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Case Series: Use of Ziprasidone for Maladaptive Symptoms in Youths With Autism

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ABSTRACT

Objective

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

Method

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).

Results

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.

Conclusions

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.

Section snippets

Subjects

This study was approved by the Institutional Review Board of Indiana University. The diagnoses, demographic information, treatment history with antipsychotic drugs, and rationale for ziprasidone administration are presented in Table 1. The sample included 12 patients (2 females, 10 males) (mean age, 11.62 ± 4.38 years; range, 8–20 years), including nine with autistic disorder and three with PDD NOS. All diagnoses were made by two board-certified child and adolescent psychiatrists during a

RESULTS

The final mean daily dose of ziprasidone was 59.23 ± 34.76 mg (range, 20–120 mg). All of the patients completed at least 6 weeks of treatment with ziprasidone (mean duration, 14.15 ± 8.29 weeks; range, 6–30 weeks). Six (50%) of the 12 patients were considered responders to treatment. Two were rated as “much worse.” Both of these patients had comorbid bipolar I disorder. Five of the six responders continued to take ziprasidone at the end of the trial. The sixth patient was asked to discontinue

DISCUSSION

This report describes our initial clinical impressions and experience with regard to the first 12 patients with autism or PDD NOS whom we treated with ziprasidone. Although the sample size is small, the overall rate of response is similar to prior reports of treatment with risperidone (McDougle et al., 1998) and olanzapine (Malone et al., 2001;Potenza et al., 1999) in subjects with autism and other PDDs. Unlike earlier studies involving children and adolescents with autism, the patients in the

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    This work was supported in part by a Young Investigator Award from the National Alliance for Research in Schizophrenia and Depression (Dr. Posey), a Daniel X. Freedman Psychiatric Research Fellowship Award (Dr. Posey), Department of Housing and Urban Development grant B-01-SP-IN-0200 ( Representative Dan Burton), and a Research Unit on Pediatric Psychopharmacology Contract ( NO1MH70001 ) from the NIMH to Indiana University (Drs. McDougle and Posey and Ms. Kem).

    Reprint requests to Dr. McDougle, Indiana University School of Medicine, Department of Psychiatry, Krannert Building, Room A305, 1111 W. 10th Street, Indianapolis, IN 46202-4800.

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