Clinical trial NCT01850459: Extracellular Signal-Related Kinase Biomarker Development in Autism
Official title: Extracellular Signal-Related Kinase Biomarker Development in Autism
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Autism Spectrum Disorders
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2013-05-09
Enrollment: 213
Sex: ALL
Minimum age (years): 3
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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

Eligibility 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.

Primary outcomes:
measure: ERK activation
timeFrame: Up to three years
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Craig A. Erickson, M.D.
role: PRINCIPAL_INVESTIGATOR
References: