Study of Efficacy and Safety of Seroquel (Quetiapine Fumarate) as Mono-Therapy for Acute Schizophrenic
Phase 4
Completed
- Conditions
- Schizophrenia
- Registration Number
- NCT00428350
- Lead Sponsor
- AstraZeneca
- 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 evaluation of the change from baseline in PANSS total score at Day 56 using the last observation carried forward (LOCF) method.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria
- 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
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Exclusion Criteria
- CCMD-3 diagnosis of mental retardation
- Psychosis judged to be the direct physiological effect of an abused medication or substance
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Change from baseline in PANSS total score at Day 56 (LOCF)
- Secondary Outcome Measures
Name Time Method Change from baseline in PANSS positive scale score at Day 56 (LOCF) Change from baseline in PANSS negative scale score at Day 56 (LOCF) Change from baseline in PANSS EC score at day 56 , Change from baseline in MADRS total score at Day 56. etc
Trial Locations
- Locations (2)
Research SIte
🇨🇳Wuhan, Hubei, China
Research Site
🇨🇳Beijing, China