International Psychogeriatrics

Research and Reviews

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.

Article author query
tollefson g   [PubMed][Google Scholar] 
bosomworth j   [PubMed][Google Scholar] 
heiligenstein j   [PubMed][Google Scholar] 
potvin j   [PubMed][Google Scholar] 
holman s   [PubMed][Google Scholar] 


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.