Mirtazapine Reduces ICD Shocks in ICD Patients With Depression and Anxiety
Mirtazapine Reduces ICD Appropriate Shocks in Cardioverter Implanted Patients With Depression and Anxiety
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable depression
Started Apr 2007
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 21, 2009
CompletedFirst Posted
Study publicly available on registry
August 18, 2009
CompletedAugust 18, 2009
August 1, 2009
1 year
July 21, 2009
August 17, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
number of implantable cardioverter defibrillator shocks
one year
Secondary Outcomes (1)
improvement of depression
one year
Study Arms (2)
mirtazapine
PLACEBO COMPARATORmirtazapine, sugar pill
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- cardioverter implanted patients
- depression
- anxiety
You may not qualify if:
- heart failure
- other diseases reducing physical fitness
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cl Sn Nicol
San Nicolás, Bs As, 1900, Argentina
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
daniel jl serrani, MD
facultad de psicologia
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 21, 2009
First Posted
August 18, 2009
Study Start
April 1, 2007
Primary Completion
April 1, 2008
Study Completion
November 1, 2008
Last Updated
August 18, 2009
Record last verified: 2009-08