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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 Sixteen (64%) of those in the placebo group and four (15%) in the reboxetine group were withdrawn during the study because of lack of efficacy.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.

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                Reboxetine  research / abstracts

         1.   Reboxetine  role in antidepressant therapy
         2.   Reboxetine  efficacy and tolerability
         3.   Reboxetine  clinical pharmacologic profile
         4.   Inhibiting  the reuptake of noradrenaline and serotonin
         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  
Reboxetine  efficacy compared with imipramine
       
14.  Noradrenaline reuptake inhibition
        15.  Antidepressants  noradrenergic versus serotonergic 
        16. 
Reboxetine  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)

 

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