Effect of Atomoxetine on ADHD-Related Insomnia in Children and Adolescents
NCT ID: NCT00252278
Last Updated: 2006-07-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
36 participants
INTERVENTIONAL
2005-11-30
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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atomoxetine
Eligibility Criteria
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Inclusion Criteria
* 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 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
6 Years
17 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Rhode Island Hospital
OTHER
Principal Investigators
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Judith Owens, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Rhode Island Hospital
Locations
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Rhode Island Hospital
Providence, Rhode Island, United States
Countries
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Central Contacts
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Other Identifiers
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0120-05
Identifier Type: -
Identifier Source: org_study_id