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 @ 9:40 PM
Ignite Modification Date:
2025-12-24 @ 9:40 PM
NCT ID:
NCT01506232
Eligibility Criteria:
Inclusion Criteria:
* Male or female participants between 6 and 17 years of age.
* Right handedness.
* Fulfills DSM-IV-TR diagnostic criteria for ADHD, bipolar disorder (BPD I, II, or NOS), or ASD (autistic disorder, Asperger's disorder, or PDD-NOS) as established by clinical diagnostic interview and supported by K-SADS-E module for respective diagnoses.
* 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.
* Each subject and his/her authorized legal representative must understand the nature of the study. The subject's authorized legal representative must sign an informed consent document and the subject must sign an informed assent document.
Exclusion Criteria:
* Investigator and his/her immediate family; defined as the investigator's spouse, parent, child, grandparent, or grandchild.
* I.Q. \< 85
* History of active seizure disorder (as suggested by EEG suggestive of seizure activity and/or history of seizure in last 1 month)
* Pregnant or nursing females.
* Subjects with a medical condition that will either jeopardize subject safety or affect the scientific merit of the study, including:
* Organic brain disorders
* Uncorrected hypothyroidism or hyperthyroidism
* Renal or hepatic impairment.
* Clinically unstable psychiatric conditions or judged to be at serious suicidal risk
* Current diagnosis of schizophrenia
* History of substance use (except nicotine or caffeine) within past 3 months or urine drug screen positive for substances of abuse
* Significant sensory deficits such as deafness or blindness.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
17 Years
Study:
NCT01506232
Study Brief:
Protocol Section:
NCT01506232