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 @ 3:28 AM
Ignite Modification Date:
2025-12-25 @ 3:28 AM
NCT ID:
NCT02536105
Eligibility Criteria:
Inclusion Criteria:
1. Male and female outpatients
2. Ages 6-12 years at time of screening
3. Judged by the investigator to be physically healthy and suitable for participation in the study
4. Diagnosis of DSM-5ADHD combined, predominantly inattentive or hyperactive/impulsive presentation, per clinical evaluation and confirmed by the MINI-KID
5. Clinical Global Impressions-Severity (CGI-S) ≥ 3
6. ≥ 90th percentile normative value for gender and age on the ADHD RS-IV total score at screening or baseline
7. Study participant has a parent/legal guardian who is willing and able to give written informed consent for him/her to participate in the study
8. Study participant must be able to give assent to participate in the trial
9. Study participant and legal guardian must be able to speak and understand English
10. Able to tolerate multiple finger pricks
11. Willing to comply with all study procedures
Exclusion Criteria:
1. Current (last month) psychiatric diagnosis other than specific phobia, motor skills disorders, oppositional defiant disorder, sleep disorders, elimination disorders, adjustment disorders, learning disorders, or communication disorders. Participants with school phobia or separation anxiety will not be eligible
2. Cognitively impaired, in the investigator's opinion
3. Any clinically significant chronic medical condition that, in the judgment of the investigator, may interfere with the participant's ability to participate in the study
4. Seizure disorder excluding a history of febrile seizures
5. Thyroid disease
6. Tourette's disorder or chronic tic disorder (mild medication induced tics are allowed)
7. Serious cardiac condition including cardiomyopathy, serious arrhythmias, structural cardiac disorders, or severe hypertension
8. Glaucoma
9. Current or recent (within the past 6 months) DSM-5 drug dependence or substance abuse (excluding nicotine and caffeine)
10. Pregnant or nursing females. Females must have a negative urine pregnancy test at screening as well as four additional visits and must be abstinent or use adequate and reliable contraception throughout the study
11. Currently treated and satisfied with ADHD medication
12. Current psychotropic medications other than sedative hypnotics for sleep
13. Use of atomoxetine, clonidine, guanfacine or a monoamine oxidase inhibitor within 28 days of the baseline visit
14. Participation in another investigational medication study within 30 days prior to screening
15. Clinically significant abnormal laboratory result, electrocardiogram (ECG) result, physical examination, or vital signs at screening that the investigator considers to be inappropriate to allow participation in the study
16. Planned use of prohibited drugs from the baseline visit through the end of the trial
17. History of allergic reaction or a known or suspected sensitivity to any substance that is contained in the study drugs
18. Food allergies that are determined by the PI as too severe to be easily accommodated for during the study
19. Inability to swallow study medication
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
12 Years
Study:
NCT02536105
Study Brief:
Protocol Section:
NCT02536105