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NCT02215538 · ClinicalTrials.gov registry record · Phase 2
OROS Methylphenidate (Concerta) in the Treatment of Adult ADHD
A Phase 2 study, sponsored by University of Utah.
- Completed
- Registry status
- Phase 2
- Development phase
- 47
- Enrollment target
NCT02215538: Completed Phase 2 study, sponsored by University of Utah.
NCT02215538 is a Phase 2 study that has completed, run by University of Utah. The registered enrollment target is 47 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02215538, a Phase 2 study, has completed, sponsored by University of Utah.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 47 participants
- Enrollment target
Study Summary
This study will look at the effectiveness of osmotic release oral system (OROS) methylphenidate (Concerta) in treating attention deficit hyperactvity disorder (ADHD) in adults. Concerta has received FDA approval for childhood ADHD and there is documentation that it is effective in adult ADHD. However this trial will explore its effectiveness in treating symptoms not a part of the Diagnostic and Statistical Manual-III (DSM-III) criteria. Subjects will experience one screening visit and one baseline visit. Those who meet admission criteria will enter the double-blind phase. This will involve two 4-week treatment periods one of which will involve the use of Concerta and the other a placebo pill. Subjects who complete the double-blind phase will be allowed to enter a 180-day, open-label Concerta phase designed to assess long-term effects.
Primary Outcome
This is an investigator rated scale which assessed the 7 domains of the Utah Criteria of Adult ADHD
Interventions
- DRUG Placebo
- DRUG OROS methylphenidate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2004-11 |
| Est. Completion | 2006-06 |
| Phase | Phase 2 |
What the finished NCT02215538 record still lists
NCT02215538 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 47 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02215538 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02215538 about?
NCT02215538 is a clinical study titled "OROS Methylphenidate (Concerta) in the Treatment of Adult ADHD". This study will look at the effectiveness of osmotic release oral system (OROS) methylphenidate (Concerta) in treating attention deficit hyperactvity disorder (ADHD) in adults. Concerta has received FDA approval for childhood ADHD and there is documentation that it is effective in adult ADHD. Howeve...
What is the current status of trial NCT02215538?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 47 participants. The study started on 2004-11. Estimated completion is 2006-06.
What interventions are being tested in trial NCT02215538?
The interventions under investigation include: Placebo (DRUG), OROS methylphenidate (DRUG).
Who is sponsoring clinical trial NCT02215538?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02215538's enrollment target sits among peer trials
47 1283rd of 2000 higher than 715 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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