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 @ 1:09 AM
Ignite Modification Date:
2025-12-25 @ 1:09 AM
NCT ID:
NCT03289793
Eligibility Criteria:
Inclusion Criteria:
* Children and teenagers aged from 8 to 17 years' old
* Children and teenagers with a deficit attention disorder with or without hyperactivity, in the mixed form or in a pure inattentive form according to Diagnostique et Statistique des troubles Mentaux (DSM)-V.
* Children and teenagers having a score in Verbal Comprehension Index (or Index Verbal Reasoning) and Perceptual Reasoning Index (or Index Reasoning fluid) ≥ 80 of WISC IV or V test, not older than two years.
* Children and teenagers without psychostimulant treatment
* Children and teenagers with psychostimulant treatment agreed to achieve a therapeutic break at each visit day and with a stable dose during all the study.
* Children and teenagers whose parents have agreed and signed informed consent form of the study.
Exclusion Criteria:
* Children aged less than 8 and teenagers are more than 18 years' old.
* Children and teenagers having a score in Verbal Comprehension Index (or Index Verbal Reasoning) and Perceptual Reasoning Index (or Index Reasoning fluid) \< 80 of WISC IV or V test, not older than two years.
* Children and teenagers with developmental disorder except "Dys" disorders.
* Children and teenagers with pure hyperactivity (without attentional deficit)
* Children and teenagers with epilepsy except benign epilepsies (without brain damage), free of crisis for two years and without treatment.
* Children and teenagers with ADHD with conduct disorders and aggression
* Children and teenagers with ADHD and Tourette's syndrome.
* Patients treated by anti / epilepsy or psychotropic treatments (with the exception of psychostimulant treatment).
* Patients with psychostimulant treatment and whose parents aren't agreed to achieve a therapeutic break at each visit day.
* Patients with visual deficiency uncorrectable with lenses or glasses.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
17 Years
Study:
NCT03289793
Study Brief:
Protocol Section:
NCT03289793