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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Eli Lilly and Company
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Attention-Deficit/Hyperactivity Disorder (ADHD) Insomnia Drug: atomoxetine Phase 4

Study Type : Interventional  (Clinical Trial)
Enrollment : 36 participants
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 : November 2005

Resource links provided by the National Library of Medicine

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

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 17 Years   (Child)
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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00252278

Contact: Gloria Velez, B.A. 401-444-3250
Contact: Juhee Lee, B.A. 401-444-8815

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 Identifier: NCT00252278     History of Changes
Other Study ID Numbers: 0120-05
First Posted: November 11, 2005    Key Record Dates
Last Update Posted: July 7, 2006
Last Verified: November 2005

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Attention Deficit Disorder with Hyperactivity
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Atomoxetine Hydrochloride
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs