Mirtazapine Reduces ICD Shocks in ICD Patients With Depression and Anxiety

NCT ID: NCT00960830

Last Updated: 2009-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2008-11-30

Brief Summary

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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

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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

Conditions

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Depression Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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mirtazapine

Group Type PLACEBO_COMPARATOR

mirtazapine

Intervention Type DRUG

mirtazapine 15 mg daily tablets

mirtazapine

Intervention Type DRUG

15 mg daily

mirtazapine, sugar pill

Group Type PLACEBO_COMPARATOR

mirtazapine

Intervention Type DRUG

15 mg daily

Interventions

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mirtazapine

mirtazapine 15 mg daily tablets

Intervention Type DRUG

mirtazapine

15 mg daily

Intervention Type DRUG

Other Intervention Names

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mirtazapine 1500 mtz remeron 1569 rem

Eligibility Criteria

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Inclusion Criteria

* cardioverter implanted patients
* depression
* anxiety

Exclusion Criteria

* heart failure
* other diseases reducing physical fitness
Minimum Eligible Age

65 Years

Maximum Eligible Age

87 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad Nacional de Rosario

OTHER

Sponsor Role lead

Responsible Party

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facultad de psicologia

Principal Investigators

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daniel jl serrani, MD

Role: PRINCIPAL_INVESTIGATOR

facultad de psicologia

Locations

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Cl Sn Nicol

San Nicolás, Bs As, Argentina

Site Status

Countries

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Argentina

Other Identifiers

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PS990

Identifier Type: -

Identifier Source: org_study_id

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