An Open-Label 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 ≥13 on the Pediatric Anxiety Rating Scale (PARS)

- Participants with a score of ≥60 or more on the Anxiety/Depression subscale of 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 trial treatment and if they are stable, provided the
medication is not listed in the Concomitant Medications section of the protocol.

- 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:

- I.Q. < 70

- DSM-IV-TR PDD diagnoses 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

- Current diagnosis of schizophrenia

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

- Current treatment with medication with primary central nervous system activity (as
specified in the Concomitant Medication section of the protocol)

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

- Subjects currently taking monoamine oxidase inhibitors (MAOI) and/or CYP3A4 inducers
or inhibitors including nefazodone, diltiazem, verapamil, erythromaycin, itraconazole,
or rifampin.