Attention-Deficit/Hyperactivity Disorder (ADHD), Insomnia
Conditions
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.
Interventions
DRUGatomoxetine
Sponsors
Eli Lilly and Company
Rhode Island Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| parent and child-reported evening settling difficulties | — |
| mean sleep onset latency | — |
Secondary
| Measure | Time frame |
|---|---|
| night wakings, sleep duration, and sleep efficiency | — |
| daytime sleepiness | — |
| ADHD symptom improvement | — |
| executive functions and functional outcomes/quality of life | — |
Countries
United States
Contacts
Primary ContactGloria Velez, B.A.
Backup ContactJuhee Lee, B.A.
Outcome results
None listed