DepressionNCT00960830
Mirtazapine Reduces ICD Shocks in ICD Patients With Depression and Anxiety
A study testing mirtazapine in people with Depression and Anxiety, run by Universidad Nacional de Rosario at 1 site in Argentina.
Trial 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 more about this study
- Who is it for?
- Ages 65 to 87 years
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- mirtazapine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteArgentina
- Study dates
- Apr 2007to Nov 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 87 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- cardioverter implanted patients
- depression
- anxiety
Who cannot join
- heart failure
- other diseases reducing physical fitness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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
- Conditions
- Depression, Anxiety
- Being tested
- mirtazapine
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mirtazapineDrug
Also called mirtazapine 1500 mtz
mirtazapine 15 mg daily tablets
mirtazapineDrug
Also called remeron 1569 rem
15 mg daily
| Study group | Role | What they receive |
|---|---|---|
| mirtazapine | Placebo comparator | Not described Receives: Drug: mirtazapine |
| mirtazapine, sugar pill | Placebo comparator | Not described Receives: Drug: mirtazapine |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of implantable cardioverter defibrillator shocks
Measured: one year
Secondary outcomes (1)
improvement of depression
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2009 (estimated)
- Study startApr 2007
- Primary completionApr 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Nacional de Rosario
- Sponsor type
- University, hospital or other
- Investigators
- daniel jl serrani, MD, Principal investigator, facultad de psicologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00960830
- Sponsor's protocol ID
- PS990
- Status last verified
- Aug 2009
- First submitted
- 21 Jul 2009
- Last updated
- 18 Aug 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mirtazapine Reduces ICD Appropriate Shocks in Cardioverter Implanted Patients With Depression and Anxiety
- ClinicalTrials.gov ID
- NCT00960830
- Acronym / sponsor ID
- PS990
- Conditions
- Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universidad Nacional de RosarioUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 18 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mirtazapine | Placebo comparator | Drug: mirtazapine |
| mirtazapine, sugar pill | Placebo comparator | Drug: mirtazapine |
Who may qualify
- Ages
- 65 to 87 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- cardioverter implanted patients
- depression
- anxiety
Key exclusion criteria (2 listed)
- heart failure
- other diseases reducing physical fitness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mirtazapineAlso: mirtazapine 1500 mtzmirtazapine 15 mg daily tablets | Drug | mirtazapine |
| mirtazapineAlso: remeron 1569 rem15 mg daily | Drug | mirtazapine, mirtazapine, sugar pill |
Primary outcome
number of implantable cardioverter defibrillator shocks
Time frame: one year
1 secondary outcome
improvement of depression
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2009.
Related trials for Depression
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
daniel jl serrani, MD principal investigator
facultad de psicologia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mirtazapine in people with Depression and Anxiety, run by Universidad Nacional de Rosario at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of implantable cardioverter defibrillator shocks (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2009.