FLUOXETINE VERSUS AMITRIPTYLINE IN THE TREATMENT OF MAJOR DEPRESSION - A MULTICENTER TRIAL

Fluoxetine, a serotonin uptake inhibitor, and amitriptyline, a tricycl ic antidepressant, were compared in a 5-week, multicenter, double-blin d, randomized trial in 136 out-patient men and women, aged 21-70 years , with major depressive disorder. Overall efficacy was comparable with fluoxetine and amitriptyline [Hamilton 21-Item Rating Scale for Depre ssion (HAM-D21), Raskin, Covi, Clinical Global Impressions-Severity an d -Improvement, Patient's Global Impressions]. Mean +/- standard devia tion decreases in HAM-D21 total score were 12.9 +/- 9.9 and 11.6 +/- 1 0.3 (p = 0.423), respectively. Response rates (greater-than-or-equal-t o 50% decrease in HAM-D21 total score) for patients treated greater-th an-or-equal-to 4 weeks were 46.7% and 66.0% (p = 0.039) and remission rates (HAM-D21 total score less-than-or-equal-to 7) were 18.3% and 28. 3% (p = 0.209), respectively. Response and remission rates for all pat ients were comparable with fluoxetine and amitriptyline. Study complet ions were higher with fluoxetine than amitriptyline (87.7% vs 66.2%; p = 0.003). Discontinuations for adverse events were higher with amitri ptyline than fluoxetine (22.5% vs 6.2%; p = 0.007). More treatment-eme rgent nausea and insomnia were reported with fluoxetine (p less-than-o r-equal-to 0.05); more anticholinergic and orthostatic events and weig ht gain were reported with amitriptyline (p less-than-or-equal-to 0.05 ). Statistically, but not clinically, significant changes were observe d in vital signs. Both fluoxetine and amitriptyline were effective tre atments for out-patients with major depressive disorder. Fluoxetine ha d a more favorable safety profile than amitriptyline.