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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2005 by Rhode Island Hospital.
Recruitment status was  Recruiting
Eli Lilly and Company
Information provided by:
Rhode Island Hospital
ClinicalTrials.gov Identifier:
First received: November 9, 2005
Last updated: July 5, 2006
Last verified: November 2005

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 Intervention Phase
Attention-Deficit/Hyperactivity Disorder (ADHD)
Drug: atomoxetine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: The Effect of a Once Daily Evening Dose of Atomoxetine (ATX) on ADHD-Related Insomnia in Children and Adolescents

Resource links provided by NLM:

Further study details as provided by Rhode Island Hospital:

Primary Outcome Measures:
  • mean sleep onset latency
  • parent and child-reported evening settling difficulties

Secondary Outcome Measures:
  • night wakings, sleep duration, and sleep efficiency
  • daytime sleepiness
  • ADHD symptom improvement
  • executive functions and functional outcomes/quality of life

Estimated Enrollment: 36
Study Start Date: November 2005

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00252278

Contact: Gloria Velez, B.A. 401-444-3250 gvelez@lifespan.org
Contact: Juhee Lee, B.A. 401-444-8815 jlee3@lifespan.org

United States, Rhode Island
Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
Rhode Island Hospital
Eli Lilly and Company
Principal Investigator: Judith Owens, MD, MPH Rhode Island Hospital
  More Information

ClinicalTrials.gov Identifier: NCT00252278     History of Changes
Other Study ID Numbers: 0120-05 
Study First Received: November 9, 2005
Last Updated: July 5, 2006
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders
Neurodevelopmental Disorders
Atomoxetine Hydrochloride
Adrenergic Agents
Adrenergic Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 25, 2016