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.