Ziprasidone in Children With Autism: A Pilot Study

I. SPECIFIC AIMS

1. To investigate the safety of clinical use of ziprasidone in children
2. To investigate the dosages that have been employed clinically.

II. BACKGROUND AND SIGNIFICANCE

Ziprasidone, a recently released atypical agent is likely to be as effective as other neuroleptics in treating psychiatric symptoms in children, but may have the considerable health advantage of not causing weight gain. Ziprasidone administration has been associated with prolongation of the QTc interval (mean=20 msec), an electrocardiographic measure of ventricular repolarization (Federal Drug Administration, 2000). There are no reports regarding the use of ziprasidone in autism, and data regarding the safety and efficacy of ziprasidone in children is extremely limited. The only published study of ziprasidone in children found that it was safe and effective in treating Tourette's syndrome in children aged 7 to 17 years of age (Sallee et al, 2000). Because children are being treated with ziprasidone despite a paucity of safety data, it is important to begin to collect and review available data, including that from clinical usage. Some children who receive services within the Child and Adolescent Psychiatric Services of Drexel University College of Medicine have been treated with ziprasidone. The charts of the children and adolescents will contain data regarding exposure to ziprasidone and laboratory data and ECG's that can be reviewed to determine whether ziprasidone treatment has been associated with changes in weight, laboratory values and ECG's. We propose to review the charts of patients who have been treated with our services since March 1, 2001 XXX because such patients may have been exposed to ziprasidone (ziprasidone received FDA approval on February 5, 2001).

III. DESIGN AND METHODS