Randomized, double-blind, placebo-controlled trial of fluoxetine treatment for elderly patients with dysthymic disorder

Am J Geriatr Psychiatry. 2005 Jan;13(1):59-68. doi: 10.1176/appi.ajgp.13.1.59.


Objective: The authors compared the efficacy and side effects of fluoxetine and placebo in elderly outpatients with dysthymic disorder.

Methods: Patients were randomly assigned to fluoxetine (20 mg-60 mg/day) or placebo for 12 weeks in a double-blind trial.

Results: Of 90 randomized patients, 71 completed the trial. In the intent-to-treat sample, random regression analyses of the Hamilton Rating Scale for Depression (Ham-D; 24-item) and Cornell Dysthymia Rating Scale (CDRS) scores at each visit produced significant time x treatment group interactions favoring the fluoxetine group. Analysis of percentage change in Ham-D scores yielded no effect for treatment group, but a similar analysis of percentage change in CDRS scores yielded a main effect for treatment group, favoring fluoxetine over placebo. In the intent-to-treat sample, response rates were 27.3% for fluoxetine and 19.6% for placebo. In the completer sample, response rates were 37.5% for fluoxetine and 23.1% for placebo.

Conclusion: Fluoxetine had limited efficacy in elderly dysthymic patients. The clinical features of elderly dysthymic patients are typically distinct from those of dysthymic disorder in young adults, and the findings suggest that treatments effective for young adult dysthymic patients may not be as useful in elderly dysthymic patients. Further research is needed to identify efficacious treatments for elderly patients with dysthymic disorder, and investigative tools such as electronic/computerized brain scans and neuropsychological testing may help identify the factors that moderate antidepressant treatment response and resistance.

Publication types

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

MeSH terms

  • Age Factors
  • Aged
  • Aging / psychology
  • Diagnostic and Statistical Manual of Mental Disorders
  • Double-Blind Method
  • Drug Administration Schedule
  • Dysthymic Disorder / diagnosis
  • Dysthymic Disorder / drug therapy*
  • Endpoint Determination
  • Female
  • Fluoxetine / administration & dosage
  • Fluoxetine / blood
  • Fluoxetine / therapeutic use*
  • Humans
  • Male
  • Middle Aged
  • Quality of Life
  • Regression Analysis
  • Serotonin Uptake Inhibitors / administration & dosage
  • Serotonin Uptake Inhibitors / blood
  • Serotonin Uptake Inhibitors / therapeutic use*
  • Severity of Illness Index


  • Serotonin Uptake Inhibitors
  • Fluoxetine