Back to resultsEffect of Atomoxetine on ADHD-Related Insomnia in Children and Adolescents
Primary Purpose
Attention-Deficit/Hyperactivity Disorder (ADHD), Insomnia
Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
atomoxetine
Sponsored by
About this trial
This is an interventional treatment trial for Attention-Deficit/Hyperactivity Disorder (ADHD)
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: difficulty initiating or maintaining sleep that is viewed as a problem by the child or caregiver 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
Sites / Locations
- Rhode Island HospitalRecruiting
Outcomes
Primary Outcome Measures
mean sleep onset latency
parent and child-reported evening settling difficulties
Secondary Outcome Measures
night wakings, sleep duration, and sleep efficiency
daytime sleepiness
ADHD symptom improvement
executive functions and functional outcomes/quality of life
Full Information
NCT ID
NCT00252278
First Posted
November 9, 2005
Last Updated
July 5, 2006
Sponsor
Rhode Island Hospital
Collaborators
Eli Lilly and Company
1. Study Identification
Unique Protocol Identification Number
NCT00252278
Brief Title
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
2. Study Status
Record Verification Date
November 2005
Overall Recruitment Status
Unknown status
Study Start Date
November 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Rhode Island Hospital
Collaborators
Eli Lilly and Company
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention-Deficit/Hyperactivity Disorder (ADHD), Insomnia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
36 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
atomoxetine
Primary Outcome Measure Information:
Title
mean sleep onset latency
Title
parent and child-reported evening settling difficulties
Secondary Outcome Measure Information:
Title
night wakings, sleep duration, and sleep efficiency
Title
daytime sleepiness
Title
ADHD symptom improvement
Title
executive functions and functional outcomes/quality of life
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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:
difficulty initiating or maintaining sleep that is viewed as a problem by the child or caregiver
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gloria Velez, B.A.
Phone
401-444-3250
Email
gvelez@lifespan.org
First Name & Middle Initial & Last Name or Official Title & Degree
Juhee Lee, B.A.
Phone
401-444-8815
Email
jlee3@lifespan.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judith Owens, MD, MPH
Organizational Affiliation
Rhode Island Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
Effect of Atomoxetine on ADHD-Related Insomnia in Children and Adolescents
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