NCT00566371

The Effect of a Once Daily Dose of Atomoxetine (ATX) on ADHD-Related Insomnia in Children and Adolescents

The Effect of a Once Daily Dose of Atomoxetine (ATX) on ADHD-Related Insomnia

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Rhode Island Hospital · Academic / Other
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Attention Deficit Hyperactivity Disorder
• Insomnia

Interventions

Type	Name	Description
DRUG	atomoxetine	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.
DRUG	placebo	placebo

Timeline

• Start date: 2005-06-01
• Primary completion: 2008-12-01
• Completion: 2009-06-01
• First posted: 2007-12-03
• Last updated: 2010-08-16

Locations

1 site across 1 country: United States