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Extracellular Signal-Related Kinase Biomarker Development in Autism (ERK)

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ClinicalTrials.gov Identifier: NCT01850459
Recruitment Status : Completed
First Posted : May 9, 2013
Last Update Posted : April 19, 2017
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

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
Autism Spectrum Disorders

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 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 : January 2013
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. ERK activation [ Time Frame: Up to three years ]

Biospecimen Retention:   Samples Without DNA
For the ERK activation assay, about 5 mL of whole blood is layered onto 3 mL Histopaque in a 15 mL centrifuge tube, and centrifuged. The lymphocyte-containing cell layer is removed and transferred for washing. After a second wash, cells are resuspended and rested. They are then stimulated by addition of phorbol myristate acetate and sample aliquots are removed at short intervals, fixed and permeabilized. Fixed, permeabilized cells are stained by addition of Alexafluor488-labeled monoclonal antibody to phospho-ERK in the dark for 30 min. Washed, resuspended cells are analyzed in a Coulter flow cytometer.


Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The subjects with autism will be recruited through the clinic population at Cincinnati Children's Hospital Medical Center. Recruitment of subjects will be conducted by notifying via, IRB approved electronic and paper ads, individuals with autistic disorder, their families, treating clinicians and agencies throughout the referral base of CCHMC and those within our existing clinical services, residential facilities, schools and group homes for the developmentally disabled.
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01850459


Locations
United States, Ohio
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

Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT01850459     History of Changes
Other Study ID Numbers: CIN001- ERK in Autism
First Posted: May 9, 2013    Key Record Dates
Last Update Posted: April 19, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders