Premium
Clinical efficacy of reboxetine: a comparative study with desipramine, with methodological considerations
Author(s) -
Ban T. A.,
Gaszner P.,
Aguglia E.,
Batista R.,
Castillo A.,
Lipcsey A.,
Macher J.P.,
TorresRuiz A.,
Vergara L.
Publication year - 1998
Publication title -
human psychopharmacology: clinical and experimental
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.461
H-Index - 78
eISSN - 1099-1077
pISSN - 0885-6222
DOI - 10.1002/(sici)1099-1077(199802)13:1+<s29::aid-hup980>3.0.co;2-d
Subject(s) - reboxetine , desipramine , pharmacology , medicine , psychology , psychiatry , antidepressant , reuptake inhibitor , anxiety
The efficacy and tolerability of 4–8 mg reboxetine, a selective noradrenaline reuptake inhibitor (NARI) was verified in a 4‐week, double‐blind, placebo‐ and desipramine‐controlled study in hospitalised patients with major depression. Two‐hundred‐and‐fifty‐eight patients were 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 rating scale total scores) was significantly higher with reboxetine than with placebo ( p <0·05). The onset of therapeutic effect [when mean efficacy rating scale total scores became significantly ( p <0·05) lower (better) than placebo] was consistently earlier with reboxetine than desipramine. From the three adverse events encountered with significant ( p <0·05) difference among the groups, dryness of mouth and blurred vision were reported more frequently with desipramine than with reboxetine and placebo, whereas urinary hesitancy was reported more frequently with reboxetine than placebo. No clinically significant changes were observed in laboratory parameters and vital signs. The mean scores on the CGI‐Efficacy Index in the reboxetine group was significantly ( p <0·05) higher (better) than in the desipramine and placebo groups. CODE‐DD demonstrated the broadness of the DSM‐III‐R diagnosis of major depression and provided information for designing studies for the detection of the treatment responsive population of reboxetine. In conclusion, reboxetine administered for 4 weeks in the daily doses of 4–8 mg was effective and well tolerated in treating hospitalised patients with major depression. © 1998 John Wiley & Sons, Ltd.