Extracellular Signal-Related Kinase Biomarker Development in Autism

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

213 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-31

Study Completion Date

2015-08-31

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.

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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

Conditions

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Autism Spectrum Disorders

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Autism Spectrum Disorder group

Diagnosis of autistic disorder as confirmed by a clinical interview, utilizing the DSM-V

No interventions assigned to this group

IQ-Matched Control Subjects

No interventions assigned to this group

Age-Matched Neurotypical Controls

No interventions assigned to this group

Shipped Biomarker Control Group Subjects

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.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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

* 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.

Minimum Eligible Age

3 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes