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Original Article
April 2002

A Randomized Placebo-Controlled Trial of Fluoxetine in Body Dysmorphic Disorder

Author Affiliations

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.

Arch Gen Psychiatry. 2002;59(4):381-388. doi:10.1001/archpsyc.59.4.381

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 (χ21 = 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.