Clinical trial NCT00252278: Effect of Atomoxetine on ADHD-Related Insomnia in Children and Adolescents
Official title: The Effect of a Once Daily Evening Dose of Atomoxetine (ATX) on ADHD-Related Insomnia in Children and Adolescents
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Attention-Deficit/Hyperactivity Disorder (ADHD)
Insomnia
Lead sponsor: Rhode Island Hospital
Sponsor class: OTHER
Collaborators: name: Eli Lilly and Company
First posted: 2005-11-11
Enrollment: 36
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: mean sleep onset latency
measure: parent and child-reported evening settling difficulties
Secondary outcomes:
measure: night wakings, sleep duration, and sleep efficiency
measure: daytime sleepiness
measure: ADHD symptom improvement
measure: executive functions and functional outcomes/quality of life
Other outcomes:
Locations:
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
Study officials:
affiliation: Rhode Island Hospital
name: Judith Owens, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: