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

Lifespan

Status and phase

Unknown

Phase 4

Conditions

Insomnia

Attention-Deficit/Hyperactivity Disorder (ADHD)

Treatments

Drug: atomoxetine

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00252278

0120-05

Details and patient eligibility

About

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.

Sex

All

Ages

6 to 17 years old

Volunteers

No Healthy Volunteers

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