Lead Investigator: Tomoya Hirota, University of California San Francisco
Title of Proposal Research: Early Prediction of Treatment Response to Antipsychotics for Irritability and Aggression in Autism Spectrum Disorder
Vivli Data Request: 7381
Funding Source: None
Potential Conflicts of Interest: None
Summary of the Proposed Research:
In this project, we will re-analyze existing data of randomized controlled trials with two medications, aripiprazole and risperidone, that are currently approved by the Food and Drug Administration for the treatment of irritability and aggression in individuals with autism spectrum disorder (ASD) that is characterized by impairment in social communication and interaction and restricted interest and repetitive behaviors. Although these medications are widely used for irritability and aggression, there is a lack of data supporting how early we can predict ultimate treatment response to these medications based on early improvement in symptoms. Therefore, we will conduct a re-analysis of raw data for individual participants in each clinical trial. Better understandings of early prediction of treatment response will assist us in deciding whether it is meaningful for us to continue treatment or switch to another treatment to minimize prolonged exposures to these medications that may lead to side effects.
Requested Studies:
A Multicenter Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study With Three Fixed Doses of Aripiprazole in the Treatment of Children and Adolescents With Autistic Disorder (AD)
Data Contributor: Otsuka Pharmaceuticals
Study ID: NCT00337571
Sponsor ID: CN138-179
A Multicenter Double-Blind, Randomized, Placebo-Controlled, Flexible-Dosed, Parallel-Group Study of Aripiprazole Flexibly Dosed in the Treatment of Children and Adolescents With Autistic Disorder (AD)
Data Contributor: Otsuka Pharmaceuticals
Study ID: NCT00332241
Sponsor ID: CN138-178
Efficacy And Safety Of Risperidone In The Treatment Of Children With Autistic Disorder And Other Pervasive Developmental Disorders: A Canadian, Multicenter, Double-Blind, Placebo-Controlled Study
Data Contributor: Johnson & Johnson
Study ID: NCT00261508
Sponsor ID: CR006106
A double-blind, placebo-controlled study of risperidone in children and adolescents with autistic disorder
Data Contributor: Johnson & Johnson
Study ID: RIS-USA-150
Sponsor ID: RIS-USA-150
Risperidone in the Treatment of Children and Adolescents With Autistic Disorder: A Double-Blind, Placebo-Controlled Study of Efficacy and Safety, Followed by an Open-Label Extension Study of Safety
Data Contributor: Johnson & Johnson
Study ID: NCT00576732
Sponsor ID: CR014740