Extracellular Signal-Related Kinase Biomarker Development in Autism

Autism Spectrum Disorders Clinical Trial

— ERK  

Official title:

Extracellular Signal-Related Kinase Biomarker Development in Autism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01850459
• Other study ID #: CIN001- ERK in Autism
• Status: Completed
• Phase: N/A
• First received: May 7, 2013
• Last updated: April 17, 2017
• Start date: January 2013
• Est. completion date: August 2015

Study information

• Verified date: April 2017
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 213
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autism Spectrum Disorders
• Autistic Disorder

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ERK activation		Up to three years