Trials / Completed
CompletedNCT00811473
Pediatric Bipolar Depression
An 8-week, Multicenter, Double-blind, Randomized, Parallel-group, Placebo-controlled Study of the Efficacy and Safety of Quetiapine Fumarate (SEROQUEL) Extended-Release in Children and Adolescent Subjects With Bipolar Depression
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 193 (actual)
- Sponsor
- AstraZeneca · Industry
- Sex
- All
- Age
- 10 Years – 17 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine if quetiapine fumarate extended-release (quetiapine XR or SEROQUEL® XR) 150 to 300 mg/day taken by itself is effective and safe in treating children or adolescents aged 10 to 17 with bipolar depression and if so, how it compares with placebo (a non-active tablet, like a sugar pill, that looks like quetiapine).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Quetiapine XR | Oral treatment with 150 up to 300 mg/day once daily in the evening |
| DRUG | Placebo | Oral treatment once daily in the evening |
Timeline
- Start date
- 2009-01-01
- Primary completion
- 2010-11-01
- Completion
- 2010-11-01
- First posted
- 2008-12-19
- Last updated
- 2014-07-15
- Results posted
- 2011-12-01
Locations
48 sites across 7 countries: United States, Colombia, India, Mexico, Serbia, South Africa, Taiwan
Source: ClinicalTrials.gov record NCT00811473. Inclusion in this directory is not an endorsement.