Status:
COMPLETED
Study of Efficacy and Safety of Seroquel (Quetiapine Fumarate) as Mono-Therapy for Acute Schizophrenic
Lead Sponsor:
AstraZeneca
Conditions:
Schizophrenia
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
Brief Summary
The primary objective of the study is to evaluate the efficacy of quetiapine fumarate (Seroquel) with daily dose 600mg-750mg used as mono-therapy in the treatment of acute schizophrenic patients by ev...
Eligibility Criteria
Inclusion
- Provision of written informed consent for study participation before initiation of any study related procedures, signed by the patient's legal guardian
- Female and/or male, aged between 18 and 60 years (inclusive)
- Is hospitalised in a psychiatric unit with an acute episode of schizophrenia defined by CCMD-3 criteria as one of the following: \[20.1\] paranoid schizophrenia, \[20.2\] hebephrenic schizophrenia, \[20.3\] catatonic schizophrenia, \[20.5\] undifferentiated schizophrenia
Exclusion
- CCMD-3 diagnosis of mental retardation
- Psychosis judged to be the direct physiological effect of an abused medication or substance
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2007
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00428350
Start Date
December 1 2006
End Date
September 1 2007
Last Update
March 25 2009
Active Locations (9)
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1
Research Site
Guangzhou, Guangdong, China
2
Research Site
Harbin, Heilongjiang, China
3
Research SIte
Wuhan, Hubei, China
4
Research Site
Nanjing, Jiangsu, China