Double-blind Trial of Buspirone for the Treatment of Anxiety in Youth With Autism Spectrum Disorders
- Registration Number
- NCT01395953
- Lead Sponsor
- Massachusetts General Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - Buspirone Buspirone -
- Primary Outcome Measures
Name Time Method Reduction in Pediatric Anxiety Rating Scale (PARS) Score baseline to 8 weeks Primary outcome measure of efficacy will be assessed by reduction in anxiety symptom severity as measured by change from baseline. Responders are defined as ≥30% reduction in the Pediatric Anxiety Rating Scale (PARS).
Clinical Global Impression-Anxiety (CGI-Anxiety) Improvement Score baseline to 8 weeks Primary outcome measure of efficacy will be assessed by reduction in anxiety symptom severity as measured by Clinical Global Impression-Anxiety (CGI-Anxiety). Responders are defined as a score of ≤2 on the improvement subscale (i.e., "much" or "very much improved").
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States