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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. 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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00181727
The ClinicalTrials.gov registry entry for NCT00181727 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which divalproex sodium extended release is the first listed.
NCT00181727 reports 0 study locations.
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.
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