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 @ 11:16 PM
Ignite Modification Date:
2025-12-24 @ 11:16 PM
NCT ID:
NCT03533556
Eligibility Criteria:
Inclusion Criteria:
1. Children and adolescents (age 8-17 years)
2. Male
3. Diagnosed with ADHD by a clinician (e.g. a psychiatrist or a pediatrician)
4. Responded to stimulants (i.e. the symptoms of ADHD have improved in the past with a prescription of stimulants)
Exclusion Criteria:
1. Gross impairment of vision or hearing that would prevent the participants from performing neuropsychological tasks
2. Inability to read and follow written instructions
3. WISC-V IQ score of \< 80
4. Physical, neurological or concurrent psychiatric impairments (except ADHD) that could affect cognitive and motor functions
5. Regular intake of medication that could alter visual, auditory, cognitive or motor functions (except stimulants)
6. History of head injury that resulted in loss of consciousness / history of brain surgery
7. Intake of drugs containing caffeine, other phosphodiesterase inhibitors or adenosine receptor blockers within the past 3 months
8. Intake of medications which are known to have pharmacological interactions with caffeine within the past 3 months
9. Current / past diagnosis of tics or other forms of dyskinesia
10. History of development of headache, drowsiness, anxiety, insomnia or nausea following intake of caffeine or caffeine containing beverages
11. Current / past history of smoking and / or alcohol or drug abuse
12. Absolute contraindications to undergo MRI
13. Unwillingness or inability to entirely refrain from use of electronic devices during study visits
14. Unwillingness or inability to refrain from intake of L-theanine and caffeine containing food or beverages within the 24 hours prior to each study visit
15. Unwillingness or inability to follow written, on-screen and verbal instructions given by the study team
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
8 Years
Maximum Age:
17 Years
Study:
NCT03533556
Study Brief:
Protocol Section:
NCT03533556