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 @ 2:36 AM
Ignite Modification Date:
2025-12-25 @ 2:36 AM
NCT ID:
NCT02618434
Eligibility Criteria:
Inclusion Criteria:
* Otherwise healthy male or female subjects, age 6 to 12 years at the time of screening with a primary diagnosis of ADHD and currently receiving monotherapy treatment with an optimized FDA-approved ADHD medication.
* Impulsive aggression will be confirmed at screening using R-MOAS and Vitiello Aggression Scale.
Exclusion Criteria:
* Current or lifetime diagnosis of epilepsy, major depressive disorder, bipolar disorder, schizophrenia or a related disorder, personality disorder, Tourette's disorder, or psychosis not otherwise specified.
* Currently meeting DSM criteria for autism spectrum disorder, pervasive developmental disorder, obsessive-compulsive disorder, post-traumatic stress disorder, or any other anxiety disorder as the primary diagnosis.
* Known or suspected intelligence quotient (IQ) \< 70, suicidality, pregnancy, or substance or alcohol abuse.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
12 Years
Study:
NCT02618434
Study Brief:
Protocol Section:
NCT02618434