Depressive symptoms in post myocardial infarction patients
Conditions
Sponsors
H. Lundbeck A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The patient is able to read and understand the patient information sheet. 2. Prior to any screening procedures, the patient must have signed the informed consent form. 3. Male or female outpatient aged from 40 to 75 years (extremes included). 4. A score above or equal to 20 on the SCL-90-R Depression subscale (13 items). 5. Admission for chest pain (or other MI symptom) with a diagnosis of evolving MI not less than 3 weeks and not more than 24 weeks prior to screening, as evidenced by either a or b: a.Elevation of biochemical markers of myocardial infarction (troponin, CK/MB). b.ECG changes that are unequivocally consistent with an acute, evolving MI, i.e. development of significant Q-wave in at least two continuous leads. 6. On the basis of a physical examination, medical history, ECG, and the results of blood biochemistry and haematology tests carried out at the screening visit, the patient is, in the investigator’s opinion, healthy, otherwise than what is part of the myocardial infarction and its sequelea. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients who have previously participated in this study. 2. Coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA) within 3 weeks of screening or CABG or PTCA during the duration of the study. 3. Known Class IV rating as defined by the Canadian Cardiovascular Society (CCS) Classification for angina, based on investigator judgment or medical chart. 4. Known Class IV rating as defined by the Congestive Heart Failure Classification of the New York Heart Association (NYHA), based on investigator judgment or medical chart. 5. Ongoing myocardial ischemia diagnosed with presence of ST-segment elevation or ST-segment depression on screening visit ECG. 6. Cardiac arrhythmias (except atrial fibrillation) necessitating other anti-arrhythmic treatment than beta-blockers or calcium-channel blockers. 7. Uncontrolled high blood pressure: diastolic above or equal to 100 mmHg or systolic above or equal to 180 mmHg. 8. Bipolar I and II disorders, major depressive episode with psychotic features or evidence of substance abuse or dependency during the previous 12 months based on investigator judgment or medical chart. 9. Patients with a baseline MADRS total score above or equal to 40. 10. Serious suicide risk based on investigator judgment or a score above or equal to 3 on item 15 of the SCL-90-R or a score above or equal to 5 on item 10 of the MADRS. 11. Use of disallowed recent or concomitant medications or treatments: ·IMAO or RIMA within 2 weeks prior to screening. ·Fluoxetine within 5 weeks and other SSRIs or TCAs or SNRIs within the past 2 weeks prior to screening. ·Herbal remedies, which are psychoactive (including St-John’s Wort, S-adenosylmethionine or SAMe, kava kava, valerian, ginkgo biloba) within 2 weeks prior to screening. ·Tryptophan within 2 weeks prior to screening. ·Any drug used for the augmentation of antidepressant action within 2 weeks prior to screening. ·Any other anti-depressants within the 2 weeks prior to screening. ·Mood stabilisers/antimanic drugs/anticonsulvants (e.g. lithium, lamotrigine, valproic acid, gabapentine, carbamazepine, phenytoin) within the 2 weeks prior to screening. ·Oral antipsychotics in the 2 weeks or depot anti-psychotics in the 6 months prior to screening. ·Electroconvulsive therapy (ECT) within the 6 months prior to screening. ·Benzodiazepines are only allowed if the patient is on stable treatment prior to screening with a maximum daily dose of diazepam 10 mg (or its equivalent). This dose should remain fixed for the duration of the study. ·During the course of the study period, if needed, the use of hypnotics is allowed (zolpidem, zaleplon or zopiclone) for a maximum of 3 evenings per week. ·Dopamine antagonists (e.g. metoclopramide) for any indication within 2 weeks prior to screening. ·Serotonergic agonists (e.g. triptans) within 2 weeks prior to screening. ·Any other drugs with potential psychotropic effects within 2 weeks prior to screening. 12. Patient was receiving, within 4 weeks prior to screening, formal behaviour therapy or systematic psychotherapy, or was planning to initiate such therapy during the study. 13. The patient has a serious illness or serious sequelae thereof, including liver or renal insufficiency, or a pulmonary, gastrointestinal, endocrine, neurological, infectious, neoplastic, or metabolic disturbance. 14. The patient has laboratory values outside the normal ranges and considered by the investigator to be clinically sign
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy and safety of 8 weeks of escitalopram treatment on depressive symptoms in post myocardial infarction outpatients.;Secondary Objective: During a 24-week study period: to assess the efficacy of escitalopram to assess the safety and tolerability of escitalopram to assess quality of life to evaluate resource utilization ;Primary end point(s): Change from baseline to week 8 in SCL-90-R depression subscale score (LOCF) | — |
Countries
Denmark, Finland
Outcome results
None listed