A Pilot Study 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

- DSM-5 ASD diagnostic criteria as established by clinical diagnostic interview

- Participants with a score of ≥60 or more on the Anxiety/Depression subscale of CBCL

- Subjects can be taking psychotropic medications 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, provided the medication is not listed in the Concomitant Medications section of
the protocol.

Exclusion Criteria:

- 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 or bipolar disorder

- 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.