Status:
COMPLETED
Quetiapine Fumarate (SEROQUEL) Compared to Placebo in the Treatment of Children & Adolescents With Bipolar I Mania
Lead Sponsor:
AstraZeneca
Conditions:
Bipolar Disorder
Eligibility:
All Genders
10-17 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to demonstrate efficacy and safety of quetiapine fumarate (SEROQUEL) compared with placebo in the treatment of children and adolescent patients with Bipolar I mania.
Eligibility Criteria
Inclusion
- Patient is able to provide written assent and the parents or legal guardian of the patient is able to provide written informed consent before beginning and study related procedures
- Patient has a documented clinical diagnosis of Bipolar I mania
- Patient's parent or legal guardian will be able to accompany the patient at each scheduled study visit
Exclusion
- Patients (female) must not be pregnant or lactating
- Patients with a known intolerance or lack of response to previous treatment with quetiapine
- Patients who have previously participated in this study
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2006
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT00090311
Start Date
July 1 2004
End Date
July 1 2006
Last Update
January 4 2013
Active Locations (32)
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1
Research Site
Scottsdale, Arizona, United States
2
Research Site
Riverside, California, United States
3
Research Site
Sacramento, California, United States
4
Research Site
San Diego, California, United States