Clinical trials test drugs in managing behavior in autism


    LOUISVILLE, Ky. — Aripiprazole, an antipsychotic agent used in children with schizophrenia and bipolar mania, is effective in managing extreme behavior and self-injury among children and adolescents with autism spectrum disorders, according to a study published online in the journal Pediatrics. The University of Louisville was one of 20 centers that participated in the study.

    Individuals with autism are sometimes prone to moderate to severe irritability including temper tantrums, self injury and aggression. Researchers found that eight-week treatment with aripiprazole produced a statistically significant reduction in symptoms of irritability as well as positive results for hyperactivity, repetitive actions and inappropriate speech.

    “It’s exciting to have a second medication that is FDA approved for treatment of severe behavior problems associated with autism. While these medications do not address core features of autism, they allow many children to function successfully in school, at home and in the community,” said Gail Williams, developmental pediatrician at the UofL Weisskopf Child Evaluation Center and a co-principal investigator for the Louisville center.

    Glutathione study
    Williams and co-principal investigator Janice Sullivan, director of UofL’s Kosair Charities Pediatric Clinical Research Unit, continue work on a similar study, evaluating the effect of a nontraditional treatment on the behavior of children with autism.

    Anecdotal evidence suggests that a combination of glutathione, vitamin C and N-acetylcysteine may help reduce aggressive outbursts and ease transitions for children with autism and severe behavior problems, but no clinical studies have been done to assess this treatment.

    “Because of autism’s devastating effects, many medical and nontraditional treatments are being implemented without the benefit of research that justifies or refutes these interventions. This study addresses the knowledge gap about glutathione and serves as the basis for ongoing research in this area,” Williams said.

    Approximately one-quarter of the study’s patients are receiving treatment now or have completed their participation in the study.

    Participants for the study are being chosen from nearly 400 families who live within a 60-mile radius of the KCPCRU, where the children come weekly for 18 weeks to receive intravenous infusions of combination therapy with glutathione or placebo.

    The study is partially funded by the Michala Riggle Autism Research & Treatment Fund.

    Experts say that autism rates are increasing. In 2007 the Centers for Disease Control reported that autism affected 1 in 150 children. A recent survey published in the journal Pediatrics estimated that today autism spectrum disorders affect approximately one in 91 American children. These figures emphasize the need for early and effective interventions for children with autism.