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

Cincinnati Children's Hospital Medical Center

Status: Completed

Conditions: Autism Spectrum Disorders

Study type: Observational

Funder types: Other

Identifiers

NCT01850459

CIN001- ERK in Autism

Details and patient eligibility

About

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.

Full 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

Enrollment: 213 patients

Sex: All

Ages: 3 to 25 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

213 participants in 4 patient groups

Autism Spectrum Disorder group

Description:

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

Description:

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.