Treatment of post-myocardial infarction depressive disorder: a randomized, placebo-controlled trial with mirtazapine.
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.
Honig
Adriaan
A
Department of Psychiatry, St. Lucas Andreas Hospital Amsterdam, PO Box 9243, 1006 AE, Amsterdam, The Netherlands. a.honig@slaz.nl
Kuyper
Astrid M G
AM
Schene
Aart H
AH
van Melle
Joost P
JP
de Jonge
Peter
P
Tulner
Dorien M
DM
Schins
Annique
A
Crijns
Harry J G M
HJ
Kuijpers
Petra M J C
PM
Vossen
Helen
H
Lousberg
Richel
R
Ormel
Johan
J
D000368:Aged; D018687:Antidepressive Agents, Second-Generation / Q000009:adverse effects / Q000627:therapeutic use*; D003866:Depressive Disorder / Q000188:drug therapy* / Q000209:etiology*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008803:Mianserin / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D008875:Middle Aged; D000078785:Mirtazapine; D009203:Myocardial Infarction / Q000150:complications* / Q000523:psychology
D018687:Antidepressive Agents, Second-Generation; D008803:Mianserin; D000078785:Mirtazapine