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

Primary Purpose

Attention Deficit Hyperactivity Disorder, Insomnia

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
atomoxetine
placebo
Sponsored by
Rhode Island Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder focused on measuring attention deficit hyperactivity disorder, insomnia, atomoxetine

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rhode Island Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
November 30, 2007
Last Updated
August 13, 2010
Sponsor
Rhode Island Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00566371
Brief Title
The Effect of a Once Daily Dose of Atomoxetine (ATX) on ADHD-Related Insomnia in Children and Adolescents
Official Title
The Effect of a Once Daily Dose of Atomoxetine (ATX) on ADHD-Related Insomnia
Study Type
Interventional

2. Study Status

Record Verification Date
November 2007
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Rhode Island Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder, Insomnia
Keywords
attention deficit hyperactivity disorder, insomnia, atomoxetine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
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.
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
atomoxetine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judith Owens, MD
Organizational Affiliation
Lifespan
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

12. IPD Sharing Statement

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

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