A Study for the Treatment of Mania Associated With Bipolar I Disorder in Children and Adolescents
NCT00195780 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 227
Last updated 2007-07-02
Summary
The purpose of the study is to evaluate the long-term safety profile of the Investigational Medication Depakote ER in the treatment of Bipolar I Disorder, manic or mixed episode, in children and adolescents ages 10-17.
Conditions
Interventions
- DRUG
-
Divalproex Sodium (Depakote ER)
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Global Medical Information · Abbott
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 10 Years
- Max Age
- 17 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2005-02-28
Countries
- United States
Study Locations
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