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

Sponsors and Collaborators:	Rhode Island Hospital Eli Lilly and Company
Information provided by:	Rhode Island Hospital
ClinicalTrials.gov Identifier:	NCT00252278

Purpose

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) Insomnia	Drug: atomoxetine	Phase IV

Drug Information available for: Atomoxetine Atomoxetine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	The Effect of a Once Daily Evening Dose of Atomoxetine (ATX) on ADHD-Related Insomnia in Children and Adolescents

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

Eligibility

Ages Eligible for Study:	6 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00252278

Contacts

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

Locations

United States, Rhode Island
Rhode Island Hospital	Recruiting
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

More Information

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

Study placed in the following topic categories:

Sleep Initiation and Maintenance Disorders
Sleep Disorders
Dyssomnias
Attention Deficit and Disruptive Behavior Disorders
Atomoxetine
Dyskinesias
Sleep Disorders, Intrinsic

Signs and Symptoms
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Mental Disorders Diagnosed in Childhood
Hyperkinesis
Neurologic Manifestations

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents

Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Nervous System Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009