Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00778310 · ClinicalTrials.gov registry record · Phase 4
Neuroimaging of the Effects of Concerta in the Treatment of ADHD
A Phase 4 study, sponsored by The University of Texas Health Science Center at San Antonio.
- Completed
- Registry status
- Phase 4
- Development phase
- 76
- Enrollment target
NCT00778310: Completed Phase 4 study, sponsored by The University of Texas Health Science Center at San Antonio.
NCT00778310 is a Phase 4 study that has completed, run by The University of Texas Health Science Center at San Antonio. The registered enrollment target is 76 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00778310, a Phase 4 study, has completed, sponsored by The University of Texas Health Science Center at San Antonio.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 76 participants
- Enrollment target
Study Summary
A number of brain regions have been down to be altered in both structure and function in patients with ADHD, including prefrontal cortex, anterior cingulate, caudate and cerebellum. Patients with ADHD often show reduced levels of activity in the frontal and cingulate regions of brain while performing measures of inhibitory control during functional magnetic resonance imaging (fMRI). While stimulant medications robustly improve the clinical symptoms of ADHD, there are only a small number of studies examining the effects of these commonly prescribed medications on brain activity. We propose to obtain fMRI in patients with ADHD on placebo and on their individualized dose of OROS methylphenidate (Concerta). Our hypothesis is that Concerta will increase the activity of the brain in the frontal, cingulate and amygdala of the brain and that these brain changes will be associated with clinical improvement of symptoms.
Primary Outcome
Each subject viewed shapes and faces on multiple trials. The subject matched faces or shapes on each trial. BOLD activity during shape trials was subtracted from BOLD activity during Face trials and this value was compared on drug vs. placebo trials.
Interventions
- DRUG Placebo
- DRUG methylphenidate-OROS
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 76 participants |
| Start Date | 2008-11 |
| Est. Completion | 2010-12 |
| Phase | Phase 4 |
What the finished NCT00778310 record still lists
NCT00778310 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 76 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00778310 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00778310 about?
NCT00778310 is a clinical study titled "Neuroimaging of the Effects of Concerta in the Treatment of ADHD". A number of brain regions have been down to be altered in both structure and function in patients with ADHD, including prefrontal cortex, anterior cingulate, caudate and cerebellum. Patients with ADHD often show reduced levels of activity in the frontal and cingulate regions of brain while performin...
What is the current status of trial NCT00778310?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 76 participants. The study started on 2008-11. Estimated completion is 2010-12.
What interventions are being tested in trial NCT00778310?
The interventions under investigation include: Placebo (DRUG), methylphenidate-OROS (DRUG).
Who is sponsoring clinical trial NCT00778310?
This trial is sponsored by The University of Texas Health Science Center at San Antonio, which has 378 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00778310's enrollment target sits among peer trials
76 994th of 2000 higher than 999 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02615184 · 76 participants · Phase 2
A Study to Check the Safety of Dexlansoprazole and Learn If it Can Heal Erosive Esophagitis (EE) and Keep it Healed in Children 2 to 11 Years Old
- NCT02821741 · 76 participants · NA
Effects of External Ear Stimulation on Pain Perception and Mood
- NCT03019757 · 76 participants
Distinguishing Between Alzheimer's Disease, Lewy Body Dementia, and Parkinson's Disease
- NCT03353584 · 76 participants · NA
Effect of Virtual Reality Technology for Pain Management of Vaso-Occlusive Crisis in Patients With Sickle Cell Disease
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia