CLINICAL EFFICACY OF REBOXETINE - A COMPARATIVE-STUDY WITH DESIPRAMINE, WITH METHODOLOGICAL CONSIDERATIONS

The efficacy and tolerability of 4-8 mg reboxetine, a selective noradr enaline reuptake inhibitor (NARI) was verified in a 4-week, double-bli nd, placebo-and desipramine-controlled study in hospitalised patients with major depression. Two-hundred-and-fifty-eight patients were recru ited and randomised to treatment with 4-8 mg reboxetine, 100-200 mg de sipramine or placebo on a fixed, changing dosage regimen. Tile therape utic response rate (<50% reduction in mean efficacy rating scale total scores) was significantly higher with reboxetine than with placebo (p < 0.05). The onset of therapeutic effect [when mean efficacy rating s cale total scores became significantly (p < 0.05) lower (better) than placebo] was consistently earlier with reboxetine than desipramine. Fr om the three adverse events encountered with significant (p < 0.05) di fference among the groups, dryness of mouth and blurred vision were re ported more frequently with desipramine than with reboxetine and place bo, whereas urinary hesitancy was reported more frequently with reboxe tine than placebo. No clinically significant changes were observed in laboratory parameters and vital signs. The mean scores on the CGI-Effi cacy Index in the reboxetine group was significantly (p < 0.05) higher (better) than in the desipramine and placebo groups. CODE-DD demonstr ated the broadness of the DSM-III-R diagnosis of major depression and provided information for designing studies for the detection of the tr eatment responsive population of reboxetine. In conclusion, reboxetine administered for 4 weeks in the daily doses of 4-8 mg was effective a nd well tolerated in treating hospitalised patients with major depress ion. (C) 1998 John Wiley & Sons, Ltd.