Suicidality in a placebo-controlled fluoxetine study of body dysmorphic disorder.

Serotonin reuptake inhibitors are considered the first-line medication for body dysmorphic disorder (BDD). The relationship between serotonin reuptake inhibitor treatment and suicidality in BDD has been only minimally studied, despite high suicidality rates in BDD. Sixty-seven adults with the Diagnostic and Statistical Manual of Mental Disorders edition IV BDD participated in a 12-week randomized double-blind placebo-controlled study of fluoxetine. Suicidality was assessed with the Hamilton Rating Scale for Depression suicidal ideation item. Analyses examined group differences in worsening and emergence of suicidality, using standard definitions. Among the entire sample, when comparing study baseline with end of week 2 and study endpoint, no patient on fluoxetine had suicidality worsening; a higher proportion of placebo-treated patients had suicidality worsening after 2 weeks of treatment (P=0.014) and at study endpoint (P=0.010). Among patients aged 18-24 years, one patient on placebo had suicidality worsening at the end of week 2, and none in either treatment group had suicidality worsening at study endpoint. With regard to emergence of suicidality at any point during the study, the treatment groups did not significantly differ. Neither suicide attempts nor completed suicides occurred. In summary, fluoxetine and placebo did not significantly differ with regard to emergence of suicidality. Among the entire sample, fluoxetine appeared to exert a protective effect against suicidality worsening.

RCT Entities:   Population Interventions Outcomes