Mirtazapine Reduces ICD Shocks in ICD Patients With Depression and Anxiety

August 17, 2009 updated by: Universidad Nacional de Rosario

Mirtazapine Reduces ICD Appropriate Shocks in Cardioverter Implanted 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
    • Bs As
      • San Nicolas, Bs As, Argentina, 1900
        • Cl Sn Nicol

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 87 years (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • cardioverter implanted patients
  • depression
  • anxiety

Exclusion Criteria:

  • heart failure
  • other diseases reducing physical fitness

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: mirtazapine
Drug: mirtazapine
mirtazapine 15 mg daily tablets
Other Names:
  • mirtazapine 1500 mtz
Drug: mirtazapine
15 mg daily
Other Names:
  • remeron 1569 rem
PLACEBO_COMPARATOR: mirtazapine, sugar pill
Drug: mirtazapine
mirtazapine 15 mg daily tablets
Other Names:
  • mirtazapine 1500 mtz
Drug: mirtazapine
15 mg daily
Other Names:
  • remeron 1569 rem

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
number of implantable cardioverter defibrillator shocks
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
improvement of depression
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Nacional de Rosario

Investigators

  • Principal Investigator: daniel jl serrani, MD, facultad de psicologia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (ACTUAL)

April 1, 2008

Study Completion (ACTUAL)

November 1, 2008

Study Registration Dates

First Submitted

July 21, 2009

First Submitted That Met QC Criteria

August 17, 2009

First Posted (ESTIMATE)

August 18, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

August 18, 2009

Last Update Submitted That Met QC Criteria

August 17, 2009

Last Verified

August 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PS990

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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