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 @ 12:19 PM
Ignite Modification Date:
2025-12-24 @ 12:19 PM
NCT ID:
NCT01470261
Eligibility Criteria:
Inclusion Criteria:
ADHD-treated group:
* Clinical diagnosis of ADHD
* Aged between 5 and 17 years.
* Not previously treated with methylphenidate
* Agreement between clinician, patient and their family to commence on methylphenidate (baseline measures will be taken before first prescription of methylphenidate is issued).
* Any co-medication other than dexamfetamine or atomoxetine will be allowed.
* All psychiatric and physical illness comorbidities will be allowed
ADHD-unmedicated controls:
* Clinical diagnosis of ADHD not previously treated with medication.
* Aged between 5 and 17 years.
* Agreement between clinician, patient and their family not to treat with methylphenidate.
* Any medication other than dexamfetamine or atomoxetine will be allowed.
* All comorbidities will be allowed.
Non-ADHD controls:
* Child who does not have ADHD.
* Aged between 5 and 17 years.
* Mean total clinician rated Swanson Nolan and Pelham IV Rating scale (SNAP IV) score (ADHD items) \< 1.5
* Parent rated Strengths and Difficulties Questionnaire (SDQ) Hyperactivity Score within normal range for country (e.g. \< 6 for UK)
* Any current medication other than dexamfetamine or atomoxetine will be allowed.
* Must never have taken methylphenidate
* Any other mental health or physical illness diagnoses will be allowed.
Exclusion Criteria:
All Groups:
* Current or past treatment with dexamfetamine or atomoxetine.
Un-medicated ADHD controls:
* Previous or current treatment with methylphenidate.
Non-ADHD controls:
* Previous or current treatment with methylphenidate.
* Clinician rated SNAP score ≥ 1.5. Parent rated SDQ Hyperactivity Score in Borderline or Abnormal range.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
17 Years
Study:
NCT01470261
Study Brief:
Protocol Section:
NCT01470261