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

Condition(s) targeted: Autism Spectrum Disorder (ASD)

Intervention: Buspirone (Drug); Placebo (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Massachusetts General Hospital

Official(s) and/or principal investigator(s):
Gagan Joshi, M.D., Principal Investigator, Affiliation: Massachusetts General Hospital

Overall contact:
Katie McDermott, BS, Phone: 617-503-1008, Email: kmmcdermott@partners.org

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 hypotheses for a larger randomized controlled clinical trial with explicit hypotheses and sufficient statistical power.

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

Reduction in Pediatric Anxiety Rating Scale (PARS) Score

Clinical Global Impression-Anxiety (CGI-Anxiety) Improvement Score

Minimum age: 6 Years. Maximum age: 17 Years. Gender(s): Both.

Criteria:

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.

Katie McDermott, BS, Phone: 617-503-1008, Email: kmmcdermott@partners.org

Massachusetts General Hospital, Cambridge, Massachusetts 02140, United States; Recruiting
Gagan Joshi, M.D., Principal Investigator

Starting date: November 2011
Last updated: August 21, 2012