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 @ 6:29 PM
Ignite Modification Date:
2025-12-24 @ 6:29 PM
NCT ID:
NCT02638168
Eligibility Criteria:
Inclusion Criteria:
1. Ages 6-12 (inclusive), and able to swallow capsule
2. Children who have been treated with a stable morning dose of Extended Release Methylphenidate or twice daily dose of Immediate Release Methylphenidate for an extended period of time (30 days or longer).
3. DSM V diagnosis of Attention Deficit Hyperactivity Disorder (ADHD): Diagnosis will be assessed on the NIMH Computerized Diagnostic Interview Schedule for Children (C-DISC), and parent and teacher rating scales.
4. Children with any ADHD subtype meeting the above criteria will be eligible, although, it is expected that the majority will be of the combined subtype of ADHD given the associate between this subtype and ODD symptoms. A diagnosis of any of the two Behavioral Insomnia of Childhood (BIC) subtypes associated with delayed SOL (limit setting or combined type) will be required.
5. Sex: male or female
6. Fluent in written and spoken English.
Exclusion Criteria:
1. Age \< 6 years of age or \>12 years of age.
2. Children who have not had Methylphenidate (Extended Release) treatment for an extended period of time (30 days or longer).
3. A diagnosis or suspicion of sleep-disordered breathing will be exclusionary as it is not expected to be impacted by Immediate Release Methylphenidate treatment.
4. Current psychotropics other than Methylphenidate (Extended Release or Immediate Release Methylphenidate). Children prescribed alpha agonists for adjunctive control of ADHD in combination with a MPH product will be allowed to enroll as long as they meet all other entry criteria (i.e. sleep must remained impaired with use of alpha agonist).
5. Regular use of other medications that impact sleep within the last 14 days (i.e.: sedating antihistamines, melatonin).
6. Active medical/psychiatric conditions that impact sleep (i.e.: severe asthma, Autism Spectrum Disorder diagnosis, marked developmental delay, or mood/anxiety disorder).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
12 Years
Study:
NCT02638168
Study Brief:
Protocol Section:
NCT02638168