Clinical efficacy of reboxetine: a comparative study with desipramine, with methodological considerations

Abstract

The efficacy and tolerability of 4-8 mg reboxetine, a selectivenoradrenaline reuptake inhibitor (NARI) was verified in a 4-week,double-blind, placebo-and desipramine-controlled study in hospitalisedpatients with major depression. Two-hundred-and-fifty-eight patientswere recruited and randomised to treatment with 4-8 mg reboxetine,100-200 mg desipramine or placebo on a fixed, changing dosage regimen.The therapeutic response rate (<50% reduction in mean efficacy ratingscale total scores) was significantly higher with reboxetine than withplacebo (p < 0.05). The onset of therapeutic effect {[}when meanefficacy rating scale total scores became significantly (p < 0.05) lower(better) than placebo] was consistently earlier with reboxetine thandesipramine. From the three adverse events encountered with significant(p < 0.05) difference among the groups, dryness of mouth and blurredvision were reported more frequently with desipramine than withreboxetine and placebo, whereas urinary hesitancy was reported morefrequently with reboxetine than placebo. No clinically significantchanges were observed in laboratory parameters and vital signs. The meanscores on the CGI-Efficacy Index in the reboxetine group wassignificantly (p < 0.05) higher (better) than in the desipramine andplacebo groups. CODE-DD demonstrated the broadness of the DSM-III-Rdiagnosis of major depression and provided information for designingstudies for the detection of the treatment responsive population ofreboxetine. In conclusion, reboxetine administered for 4 weeks in thedaily doses of 4-8 mg was effective and well tolerated in treatinghospitalised patients with major depression. (C) 1998 John Wiley &Sons, Ltd.