Mirtazapine Reduces ICD Shocks in ICD Patients With Depression and Anxiety

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00960830
• Other study ID #: PS990
• Status: Completed
• Phase: N/A
• First received: July 21, 2009
• Last updated: August 17, 2009
• Start date: April 2007
• Est. completion date: November 2008

Study information

• Verified date: August 2009
• Source: Universidad Nacional de Rosario
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Human Research Bioethics Committee
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years to 87 Years

Eligibility

Inclusion Criteria:

• cardioverter implanted patients

• depression

• anxiety

Exclusion Criteria:

• heart failure

• other diseases reducing physical fitness

Study Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Depression
• Depressive Disorder

Intervention

Drug:
• mirtazapine
mirtazapine 15 mg daily tablets
• mirtazapine
15 mg daily

Locations

Country	Name	City	State
Argentina	Cl Sn Nicol	San Nicolas	Bs As

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Nacional de Rosario

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of implantable cardioverter defibrillator shocks		one year	No
Secondary	improvement of depression		one year	No