Extracellular Signal-Related Kinase Biomarker Development in Autism
| Status: | Completed |
|---|---|
| Conditions: | Neurology, Psychiatric, Autism |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 3 - 25 |
| Updated: | 4/2/2016 |
| Start Date: | January 2013 |
| End Date: | February 2015 |
| Contact: | Katie Friedmann, RN |
| Email: | autism@cchmc.org |
| Phone: | 513-636-0523 |
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.
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.
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
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.
We found this trial at
1
site
3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
Cincinnati, Ohio 45229
1-513-636-4200
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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