Status:
COMPLETED
Efficacy and Safety of Seroquel and Lithium as Monotherapy in Acute Mania Treatment in Bipolar Disorder Patients
Lead Sponsor:
AstraZeneca
Conditions:
Mania
Bipolar Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
This is a randomised, double blind, double dummy, multicentre, parallel-group study to compare the efficacy and safety of quetiapine and lithium used as monotherapy in the treatment of mania in patien...
Eligibility Criteria
Inclusion
- Written informed consent for study participation, signed by the patient's legal guardian.
- Both at screening and at randomization (Day 1), had a YMRS total score of at least 20.
Exclusion
- Known intolerance or lack of response to quetiapine or lithium, as judged by the investigator.
- Known or suspected hypersensitivity to quetiapine or lithium.
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
End Date :
June 1 2006
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00448578
Start Date
August 1 2005
End Date
June 1 2006
Last Update
December 9 2010
Active Locations (6)
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1
Research Sites
Beijing, China
2
Research Site
Guangzhou, China
3
Research Site
Kunming, China
4
Research Site
Nanjing, China