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Completed

NCT Number: NCT00960830

Mirtazapine Reduces ICD Shocks in ICD Patients With Depression and Anxiety

The purpose of this study is to evaluate if the use of antidepressant medication in depressed patients with implantable cardioverter defibrillator reduces the number of ICD's shocks as it improves depressive affect.

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Key information

Conditions

Depression Anxiety Anxiety Disorders Behavior Behavioral Symptoms Mental Disorders

Age range

65 year–87 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cl Sn Nicol

San Nicolás, Bs As, 1900, Argentina

About this study

episodes of arrhythmia remain present even after icd implantation, this is specially true in depressed patients. it is hypothesized that improving mood state by means of an antidepressant drug . namely mirtazapine. could be responsible of alleviating the number of appropriate shocks delivered by the cardioverter. this could be due to a direct effect of the drug itself or an indirect effect of improving anxious and depressive affect. the mood and anxiety state are measured with the HADS scale

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • cardioverter implanted patients
  • depression
  • anxiety

Exclusion criteria

  • heart failure
  • other diseases reducing physical fitness

Treatment and study plan

mirtazapine

Drug

mirtazapine 15 mg daily tablets

Other names: mirtazapine 1500 mtz

Primary outcomes

  1. number of implantable cardioverter defibrillator shocks

    Time frame: one year

Secondary outcomes

  1. improvement of depression

    Time frame: one year

Sponsors and collaborators

Lead sponsor

Universidad Nacional de Rosario

Other

Registry information

Official study title

Mirtazapine Reduces ICD Appropriate Shocks in Cardioverter Implanted Patients With Depression and Anxiety

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Aug 18, 2009
Registry last updated
Aug 18, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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