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 @ 9:26 PM
Ignite Modification Date:
2025-12-24 @ 9:26 PM
NCT ID:
NCT02114632
Eligibility Criteria:
Inclusion Criteria:
1. Patients will be boys between the ages of 8-16 years.
2. Patients must meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnostic criteria for ADHD confirmed by Schedule for Affective Disorders and Schizophrenia - Present and Lifetime Version (K-SADS-PL)
3. Patients must be of normal intelligence as assessed by the Wechsler Intelligence Scale for Children - Revised Edition (WISC-R).
4. Treatment of ADHD by such drugs as: atomoxetine, reboxetine, clonidine, desipramine or clomipramine or children with ADHD without pharmacological treatment
Exclusion Criteria:
1. Patients who have a documented history of Bipolar I or II disorder, psychosis or autism.
2. Patients with a history of epilepsy
3. Patients with a history of asthma treated with corticosteroids.
4. Patients with diabetes, haemorrhagic problem, hyperlipidemia, hypertension, hyperthyroidism or hypothyroidism.
5. Patients taking any psychotropic medication other than above-mentioned on a regular basis, including health-food supplements that the investigator feels have central nervous system activity, must have a washout equal of at least three months before study entry, and such medications are not allowed during the study.
6. Patients with a history of alcohol or drug abuse within the past 3 months (excessive or compulsive use as judged by the investigator).
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
8 Years
Maximum Age:
16 Years
Study:
NCT02114632
Study Brief:
Protocol Section:
NCT02114632