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NCT00593112 · ClinicalTrials.gov registry record · Phase 4
Proton Magnetic Spectroscopy in Children and Adolescents With ADHD Before and After Treatment With OROS Methylphenidate
A Phase 4 study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 4
- Development phase
- 39
- Enrollment target
NCT00593112: Completed Phase 4 study, sponsored by Massachusetts General Hospital.
NCT00593112 is a Phase 4 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 39 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00593112, a Phase 4 study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 39 participants
- Enrollment target
Study Summary
This will be an open label study using daily does of up to 126mg/day of Concerta in the treatment of children and adolescents, ages 12-17, who meet DSM-IV criteria for ADHD. Specific hypotheses are as follows: Hypothesis 1: Children and adolescents with ADHD will have significantly higher ACC and DLPFC Glutamate/myo-Inositol containing compounds (Glu/Ino) and Glutamate/creatine + phosphocreatine (Glu/Cr) than matched HCS. Hypothesis 2: After six weeks of treatment, OROS methylphenidate will lower ACC and DLPFC Glu/Ino and Glu/Cr levels in children with ADHD who are methylphenidate responders.
Primary Outcome
Comparison of treated ADHD participants (6 weeks on Concerta) and Healthy Control Subjects (HCS) This measure is a ratio of Glutamate (excitatory neurotransmitter) to myo-inositol (cyclic sugar alcohol) containing compounds in the anterior cingulate.
Interventions
- OTHER No intervention
- DRUG OROS methylphenidate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2006-11 |
| Est. Completion | 2009-05 |
| Phase | Phase 4 |
What the finished NCT00593112 record still lists
NCT00593112 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which No intervention is the first listed.
NCT00593112 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00593112 about?
NCT00593112 is a clinical study titled "Proton Magnetic Spectroscopy in Children and Adolescents With ADHD Before and After Treatment With OROS Methylphenidate". This will be an open label study using daily does of up to 126mg/day of Concerta in the treatment of children and adolescents, ages 12-17, who meet DSM-IV criteria for ADHD. Specific hypotheses are as follows: Hypothesis 1: Children and adolescents with ADHD will have significantly higher ACC and D...
What is the current status of trial NCT00593112?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 39 participants. The study started on 2006-11. Estimated completion is 2009-05.
What interventions are being tested in trial NCT00593112?
The interventions under investigation include: No intervention (OTHER), OROS methylphenidate (DRUG).
Who is sponsoring clinical trial NCT00593112?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00593112's enrollment target sits among peer trials
39 1468th of 2000 higher than 525 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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