Celexa ineffective in children wwith autism

Although no medications are currently approved by the US Food and Drug Administration for core symptoms of autism spectrum disorders (ASDs), selective serotonin reuptake inhibitors are widely prescribed for children with these conditions. The goal of this National Institutes of Health-sponsored, randomized, controlled trial was to evaluate the efficacy and safety of Celexa (citalopram hydrobromide) therapy for repetitive behavior in children with ASDs.

At 6 US academic centers, 149 children aged 5 to 17 years old with ASDs were randomly assigned to receive oral citalopram or placebo for 12 weeks.

Neither the CGI improvement subscale nor the secondary endpoint showed any significant difference between groups. Positive response occurred in 32.9% of the citalopram group and in 34.2% of the placebo group. Adverse events were significantly more common with citalopram than with placebo; notably, increased energy level, impulsiveness, decreased concentration, hyperactivity, stereotypy, diarrhea, insomnia, and dry skin or pruritus.

Based on these findings, there is no support for citalopram treatment of repetitive behavior in children and adolescents with ASDs. Given the high positive response rate in the placebo group, other medications often used off-label for children with ASDs should also be tested in randomized, placebo-controlled trials to evaluate their risk-benefit ratio.

Arch Gen Psychiatry. 2009;66:583-590