Switching to reboxetine: An efficacy and safety study in patients with major depressive disorder unresponsive to fluoxetine

The aim of the present study was to evaluate the efficacy and safety of an immediate switch to reboxetine, a selective noradrenaline reuptake inhibitor (selective NRI), in patients with depression unresponsive to the selective serotonin reuptake inhibitor (SSRI) fluoxetine. The study included 128 adult outpatients with DSM-IV major depressive disorder (MDD) who had not responded to at least 6 to 12 weeks of fluoxetine treatment, with at least 3 weeks of treatment on a minimum dose of 40 mg/d. Patients were switched, without a washout period, to reboxetine 4 mg twice daily, with the possibility of increasing the dose to 10 mg/d (given in divided doses) after 4 weeks of treatment. Efficacy was assessed using the 17-item Hamilton Rating Scale for Depression (HAM-D-17) and the Clinical Global Impression Improvement (CGI-1) and Severity (CGI-S) scales. Safety was evaluated by recording spontaneously reported adverse events. A statistically significant (P < 0.001) improvement in the mean total HAM-D-17 score was seen from baseline by week 1 of treatment with reboxetine, and the improvement continue to week 8. CGI-I and CGI-S scores were similarly improved. The switch to reboxetine was well tolerated; the most common treatment-emergent adverse events were insomnia, headache, dry mouth, diaphoresis. and constipation, all of which were mild to moderate in severity and decreased in frequency as the study progressed. Immediate switching to reboxetine appears to be a safe and effective treatment for patients with depression who have failed to respond to an adequate dose of fluoxetine.