search
Back to results

Mirtazapine Reduces ICD Shocks in ICD Patients With Depression and Anxiety

Primary Purpose

Depression, Anxiety

Status
Completed
Phase
Not Applicable
Locations
Argentina
Study Type
Interventional
Intervention
mirtazapine
mirtazapine
Sponsored by
Universidad Nacional de Rosario
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Depression

Eligibility Criteria

65 Years - 87 Years (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • cardioverter implanted patients
  • depression
  • anxiety

Exclusion Criteria:

  • heart failure
  • other diseases reducing physical fitness

Sites / Locations

  • Cl Sn Nicol

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Placebo Comparator

Arm Label

mirtazapine

mirtazapine, sugar pill

Arm Description

Outcomes

Primary Outcome Measures

number of implantable cardioverter defibrillator shocks

Secondary Outcome Measures

improvement of depression

Full Information

First Posted
July 21, 2009
Last Updated
August 17, 2009
Sponsor
Universidad Nacional de Rosario
search

1. Study Identification

Unique Protocol Identification Number
NCT00960830
Brief Title
Mirtazapine Reduces ICD Shocks in ICD Patients With Depression and Anxiety
Official Title
Mirtazapine Reduces ICD Appropriate Shocks in Cardioverter Implanted Patients With Depression and Anxiety
Study Type
Interventional

2. Study Status

Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
November 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Universidad Nacional de Rosario

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
mirtazapine
Arm Type
Placebo Comparator
Arm Title
mirtazapine, sugar pill
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
mirtazapine
Other Intervention Name(s)
mirtazapine 1500 mtz
Intervention Description
mirtazapine 15 mg daily tablets
Intervention Type
Drug
Intervention Name(s)
mirtazapine
Other Intervention Name(s)
remeron 1569 rem
Intervention Description
15 mg daily
Primary Outcome Measure Information:
Title
number of implantable cardioverter defibrillator shocks
Time Frame
one year
Secondary Outcome Measure Information:
Title
improvement of depression
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
87 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: cardioverter implanted patients depression anxiety Exclusion Criteria: heart failure other diseases reducing physical fitness
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
daniel jl serrani, MD
Organizational Affiliation
facultad de psicologia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cl Sn Nicol
City
San Nicolas
State/Province
Bs As
ZIP/Postal Code
1900
Country
Argentina

12. IPD Sharing Statement

Learn more about this trial

Mirtazapine Reduces ICD Shocks in ICD Patients With Depression and Anxiety

We'll reach out to this number within 24 hrs