A double-blind, placebo-controlled study of fluoxetine in depressed patients with Alzheimer's disease

Objective: To examine the efficacy of fluoxetine in the treatment of depres sion in patients with probable Alzheimer's disease (AD). Methods: This doub le-blind, parallel-design study included a consecutive series of 41 AD subj ects meeting DSM-IV criteria for major or minor depression who were randomi zed to receive fluoxetine (up to 40 mg/day) or identical-appearing placebo. All patients received biweekly evaluations consisting of the Hamilton Depr ession Scale (HAM-D) and the Clinical Global Impression as primary efficacy measures, and the Mini-Mental State Exam, Hamilton Rating Scale for Anxiet y, and the Functional Independence Measure as secondary efficacy measures. Results: Complete remission of depression was found in 47% of subjects trea ted with fluoxetine and in 33% of subjects treated with placebo. Both the f luoxetine and the placebo groups showed a significant decline in HAM-D scor es over time, but the magnitude of mood improvement was similar for both gr oups. Fluoxetine was well tolerated, and most side effects were mild. Concl usion: Fluoxetine treatment for depression in AD did not differ significant ly from treatment with placebo. Our study also confirms the presence of a p lacebo effect in the treatment of depression in AD.