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

• Sponsor: Rhode Island Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00252278
• Collaborator: Eli Lilly and Company (Industry)
• Enrollment: 36
• Location: 1

Study Details

Study Description

Brief Summary

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 Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: The Effect of a Once Daily Evening Dose of Atomoxetine (ATX) on ADHD-Related Insomnia in Children and Adolescents
• Study Start Date: Nov 1, 2005

Outcome Measures

Primary Outcome Measures

1. mean sleep onset latency []

2. parent and child-reported evening settling difficulties []

Secondary Outcome Measures

1. night wakings, sleep duration, and sleep efficiency []

2. daytime sleepiness []

3. ADHD symptom improvement []

4. executive functions and functional outcomes/quality of life []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rhode Island Hospital	Providence	Rhode Island	United States	02903

Sponsors and Collaborators

• Rhode Island Hospital
• Eli Lilly and Company

Investigators

• Principal Investigator: Judith Owens, MD, MPH, Rhode Island Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00252278
• Other Study ID Numbers: 0120-05
• First Posted: Nov 11, 2005
• Last Update Posted: Jul 7, 2006
• Last Verified: Nov 1, 2005

• Additional relevant MeSH terms: Sleep Initiation and Maintenance Disorders; Attention Deficit Disorder with Hyperactivity; Atomoxetine Hydrochloride

Study Results

No Results Posted as of Jul 7, 2006