Reboxetine, a unique selective NRI, prevents relapse and recurrence in long-term treatment of major depressive disorder.
BACKGROUND
The long-term efficacy and tolerability of the antidepressant reboxetine, a unique selective norepinephrine reuptake inhibitor (selective NRI), were assessed in an international study.


METHODS
Two hundred eighty-three patients with recurrent DSM-III-R major depression who responded to 6 weeks of reboxetine treatment (> or =50% decrease in Hamilton Rating Scale for Depression [HAM-D] total score) were randomly assigned to receive reboxetine or placebo for 46 weeks in a double-blind phase. Relapse (> or =50% increase in HAM-D total score and/or a HAM-D total score > or =18) rate was the principal assessment criterion and included patients who experienced relapse or recurrence. Only patients who remained relapse-free at the end of the first 6-month treatment period were included in the relapse rate assessment at the end of the second 6-month treatment period.


RESULTS
Reboxetine was associated with a markedly lower relapse rate than placebo (22% vs. 56%; p<.001) and a greater cumulative probability of a maintained response (p = .0001) during long-term treatment. Patients in remission (HAM-D total score < or =10) at the time of random assignment were less likely to relapse (16% reboxetine, 48% placebo; p<.001). The proportion of patients who were relapse-free and therefore remained in the study was significantly (p< or =.001) higher among those on reboxetine treatment than on placebo at the end of the first (61% vs. 40%) and second (88% vs. 59%) 6 months of treatment. Additional efficacy measures supported these findings. The incidence of adverse events with reboxetine was low and comparable with that for placebo. Discontinuation due to adverse events occurred infrequently.


CONCLUSIONS
Reboxetine treatment over 1 year is more effective than placebo in the prevention of relapse in patients with recurrent depression. The low relapse rates at the end of the second 6 months of treatment further suggest that reboxetine effectively prevents recurrence of depressive symptoms following episode resolution. Reboxetine is well tolerated in long-term treatment of depression, a finding that bodes well for long-term patient compliance.
Institute of Psychiatry, Federal University, Rio de Janeiro, Brazil.
M
M
Versiani
L
L
Mehilane
P
P
Gaszner
R
R
Arnaud-Castiglioni
D018759:Adrenergic Uptake Inhibitors / Q000627:therapeutic use*; D000328:Adult; D003866:Depressive Disorder / Q000188:drug therapy / Q000517:prevention & control* / Q000523:psychology; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D009025:Morpholines / Q000627:therapeutic use*; D009638:Norepinephrine; D010352:Patient Dropouts; D010919:Placebos; D011569:Psychiatric Status Rating Scales / Q000706:statistics & numerical data; D000077593:Reboxetine; D055502:Secondary Prevention; D016896:Treatment Outcome
D018759:Adrenergic Uptake Inhibitors; D009025:Morpholines; D010919:Placebos; D000077593:Reboxetine; D009638:Norepinephrine