Efficacy of amineptine in the prevention of relapse in unipolar depression.

The clinical properties of amineptine, a mainly dopaminergic antidepressant, were assessed in a double-blind controlled study involving patients fulfilling Diagnostic and Statistical Manual of Mental Disorders (DSM-III) criteria for unipolar depression. The aim was to determine how relapses could be prevented in this frequently recessing disorder. The study was a two-phase, 12-month, multicentre trial of patients suffering from major depression or dysthymia, diagnosed using DSM-III criteria and evaluated on the Montgomery-Asberg Depression Rating Scale and the Mood, Anxiety, Retardation, Danger scale. Phase I was an open-label 3-month period, with the patients being given 200 mg amineptine per day. The second, 9-month period was a placebo-controlled prophylactic phase. A total of 458 patients were initially included in the study. Of the 376 who completed phase I, 303 (66%) were responders; 284 entered the prophylactic study, randomly assigned to two groups. Of the 134 patients in the placebo group who completed phase II, 25 (18.7%) suffered a relapse, compared with nine out of the 136 (6.6%) in the amineptine group. After resolution of an acute episode of major depression or dysthymia, long-term antidepressant therapy with amineptine significantly reduced the relapse rate.