The Effect of a Once Daily Dose of Atomoxetine (ATX) on ADHD-Related Insomnia in Children and Adolescents
| Status: | Completed |
|---|---|
| Conditions: | Insomnia Sleep Studies, Neurology, Psychiatric |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 6 - 17 |
| Updated: | 10/14/2017 |
| Start Date: | June 2005 |
| End Date: | June 2009 |
The Effect of a Once Daily Dose of Atomoxetine (ATX) on ADHD-Related Insomnia
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).
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).
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
We found this trial at
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Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
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