[Comparative study of the efficacy and acceptability of amineptine and fluoxetine in patients with major depression]

Abstract

We compare two anti-depressant drugs, amineptine and fluoxetine, in a multicentric study. Amineptine is a dopamine reuptake inhibitor, and fluoxetine a serotonin reuptake inhibitor. Eighteen french centers participate in the study. One hundred and sixty nine outpatients were randomly assigned to either 200 mg of amineptine or 20 mg of fluoxetine during 90 days. They fulfilled the DSM III-R criteria of major depressive disorder. They were aged from 18 to 70. Minor tranquilizers were allowed during the study. The patients were evaluated at D0, D7, D21, D42 and D90. If possible, an additional evaluation was made at D4. Clinical evaluations included Clinical Global Investigation (CGI), Montgomery and Asberg Depressive Rating Scale (MADRS), HARD scale, Widlocher Retardation rating scale and Hopkins Symptom Check-list (HSCL). Somatic concerns were recorded at each visit. Among the 169 patients included in the study, only 141 ended it at D90. The two drugs had good antidepressive efficacy which was noticed as soon as D7 up to D90. If we compare the antidepressant activity, no statistical differences could be observed between the two drugs using different scales. The percentage of patients with an improvement of at least 50% of the global score at MADRS was 8.3% at D7; 41% at D21, 69.2% at D42 and 83.2% at D90 for the amineptine group. For the fluoxetine group, these percentages were, 7.7%; 37.8%; 78.9%; 82.1%. No statistical differences could be noticed between the two groups, and at any time of the study. We have tried to look for a rapid antidepressive action by a clinical evaluation at D4.(ABSTRACT TRUNCATED AT 250 WORDS)