Trials / Completed
CompletedNCT00067262
An Outpatient Study of the Effectiveness and Safety of Depakote ER in the Treatment of Mania/Bipolar Disorder in Children and Adolescents
A Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Efficacy of Depakote ER for the Treatment of Bipolar Disorder in Children and Adolescents
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 150 (planned)
- Sponsor
- Abbott · Industry
- Sex
- All
- Age
- 10 Years – 17 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine the safety and effectiveness of Depakote ER (Divalproex Sodium Extended-Release Tablets) compared to placebo in the treatment of bipolar disorder, manic or mixed type in children and adolescents ages 10-17 years.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Divalproex Sodium Extended-Release Tablets |
Timeline
- Start date
- 2003-03-01
- First posted
- 2003-08-15
- Last updated
- 2006-08-04
Locations
16 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00067262. Inclusion in this directory is not an endorsement.