Effect of Atomoxetine on ADHD-Related Insomnia in Children and Adolescents
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|ClinicalTrials.gov Identifier: NCT00252278|
Recruitment Status : Unknown
Verified November 2005 by Rhode Island Hospital.
Recruitment status was: Recruiting
First Posted : November 11, 2005
Last Update Posted : July 7, 2006
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.
|Condition or disease||Intervention/treatment||Phase|
|Attention-Deficit/Hyperactivity Disorder (ADHD) Insomnia||Drug: atomoxetine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||36 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||The Effect of a Once Daily Evening Dose of Atomoxetine (ATX) on ADHD-Related Insomnia in Children and Adolescents|
|Study Start Date :||November 2005|
- mean sleep onset latency
- parent and child-reported evening settling difficulties
- night wakings, sleep duration, and sleep efficiency
- daytime sleepiness
- ADHD symptom improvement
- executive functions and functional outcomes/quality of life
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00252278
|Contact: Gloria Velez, B.A.||firstname.lastname@example.org|
|Contact: Juhee Lee, B.A.||email@example.com|
|United States, Rhode Island|
|Rhode Island Hospital||Recruiting|
|Providence, Rhode Island, United States, 02903|
|Principal Investigator:||Judith Owens, MD, MPH||Rhode Island Hospital|