A Prospective Open-Label Trial of Aripiprazole Monotherapy in the Autism Spectrum Disorders (ASD)

Study Design: Fifteen patients with DSM-IV diagnoses of Autism, Asperger's Disorder or Pervasive Developmental Disorder Not Otherwise Specified (PDD NOS) will be enrolled in this 12-week open-label study. Parents of potential subjects will do a preliminary phone screen, followed by a clinical evaluation by a psychiatrist for possible inclusion in the study. Informed written consent and assent will be obtained from the parents and subjects respectively once deemed competent and before the initiation of any study procedures.

Clinical Evaluation will use the Autism Diagnostic Interview (ADI-R) and the Autism Diagnostic Observation Schedule (ADOS) to establish a formal diagnosis.

Study Procedures Baseline Assessments: Many baseline measures for physical health will be done at the screening visit and during the first weekly visit. These will include a clinical interview, physical and neurological examination will be done during the screening period and height, weight and vital signs, and a calculation of his/her Body Mass Index (BMI) will be done during the screening period and during the first weekly visit. Laboratory measures at baseline and study completion will include a complete metabolic panel (with liver transaminases) and complete blood count with differential. Further measures will include a fasting lipid profile, hemoglobin A1C, prolactin level and insulin levels, and fasting blood sugar level (FBS). Serum albumin will be measured not only as a measure of nutritional state, but also in accordance with the fact that aripiprazole is 99% protein-bound. An electrocardiogram (ECG) will be performed at the beginning and end of the study to monitor for possible cardiac effects. These measures are aimed at monitoring side effects reported in the use of other medications in this class. Urine pregnancy tests will be performed for each female subject at the beginning and end of the study.

Outcome measures will include the Yale-Brown Obsessive Compulsive Scale (Y-BOCS), Brief Psychiatric Rating Scale for children (BPRS-C), Clinical Global Impression - Severity (CGI-S), Vineland Adaptive Behavior Scale (VABS) and the Atypical Children's Development Scale (ACDS).

Baseline parameters for extrapyramidal side effects will be established using the Abnormal Involuntary Movement Scale (AIMS), the Simpson Angus Extrapyramidal Side Effect Scale (SAEPS) and the Barnes Akathisia Rating Scale. Baseline values for general side effects will be compiled using the Monitoring of Side Effects System (MOSES).