Plain English Summary
Background and study aims:
Depression after myocardial infarction (heart attack) is associated with an increased risk of new cardiovascular events and mortality. The aim of MIND-IT was to find out whether offering antidepressant treatment improves cardiovascular prognosis in depressed myocardial infarction patients.
Who can participate?
Patients admitted for myocardial infarction to one of 10 hospitals in the Netherlands with a depressive episode during the first year after the myocardial infarction. In total of 331 patients participated.
What does the study involve?
The study investigates the effects of an antidepressant treatment strategy on depression and cardiovascular events in depressed myocardial infarction patients. Patients were randomly allocated into two groups: a study group and a usual care group. Patients in the study group were offered several types of antidepressant treatments from which they could choose
1. Mirtazapine versus placebo (dummy drug) on depression. If after 8 weeks there is no sufficient improvement in depression, open treatment with the antidepressant citalopram is offered.
2. Citalopram versus placebo on depression
The patients in the usual care received feedback about their depression status, but were told they were free to seek treatment for mood problems outside the study protocol. Hospital readmissions for cardiovascular reasons and mortality during the years following the treatment period were monitored.
What are the possible benefits and risks of participating?
Potential benefits are regular screening for depression after the myocardial infarction may identify patients at increased risk of new cardiovascular events who would otherwise perhaps not be identified. Potential risks of participation in the trial for those in the placebo groups, is that depressed patients may be in need of antidepressants.
Where is the study run from?
Multiple sites in the Netherlands.
When is the study starting and how long is it expected to run for?
Recruitment of patients was between May 2000 and January 2003. The duration of trial for each patient was 6 months.
Who is funding the study?
The Netherlands Heart Foundation
Who is the main contact?
Prof. Dr. Peter de Jonge
peter.de.jonge@umcg.nl
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Effects of antidepressant treatment following myocardial infarction: a randomized controlled trial
Acronym
MIND-IT
Study hypothesis
It is the aim of the Netherlands Heart Foundation's Myocardial INfarction and Depression-Intervention Trial (MIND-IT) to evaluate the influence of antidepressive treatment versus care-as-usual for post-myocardial infarction (MI) depression on cardiac prognosis.
Ethics approval
Medical Ethical Commitee, University Medical Center Groningen, 1998, ref: METc: 98/11/191
Study design
Multicenter single-blind randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Myocardial infarction and depression
Intervention
Patients in the intervention arm were offered several treatment options according to a strictly defined protocol:
First-choice treatment was double-blind placebo-controlled treatment with the selective noradrenaline reuptake inhibitor mirtazapine. In case of refusal or insufficient treatment response after 8 weeks, open treatment with the selective serotonin reuptake inhibitor (SSRI) citalopram was offered. Sufficient treatment response was defined as at least 50% reduction on the Hamilton Depression Rating Scale (HDRS) compared with baseline score or a HDRS score at 8 weeks of 49. Thus, patients who were initially treated with placebo and who did not improve within 8 weeks were subsequently treated with an SSRI.
The third option was 'tailored treatment' which was at the discretion of the clinical psychiatrist (e.g. SSRI, psychotherapy, etc.). Patients were scheduled to visit the psychiatrist on average once a month during the treatment period of 6 months.
Patients in the care as usual arm were not given feedback about their depression status, but were told that they were free to seek treatment for mood problems outside study procedures, which was monitored.
Intervention type
Drug
Phase
Not Applicable
Drug names
Mirtazapine, citalopram
Primary outcome measure
The occurrence of any significant cardiac event. Cardiac events included:
1. Cardiac death or hospital admission for documented non-fatal myocardial infarction
2. Myocardial ischaemia
3. Coronary revascularisation (coronary angioplasty or bypass surgery)
4. Heart failure or ventricular tachycardia occurring in the time between randomisation and 18 months postmyocardial infarction
Secondary outcome measures
Other cardiac-related hospital admissions (defined as admissions with an initial evaluation by a cardiologist or hospitalisations at the cardiology ward)
Overall trial start date
01/09/1999
Overall trial end date
31/12/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Hospital admission for myocardial infarction, defined as: Documentation of an increase in cardiac enzymes and either electrocardiographic changes and/or chest pain (Enzyme changes: elevation of creatine kinase isoenzyme (CK-MB) (CK-MB _1_ ULN and CK-MB/CK ratio above the local normal limit) or in case CKMB is not available, elevation of total CK (total CK _2 _ ULN); electrocardiographic changes: new significant Q waves in at least 2 out of 12 leads or new R in V1 with R/S ratio _1;
Chest pain: _20 minutes of new or markedly increased chest pain)
2. Age more than or equal to18 years
3. Signed informed consent for study
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
331 randomized (209 intervention, 122 care as usual)
Participant exclusion criteria
1. Occurrence of MI while the patient was hospitalized for another reason, except for unstable angina pectoris
2. Lacking capability to participate in study procedures (ie, patients notable to communicate and patients not available for follow-up)
3. Any disease likely to influence short-term survival
4. Already receiving psychiatric treatment for depression
5. Participation in any clinical trial that might intervene with the study objectives and/or safety of the patient
Recruitment start date
01/05/2000
Recruitment end date
01/01/2003
Locations
Countries of recruitment
Netherlands
Trial participating centre
University Medical Center Groningen
-
Trial participating centre
Medical Centre Leeuwarden
-
Trial participating centre
Medical Centre in Enschede
-
Trial participating centre
Medical Centre in Heerenveen
-
Trial participating centre
Medical Centre Drachten
-
Trial participating centre
University Medical Centre Maastricht
-
Trial participating centre
Medical Centre in Heerlen
-
Trial participating centre
University Medical Centre Amsterdam
-
Trial participating centre
Medical Centre in Amsterdam
-
Trial participating centre
Medical Centre in Almere
-
Trial participating centre
University Medical Centre Utrecht
-
Sponsor information
Organisation
The Netherlands Heart Foundation (Netherlands)
Sponsor details
Prinses Catharina Amaliastraat 10
Den Haag
2496 XD
Netherlands
Sponsor type
Government
Website
Funders
Funder type
Industry
Funder name
Organon (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Lundbeck (Denmark)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2002 study protocol on www.ncbi.nlm.nih.gov/pubmed/12177637
2. 2007 results in www.ncbi.nlm.nih.gov/pubmed/17541103
Publication citations
-
Study protocol
van den Brink RH, van Melle JP, Honig A, Schene AH, Crijns HJ, Lambert FP, Ormel J, Treatment of depression after myocardial infarction and the effects on cardiac prognosis and quality of life: rationale and outline of the Myocardial INfarction and Depression-Intervention Trial (MIND-IT)., Am. Heart J., 2002, 144, 2, 219-225.
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Results
van Melle JP, de Jonge P, Honig A, Schene AH, Kuyper AM, Crijns HJ, Schins A, Tulner D, van den Berg MP, Ormel J, , Effects of antidepressant treatment following myocardial infarction., Br J Psychiatry, 2007, 190, 460-466, doi: 10.1192/bjp.bp.106.028647.