A Double-Blind, Placebo-Controlled Clinical Trial of Fluoxetine in Geriatric Patients With Major Depression
|Fluoxetine Collaborative Study Group, Gary D. Tollefson a1, Janet C. Bosomworth a1, John H. Heiligenstein a1, Janet H. Potvin a1 and Susan Holman a1|
a1 Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana, U.S.A.
Depression in the geriatric population is a frequents, serious, and potentially reversible disorder, yet relatively few blinded, controlled, antidepressant trial have been reported. A number of age-related issues complicate safe and effective pharmacotherapy. In a 6-week, double-blind trial in moderately to severely depressed (nonpsychotic) outpatients over age 60, fluoxetine (N = 335) was statistically significantly more efficacious than placebo (N = 336) in overall response (43.9% vs. 31.6%, p = .002) and remission (31.6% vs. 18.6%, p < .001) rates. Analyses of early discontinuations because of an adverse drug event revealed no statistically significantly greater rate with fluoxetine (n = 39; 11.6%) than was seen with placebo (n = 29; 8.6%). These results corroborate that major depression in an older population is responsive to antidepressant pharmacotherapy. Specifically, fluoxetine, at a conventional 20-mg dose, was both safe and effective relative to placebo in this special population.