Aripiprazole in Children With Autism: A Pilot Study

I. SPECIFIC AIM

To obtain pilot data regarding the safety, dosing, and efficacy of open-labeled aripiprazole in children, aged 12 to 18 years, diagnosed with autism. A larger, more controlled trial will be planned for this population if the drug is safe and tends to be efficacious.

II. BACKGROUND AND SIGNIFICANCE

Autism is a serious disorder that first presents in childhood, usually before three years of age (American Psychiatric Association, 1994). Though the incidence of autism is low (approximately 3-6 cases per 10,000 live births), the consequences of the disorder are severe. As the term "pervasive" implies, the symptoms affect most areas of functioning in the developing child, and the disabilities associated with the disorder tend to persist throughout life. Symptoms of autism include abnormalities in social relatedness including extreme withdrawal; communication including no or little speech; and a sameness or repetitiveness in behaviors and interests. Children diagnosed with autism can have severe problems including hyperactivity, lability of mood, irritability, withdrawal, and stereotypical behavior. Because of these severe problems, treatment of symptomatology often includes pharmacotherapy.

The most studied drug for treating children and adolescents with autism is the typical neuroleptic, haloperidol (Anderson et al, 1989; Anderson et al, 1984; Campbell et al, 1978; and Cohen et al, 1980). The main public health concern regarding the use of haloperidol is the risk of inducing dyskinesias (Campbell et al, 1988, 1997), though the dyskinesias have been reversible.