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

Insomnia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00252278
• Other study ID #: 0120-05
• Status: Recruiting
• Phase: Phase 4
• First received: November 9, 2005
• Last updated: July 5, 2006
• Start date: November 2005

Study information

• Verified date: November 2005
• Source: Rhode Island Hospital
• Contact: Gloria Velez, B.A.
• Phone: 401-444-3250
• Email: gvelez[@]lifespan.org
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 17 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention-Deficit/Hyperactivity Disorder (ADHD)
• Insomnia

Intervention

Drug:
• atomoxetine

Locations

Country	Name	City	State
United States	Rhode Island Hospital	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Rhode Island Hospital	Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mean sleep onset latency
Primary	parent and child-reported evening settling difficulties
Secondary	night wakings, sleep duration, and sleep efficiency
Secondary	daytime sleepiness
Secondary	ADHD symptom improvement
Secondary	executive functions and functional outcomes/quality of life