Attention Deficit Hyperactivity Disorder, Insomnia
Conditions
Keywords
attention deficit hyperactivity disorder, insomnia, atomoxetine
Brief summary
This study is a single site, double-blind, randomized, placebo-controlled parallel group design. this study is designed to directly examine the efficacy of a single daily dose of atomoxetine taken in the morning in alleviating sleep initiation insomnia in children with ADHD. Primary outcome measures are sleep parameters, specifically mean sleep onset latency (time of onset to persistent sleep), as measured by actigraphy/sleep diary, and parent and child-reported evening settling difficulties, as measured on the evening subscale items of the parent and child versions of the DPREMB-R. Secondary outcome measures include: additional actigraphic sleep parameters (night wakings, sleep duration, and sleep efficiency), daytime sleepiness (Pediatric Daytime Sleepiness Scale, sleepiness visual analogue scale (VAS), and morning behaviors on the DPREMB-R); ADHD symptom improvement (ADHD-RS, parent version; provider-completed CGI); a neurocognitive measure of attention and impulsivity (CPT); executive functions (Brown ADD Scale for Children) and functional outcomes/quality of life (CHQ).
Interventions
DRUGatomoxetine
Patients will then be randomized (at Visit 2) to receive either atomoxetine or placebo for 4 weeks (Treatment Period); study drug will be titrated individually according to tolerability and efficacy (measured by ADHD-RS and CGI-I) completed at Visits 3, 4, 5, and 6) at 7-10 day intervals to a maximum dose of 1.8 mg/kg.
DRUGplacebo
placebo
Sponsors
Rhode Island Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
Subjects are children aged 6 through 17 years with DSM-IV criteria-defined ADHD and sleep initiation insomnia.
Exclusion criteria
the sleep onset delay must not be exclusively related to direct or rebound effects of psychostimulant treatment. All subjects will be screened for primary sleep disorders with survey questionnaires (Children's Sleep Habits Questionnaire, CSHQ (12) and Restless Sleep Questionnaire) (Visit 1); subjects scoring above a pre-defined threshold for OSA and/or RLS/PLMD symptoms will be excluded from the study. Other
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome measures are sleep parameters, specifically mean sleep onset latency as measured by actigraphy/sleep diary, and parent and child-reported evening settling difficulties. | 3 years |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures include: additional actigraphic sleep parameters daytime sleepiness, ADHD symptom improvement; a neurocognitive measure of attention and impulsivity, executive functions, and functional outcomes/quality of life. | 3 years |
Countries
United States
Outcome results
None listed