Double-blind comparison of the efficacy and safety of nomifensine maleate vs. placebo in depressed outpatients.
Nomifensine maleate in doses of 100-200 mg/day was compared to placebo in a double-blind study of 50 moderately to severely depressed outpatients seen in a private practice. Efficacy ratings over the 28-day treatment period revealed significant improvement in the nomifensine group on the Hamilton Depression Rating Scale and Clinical Global Impressions, as well as the Self-Rating Symptom Scale, Brief Psychiatric Rating Scale, and Hamilton Anxiety Scale. These differences in favor of nomifensine were seen as early as Day 7 of treatment and were generally consistent throughout the trial. No clinically meaningful changes in vital signs or laboratory values were found over the course of treatment. Only one side effect, a pruritic rash in one patient, was directly attributable to active drug treatment. The CGI Therapeutic Index revealed a very favorable ratio of clinical benefit to side effects for nomifensine maleate.
D000293:Adolescent; D000328:Adult; D000553:Ambulatory Care; D002648:Child; D002986:Clinical Trials as Topic; D003866:Depressive Disorder / Q000188:drug therapy* / Q000523:psychology; D003875:Drug Eruptions / Q000209:etiology; D005260:Female; D006801:Humans; D007546:Isoquinolines / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009627:Nomifensine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D010043:Outcome and Process Assessment, Health Care; D010555:Personality Inventory; D010919:Placebos; D011537:Pruritus / Q000139:chemically induced; D011569:Psychiatric Status Rating Scales
D007546:Isoquinolines; D010919:Placebos; D009627:Nomifensine