting
Last Updated
11 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 27, 2008
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Julius Maximilians Universität Würzburg

Eligibility Criteria

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

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

Outcomes

Primary Outcomes

Not specified

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