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 @ 5:12 AM
Ignite Modification Date:
2025-12-25 @ 5:12 AM
NCT ID:
NCT02633527
Eligibility Criteria:
Inclusion Criteria:
1. Healthy male or female subjects, 6-12 years of age, inclusive, with a diagnosis of ADHD according to the Diagnostic and Statistical Manual of Mental Disorders-IV (DSM IV), confirmed with the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID).
2. ADHD-RS-IV-Parent Version: Investigator Administered and Scored score of at least 26.
3. CGI-S score of at least 4
4. Weight of at least 20 kg.
5. Free of medication for the treatment of ADHD or any psychosis for at least one week prior to enrollment.
Exclusion Criteria:
1. Current or lifetime diagnosis of major depressive disorder, bipolar disorder, personality disorder, Tourette's disorder, or psychosis not otherwise specified.
2. Currently meeting DSM-IV criteria for pervasive developmental disorder, obsessive compulsive disorder, post-traumatic stress disorder, or any other anxiety disorder as primary diagnosis.
3. Significant systemic disease.
4. Evidence of suicidality within the six months before Screening or at Screening.
5. BMI greater than 95th percentile for the appropriate age and gender.
6. Pregnancy or refusal to practice abstinence during the study for female subjects of childbearing potential (FOCP).
7. Substance or alcohol use during the last three months.
8. Positive urine screen for cotinine, alcohol, or drugs of abuse at Screening.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
12 Years
Study:
NCT02633527
Study Brief:
Protocol Section:
NCT02633527