Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:24 PM
Ignite Modification Date:
2025-12-24 @ 2:24 PM
NCT ID:
NCT01850459
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
25 Years
Study:
NCT01850459
Study Brief:
Protocol Section:
NCT01850459