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

Conditions:Insomnia Sleep Studies, Neurology, Psychiatric
Therapuetic Areas:Neurology, Psychiatry / Psychology
Age Range:6 - 17
Start Date:November 2005
Contact:Gloria Velez, B.A.

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The Effect of a Once Daily Evening Dose of Atomoxetine (ATX) on ADHD-Related Insomnia in Children and Adolescents

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.

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
We found this trial at
593 Eddy Street
Providence, Rhode Island 02903
Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
Providence, RI
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