Mirtazapine Reduces ICD Shocks in ICD Patients With Depression and Anxiety

Not Applicable

Completed

• Conditions: Depression; Anxiety
• Interventions: Drug: mirtazapine

• Registration Number: NCT00960830
• Lead Sponsor: Universidad Nacional de Rosario

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study Start: 2007-04
• Primary Completion: 2008-04
• Study Completion: 2008-11
• Study First Submitted: 2009-07-21
• Status Verified: 2009-08
• Study First Submitted QC: 2009-08-17
• Last Update Submitted: 2009-08-17
• Study First Posted: 2009-08-18
• Last Update Posted: 2009-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• cardioverter implanted patients
• depression
• anxiety

Exclusion Criteria

• heart failure
• other diseases reducing physical fitness

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
mirtazapine	mirtazapine	-
mirtazapine, sugar pill	mirtazapine	-

Primary Outcome Measures

Name	Time	Method
number of implantable cardioverter defibrillator shocks	one year

Secondary Outcome Measures

Name	Time	Method
improvement of depression	one year

Trial Locations

Locations (1)

Cl Sn Nicol; 🇦🇷 San Nicolas, Bs As, Argentina