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NCT00566371 · ClinicalTrials.gov registry record · Phase 4
The Effect of a Once Daily Dose of Atomoxetine (ATX) on ADHD-Related Insomnia in Children and Adolescents
A Phase 4 study, sponsored by Rhode Island Hospital.
- Completed
- Registry status
- Phase 4
- Development phase
- 36
- Enrollment target
NCT00566371 is a Phase 4 study that has completed, run by Rhode Island Hospital. The registered enrollment target is 36 participants.
The verdict
NCT00566371, a Phase 4 study, has completed, sponsored by Rhode Island Hospital.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 36 participants
- Enrollment target
Study 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).
Interventions
- DRUG placebo
- DRUG atomoxetine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2005-06 |
| Est. Completion | 2009-06 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00566371
The ClinicalTrials.gov registry entry for NCT00566371 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Rhode Island Hospital, which has 130 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00566371 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00566371 about?
NCT00566371 is a clinical study titled "The Effect of a Once Daily Dose of Atomoxetine (ATX) on ADHD-Related Insomnia in Children and Adolescents". 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...
What is the current status of trial NCT00566371?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 36 participants. The study started on 2005-06. Estimated completion is 2009-06.
What interventions are being tested in trial NCT00566371?
The interventions under investigation include: placebo (DRUG), atomoxetine (DRUG).
Who is sponsoring clinical trial NCT00566371?
This trial is sponsored by Rhode Island Hospital, which has 130 total clinical trials registered on ClinicalTrials.gov.
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