The Effect of a Once Daily Dose of Atomoxetine (ATX) on ADHD-Related Insomnia in Children and Adolescents
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Purpose
This study is a single site, double-blind, randomized, placebo-controlled parallel group design. this study is designed to directly examine the efficacy of a single daily dose of atomoxetine taken in the morning in alleviating sleep initiation insomnia in children with ADHD. Primary outcome measures are sleep parameters, specifically mean sleep onset latency (time of onset to persistent sleep), as measured by actigraphy/sleep diary, and parent and child-reported evening settling difficulties, as measured on the evening subscale items of the parent and child versions of the DPREMB-R. Secondary outcome measures include: additional actigraphic sleep parameters (night wakings, sleep duration, and sleep efficiency), daytime sleepiness (Pediatric Daytime Sleepiness Scale, sleepiness visual analogue scale (VAS), and morning behaviors on the DPREMB-R); ADHD symptom improvement (ADHD-RS, parent version; provider-completed CGI); a neurocognitive measure of attention and impulsivity (CPT); executive functions (Brown ADD Scale for Children) and functional outcomes/quality of life (CHQ).
| Condition | Intervention | Phase |
|---|---|---|
|
Attention Deficit Hyperactivity Disorder Insomnia |
Drug: atomoxetine Drug: placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | The Effect of a Once Daily Dose of Atomoxetine (ATX) on ADHD-Related Insomnia |
- Primary outcome measures are sleep parameters, specifically mean sleep onset latency as measured by actigraphy/sleep diary, and parent and child-reported evening settling difficulties. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Secondary outcome measures include: additional actigraphic sleep parameters daytime sleepiness, ADHD symptom improvement; a neurocognitive measure of attention and impulsivity, executive functions, and functional outcomes/quality of life. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 36 |
| Study Start Date: | June 2005 |
| Study Completion Date: | June 2009 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Patients will then be randomized (at Visit 2) to receive either atomoxetine or placebo for 4 weeks (Treatment Period); study drug will be titrated individually according to tolerability and efficacy (measured by ADHD-RS and CGI-I) completed at Visits 3, 4, 5, and 6) at 7-10 day intervals to a maximum dose of 1.8 mg/kg.
|
Drug: atomoxetine
Patients will then be randomized (at Visit 2) to receive either atomoxetine or placebo for 4 weeks (Treatment Period); study drug will be titrated individually according to tolerability and efficacy (measured by ADHD-RS and CGI-I) completed at Visits 3, 4, 5, and 6) at 7-10 day intervals to a maximum dose of 1.8 mg/kg.
|
|
Placebo Comparator: 2
Patients will then be randomized (at Visit 2) to receive either atomoxetine or placebo for 4 weeks (Treatment Period); study drug will be titrated individually according to tolerability and efficacy (measured by ADHD-RS and CGI-I) completed at Visits 3, 4, 5, and 6) at 7-10 day intervals to a maximum dose of 1.8 mg/kg.
|
Drug: placebo
placebo
|
Eligibility| Ages Eligible for Study: | 6 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subjects are children aged 6 through 17 years with DSM-IV criteria-defined ADHD and sleep initiation insomnia.
Exclusion Criteria:
the sleep onset delay must not be exclusively related to direct or rebound effects of psychostimulant treatment. All subjects will be screened for primary sleep disorders with survey questionnaires (Children's Sleep Habits Questionnaire, CSHQ (12) and Restless Sleep Questionnaire) (Visit 1); subjects scoring above a pre-defined threshold for OSA and/or RLS/PLMD symptoms will be excluded from the study. Other exclusion criteria include IQ < 80 (WISC-III screen at baseline), history of significant chronic medical illness (diabetes, severe asthma), co-morbid depression or other significant psychiatric co-morbidities (ODD, LD not excluded; determined by screening with the Diagnostic Interview Schedule for Children (DISC)), history of chronic use of sedating (eg, antihistamines) or alertness-enhancing (eg, caffeine) medications, history of conditions for which use of atomoxetine is contraindicated (eg, narrow angle glaucoma), use of other prescription medication for ADHD and/or use of prescription/OTC medication for sleep (eg, alpha agonists, hypnotics, melatonin, antihistamines) following the screening visit, and history of failure to respond to an adequate (defined as appropriate dose and adequate duration of therapy) previous trial of atomoxetine
Contacts and Locations More Information
No publications provided
| Responsible Party: | Judith Owens, Lifespan |
| ClinicalTrials.gov Identifier: | NCT00566371 History of Changes |
| Other Study ID Numbers: | 701-1315, 0120-05 |
| Study First Received: | November 30, 2007 |
| Last Updated: | August 13, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Rhode Island Hospital:
|
attention deficit hyperactivity disorder insomnia atomoxetine |
Additional relevant MeSH terms:
|
Attention Deficit Disorder with Hyperactivity Hyperkinesis Sleep Initiation and Maintenance Disorders Attention Deficit and Disruptive Behavior Disorders Mental Disorders Diagnosed in Childhood Mental Disorders Dyskinesias Neurologic Manifestations Nervous System Diseases Signs and Symptoms Sleep Disorders, Intrinsic |
Dyssomnias Sleep Disorders Atomoxetine Adrenergic Uptake Inhibitors Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Neurotransmitter Uptake Inhibitors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 21, 2013