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 @ 11:57 PM
Ignite Modification Date:
2025-12-24 @ 11:57 PM
NCT ID:
NCT01156051
Eligibility Criteria:
Inclusion Criteria:
1. Subject must be male or female, aged 6 - 12 years with ADHD.
2. Subject must (a) be taking methylphenidate, amphetamine, or atomoxetine for treatment of ADHD with parent or subject concerns of inadequate efficacy or intolerable side effects, or (b) free of any other medication used to treat ADHD for at least 30 days at the time of the initial sleep study.
3. Subject must have repeated difficulty with sleep initiation or persistence despite attempts at adequate sleep hygiene.
4. Subject must be able to swallow tablets.
Exclusion Criteria:
1. Subject or parent/LAR is unable or unwilling to discontinue present medications used to treat ADHD.
2. Subject has a body mass index \< 5th percentile for age, using the Centers for Disease Control standards reported in 2000.
3. Subject has a body weight \> 176 pounds.
4. Subject has a diagnosis of Autism or Autism Spectrum Disorder.
5. Subject has other serious psychiatric diagnoses.
6. Subject has a medical condition that may require treatment with an unapproved medication, that may cause a safety concern, or that may confound outcome results
7. Subject has an excessive caffeine intake (greater than 2.5 mg/kg/d).
8. Subject has a prior problem with clonidine or guanfacine.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
12 Years
Study:
NCT01156051
Study Brief:
Protocol Section:
NCT01156051