Dose Finding Study of Pioglitazone in Children With Autism Spectrum Disorders (ASD) (PIO)

Inclusion criteria

• Male or female outpatients 5-12 years of age inclusive (see Note below).
• Meet Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV) criteria. DSM-IV criteria for Autistic Disorder or Asperger's Disorder (autism spectrum disorder) will be confirmed by a clinician with expertise with individuals with ASD. Best estimate Diagnosis will be reached using DSM-IV criteria, the Autism Diagnostic Observation Schedule (ADOS-G) and the Autism Diagnostic Interview-Revised (ADI-R).
• Have a Clinical Global Impression-Severity (CGI-S) score ≥ 4 (moderately ill) at Baseline.
• If already receiving stable non-pharmacologic educational, behavioural, and/or dietary interventions, have continuous participation during the preceding 3 months prior to Screening and will not electively initiate new or modify ongoing interventions for the duration of the study.
• Have normal physical examination and laboratory test results at Screening. If abnormal, the finding(s) must be deemed clinically insignificant by the Investigator.

Exclusion criteria

• Patients born prior to 35 weeks gestational age.
• Families without sufficient command of the English Language.
• Patients with any primary psychiatric diagnosis other than autism at Screening.
• Patients with a current neurological disease, including, but not limited to, movement disorder, tuberous sclerosis, fragile X, and any other known genetic syndromes.
• Pregnant female patients, female patients who are sexually active, female patients using the birth control pill for whatever reason.
• Patients with a medical condition that might interfere with the conduct of the study, confound interpretation of the study results, or endanger their own well-being. Patients with evidence or history of malignancy or any significant hematological, endocrine, cardiovascular (including any rhythm disorder), respiratory, renal, hepatic, or gastrointestinal disease. Patients with stable epilepsy (no seizures for 6 months) and on stable doses of antiepileptic medications (no changes in 3 months) will be allowed in the study.
• Patients taking psychoactive medication(s).
• Patients taking insulin.
• Patients unable to tolerate venipuncture procedures for blood sampling.
• Patients with parent(s)/caregiver(s) who smoke.
• Patients who have had previous bladder infection(s).
• Patients with a family history of bladder cancer.