Status:
UNKNOWN
Effect of Atomoxetine on ADHD-Related Insomnia in Children and Adolescents
Lead Sponsor:
Rhode Island Hospital
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Attention-Deficit/Hyperactivity Disorder (ADHD)
Insomnia
Eligibility:
All Genders
6-17 years
Phase:
PHASE4
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 result...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00252278
Start Date
November 1 2005
Last Update
July 7 2006
Active Locations (1)
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1
Rhode Island Hospital
Providence, Rhode Island, United States, 02903