Reboxetine, a new noradrenaline selective antidepressant, is at least as effective as fluoxetine in the treatment of depression.
The clinical profile of reboxetine, a selective noradrenaline reuptake inhibitor, was compared with that of the selective serotonin reuptake inhibitor fluoxetine and placebo in a double-blind, multicenter, parallel-group clinical trial of patients with major depression. Among the 381 patients treated with reboxetine 8 to 10 mg/day, fluoxetine 20 to 40 mg/day, or placebo for up to 8 weeks, a statistically significant greater reduction in the mean Hamilton Rating Scale for Depression (21-item HAM-D) total score (the primary efficacy variable) was seen for both active treatment groups compared with placebo (p < 0.024). A significantly greater proportion of patients treated with either reboxetine or fluoxetine also achieved a response (>or=50% reduction in HAM-D) or remission (HAM-D <or=10 points) than those who received placebo (p < 0.01 for both analyses). Similar findings were recorded in a subpopulation of severely ill patients, with statistically significantly greater decreases in the mean HAM-D total score between both active treatment groups compared with placebo (p < 0.024). Additional efficacy assessments (Montgomery-Asberg Depression Rating Scale, Clinical Global Impression) reflected the primary efficacy analysis, with both active treatments offering comparable efficacy that was superior to that of placebo. Reboxetine and fluoxetine are more effective than placebo in the treatment of major depression. Futhermore, both antidepressants are well tolerated but possess different adverse event profiles.
Andreoli
Vittorino
V
Primario Servizi Psychiatri, Ospedale di Soave, Soave, Italy. andreoliv@easyasp.it
Caillard
Vincent
V
Deo
Ripu S
RS
Rybakowski
Janusz K
JK
Versiani
Marcio
M
D018759:Adrenergic Uptake Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D000328:Adult; D000704:Analysis of Variance; D000928:Antidepressive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D016009:Chi-Square Distribution; D016001:Confidence Intervals; D003865:Major Depressive Disorder / Q000188:drug therapy* / Q000523:psychology; D004311:Double-Blind Method; D005260:Female; D005473:Fluoxetine / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009025:Morpholines / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D011569:Psychiatric Status Rating Scales / Q000706:statistics & numerical data; D000077593:Reboxetine; D017367:Selective Serotonin Reuptake Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*
D018759:Adrenergic Uptake Inhibitors; D000928:Antidepressive Agents; D005473:Fluoxetine; D009025:Morpholines; D000077593:Reboxetine; D017367:Selective Serotonin Reuptake Inhibitors