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Published online before print September 10, 2007, 10.1097/PSY.0b013e31814b260d
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Psychosomatic Medicine 69:606-613 (2007)
© 2007 American Psychosomatic Society

ORIGINAL ARTICLES

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*

From the Department of Psychiatry (A.M.G.K., A.H.S.), Academic Medical Center Amsterdam, Netherlands; Department of Cardiology (J.P.v.M.), Thoraxcenter, University Medical Center Groningen, Netherlands; Department of Internal Medicine and Psychiatry (P.d.J.), University Medical Center Groningen, Netherlands; Department of Psychiatry (D.T.), Medical Center Leeuwarden, Netherlands; Department of Psychiatry (A.S.), Academical Hospital Maastricht, Netherlands; Department of Cardiology (H.J.G.M.C., P.M.J.C.K.) and Psychiatry (H.V., R.L.), University Hospital Maastricht, Netherlands; and Department of Social Psychiatry and Psychiatric Epidemiology (J.O.), University Medical Center, Groningen, Netherlands.

Address correspondence and reprint requests to Adriaan Honig, Department of Psychiatry, St. Lucas Andreas Hospital Amsterdam, PO Box 9243, 1006 AE, Amsterdam, Netherlands. E-mail: a.honig{at}slaz.nl

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

Abbreviations: MI = myocardial infarction; RCT = randomized controlled trial; DSM-IV = Diagnostic and Statistical Manual of Mental Disorders; CAD = coronary artery disease; SSRI = selective serotonin reuptake inhibitors; TCA = tricyclic antidepressant; Ham-D = Hamilton-Depression Rating Scale; BDI = Beck Depression Inventory; CGI = Clinical Global Impression; dSCL-90 = Symptom Check List 90 items, depression subscale; SES = standardized effect size.




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