Treatment of elective mutism with fluoxetine: a double-blind, placebo-controlled study

J Am Acad Child Adolesc Psychiatry. 1994 Sep;33(7):1000-6. doi: 10.1097/00004583-199409000-00010.


Objective: To evaluate the efficacy of treatment with fluoxetine in reducing symptoms associated with elective mutism.

Method: Sixteen subjects with elective mutism were treated with placebo (single-blind) for 2 weeks. Fifteen placebo nonresponders were then randomly assigned to double-blind treatment with fluoxetine at a dose of 0.6 mg/kg/day (N = 6) or continued placebo (N = 9) for an additional 12 weeks. Outcome ratings were completed by the treating psychiatrist, parents, and teachers.

Results: Significant improvements over time on ratings of elective mutism, anxiety, and social anxiety, rated by clinician, parents, and teachers, were demonstrated in both fluoxetine- and placebo-treated subjects. Subjects treated with fluoxetine were significantly more improved than placebo-treated subjects on parent's ratings of mutism change and global change. Clinician and teacher ratings did not reveal significant differences between treatment groups. Although improved, most subjects in both treatment groups remained very symptomatic at the end of the study period. Side effects were minimal.

Conclusion: Fluoxetine may be beneficial and safe in the treatment of children with elective mutism. Longer periods of treatment may yield more substantial therapeutic benefits. Further study is indicated.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Child
  • Child, Preschool
  • Double-Blind Method
  • Female
  • Fluoxetine / administration & dosage
  • Fluoxetine / adverse effects
  • Fluoxetine / therapeutic use*
  • Humans
  • Male
  • Mutism / complications
  • Mutism / diagnosis
  • Mutism / drug therapy*
  • Phobic Disorders / complications
  • Phobic Disorders / diagnosis
  • Placebos
  • Psychiatric Status Rating Scales
  • Severity of Illness Index
  • Treatment Outcome


  • Placebos
  • Fluoxetine