A MULTICENTER DOUBLE-BLIND COMPARISON OF NEFAZODONE AND PAROXETINE INTHE TREATMENT OF OUTPATIENTS WITH MODERATE-TO-SEVERE DEPRESSION

Background: The efficacy, safety, and tolerance of nefazodone and paro xetine in the treatment of depressed outpatients were compared in a ra ndomized, double-blind parallel group study at 20 centers in the Unite d Kingdom and Republic of Ireland. Method: The study population compri sed 206 outpatients meeting DSM-III-R criteria for a moderate-to-sever e nonpsychotic major depressive episode. Patients considered to be at serious risk of suicide were excluded from participation in the study. After a drug-free baseline phase of 1 to 4 weeks, patients were rando mly assigned to treatment with either nefazodone or paroxetine. Outcom e measures for efficacy included the Clinical Global Impressions scale s, Hamilton Rating Scale for Depression, Hamilton Rating Scale for Anx iety, Montgomery-Asberg Depression Rating Scale, and Patient Global As sessment scale. Tolerance and safety were assessed using spontaneously reported adverse events, vital signs, and laboratory investigations. Results: There were no significant differences between the groups in c linical outcome. Analysis of the efficacy measures revealed a consiste nt and continuous improvement in both groups. A similar proportion of patients in each group discontinued treatment owing to adverse events: 15 (14%) in the nefazodone group and 13 (13%) in the paroxetine group . Conclusion: Nefazodone and paroxetine have similar efficacy and tole rability in the treatment of outpatients with major depression.