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NCT00181727 · ClinicalTrials.gov registry record · Phase 4
Study of Depakote ER for the Treatment of Mania in Children Ages 6-12 With Bipolar Disorder
A Phase 4 study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 4
- Development phase
- 14
- Enrollment target
NCT00181727: Completed Phase 4 study, sponsored by Massachusetts General Hospital.
NCT00181727 is a Phase 4 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 14 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00181727, a Phase 4 study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 14 participants
- Enrollment target
Study Summary
This is an open-labeled study of Divalproex Sodium Extended Release (Depakote ER), testing its efficacy for the treatment of mania in children between the ages of 6-12 who have been diagnosed with Bipolar I, Bipolar II, and Bipolar Spectrum Disorders. This is an exploratory, pilot study, seeking to determine whether Divalproex Sodium Extended Release is efficacious and well tolerated in the treatment of youth with pediatric bipolar and bipolar spectrum disorder, and the study results will be used to generate hypotheses for a larger randomized controlled clinical trial with explicit hypotheses and sufficient statistical power.
Interventions
- DRUG divalproex sodium extended release
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2004-01 |
| Est. Completion | 2006-11 |
| Phase | Phase 4 |
What the finished NCT00181727 record still lists
NCT00181727 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which divalproex sodium extended release is the first listed.
NCT00181727 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00181727 about?
NCT00181727 is a clinical study titled "Study of Depakote ER for the Treatment of Mania in Children Ages 6-12 With Bipolar Disorder". This is an open-labeled study of Divalproex Sodium Extended Release (Depakote ER), testing its efficacy for the treatment of mania in children between the ages of 6-12 who have been diagnosed with Bipolar I, Bipolar II, and Bipolar Spectrum Disorders. This is an exploratory, pilot study, seeking to ...
What is the current status of trial NCT00181727?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 14 participants. The study started on 2004-01. Estimated completion is 2006-11.
What interventions are being tested in trial NCT00181727?
The interventions under investigation include: divalproex sodium extended release (DRUG).
Who is sponsoring clinical trial NCT00181727?
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 NCT00181727's enrollment target sits among peer trials
14 1901st of 2000 higher than 91 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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