The aim of this study was to compare the efficacy and tolerability of rebox
etine, a uniquely selective noradrenaline reuptake inhibitor, with the sele
ctive serotonin reuptake inhibitor, fluoxetine. A double-blind, randomized,
parallel-group, multicentre design was employed. One hundred and sixty-eig
ht patients with acute major depressive episodes were randomized to receive
oral reboxetine (8-10 mg/day) or oral fluoxetine (20-40 mg/day). The treat
ment period was 8 weeks. Reboxetine and fluoxetine were similarly effective
as assessed by the mean reduction in total Hamilton Depression Rating Scal
e score, the percentage of responders and patients in remission, Clinical G
lobal Impression severity of illness and global improvement scores and Mont
gomery-Asberg Depression Rating Scale. A sub-analysis of patients with seve
re depression indicated that reboxetine had superior efficacy compared with
fluoxetine. Both treatments resulted in some improvement in Social Adaptat
ion Self-evaluation Scale total scores and this was more evident for those
patients treated with reboxetine who achieved remission. Both treatments we
re well tolerated. The results indicate that reboxetine is an effective and
well tolerated antidepressant, being more effective than fluoxetine in pat
ients with severe depression, and more effective in terms of social functio
ning in those patients who achieved remission. Int Clin Psychopharmacol 14:
73-80 (C) 1999 Lippincott Williams & Wilkins.