Placebo-controlled study of pimozide augmentation of fluoxetine in body dysmorphic disorder

Am J Psychiatry. 2005 Feb;162(2):377-9. doi: 10.1176/appi.ajp.162.2.377.


Objective: Although body dysmorphic disorder often responds to serotonin reuptake inhibitors (SRIs), most patients do not respond or respond only partially. However, placebo-controlled studies of augmentation of SRIs have not been done. Furthermore, although 40%-50% of patients are delusional, studies of antipsychotic medications have not been done.

Method: Twenty-eight patients with body dysmorphic disorder or its delusional variant participated in an 8-week, placebo-controlled, double-blind, parallel-group study of pimozide augmentation of fluoxetine.

Results: Pimozide was not more effective than placebo: two (18.2%) of 11 subjects responded to pimozide and three (17.6%) of 17 subjects responded to placebo. There was no significant effect of baseline delusionality on endpoint severity of body dysmorphic disorder. Delusionality did not decrease significantly more with pimozide than placebo.

Conclusions: Pimozide augmentation of fluoxetine treatment for body dysmorphic disorder was not more effective than placebo, even in more delusional patients. Further studies of augmentation for SRIs are needed.

Publication types

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

MeSH terms

  • Adult
  • Antipsychotic Agents / therapeutic use*
  • Delusions / drug therapy
  • Delusions / psychology
  • Double-Blind Method
  • Drug Therapy, Combination
  • Female
  • Fluoxetine / therapeutic use*
  • Humans
  • Male
  • Pimozide / therapeutic use*
  • Placebos
  • Psychiatric Status Rating Scales
  • Serotonin Uptake Inhibitors / therapeutic use*
  • Somatoform Disorders / diagnosis
  • Somatoform Disorders / drug therapy*
  • Somatoform Disorders / psychology
  • Treatment Outcome


  • Antipsychotic Agents
  • Placebos
  • Serotonin Uptake Inhibitors
  • Fluoxetine
  • Pimozide