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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: Completed Phase 4 study, sponsored by Rhode Island Hospital.
NCT00566371 is a Phase 4 study that has completed, run by Rhode Island Hospital. The registered enrollment target is 36 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00566371 record still lists
NCT00566371 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00566371 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00566371's enrollment target sits among peer trials
36 1490th of 2000 higher than 495 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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