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Published online before print September 10, 2007
Psychosom Med 2007, doi:10.1097/PSY.0b013e31814b260d
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© 2007 by American Psychosomatic Society

Original Article


Received October 16, 2006
Returned for revision May 2, 2007

Treatment of Post-Myocardial Infarction Depressive Disorder: A Randomized, Placebo-Controlled Trial With Mirtazapine

Adriaan Honig , MD, PhD, Astrid M. G. Kuyper , MD, Aart H. Schene , MD, PhD, Joost P. van Melle , MD, PhD, Peter de Jonge , MD, PhD, Dorien M. Tulner , MD, Annique Schins , MD, PhD, Harry J. G. M. Crijns , MD, PhD, Petra M. J. C. Kuijpers , MD, PhD, Helen Vossen , MPsych, Richel Lousberg , PhD, Johan Ormel , PhD, On behalf of the MIND-IT investigators



  Abstract

Objective: To examine the antidepressant efficacy of a dual-acting antidepressant (mirtazapine) in patients with post-myocardial infarction (MI) depressive disorder. Antidepressants used in post MI trials with a randomized, double-blind, placebo-controlled design have been restricted to selective serotonin reuptake inhibitors (SSRIs). Antidepressant effects have been limited. Methods: In a prospective multicenter study, 2177 patients with MI were evaluated for depressive disorder during the first year post MI. Ninety-one patients who met the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for major or minor depressive disorder were randomized to a 24-week, double-blind, placebo-controlled trial. Antidepressant efficacy was tested using last-observation-carried-forward procedure and repeated measurements analysis using the SPPS mixed models approach, with as primary outcome reduction in depressive symptomatology on the 17-item Hamilton-Depression Rating Scale (Ham-D), and secondary outcomes the Beck Depression Inventory (BDI) and depression subscale of the Symptom Check List 90 items (dSCL-90) as well as the Clinical Global Impression (CGI) scale. Results: Using the "last observation carried forward" (LOCF) method, mirtazapine did not show to be superior to placebo on the Ham-D, but did on the BDI, dSCL-90, and CGI scale over the acute treatment phase of 8 weeks (n = 91). Using mixed models analysis over the entire 24 weeks of treatment (n = 40), we did find a significant difference favoring mirtazapine to placebo on the Ham-D, BDI, and CGI, but on the dSCL-90, this difference was not significant. Conclusions: This trial shows efficacy of mirtazapine on primary and secondary depression measures. Mirtazapine seems to be safe in the treatment of post-MI depression.

Key Words: post myocardial infarction, depressive disorder, antidepressive treatment, mirtazapine.




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Copyright © 2007 by the American Psychosomatic Society