Risperidone Treatment In Children With Autism Spectrum Disorder And High Levels Of Repetitive Behavior
Status:
Completed
Trial end date:
2016-12-01
Target enrollment:
Participant gender:
Summary
The proposed study attempts to deepen our understanding of repetitive behaviors in autism
spectrum disorders (ASD) and its treatment by examining the changes in key neural circuits
associated with risperidone treatment using functional MRI. This study is a substudy of a
larger center grant (IRB#07-03-066). Other studies also under this center grant, include:
IRB#03-02-085, IRB#95-01-028. All participants will have the option to enter another
sub-study, should they meet criteria. The proposed study will address this aim by mounting a
controlled trial of 52 children with Autism Spectrum Disorder. After screening assessment,
children will enter a three-part study. Phase 1 will be an 8-week, double-blind,
placebo-controlled flexible dose trial of risperidone. The extension phase is a 16-week
open-label maintenance phase for responders to risperidone or placebo. Non-responders to
placebo will be invited to enroll in the eight-week open-label study. 48 of the participants
will also undergo fMRI at Week 8 while on blinded treatment, as an optional sub-study. The
medication will be dispensed in a liquid suspension and the dose will range from 0.5 mg to
4.0mg.
Phase:
Phase 2
Details
Lead Sponsor:
University of California, Los Angeles
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)