Trials / Completed
CompletedNCT00350857
The Young Adult and Pediatric Bipolar Study
A Phase IV, Multi-Center, Open-Label, Safety and Effectiveness Study of Extended-Release Carbamazepine in the Treatment of Mania in Children and Adolescents Aged 10-17 Years With Acute Manic or Mixed Bipolar I Disorder.
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 161 (actual)
- Sponsor
- Validus Pharmaceuticals · Industry
- Sex
- All
- Age
- 10 Years – 17 Years
- Healthy volunteers
- Not accepted
Summary
To examine the safety and effectiveness of extended-release carbamazepine in the treatment of children and adolescents aged 10-17 years with acute manic or mixed bipolar I disorder.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Extended-Release Carbamazepine |
Timeline
- Start date
- 2006-07-01
- Primary completion
- 2007-10-01
- Completion
- 2007-10-01
- First posted
- 2006-07-11
- Last updated
- 2014-02-20
Locations
26 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00350857. Inclusion in this directory is not an endorsement.