Effects of adjunctive reboxetine in patients with duloxetine-resistant depression: a 12-week prospective study

Abstract

The efficacy of the combination therapy with two antidepressants from different pharmacological families in patients with treatment-resistant depression has been reported in multiple studies. In this prospective 12-weeks open-label study, we assessed the effectiveness of the addition of reboxetine to 79 depressive outpatients diagnosed with major depressive disorder (MDD) according to the DSM-IV criteria who had previously not responded, or had done so only in a partial way, over 8 weeks of conventional treatment, in monotherapy, with duloxetine. Efficacy was assessed using the 21-item Hamilton Depression Rating Scale (HDRS) and the Clinical Global Impression-Improvement (CGI-I). Safety was evaluated by recording spontaneously reported adverse events. Data were analysed on an intent-to-treat basis, using the last-observation-carried-forward method. Mean HDRS reduction was 65.5% (P < 0.0001). The percentages of responders (≥50% reduction in HDRS) and patients considered benefiting from complete remission (HDRS ≤ 10 points) at week 12 were 76% and 69.3%, respectively. By the end of the treatment, the score of CGI-I decreased 68.5% (P < 0.0001). Percentage of patient improving (CGI < 4 points) was 95.8%. The most common non-serious adverse events were dry mouth, increased sweating, constipation and difficulty passing urine. The results of this study suggest that the combination strategy with reboxetine may be an effective and well-tolerated tool in duloxetine-resistant patients.