Aripiprazole: Aged 6–17 - 05/31/2012

Title:   Aripiprazole: A Review of its Use in the Treatment of Irritability Associated with Autistic Disorder Patients Aged 6–17

A systematic review and meta-analysis were performed examining the efficacy of aripiprazole for the treatment of irritability associated with autistic disorder in children and adolescents. Aripiprazole was found to be more effective in reducing irritability compared with placebo at 8 weeks, SMD -0.64 [-0.90 to -0.39, P < 0.00001] as determined by the Aberrant Behaviour Checklist irritability subscale (ABC-I). Pooled data from two eight week trials show that sedation is the most commonly reported adverse event. Statistically significant weight gain was also associated with aripiprazole, but there was a decrease in serum prolactin. Most adverse effects were deemed to be mild to moderate in severity. Four open trials and three case series all show support for aripiprazole in reducing the behavioural symptoms of autism. Long-term studies are required to determine the efficacy and safety of aripiprazole in autistic disorder in children.

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Title:   Ziprasidone in adolescents with autism: an open-label pilot study

INTRODUCTION:

The antipsychotic drugs are the best-studied agents shown to reduce symptoms in autism, including hyperactivity, aggression, self-abusive behavior, temper tantrums, lability, irritability, social withdrawal, and stereotypical behaviors. However, significant weight gain has been associated with use of many atypical agents. Ziprasidone has been weight neutral in adult populations, but data from adolescents and patients with autism are sparse. However, ziprasidone administration has been associated with increases in the QTc. The purpose of this study was to collect pilot data on the efficacy and safety of ziprasidone in adolescents with autism, focusing on safety issues of weight gain and QTc.

METHODS:

Twelve adolescents with autism (mean age 14.5 +/- 1.8 years) were treated in a 6-week open pilot study. Ziprasidone dosage ranged from 20 to 160 mg/day (mean, 98.3 +/- 40.4 mg/day). The primary efficacy measure was the Clinical Global Impressions-Improvement item (CGI-I); other efficacy measures included the Aberrant Behavior Checklist and the Children's Psychiatric Rating Scale.

RESULTS:

Based on the CGI-I, 9 of 12 (75%) patients were treatment responders. Ziprasidone was weight neutral, and the QTc increased by a mean of 14.7 msec. Two subjects had acute dystonic reactions. Cholesterol decreased and prolactin remained the same.

CONCLUSIONS:

Ziprasidone shows promise as a treatment for adolescents with autism. More definitive trials are needed.