Status:
COMPLETED
Quetiapine Fumarate (SEROQUEL) in the Treatment of Adolescent Patients With Schizophrenia and Bipolar I Disorder
Lead Sponsor:
AstraZeneca
Conditions:
Schizophrenia
Bipolar I Disorder
Eligibility:
All Genders
10-17 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to demonstrate the efficacy and safety of quetiapine fumarate (SEROQUEL) in the treatment of adolescent patients with schizophrenia and bipolar I disorder.
Eligibility Criteria
Inclusion
- Patient is able to provide written assent and the parents or legal guardian of the patient are/is able to provide written informed consent before beginning any study related procedures
- Patient previously enrolled in either double-blind Study D1441C00149 or D1441C00112
- Patient has documented clinical diagnosis of schizophrenia or bipolar I disorder
- Patient's parent or legal guardian will be able to accompany the patient to 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 :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
381 Patients enrolled
Trial Details
Trial ID
NCT00227305
Start Date
August 1 2004
End Date
December 1 2007
Last Update
January 8 2013
Active Locations (48)
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1
Research Site
Dothan, Alabama, United States
2
Research Site
Scottsdale, Arizona, United States
3
Research Site
Cerritos, California, United States
4
Research Site
Riverside, California, United States