NCT01850459

Extracellular Signal-Related Kinase Biomarker Development in Autism

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 213 (actual)
• Sponsor: Children's Hospital Medical Center, Cincinnati · Academic / Other
• Sex: All
• Age: 3 Years – 25 Years
• Healthy volunteers: Accepted

Summary

The purpose of this research study is to establish a way to help the development of targeted treatments in autism spectrum disorders. This may also help in early diagnosis of autism and may possibly predict severity. The study will compare subject's ERK (extracellular signal-related kinase) signaling to age- and gender-matched neurotypical controls and Intelligence quotient (IQ)-matched developmental disabilities.

Detailed description

Autism Spectrum Disorder Subject Criteria: Inclusion Criteria: * Diagnosis of autism spectrum disorder, based upon a clinical interview utilizing the Diagnostic and Statistical Manual-V (DSM-V) * Age 3-25 years * Stable dosing of psychotropic drugs for greater than or equal to 5 half-lives Exclusion Criteria: * Diagnosis of schizophrenia, another psychotic disorder, bipolar disorder, or alcohol or other substance abuse based on Diagnostic and Statistical Manual-V criteria * Use of lithium, riluzole or other known modulators of ERK activation Age-Matched Neurotypical Control Subjects: * Age matched to the age of an Autistic Disorder Subject * History of normal development IQ-Matched Control Subjects: * Those subjects who are included in the study based on having an IQ and age that matches the IQ and age of an Autistic Disorder Subject who has an IQ less than 70 * All IQ-Matched Control Subjects will then also have an IQ less than 70

Conditions

• Autism Spectrum Disorders

Timeline

• Start date: 2013-01-01
• Primary completion: 2015-08-01
• Completion: 2015-08-01
• First posted: 2013-05-09
• Last updated: 2017-04-19

Locations

1 site across 1 country: United States