To conduct a preliminary evaluation of the safety and effectiveness of ziprasidone in children, adolescents, and young adults with autism.

Twelve patients (mean age ± SD, 11.62 ± 4.38 years; range, 8–20 years) with DSM-IV– defined autism (n = 9) or pervasive developmental disorder not otherwise specified (n = 3) received open-label treatment with ziprasidone (mean daily dose, 59.23 ± 34.76 mg; range, 20–120 mg) for at least 6 weeks (mean duration, 14.15 ± 8.29 weeks; range, 6–30 weeks).

Six (50%) of the 12 patients were considered responders based on a Clinical Global Impression Scale rating of “much improved” or “very much improved.” Transient sedation was the most common side effect. No cardiovascular side effects, including chest pain, tachycardia, palpitations, dizziness, or syncope, were observed or reported. The mean change in body weight for the group was –5.83 ± 12.52 lb (range, –35 to +6 lb). Five patients lost weight, five had no change, one gained weight, and one had no follow-up weight obtained beyond the baseline measurement.

Ziprasidone appears to have the potential for improving symptoms of aggression, agitation, and irritability in children, adolescents, and young adults with autism. Significant weight gain was not observed in this short-term trial. Double-blind, placebo-controlled studies are needed to substantiate these preliminary findings.