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NCT00586573 · ClinicalTrials.gov registry record · Phase 4
Open-Label Pilot Study of Namenda in Adult Subjects With ADHD and ADHD NOS
A Phase 4 study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 4
- Development phase
- 34
- Enrollment target
NCT00586573: Completed Phase 4 study, sponsored by Massachusetts General Hospital.
NCT00586573 is a Phase 4 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 34 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00586573, a Phase 4 study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 34 participants
- Enrollment target
Study Summary
The primary objective of the study is to assess the efficacy and tolerability of a 12-week trial of memantine hydrochloride administered twice daily in 20 adults (ages 18-55) with ADHD and ADHD NOS. Improvement will be defined as: 1) changes from baseline on the investigator-rated DSM-IV based ADHD Rating Scale; 2) changes from baseline in a questionnaire aimed at assessing executive functions (BRIEF); and 3) changes from screening in a computerized neuropsychological battery (CANTAB). We hypothesize that memantine hydrochloride will be associated with improving ADHD symptoms and associated deficits in executive functions. We also expect that memantine will be well-tolerated with predictable adverse events.
Primary Outcome
AISRS used to assess 18 individual criteria symptoms of ADHD in DSM-IV on a severity grid (0=not present, 3=severe; minimum score=0, maximum score=54). This is a composite score assessing both inattention and hyperactivity, which are not assessed individually in this scale. Score change from baseline.
Interventions
- DRUG memantine hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2007-03 |
| Est. Completion | 2009-10 |
| Phase | Phase 4 |
What the finished NCT00586573 record still lists
NCT00586573 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 1 intervention - of which memantine hydrochloride is the first listed.
NCT00586573 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00586573 about?
NCT00586573 is a clinical study titled "Open-Label Pilot Study of Namenda in Adult Subjects With ADHD and ADHD NOS". The primary objective of the study is to assess the efficacy and tolerability of a 12-week trial of memantine hydrochloride administered twice daily in 20 adults (ages 18-55) with ADHD and ADHD NOS. Improvement will be defined as: 1) changes from baseline on the investigator-rated DSM-IV based ADHD ...
What is the current status of trial NCT00586573?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 34 participants. The study started on 2007-03. Estimated completion is 2009-10.
What interventions are being tested in trial NCT00586573?
The interventions under investigation include: memantine hydrochloride (DRUG).
Who is sponsoring clinical trial NCT00586573?
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 NCT00586573's enrollment target sits among peer trials
34 1520th of 2000 higher than 473 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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