DepressionPhase 4NCT00140257
DECARD: Study of Escitalopram in the Prevention of Depression in Patients With Acute Coronary Syndrome
A Phase 4 study testing Escitalopram in people with Depression, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
Objective: To evaluate the efficacy of preventive treatment with a selective serotonin reuptake inhibitor (SSRI) (escitalopram) in the first year after acute coronary syndromes (ACS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Escitalopram
- How many people
- 240 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2004to Dec 2008
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ACS
- Randomization within 8 weeks form index hospitalization for ACS
- Age > 18 years
- Not pregnant
- Signed informed consent
Who cannot join
- Current depression
- Use of antidepressants < 4 weeks
- Previous intolerance to SSRI
- Severe medical conditions
- Severe heart failure
- Alcohol or substance abuse
Show all 10Show fewer
- Psychosis or dementia
- Current participation in other intervention trials
- Pregnancy and lactation
- Linguistic difficulties
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-Blind, Placebo-Controlled Study of Escitalopram in the Prevention of Depression in Patients With Acute Coronary Syndrome
Objective: To evaluate the efficacy of preventive treatment with a selective serotonin reuptake inhibitor (SSRI) (escitalopram) in the first year after acute coronary syndromes (ACS).
Methods: 240 patients with acute coronary syndromes (ST-elevation myocardial infarction [STEMI]), non-STEMI or unstable angina) will be enrolled within 8 weeks after ACS and will be randomly assigned to treatment with escitalopram/placebo (5-20 mg) in 52 weeks. Primary outcome measures are the diagnosis of depression and HDS (Hamilton Depression Scale). Psychiatric measurements: SCAN (Schedules for Clinical Assessment in Neuropsychiatry), HDS, HAS (Hamilton Anxiety Rating Scale), Udvalg for Kliniske Undersogelser (UKU) Side Effect Rating Scale, ESSI (Enhancing Recovery in Coronary Heart Disease [ENRICHD] Social Support Instrument), SF-36 (Short Form-36 Health Survey), SCL-92 (Symptom Check List) and BDI (Beck´s Depression Inventory). Cardiological measurements are blood pressure, electrocardiography, echocardiography (left ventricular ejection fraction), heart rate variability and use of medicine.
Read more
Discussion: ACS patients with mental illness are usually only diagnosed to a very small extent during admission in a cardiologic department. These patients mainly remain untreated with an increased risk of somatic comorbidity and mortality. Therefore, it is in accordance with ethical principles to conduct a double blind, placebo-controlled study investigating the interface between anxiety, depression and ACS. Even in this blinded study, where one of the groups are treated with placebo, there will be a higher degree of treatment of depressive symptoms due to the low recognition of this problem.
Conclusion: The DECARD study is the first study evaluating the effect of prophylactic treatment of depression in patients with ACS. The study will show if prophylactic treatment will improve cardiac prognosis.
- Conditions
- Depression
- Being tested
- Escitalopram
- Keywords
- Myocardial Infarction
- Medical subject headings
- Depression, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EscitalopramDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Depression Scale
International Classification of Diseases, Revision 10 (ICD-10) Mood Disorder Diagnosis
Secondary outcomes (2)
Cardiac status
Medical comorbidity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2005 (estimated)
- Study startNov 2004
- Primary completionDec 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- H. Lundbeck A/S, Danish Heart Foundation, The Danish Medical Research Council
- Investigators
- Morten Birket-Smith, MD, DMSci, Study director, Psychiatric Centre Bispebjerg, Bispebjerg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00140257
- Sponsor's protocol ID
- KF 12-134/04
- Status last verified
- Dec 2008
- First submitted
- 30 Aug 2005
- Last updated
- 31 Dec 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Hansen BH, Hanash JA, Rasmussen A, Hansen JF, Birket-Smith M. Rationale, design and methodology of a double-blind, randomized, placebo-controlled study of escitalopram in prevention of Depression in Acute Coronary Syndrome (DECARD). Trials. 2009 Apr 7;10:20. doi: 10.1186/1745-6215-10-20.
PubMed 19351383
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled Study of Escitalopram in the Prevention of Depression in Patients With Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT00140257
- Acronym / sponsor ID
- KF 12-134/04
- Conditions
- Depression
- Keywords
- Myocardial Infarction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Collaborators
- H. Lundbeck A/S, Danish Heart Foundation, The Danish Medical Research Council
- Study start
- Nov 2004
- Primary completion
- Dec 2008 (estimated)
- First posted
- 1 Sep 2005 (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.
Objective: To evaluate the efficacy of preventive treatment with a selective serotonin reuptake inhibitor (SSRI) (escitalopram) in the first year after acute coronary syndromes (ACS).
Methods: 240 patients with acute coronary syndromes (ST-elevation myocardial infarction [STEMI]), non-STEMI or unstable angina) will be enrolled within 8 weeks after ACS and will be randomly assigned to treatment with escitalopram/placebo (5-20 mg) in 52 weeks. Primary outcome measures are the diagnosis of depression and HDS (Hamilton Depression Scale). Psychiatric measurements: SCAN (Schedules for Clinical Assessment in Neuropsychiatry), HDS, HAS (Hamilton Anxiety Rating Scale), Udvalg for Kliniske Undersogelser (UKU) Side Effect Rating Scale, ESSI (Enhancing Recovery in Coronary Heart Disease [ENRICHD] Social Support Instrument), SF-36 (Short Form-36 Health Survey), SCL-92 (Symptom Check List) and BDI (Beck´s Depression Inventory). Cardiological measurements are blood pressure, electrocardiography, echocardiography (left ventricular ejection fraction), heart rate variability and use of medicine.
Discussion: ACS patients with mental illness are usually only diagnosed to a very small extent during admission in a cardiologic department. These patients mainly remain untreated with an increased risk of somatic comorbidity and mortality. Therefore, it is in accordance with ethical principles to conduct a double blind, placebo-controlled study investigating the interface between anxiety, depression and ACS. Even in this blinded study, where one of the groups are treated with placebo, there will be a higher degree of treatment of depressive symptoms due to the low recognition of this problem.
Conclusion: The DECARD study is the first study evaluating the effect of prophylactic treatment of depression in patients with ACS. The study will show if prophylactic treatment will improve cardiac prognosis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ACS
- Randomization within 8 weeks form index hospitalization for ACS
- Age > 18 years
- Not pregnant
- Signed informed consent
Key exclusion criteria (10 listed)
- Current depression
- Use of antidepressants < 4 weeks
- Previous intolerance to SSRI
- Severe medical conditions
- Severe heart failure
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 |
|---|---|---|
| Escitalopram | Drug | – |
Primary outcome
Hamilton Depression Scale
International Classification of Diseases, Revision 10 (ICD-10) Mood Disorder Diagnosis
2 secondary outcomes
Cardiac status
Medical comorbidity
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2008.
- Derived from this study: PubMed 19351383Hansen BH, Hanash JA, Rasmussen A, Hansen JF, Birket-Smith M. Rationale, design and methodology of a double-blind, randomized, placebo-controlled study of escitalopram in prevention of Depression in Acute Coronary Syndrome (DECARD). Trials. 2009 Apr 7;10:20. doi: 10.1186/1745-6215-10-20.
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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.
Morten Birket-Smith, MD, DMSci study director
Psychiatric Centre Bispebjerg, Bispebjerg University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Escitalopram in people with Depression, run by Bispebjerg Hospital at 1 site in Denmark.
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 5 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 31 Dec 2008. 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 Denmark. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Hamilton Depression Scale. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00140257, which also lists 1 linked publication.
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 31 Dec 2008.