Double-blind Trial of Buspirone for the Treatment of Anxiety in Youth With Autism Spectrum Disorders

Inclusion Criteria:

- Male or female participants between 6 and 17 years of age.

- Fulfills diagnosis of autism spectrum disorders by meeting DSM-IV-TR PDD diagnostic
criteria of autistic disorder, Asperger's disorder, or PDD-NOS as established by
clinical diagnostic interview.

- Participants with a score of ≥60 on the Anxiety/Depression subscale of Child Behavior
Checklist (CBCL) and CGI-Anxiety severity of ≥4.

- Subjects can be on psychotropic drugs if they have been on the medication for at
least 4 weeks prior to initiating study treatment and if they are on a stable dose.

- Subjects with disruptive behavior disorders, mood, or psychosis will be allowed to
participate in the study provided they do not meet any exclusionary criteria.

Exclusion Criteria:

- Mental retardation (I.Q. <70)

- DSM-IV-TR PDD diagnosis of Rett's disorder, and childhood disintegrative disorder.

- History of active seizure disorder (EEG suggestive of seizure activity and/or history
of seizure in last 1 month).

- Subjects with a medical condition or treatment that will either jeopardize subject
safety or affect the scientific merit of the study, including: pregnant or nursing
females, organic brain disorders, uncorrected hypothyroidism or hyperthyroidism,
clinically significant abnormalities on ECG (e.g. QT prolongation, arrhythmia),
history of renal or hepatic impairment.

- Clinically unstable psychiatric conditions or judged to be at serious suicidal risk.

- History of substance abuse (except nicotine of caffeine) within past 3 months or
urine drug screen positive for substances of abuse.

- Any other concomitant medication with primary central nervous system activity other
than stable regimens for >2 weeks.

- A non-responder or history of intolerance to buspirone, after treatment at an
adequate dose and duration as determined by the clinician.