Effect of Atomoxetine on ADHD-Related Insomnia in Children and Adolescents
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...
Brief Summary
Official Title: “The Effect of a Once Daily Evening Dose of Atomoxetine (ATX) on ADHD-Related Insomnia in Children and Adolescents”
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.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Intervention(s) in this Clinical Trial
- Drug: atomoxetine
Outcome Measures for this Clinical Trial
Primary Measures
- mean sleep onset latency
- parent and child-reported evening settling difficulties
Secondary Measures
- night wakings, sleep duration, and sleep efficiency
- daytime sleepiness
- ADHD symptom improvement
- executive functions and functional outcomes/quality of life
Criteria for Participation in this Clinical Trial
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:
- 1. difficulty initiating or maintaining sleep that is viewed as a problem by the child or caregiver
- 2. 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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 6 Years
Maximum Age for this Clinical Trial: 17 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Rhode Island Hospital Other
Overall Clinical Trial Officials and Contacts
Judith Owens, MD, MPH Principal Investigator Rhode Island Hospital
Overall Contact: Gloria Velez, B.A. 401-444-3250 gvelez@lifespan.org
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00252278
Study ID Number: 0120-05
ClinicalTrials.gov Identifier: NCT00252278
Health Authority: United States: Institutional Review Board
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00252278
