Study of Depakote ER for the Treatment of Mania in Children Ages 6-12 With Bipolar Disorder
Public ClinicalTrials.gov record NCT00181727. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Open-Label Study of Divalproex Sodium Extended Release for the Treatment of Mania in Children Ages 6-12 With Bipolar I, Bipolar II, and Bipolar Spectrum Disorder
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00181727
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 14 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 6 Years to 12 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 31, 2003
- Primary completion
- Oct 31, 2006
- Completion
- Oct 31, 2006
- Last update posted
- Oct 21, 2013
2004 – 2006
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Massachusetts General Hospital | Cambridge | Massachusetts | 02138 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00181727, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 21, 2013 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00181727 live on ClinicalTrials.gov.