Prophylactic efficacy of maprotiline on unipolar depression relapse.
BACKGROUND
Although antidepressant medications have been in use for about 30 years, the question remains about their utility in the prophylaxis of recurrent depression. The purpose of this study was to evaluate the efficacy of maprotiline, a tetracyclic antidepressant, for depression prophylaxis.


METHODS
We conducted a vast, prospective, multicenter, double-blind, placebo-controlled study of 1141 outpatients suffering from depression and treated with maprotiline or placebo for 1 year. The very large size of the study population allowed for the testing of two drug doses. The study design included a pre-inclusion treatment phase that assured that all study patients had recently suffered from a depressive episode and were in remission at the time they were randomized into two treatment groups (1 and 1/2 tablet of maprotiline 75 mg) and two control groups (1/2 and 1 tablet of placebo).


RESULTS
The actuarial relapse rate at 1 year was 16% for maprotiline 75 mg, 1 tablet; 23.8% for maprotiline 75 mg, 1/2 tablet; 31.5% for 1 tablet placebo, and 37.5% for 1/2 tablet placebo. The difference between each group is statistically significant, except for the difference between the two placebo groups. The actuarial incidence of adverse drug reactions during the year was not statistically significant between the treatment and control groups.


CONCLUSIONS
This study demonstrates maprotiline's prophylactic effectiveness for depressive relapses, the 75-mg dose being more effective than the 37.5-mg dose. The patients' tolerance of maprotiline therapy was satisfactory at both doses with prolonged prescription.
Rouillon
F
F
Laboratory CIBA-GEIGY, Medical Department, Rueil-Malmaison, France.
Serrurier
D
D
Miller
H D
HD
Gerard
M J
MJ
D000293:Adolescent; D000328:Adult; D000368:Aged; D003866:Depressive Disorder / Q000175:diagnosis / Q000517:prevention & control* / Q000523:psychology; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008376:Maprotiline / Q000008:administration & dosage / Q000627:therapeutic use*; D008875:Middle Aged; D010919:Placebos; D011446:Prospective Studies; D012008:Recurrence
D010919:Placebos; D008376:Maprotiline