[Recurrence of unipolar depression and efficacy of maprotiline].

Although antidepressive treatments have been used for about thirty years, the question of their duration remains controverted. In fact, among the large number of therapeutic trials, only about fifteen control studies versus placebo, have evaluated the prophylactic advantage of a long-term antidepressive treatment. In order to complete the small number of products evaluated for this indication (imipramine, amitriptyline, zimelidine, nomifensine, fluoxetine), we have undertaken a vast multicenter study (130 psychiatrists), including 1,141 patients suffering from depression and treated with maprotiline, double-blind versus placebo, in ambulatory, for 1 year. The controlled trial was preceded with a pre-inclusion period in which 1,339 patients suffering from depression were treated, in an open study, with maprotiline at a dose of 75 to 150 mg. Only patients who were clinically improved during this preliminary study (MADRS less than 10), were included in the prophylactic evaluation phase, and divided into four groups: maprotiline 75 mg, maprotiline 1/2 tablet of 75 mg, placebo 1 tablet or placebo 1/2 tablet. The relapse was defined by a score exceeding 27 on the MADRS or exceeding 25 during two separate work-ups of 8 days or according to the experimenter's judgment. The actuarial relapse rate at 1 year was: 16% with 75 mg of maprotiline, 23.8% with 37.5 mg of maprotiline, 31.5% with one placebo tablet and 37.5% with 1/2 tablet of placebo, the difference being statistically significant between the 4 groups except for the "placebo" groups between them. In addition, the tolerance of maprotiline was satisfactory with prolonged prescription.

RCT Entities:   Population Interventions Outcomes