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NCT00889915 · ClinicalTrials.gov registry record · Phase 4
Comparing the Effectiveness of New Versus Older Treatments for Attention Deficit Hyperactivity Disorder (The NOTA Study)
A Phase 4 study, sponsored by Duke University.
- Completed
- Registry status
- Phase 4
- Development phase
- 228
- Enrollment target
NCT00889915: Completed Phase 4 study, sponsored by Duke University.
NCT00889915 is a Phase 4 study that has completed, run by Duke University. The registered enrollment target is 228 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (56% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00889915, a Phase 4 study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 228 participants
- Enrollment target
Study Summary
This study will determine whether two new psychostimulant medications are more effective, tolerable, and acceptable than two older medications for treating attention deficit hyperactivity disorder.
Primary Outcome
The CGI-E is the value at which the participant's Therapeutic Benefit and Adverse Impact to the study drug intersect. This number is determined by combining each participant's scores for the degree of Therapeutic Benefit versus the degree to which problems with Tolerability and/or Acceptability adversely impact the subject. Participants are then determined to be Responders or Non-responders to the study medication. For example, a subject who is very much improved (CGI-I=1) or much improved (CGI-
Interventions
- DRUG Lisdexamfetamine dimesylate
- DRUG Methylphenidate transdermal system
- DRUG Osmotic-release oral system methylphenidate (OROS MPH)
- DRUG Mixed amphetamine salts extended release
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 228 participants |
| Start Date | 2009-04 |
| Est. Completion | 2009-12 |
| Phase | Phase 4 |
What the finished NCT00889915 record still lists
NCT00889915 is an interventional study that assigns participants to a tested intervention. The registered 228 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (56% lower).
The record links to 0 conditions, and to 4 interventions - of which Lisdexamfetamine dimesylate is the first listed.
NCT00889915 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00889915 about?
NCT00889915 is a clinical study titled "Comparing the Effectiveness of New Versus Older Treatments for Attention Deficit Hyperactivity Disorder (The NOTA Study)". This study will determine whether two new psychostimulant medications are more effective, tolerable, and acceptable than two older medications for treating attention deficit hyperactivity disorder.
What is the current status of trial NCT00889915?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 228 participants. The study started on 2009-04. Estimated completion is 2009-12.
What interventions are being tested in trial NCT00889915?
The interventions under investigation include: Lisdexamfetamine dimesylate (DRUG), Methylphenidate transdermal system (DRUG), Osmotic-release oral system methylphenidate (OROS MPH) (DRUG), Mixed amphetamine salts extended release (DRUG).
Who is sponsoring clinical trial NCT00889915?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00889915's enrollment target sits among peer trials
228 374th of 2000 higher than 1,625 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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