Double-blind, placebo-controlled study with reboxetine in inpatients with severe major depressive disorder 

Versiani M, Amin M, Chouinard G

Federal University, 
Rio de Janeiro, Ipanema, Brazil.
J Clin Psychopharmacol 2000 Feb; 20(1):28-34 

ABSTRACT

The efficacy and tolerability of reboxetine, a unique selective noradrenaline reuptake inhibitor, were compared with those of placebo in a 6-week, randomized, double-blind study of hospitalized patients with a DSM-III-R diagnosis of major depressive disorder. Fifty-two patients (25 in the placebo group, 27 in the reboxetine group) were included in the efficacy analysis. Sixteen (64%) of those in the placebo group and four (15%) in the reboxetine group were withdrawn during the study because of lack of efficacy. Improvement in the mean Hamilton Rating Scale for Depression (HAM-D) total score at last assessment was significantly greater in the reboxetine group than in the placebo group (p < 0.001). Similarly, the response rate to treatment, defined as > or =50% reduction in HAM-D total score, was 74% for patients who received reboxetine compared with 20% for those who received placebo (p < 0.001). A significantly greater response with reboxetine than with placebo was seen as early as day 10 of treatment (p = 0.006). The therapeutic efficacy of reboxetine was substantiated by improvement in mean scores on the Zung Self-Rating Scale and on the Clinical Global Impression Severity of Illness and Global Improvement scales. Reboxetine was well tolerated, and only one patient in each group withdrew because of adverse events. Dry mouth, insomnia, blurred vision, sweating, and constipation were recorded more frequently in the reboxetine group than in the placebo group. There was a tendency toward orthostatic changes in the systolic blood pressure, but this was not clinically significant. This study demonstrated that reboxetine is significantly more effective than placebo in the treatment of hospitalized patients with severe major depressive disorder and is well tolerated.

  
 Reboxetine
  
research / abstracts

  1.  Reboxetine  role in antidepressant therapy
  2.  Reboxetine  efficacy and tolerability
  3.  Reboxetine  clinical pharmacologic profile
  4.  Reboxetine  Inhibiting noradrenaline and serotonin reuptake 
  5.  Reboxetine  and depression in the elderly
  6.  Reboxetine  with severe major depressive disorder
  7.  Reboxetine  clinical efficacy in major depression
  8.  Reboxetine  tolerability and safety for major depression
  9.  Reboxetine  comparison with fluoxetine
 10. Reboxetine  versus fluoxetine, impact on social functioning
 11. Reboxetine  versus fluoxetine, differential effects
 12. Reboxetine  prevents relapse in  major depression
 13. Rebox
etine  efficacy compared with imipramine
 14. Noradrenaline reuptake inhibition
 15. Antidepressants  noradrenergic versus serotonergic
 16. Reb
oxetine  in the treatment of bulimia
 17. Reboxetine  hemodynamic effects in healthy males
 18. Reboxetine  effects of antidepressant therapy
 19. Reboxetine  place in antidepressant therapy
 20. Reboxetine  stimulant effects in patients with narcolepsy
 21. Reboxetine  selective noradrenaline reuptake inhibitor (NARI)

       Reboxetine  manufacturer's product insert                                

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