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CompletedNCT00960830Updated Aug 18, 2009

Mirtazapine Reduces ICD Shocks in ICD Patients With Depression and Anxiety

An interventional study of mirtazapine and mirtazapine in Depression and Anxiety, sponsored by Universidad Nacional de Rosario. Completed at 1 site in Argentina. Open to participants aged 65 Years to 87 Years. Per ClinicalTrials.gov, last updated 2009-08-18.

Sponsored by Universidad Nacional de Rosario · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
65 Years to 87 Years
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

03

In context

Depression

8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's enrollment of 40 is below the median of 84 across 6,720 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

Universidad Nacional de Rosario is the lead sponsor of 9 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years to 87 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • cardioverter implanted patients
  • depression
  • anxiety

Exclusion criteria

Exclusion Criteria:

  • heart failure
  • other diseases reducing physical fitness
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Double (Participant, Investigator)
Enrollment
40 participants (actual)

Study arms

  • Placebo comparator
    mirtazapine

    Drug: mirtazapine

  • Placebo comparator
    mirtazapine, sugar pill

    Drug: mirtazapine

Interventions

  • Drugmirtazapine

    mirtazapine 15 mg daily tablets

    Also known as: mirtazapine 1500 mtz

  • Drugmirtazapine

    15 mg daily

    Also known as: remeron 1569 rem

06

What researchers measure

Primary outcomes

  1. number of implantable cardioverter defibrillator shocks

    Time frame: one year

Secondary outcomes

  1. improvement of depression

    Time frame: one year

07

Study locations

1 site
  • Cl Sn Nicol
    San Nicolas, Bs As 1900, Argentina
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 18, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00960830
Lead sponsor
Universidad Nacional de Rosario
First posted
Aug 18, 2009
Start date
Apr 2007
Primary completion
Apr 2008
Completion
Nov 2008
Last update
Aug 18, 2009

Study contacts

daniel jl serrani, MD
principal investigator · facultad de psicologia

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2009. You cannot join it, but the record below documents what was studied.

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