Extracellular Signal-Related Kinase Biomarker Development in Autism

Study Overview
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Brief Summary
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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
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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

Official Title
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Extracellular Signal-Related Kinase Biomarker Development in Autism

Conditions
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Autism Spectrum Disorders

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Autism Spectrum Disorder group<br>Diagnosis of autistic disorder as confirmed by a clinical interview, utilizing the DSM-V | |
| IQ-Matched Control Subjects<br> | |
| Age-Matched Neurotypical Controls<br> | |
| Shipped Biomarker Control Group Subjects<br>These subjects provide a blood sample only that serves as a shipping control that is shipped along with all blood samples from Autistic Disorder Subjects, IQ-Matched Control Subjects or Age-Matched Neurotypical Control Subjects. For these shipping control samples, blood samples will also be drawn from the subjects. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ERK activation |  | Up to three years |