The Effect of a Once Daily Dose of Atomoxetine (ATX) on ADHD-Related Insomnia in Children and Adolescents
Status:
Completed
Trial end date:
2009-06-01
Target enrollment:
Participant gender:
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).