A randomized placebo-controlled trial of fluoxetine in body dysmorphic disorder.

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 (F(1,64) = 16.5; P<.001). The response rate was 18 (53%) of 34 to fluoxetine and 6 (18%) of 33 to the placebo (chi(2)(1) = 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.