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J Clin Pharm Ther ; 30(2): 133-8, 2005 Apr.
Article in English | MEDLINE | ID: mdl-15811165

ABSTRACT

BACKGROUND: Depression is an international public health problem. The aim of this study was to compare the efficacy and tolerability of mirtazapine and fluoxetine treatment in a sample population consisting of Iranian patients suffering major depressive disorder. METHODS: Thirty-six inpatients and outpatients with a diagnosis of major depressive disorder (Diagnostic and Statistical Manual of Mental Disorders-IV) and a score > or = 18 on the 17-item Hamilton Rating Scale for Depression (HAM-D-17) were randomly assigned to 6 weeks of treatment with mirtazapine (30 mg/day) or fluoxetine (20 mg/day). Efficacy was assessed by HAM-D-17. Information about adverse events was obtained by questioning of participants and/or their examination. Assessments were performed at weeks 0, 1, 2, 3, 4 and 6. RESULTS: Sixteen of mirtazapine-treated patients and fifteen of fluoxetine-treated patients completed the 6-week study period. Both treatment groups were well matched at baseline with respect to demographic and disease characteristics. Both drugs showed a significant improvement over the 6 weeks of treatment (P < 0.001). There was no statistically significant difference between the mean +/- SEM HAM-D scores of two groups at weeks 1, 2, 3, 4, and at the end point. There were no significant differences between two groups in terms of response to treatment (> or = 50% decrease from baseline in HAM-D-17 total score) and remission (HAM-D-17 score of < or = 7). None of the differences in reported adverse events was statistically significant. CONCLUSION: In this study, mirtazapine and fluoxetine were equally effective and well tolerated after 6 weeks of treatment in patients with major depressive disorder.


Subject(s)
Depressive Disorder, Major/drug therapy , Fluoxetine/therapeutic use , Mianserin/analogs & derivatives , Adolescent , Adult , Depressive Disorder, Major/diagnosis , Depressive Disorder, Major/physiopathology , Diagnostic and Statistical Manual of Mental Disorders , Double-Blind Method , Drug Administration Schedule , Female , Fluoxetine/administration & dosage , Fluoxetine/adverse effects , Humans , Inpatients , Male , Mianserin/administration & dosage , Mianserin/adverse effects , Mianserin/therapeutic use , Middle Aged , Mirtazapine , Outpatients , Oxazepam/administration & dosage , Treatment Outcome
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