Clinical Trial: Buspirone in the Treatment of 2-6 Year Old Children With Autistic Disorder

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized, Placebo-controlled, Double-masked Clinical Trial of Buspirone in the Treatment of 2- 6 Year Old Children With Autistic Disorder

Brief Summary: The purpose of this study is to evaluate the effects of twice-daily oral buspirone on core features of autism in autistic children aged 2-6 years as measured by the change from baseline in the Autism Diagnostic Observation Schedule (ADOS) Composite Total scores compared to placebo at 6 months.

Detailed Summary: This is a multi-center, randomized, placebo-controlled, double-masked study of 166 evaluable participants taking buspirone twice daily for 6 months. Children aged 2-6 years with autism will be randomized to receive one of three treatments: 2.5mg, 5.0mg, or matched placebo. The placebo controlled trial will be followed by an optional follow-up trial to assess the long term safety of buspirone. In addition, a PET scan of serotonin synthesis and plasma serotonin will be measured at baseline to determine whether these measures are predictors of drug response. This trial is aimed at the core features of autism. The outcome measures for efficacy will be examiner and parent ratings on psychological tests and questionnaires. The outcome measure for the primary objective will be the Autism Diagnostic Observation Scale (ADOS) Composite Total score. The behavioral outcomes for the secondary aims are delineated in the study design.
Sponsor: Chugani, Diane C.

Current Primary Outcome: To evaluate the effects of twice-daily oral buspirone on core features of autism in autistic children 2-6 years measuring the change from baseline in ADOS (Autism Diagnostic Observation Schedule) Composite Total scores compared to placebo at 6 months. [ Time Frame: Baseline 1, Week 24 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • To evaluate the effects of twice-daily oral buspirone on the ADOS Composite calibrated severity score, social behavior, repetitive behavior, language, sensory dysfunction and anxiety. [ Time Frame: Baseline 1, Week 24 and Week 48 ]
  • To determine whether there are age group differences in the effects of buspirone on social interaction, repetitive behavior, language, sensory dysfunction and anxiety. [ Time Frame: Baseline 1, Week 1, Week 24, Week 48 ]
  • To determine whether there is a difference in the incidence of side effects and long term safety between the buspirone and placebo groups, and between the different dose groups. [ Time Frame: Duration of the study ]
  • To determine whether the whole brain PET measure of serotonin synthesis capacity is a predictor of buspirone effect. [ Time Frame: Baseline 2 ]
  • To determine whether blood serotonin concentration is a predictor of buspirone effect. [ Time Frame: Baseline 2 ]


Original Secondary Outcome: Same as current

Information By: Chugani, Diane C.

Dates:
Date Received: March 30, 2009
Date Started: May 2009
Date Completion:
Last Updated: July 25, 2016
Last Verified: July 2016