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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| atomoxetine | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| mean sleep onset latency | ||
| parent and child-reported evening settling difficulties |
| Measure | Description | Time Frame |
|---|---|---|
| night wakings, sleep duration, and sleep efficiency | ||
| daytime sleepiness | ||
| ADHD symptom improvement |
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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:
Have a parent or legal guardian willing to participate in the study
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gloria Velez, B.A. | Contact | 401-444-3250 | gvelez@lifespan.org | |
| Juhee Lee, B.A. | Contact | 401-444-8815 | jlee3@lifespan.org |
| Name | Affiliation | Role |
|---|---|---|
| Judith Owens, MD, MPH | Rhode Island Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rhode Island Hospital | Recruiting | Providence | Rhode Island | 02903 | United States |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D020919 | Sleep Disorders, Intrinsic |
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| ID | Term |
|---|---|
| D000069445 | Atomoxetine Hydrochloride |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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| executive functions and functional outcomes/quality of life |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |