Reboxetine: A randomized controlled open-label study in children and adolescents with major depression

Objective: This study is the first to examine the efficacy of reboxetine in the treatment of children and adolescents with depression. Method: In this open-label randomized controlled study, 14 youths (aged 9-18 years) with major depression received either reboxetine (4mg/day) or fluoxetine (20mg/day) in a 2:1 ratio. Primary outcome measures included the Children’s Depression Rating Scale-Revised (CDRS-R), the Clinical Global Impression-Improvement scale (CGI-I), and the Children’s Depression Inventory (CDI). Response was defined by either a 20% reduction in CDRS-R or a 2-point reduction in CGI-I. Results: Improvement in depression with reboxetine was noted within 4 weeks. A further non-significant improvement was noted after 8 weeks, proceeding through week 12. Response was achieved by six subjects (66.7%) by week 4 and eight subjects (88.9%) by week 12. Both reboxetine and fluoxetine were safe with tolerable adverse effects, although several non-significant differences in efficacy and overall frequency of side effects were found in favor of fluoxetine. Conclusions: Reboxetine was safe and effective in treating youth with major depressive disorder. Further studies with long-term follow up are needed in order to replicate our findings and determine the relative efficacy of reboxetine compared to fluoxetine.