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| Descriptive Information Fields | |||||||||
| Brief Title † | The Effect of a Once Daily Dose of Atomoxetine (ATX) on ADHD-Related Insomnia in Children and Adolescents | ||||||||
| Official Title † | The Effect of a Once Daily Dose of Atomoxetine (ATX) on ADHD-Related Insomnia | ||||||||
| 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). |
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| Detailed Description | |||||||||
| Study Phase | Phase IV | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study | ||||||||
| Primary Outcome Measure † | 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. [ Time Frame: 3 years ] [ Designated as safety issue: No ] | ||||||||
| Secondary Outcome Measure † | 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. [ Time Frame: 3 years ] [ Designated as safety issue: No ] | ||||||||
| Condition † | Attention Deficit Hyperactivity Disorder Insomnia |
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| Intervention † | Drug: atomoxetine Drug: placebo |
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| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 36 | ||||||||
| Start Date † | June 2005 | ||||||||
| Completion Date | June 2009 | ||||||||
| Eligibility Criteria † | 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 exclusion criteria include IQ < 80 (WISC-III screen at baseline), history of significant chronic medical illness (diabetes, severe asthma), co-morbid depression or other significant psychiatric co-morbidities (ODD, LD not excluded; determined by screening with the Diagnostic Interview Schedule for Children (DISC)), history of chronic use of sedating (eg, antihistamines) or alertness-enhancing (eg, caffeine) medications, history of conditions for which use of atomoxetine is contraindicated (eg, narrow angle glaucoma), use of other prescription medication for ADHD and/or use of prescription/OTC medication for sleep (eg, alpha agonists, hypnotics, melatonin, antihistamines) following the screening visit, and history of failure to respond to an adequate (defined as appropriate dose and adequate duration of therapy) previous trial of atomoxetine |
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| Gender | Both | ||||||||
| Ages | 6 Years to 17 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
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| Location Countries † | United States | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00566371 | ||||||||
| Organization ID | 701-1315 | ||||||||
| Secondary IDs †† | 0120-05 | ||||||||
| Study Sponsor † | Rhode Island Hospital | ||||||||
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| Information Provided By | Rhode Island Hospital | ||||||||
| Verification Date | November 2007 | ||||||||
| First Received Date † | November 30, 2007 | ||||||||
| Last Updated Date | May 27, 2008 | ||||||||
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