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 @ 2:34 AM
Ignite Modification Date:
2025-12-25 @ 2:34 AM
NCT ID:
NCT01141634
Eligibility Criteria:
Inclusion Criteria:
* Males and females aged 6-16 diagnosed with ADHD of any subtype according to DSM-IV criteria.
* Mentally competent participants able to adhere to the given protocol and treatments administered as interventions, and able to answer outcome measures.
* Primary caregiver (parent or guardian) has given informed consent; child participant gives ongoing assent throughout the study.
Exclusion Criteria:
* Changes to participants' medication for ADHD within 6 weeks of study onset.
* Diagnosis of additional mental health disorder including but not limited to: Conduct Disorder, Autism Spectrum Disorder, Bipolar Disorder, and Major Depressive Disorder. The patient should not have current suicidal or homicidal ideation.
* Participants should have no history of head injury of seizures, organ system damage and should have an estimated I.Q within the normal range.
* Pregnancy and Lactation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
16 Years
Study:
NCT01141634
Study Brief:
Protocol Section:
NCT01141634