Condition category
Circulatory System
Date applied
02/04/2012
Date assigned
22/05/2012
Last edited
25/08/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Prof Peter de Jonge

ORCID ID

Contact details

University Medical Center Groningen
Hanzeplein 1
Groningen
9713 GZ
Netherlands

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 measures

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

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

http://www.harstichting.nl

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

Results - basic reporting

Publication summary

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

  1. 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.

  2. 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.

Additional files

Editorial Notes