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A Randomized Placebo-Controlled Trial of Fluoxetine in Body Dysmorphic Disorder
Katharine A. Phillips, MD;
Ralph S. Albertini, MD;
Steven A. Rasmussen, MD
Arch Gen Psychiatry. 2002;59:381-388.
Background Research on the pharmacotherapy of body dysmorphic disorder (BDD), a
common and often disabling disorder, is limited. Available data suggest that
this disorder may respond to serotonin reuptake inhibitors. However, no placebo-controlled
treatment studies of BDD have been published.
Methods Seventy-four patients with DSM-IV BDD or its
delusional variant were enrolled and 67 were randomized into a placebo-controlled
parallel-group study to evaluate the efficacy and safety of fluoxetine hydrochloride.
After 1 week of single-blind placebo treatment, patients were randomized to
receive 12 weeks of double-blind treatment with fluoxetine or placebo. Outcome
measures included the Yale-Brown Obsessive Compulsive Scale Modified for Body
Dysmorphic Disorder (BDD-YBOCS) (the primary outcome measure), the Clinical
Global Impressions Scale, the Brown Assessment of Beliefs Scale, and other
measures.
Results Results of the BDD-YBOCS indicated that fluoxetine was significantly
more effective than placebo for BDD beginning at week 8 and continuing at
weeks 10 and 12 (F1,64 = 16.5; P<.001).
The response rate was 18 (53%) of 34 to fluoxetine and 6 (18%) of 33 to the
placebo ( 21 = 8.8; P=.003).
The BDD symptoms of delusional patients were as likely as those of nondelusional
patients to respond to fluoxetine, and no delusional patients responded to
the placebo. In the sample as a whole, treatment response was independent
of the duration and severity of BDD and the presence of major depression,
obsessive-compulsive disorder, or a personality disorder. Fluoxetine was generally
well tolerated.
Conclusion Fluoxetine is safe and more effective than placebo in delusional and
nondelusional patients with BDD.
From Butler Hospital and the Department of Psychiatry and Human Behavior,
Brown University School of Medicine, Providence, RI. Dr Phillips has received
research support and occasional speaking honoraria from Eli Lilly & Co,
Indianapolis, Ind.
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