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ERK: Extracellular Signal-Related Kinase Biomarker Development in Autism

Sponsor
Children's Hospital Medical Center, Cincinnati (Other)
Overall Status
Completed
CT.gov ID
NCT01850459
Collaborator
(none)
213
Enrollment
1
Location
30.9
Duration (Months)
6.9
Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or Disease Intervention/Treatment Phase

    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

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    213 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Extracellular Signal-Related Kinase Biomarker Development in Autism
    Study Start Date :
    Jan 1, 2013
    Actual Primary Completion Date :
    Aug 1, 2015
    Actual Study Completion Date :
    Aug 1, 2015

    Arms and Interventions

    Arm Intervention/Treatment
    Autism Spectrum Disorder group

    Diagnosis of autistic disorder as confirmed by a clinical interview, utilizing the DSM-V
    IQ-Matched Control Subjects
    Age-Matched Neurotypical Controls
    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.

    Outcome Measures

    Primary Outcome Measures

    1. ERK activation [Up to three years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    3 Years to 25 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cincinnati Children's Hospital Medical Center Cincinnati Ohio United States 45229

    Sponsors and Collaborators

    • Children's Hospital Medical Center, Cincinnati

    Investigators

    • Principal Investigator: Craig A. Erickson, M.D., Children's Hospital Medical Center, Cincinnati

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Children's Hospital Medical Center, Cincinnati
    ClinicalTrials.gov Identifier:
    NCT01850459
    Other Study ID Numbers:
    • CIN001- ERK in Autism
    First Posted:
    May 9, 2013
    Last Update Posted:
    Apr 19, 2017
    Last Verified:
    Apr 1, 2017
    Additional relevant MeSH terms:
    Autistic Disorder
    Autism Spectrum Disorder

    Study Results

    No Results Posted as of Apr 19, 2017