Extracellular Signal-Related Kinase Biomarker Development in Autism

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01850459

Acronym

ERK

Enrollment

213

Registered

2013-05-09

Start date

2013-01-31

Completion date

2015-08-31

Last updated

2017-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Spectrum Disorders

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

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

3 Years to 25 Years

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.

Design outcomes

Primary

Measure	Time frame
ERK activation	Up to three years

Countries

United States

Outcome results