Effect of Atomoxetine on ADHD-Related Insomnia in Children and Adolescents

Study Overview
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Brief Summary
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Children and adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD) very commonly experience difficulty in initiating and maintaining sleep. Studies have shown that daytime sleepiness resulting from insufficient sleep can affect attention and learning. Therefore, treating insomnia in children with ADHD may not only improve sleep, but it could potentially improve ADHD symptoms as well. The main purpose of this study is to examine the effects of atomoxetine on ADHD-related insomnia. Atomoxetine (Strattera®) is a non-stimulant drug used to treat ADHD symptoms in both children and adults, and there is evidence that it may also have a positive effect on sleep in children with ADHD. During the study, participants will receive either atomoxetine or placebo for a period of four weeks. We expect that the effects of atomoxetine on sleep will differ from those of placebo, with atomoxetine having a greater effect on improving sleep difficulties.

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

Conditions
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Insomnia, Attention-Deficit/Hyperactivity Disorder (ADHD)

Intervention / Treatment
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* Drug: atomoxetine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Boy or girl aged 6-17 years, inclusive, and English-speaking Meet the DSM-IV criteria for Attention-Deficit/Hyperactivity Disorder Have sleep initiation defined by: difficulty initiating or maintaining sleep that is viewed as a problem by the child or caregiver sleep onset delay that is not exclusively related to direct or rebound effects of psychostimulant treatment Have a parent or legal guardian willing to participate in the study Exclusion Criteria: Have any other primary sleep disorder(s) (e.g. obstructive sleep apnea or periodic limb movement disorder) Have a history of significant chronic medical (e.g. diabetes, severe asthma) or psychiatric (e.g. depression) illness Have a history of chronic use of sedating (e.g. antihistamines) or alertness enhancing (e.g. caffeine) medications Have a history of failure to respond to an adequate (defined as appropriate dose and adequate duration of therapy) previous trial with atomoxetine

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: atomoxetine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean sleep onset latency |  |  | 
| parent and child-reported evening settling difficulties |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| night wakings, sleep duration, and sleep efficiency |  |  | 
| daytime sleepiness |  |  | 
| ADHD symptom improvement |  |  | 
| executive functions and functional outcomes/quality of life |  |  |