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NCT00393042 · ClinicalTrials.gov registry record · Phase 3
Sleep and Tolerability Study: Comparing the Effects of Adderall XR and Focalin XR
A Phase 3 study, sponsored by Seattle Children's Hospital.
- Completed
- Registry status
- Phase 3
- Development phase
- 77
- Enrollment target
NCT00393042 is a Phase 3 study that has completed, run by Seattle Children's Hospital. The registered enrollment target is 77 participants.
The verdict
NCT00393042, a Phase 3 study, has completed, sponsored by Seattle Children's Hospital.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 77 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate how children and adolescents with Attention Deficit/ Hyperactivity Disorder (ADHD) respond to treatment with three differing doses of stimulant medications used to treat ADHD, Adderall XR® and Focalin XR®. Another purpose of the study is to evaluate if there are differences in sleep and other side effects, such as changes in mood or loss of appetite, which can occur with stimulant medications. A third purpose is to determine if there are differences in the characteristics of individuals who respond better to either of the medications. This research is being done because the investigators do not know if one of these two commonly used treatments is better tolerated than the other. Children and adolescents with ADHD often have a hard time sitting still, playing quietly, finishing things they start, paying attention, waiting their turn, and not distracting others. These medications improve these symptoms, but sometimes affect sleep, appetite, or mood. It is hypothesized that at effective and frequently prescribed doses, Adderall will be associated with insomnia, more stimulant side effects, and decreased tolerability during an acute trial relative to Focalin.
Interventions
- DRUG placebo
- DRUG Dexmethylphenidate
- DRUG Mixed Amphetamine Salts, ER
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 77 participants |
| Start Date | 2006-01 |
| Est. Completion | 2009-02 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00393042
The ClinicalTrials.gov registry entry for NCT00393042 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 77 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Seattle Children's Hospital, which has 168 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which placebo is the first listed.
NCT00393042 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00393042 about?
NCT00393042 is a clinical study titled "Sleep and Tolerability Study: Comparing the Effects of Adderall XR and Focalin XR". The purpose of this study is to evaluate how children and adolescents with Attention Deficit/ Hyperactivity Disorder (ADHD) respond to treatment with three differing doses of stimulant medications used to treat ADHD, Adderall XR® and Focalin XR®. Another purpose of the study is to evaluate if there ...
What is the current status of trial NCT00393042?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 77 participants. The study started on 2006-01. Estimated completion is 2009-02.
What interventions are being tested in trial NCT00393042?
The interventions under investigation include: placebo (DRUG), Dexmethylphenidate (DRUG), Mixed Amphetamine Salts, ER (DRUG).
Who is sponsoring clinical trial NCT00393042?
This trial is sponsored by Seattle Children's Hospital, which has 168 total clinical trials registered on ClinicalTrials.gov.
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