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

Phase 4

• Conditions: Attention-Deficit/Hyperactivity Disorder (ADHD); Insomnia

• Registration Number: NCT00252278
• Lead Sponsor: Rhode Island Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2005-11
• Study Start: 2005-11
• Study First Submitted: 2005-11-09
• Study First Submitted QC: 2005-11-10
• Study First Posted: 2005-11-11
• Last Update Submitted: 2006-07-05
• Last Update Posted: 2006-07-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
mean sleep onset latency
parent and child-reported evening settling difficulties

Secondary Outcome Measures

Name	Time	Method
night wakings, sleep duration, and sleep efficiency
daytime sleepiness
ADHD symptom improvement
executive functions and functional outcomes/quality of life

Trial Locations

Locations (1)

Rhode Island Hospital; 🇺🇸 Providence, Rhode Island, United States