Double-blind placebo-controlled multicenter evaluation of the efficacy and safety of nomifensine in depressed outpatients.

Outpatients with primary affective disorder-depression who scored at least 20 on the Hamilton Depression Rating Scale (HDRS) were randomly assigned to treatment for 1 month with nomifensine (100-200 mg/day) or placebo. Clinical laboratory and physical evaluations, including ECGs when feasible, revealed no clinically significant changes over the course of treatment. Nomifensine patients showed improvement compared to placebo on the HDRS total score endpoint analysis (p = .06) and the Cognitive Disturbance and Retardation factors (p less than or equal to .05). A better rate of improvement was seen with nomifensine on the Clinical Global Impressions severity of illness (p less than or equal to .05) and therapeutic index (p less than or equal to .05) components. No differences were seen between groups in the incidence of overall or specific side effects. Nomifensine thus appeared safe and superior to placebo on several key measures of depressive symptomatology in this multicenter study of depressed outpatients.