Ignite Creation Date:
2025-12-24 @ 2:24 PM
Ignite Modification Date:
2026-03-05 @ 3:01 PM
Study NCT ID:
NCT01850459
Status:
COMPLETED
Last Update Posted:
2017-04-19
First Post:
2013-05-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Extracellular Signal-Related Kinase Biomarker Development in Autism
Sponsor:
Children's Hospital Medical Center, Cincinnati
Organization:
Study Overview
Official Title:
Extracellular Signal-Related Kinase Biomarker Development in Autism
Status:
COMPLETED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ERK
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.
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
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: