Introduction: Treatment-resistant depression is a relatively common clinical occurrence: between 60-70% of depressive patients fail to achieve total remission to the initial treatment with selective serotonin reuptake inhibitors (SSRI).
Methods: In this prospective 12-week open-label study, we evaluated the effectiveness of the addition of reboxetine to 141 outpatients diagnosed with major depressive disorder, according to DSM-IV-TR criteria, who were partial responders or non-responders over a period of 6 weeks, to previous treatment in monotherapy with SSRI. Evaluation of antidepressant efficacy was carried out through the application of the Hamilton Depression Rating Scale (HDRS) and the Clinical Global Impressions-Global Improvement Scale (CGI-I). Data were analyzed on an intent-to-treat basis, using the last-observation-carried-forward method.
Results: Mean score on the HDRS at baseline was 26.24±7.21, falling to 13.96±8.00 in week 12 (mean decrease of 46.79%; p<0.0001) The percentages of responders (HDRS total score ≥50%) and patients considered as benefiting from complete remission (HDRS score ≤10) at 12 weeks were 50.4% and 34.5%, respectively. By the end of the treatment, a mean decrease in CGI-I score of 1.88 points was obtained (41.14% of reduction; p<0.0001), and 77% of the patients were evaluated as improved (CGI-I score <4). Nervousness was the adverse effect most frequently reported (5.21%), followed by dryness of mouth (4.38%), and insomnia (3.56%).
Conclusion: The results of this study suggest that the combination strategy with reboxetine appears to be a potentially useful tool in cases of SSRI-resistant depression.
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