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 @ 7:10 PM
Ignite Modification Date:
2025-12-24 @ 7:10 PM
NCT ID:
NCT01361503
Eligibility Criteria:
Inclusion Criteria
* Male or female participants between 6 and 17 years of age.
* Fulfills diagnosis of autism spectrum disorders by meeting DSM-IV-TR PDD diagnostic criteria for autistic disorder, Asperger's disorder, or PDD-NOS as established by clinical interview.
* Subjects and their legal representative must have a level of understanding sufficient to communicate intelligently with the investigator and study coordinator, and to cooperate with all tests and examinations required by the protocol.
* Subjects and their legal representative must be considered reliable reporters.
* Each subject and his/her authorized legal representative must understand the nature of the study. The subject's authorized legal representative and the subject must sign an IRB approved informed consent and assent document respectively.
* Participants with disruptive behavior disorders, mood and anxiety disorders will be allowed to participate in the study provided they do not meet any exclusionary criteria.
Exclusion Criteria
* IQ \< 85.
* DSM-IV-TR PDD diagnoses of Rett's disorder, or childhood disintegrative disorder.
* Current diagnosis of a psychotic disorder or unstable bipolar disorder.
* History of recent or current (past 30 days) clinically significant depressive or anxiety disorder that warrants treatment.
* History of substance use (except nicotine or caffeine) within past 3 months or urine drug screen positive for substances of abuse.
* Clinically unstable psychiatric conditions or judged to be at serious safety risk to self (suicidal risk) or others.
* Subjects with a medical condition or treatment that will either jeopardize subject safety or affect the scientific merit of the study.
* Organic brain disorders.
* History of non-febrile seizures without a clear and resolved etiology in last 1 month.
* Pregnant or nursing females.
* Left hand dominant subjects.
* History of claustrophobia or fear of enclosed places.
* Presence of metal or surgical devices (aneurysm clips, metal plates, cochlear implants, neurostimulators, braces, and other items).
* Investigator and his/her immediate family; defined as the investigator's spouse, parent, child, grandparent, or grandchild.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
17 Years
Study:
NCT01361503
Study Brief:
Protocol Section:
NCT01361503