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

Int Psychogeriatr. 2001 Jun;13(2):233-40. doi: 10.1017/s104161020100761x.


Objective: To examine the efficacy of fluoxetine in the treatment of depression in patients with probable Alzheimer's disease (AD).

Methods: This double-blind, parallel-design study included a consecutive series of 41 AD subjects meeting DSM-IV criteria for major or minor depression who were randomized to receive fluoxetine (up to 40 mg/day) or identical-appearing placebo. All patients received biweekly evaluations consisting of the Hamilton Depression Scale (HAM-D) and the Clinical Global Impression as primary efficacy measures, and the Mini-Mental State Exam, Hamilton Rating Scale for Anxiety, and the Functional Independence Measure as secondary efficacy measures.

Results: Complete remission of depression was found in 47% of subjects treated with fluoxetine and in 33% of subjects treated with placebo. Both the fluoxetine and the placebo groups showed a significant decline in HAM-D scores over time, but the magnitude of mood improvement was similar for both groups. Fluoxetine was well tolerated, and most side effects were mild.

Conclusion: Fluoxetine treatment for depression in AD did not differ significantly from treatment with placebo. Our study also confirms the presence of a placebo effect in the treatment of depression in AD.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Alzheimer Disease / complications
  • Alzheimer Disease / psychology*
  • Analysis of Variance
  • Antidepressive Agents, Second-Generation / therapeutic use*
  • Depressive Disorder / drug therapy*
  • Depressive Disorder / etiology
  • Double-Blind Method
  • Female
  • Fluoxetine / therapeutic use*
  • Humans
  • Male
  • Middle Aged
  • Placebo Effect
  • Psychiatric Status Rating Scales
  • Remission Induction
  • Treatment Outcome


  • Antidepressive Agents, Second-Generation
  • Fluoxetine