Background: The efficacy, safety, and tolerance of nefazodone and paroxetine in the treatment of depressed outpatients were compared in a randomized, double-blind parallel group study at 20 centers in the United Kingdom and Republic of Ireland.
Method: The study population comprised 206 outpatients meeting DSM-III-R criteria for a moderate-to-severe 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 randomly assigned to treatment with either nefazodone or paroxetine. Outcome measures for efficacy included the Clinical Global Impressions scales, Hamilton Rating Scale for Depression, Hamilton Rating Scale for Anxiety, Montgomery-Asberg Depression Rating Scale, and Patient Global Assessment 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 clinical outcome. Analysis of the efficacy measures revealed a consistent 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 tolerability in the treatment of outpatients with major depression.