A randomized placebo-controlled trial of fluoxetine in body dysmorphic disorder
Philips KA, Albertini RS, Rasmussen SA;
Commented by , 13 Jun 2002
Background
Body dysmorphic disorder (BDD) is a disabling and common condition. Uncontrolled data suggest both delusional and nondelusional BDD may respond to serotonin reuptake inhibitors; however, placebo-controlled studies are to date lacking.
Methods
74 outpatients with a DSM-IV diagnosis of BDD were enrolled. Following further screening evaluation, 68 patients received single-blind placebo pills for 1 week. Patients were terminated from the study if their Yale Brown Obsessive Compulsive Scale Modified for Body Dysmorphic Disorder (BDD-YBOCS) score decreased by 30% or more during this week.
67 patients were then randomly assigned to 12 weeks of double-blind treatment with fluoxetine (N=34) or placebo (N=33). The starting dose of fluoxetine 20 mg/d was increased after 2 weeks by 20 mg/d every 10 days, to a maximum of 80 mg/d as tolerated. With the exception of chloral hydrate for insomnia, no other psychotropic medications were taken. No psychotherapy was initiated during the study. Following the double-blind phase, placebo patients were offered 12 weeks of open-label fluoxetine.
The BDD-YBOCS was the primary outcome measure, response defined as a 30% reduction in total score. The Clinical Global Impression (CGI-BDD) improvement scale and the National Institute of Mental Health Global Obsessive Compulsive Scale were secondary measures. The Brown Assessment of Beliefs Scale evaluated delusionality. The 17-item Hamilton Rating Scale for Depression (Ham-D) assessed depressive symptoms, and the Brief Psychiatric Rating Scale severity of psychopathology. Psychosocial functioning was evaluated using the Social and Occupational Functioning Scale (SOFAS) and the Global Assessment of Functioning (GAF).
Measures were administered at baseline and each weekly visit, with the exception of the BPRS, SOFAS and GAF, completed at baseline and endpoint. Intention-to treat analysis was used for tests of group differences.
Results
3 patients randomized to fluoxetine, and 5 to placebo discontinued participation. There were no between group differences on baseline demographic and clinical characteristics. 37.5% in the fluoxetine group and 46.9% in the placebo group were delusional at baseline.
Fluoxetine was significantly more effective than placebo on primary and secondary measures, differences beginning at week 8 with the BDD-YBOCS. Response rate to fluoxetine was 53% (18/34) vs 18% (6/33) to placebo, with a medium to large effect size (f=0.35). Of the 21 placebo patients entering the open-label fluoxetine phase, 24% responded using the BDD-YBOCS, while 43% responded using the BDD-CGI.
Delusional patients were as likely as nondelusional patients to respond to fluoxetine (50% [6/12] vs 55% [11/20]), and no delusional patients responded to placebo. Ham-D scores improved significantly more with fluoxetine than placebo. Functional outcome (GAF, SOFAS) was significantly improved with fluoxetine vs placebo.
In the entire sample, BDD response was independent of BDD duration, BDD severity, concurrent personality disorder, obsessive-compulsive disorder (OCD) or major depression. The mean fluoxetine dose at endpoint was 77.7 ± 8.0 mg/day, and 61.1 ± 21.4 mg/day during the open-label phase. Fluoxetine was generally well tolerated.
Comment
This first placebo-controlled trial for BDD supports the effectiveness and safety of fluoxetine in both delusional and nondelusional BDD. Relatively high doses and longer time to response (7.7 ± 3.5 weeks) were required, as seen with OCD. Future studies are required to determine how generalizable the results are to less strictly defined populations.