An Open-Label Trial of Buspirone for the Treatment of Anxiety in Youth With Autism Spectrum Disorders

An Open-label Trial of Buspirone for the Treatment of Anxiety in Youth With Autism Spectrum Disorders

The main objective of this exploratory 8-week pilot study is to evaluate the safety and efficacy of buspirone for the treatment of anxiety in youth (ages 6-17 years) with autism spectrum disorders. The study results will be used to generate hypothesis for a larger randomized controlled clinical trials with explicit hypotheses and sufficient statistical power.

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.