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 r eboxetine, a unique selective norepinephrine reuptake inhibitor (selective NRI), were assessed in an international study. Method: Two hundred eighty-three patients with recurrent DSM-III-R major de pression who responded to 6 weeks of reboxetine treatment (greater than or equal to 50% decrease in Hamilton Rating Scale for Depression [HAM-D] total score) were randomly assigned to receive reboxetine or placebo for 46 week s in a double-blind phase. Relapse (greater than or equal to 50% increase i n HAM-D total score and/or a HAM-D total score greater than or equal to 18) rate was the principal assessment criterion and included patients who expe rienced relapse or recurrence. Only patients who remained relapse-free at t he end of the first 6-month treatment period were included in the relapse r ate 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 m aintained response (p = .0001) during long-term treatment. Patients in remi ssion (HAM-D total score less than or equal to 10) at the time of random as signment 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 < .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 an d comparable with that for placebo. Discontinuation due to adverse events o ccurred infrequently. Conclusion: Reboxetine treatment over 1 year is more effective than placebo in the prevention of relapse in patients with recurrent depression. The lo w relapse rates at the end of the second 6 months of treatment further sugg est that reboxetine effectively prevents recurrence of depressive symptoms following episode resolution. Reboxetine is well tolerated in long-term tre atment of depression, a finding that bodes well for long-term patient compl iance.