Status:
COMPLETED
Extracellular Signal-Related Kinase Biomarker Development in Autism
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Conditions:
Autism Spectrum Disorders
Eligibility:
All Genders
3-25 years
Brief 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 p...
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) * Ag...
Eligibility Criteria
Inclusion
- Inclusion Criteria (ASD subjects):
- Diagnosis of autistic disorder as confirmed by a clinical interview, utilizing the DSM-V
- Age 3-25 years
- Stable dosing of psychotropic drugs for 5 half-lives or greater
- Exclusion Criteria (ASD subjects):
- Diagnosis of schizophrenia, another psychotic disorder, bipolar disorder, or alcohol or other substance abuse based on DSM-V criteria
- Use of lithium, riluzole or other known modulators of ERK activation
- 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. IQ-Matched Control Subjects participate in a Screen/Baseline visit only.
- Age-Matched Neurotypical Control Subjects: Those subjects who are included in the study based on having an age matched to the age of an Autistic Disorder Subject and a history of normal development. Age-Matched Neurotypical Subjects participate in a Screen/Baseline visit only.
- Shipped Biomarker Control Group Subjects: For these shipping control samples, blood samples will also be drawn from adult parent/guardians of participating subjects.
Exclusion
Key Trial Info
Start Date :
January 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
213 Patients enrolled
Trial Details
Trial ID
NCT01850459
Start Date
January 1 2013
End Date
August 1 2015
Last Update
April 19 2017
Active Locations (1)
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1
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229