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

B. J. Goldstein, B. Brauzer, D. Kentsmith, S. Rosenthal, K. D. Charalampous

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Abstract

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 ≤ .05). A better rate of improvement was seen with nomifensine on the Clinical Global Impressions severity of illness (p ≤ .05) and therapeutic index (p ≤ .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.

Original languageEnglish (US)
Pages (from-to)52-55
Number of pages4
JournalJournal of Clinical Psychiatry
Volume45
Issue number4 II
StatePublished - Jul 12 1984

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ASJC Scopus subject areas

  • Psychiatry and Mental health

Cite this

Goldstein, B. J., Brauzer, B., Kentsmith, D., Rosenthal, S., & Charalampous, K. D. (1984). Double-blind placebo-controlled multicenter evaluation of the efficacy and safety of nomifensine in depressed outpatients. Journal of Clinical Psychiatry, 45(4 II), 52-55.