Clinical trial NCT00566371: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Attention Deficit Hyperactivity Disorder
Insomnia
Keywords: attention deficit hyperactivity disorder
insomnia
atomoxetine
Lead sponsor: Rhode Island Hospital
Sponsor class: OTHER
First posted: 2007-12-03
Enrollment: 36
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
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.
timeFrame: 3 years
Secondary outcomes:
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.
timeFrame: 3 years
Other outcomes:
Locations:
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
Study officials:
affiliation: Lifespan
name: Judith Owens, MD
role: PRINCIPAL_INVESTIGATOR
References: