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 @ 3:03 PM
Ignite Modification Date:
2025-12-24 @ 3:03 PM
NCT ID:
NCT03901859
Eligibility Criteria:
The ADHD group
1. Inclusion Criteria
Patients with ADHD are eligible to be included in this study only if they meet all of the following criteria:
1. Patients will be outpatients who are between 7 and 18 years of age.
2. Patients must have ADHD that meet the Diagnostic and Statistical Manual of Mental disorders, 5th edition (DSM-V) disease diagnostic criteria assessed by the investigator's clinical evaluation, as well as confirmed by the Chinese version of the Schedule for Affective Disorders and Schizophrenia for School-Age Children-Epidemiological Version (K-SADS-E).
3. Patients must have a Clinical Global Impressions-ADHD-Severity (CGI-ADHD-S) score \> 4 at baseline.
4. Patients must be psychotropic drug-naïve. Patients will be considered to be drug-naïve if they have never received medications specifically to treat ADHD.
5. Patients and parents (or legal representative) must have a degree of understanding sufficient to be able to communicate suitably with the investigator.
6. Patients must be of normal intelligence in the judgment of the investigator. Normal intelligence is defined as achieving a score of 80 or more when IQ testing is administrated.
7. Patients must have been judged by the investigator to be reliable to keep appointments for clinic visits and all tests, including neuropsychological testing and venipunctures.
2. Exclusion Criteria
Patients will be excluded from the study if they meet any of the following criteria:
1. Patients with current or past history of schizophrenia, schizoaffective Disorder, organic psychosis, bipolar I or II disorder, autism, or autism spectrum disorder. Other comorbid psychiatric disorders are not excluded if the ADHD symptoms are the primary source of impairment for the patient.
2. Patients with a history of any seizure disorder (other than febrile convulsion) or patients who are taking anticonvulsants for seizure control.
3. Patients have been at serious suicidal risk, determined by the investigator.
4. Patients with a history of alcohol or drug abuse within the past 3 months, or who are currently using alcohol, drugs of abuse, or any described or over-the-counter medication in a manner that the investigator considers indicative of abuse.
5. Patients with cardiovascular disease or other conditions that could be aggravated by an increased heart rate or increased blood pressure.
6. Patients who are likely to need Chinese medicine or health-food supplements that have central nervous system activity.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
7 Years
Maximum Age:
18 Years
Study:
NCT03901859
Study Brief:
Protocol Section:
NCT03901859