INTRODUCTION: Recent studies have confirmed the usefulness of the therapeutical combination of two antidepressants from different pharmacological families in patients with single drug therapy resistant depression. METHODS: In this prospective 6 weeks open-labeled study, efficacy of combination strategy was evaluated. This included the addition of reboxetine to 34 outpatients with DSM-IV major depressive disorder, who had not responded previously, or who partially responded to conventional treatment in single drug therapy with serotonin selective reuptake inhibitors (SSRI). Data were analyzed on a intent-to-treat basis. RESULTS: Mean decrease in the 21 item Hamilton depression rating scale (HDRS) score was 49.4% (from 26.9 to 13.6; p<0.0001) and in the clinical global impressions scale (CGI) was 40.4% (from 4.6 to 2.7; p < 0.0001). At the end of the treatment, 47.1% of the patients we re considered in remission (HDRS < or = 10), 55.9% evaluated as responders (HDRS < or = 50%) and 58.8% considered as having improvement (CGI<4). No serious side effects were observed during combination therapy, the most frequent being nervousness and the urinary hesitancy (5.9%). CONCLUSIONS: The results of this study suggest that addition of reboxetine to SSRI may be an effective and well-tolerated strategy in treatment-resistant patients who have failed to adequately respond to single drug therapy with SSRI.
INTRODUCTION: Recent studies have confirmed the usefulness of the therapeutical combination of two antidepressants from different pharmacological families in patients with single drug therapy resistant depression. METHODS: In this prospective 6 weeks open-labeled study, efficacy of combination strategy was evaluated. This included the addition of reboxetine to 34 outpatients with DSM-IV major depressive disorder, who had not responded previously, or who partially responded to conventional treatment in single drug therapy with serotonin selective reuptake inhibitors (SSRI). Data were analyzed on a intent-to-treat basis. RESULTS: Mean decrease in the 21 item Hamilton depression rating scale (HDRS) score was 49.4% (from 26.9 to 13.6; p<0.0001) and in the clinical global impressions scale (CGI) was 40.4% (from 4.6 to 2.7; p < 0.0001). At the end of the treatment, 47.1% of the patients we re considered in remission (HDRS < or = 10), 55.9% evaluated as responders (HDRS < or = 50%) and 58.8% considered as having improvement (CGI<4). No serious side effects were observed during combination therapy, the most frequent being nervousness and the urinary hesitancy (5.9%). CONCLUSIONS: The results of this study suggest that addition of reboxetine to SSRI may be an effective and well-tolerated strategy in treatment-resistant patients who have failed to adequately respond to single drug therapy with SSRI.