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:
2025-12-25 @ 2:58 AM
Ignite Modification Date:
2025-12-25 @ 2:58 AM
NCT ID:
NCT02323633
Eligibility Criteria:
Inclusion Criteria:
* Completion of the written informed consent process for trial participation, by parent(s) or legal guardian(s), prior to all trial-related procedures
* Completion of written assent for trial participation, by participant, prior to all trial-related procedures
* Male or female participants aged 6 to 12 years
* Newly diagnosed (Diagnosis made by DSM-V criteria), treatment naïve participants
* Participants and parent(s) or legal guardian(s) must have the ability to communicate well with the investigator and to understand and comply with the requirements of the trial
* Participants and parent(s) or legal guardian(s) must agree to stay in contact with the trial site for the duration of the trial and provide updated contact information as necessary.
Exclusion Criteria:
* Existence of a major neurologic or psychiatric condition (epilepsy, severe depression etc.)
* History of head injury resulting in more than a momentary loss of consciousness
* Previous neurosurgery
* Presence of unstable medical conditions, such as: Diabetes Mellitus, Cardiac Pathology, Cancer, Kidney Insufficiency, Acute Thrombosis
* Presence of any implanted metal or electronic medical devices present in the head, excluding any dental implants
* Subjects on any prohibited concomitant medication
* Any other medical condition which, in the opinion of the Investigator, could affect the participant's health during trial participation or could compromise his/her ability to participate in the trial
* In the opinion of the investigator, the participant and his/her parent(s) or legal guardian(s) is not reliable for participation in the trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
12 Years
Study:
NCT02323633
Study Brief:
Protocol Section:
NCT02323633