Study of Efficacy and Safety of Seroquel (Quetiapine Fumarate) as Mono-Therapy for Acute Schizophrenic
A 24-Week, Multi-Centre, Open-Label, Single-Arm, Phase IV Study of the Efficacy and Safety of Seroquel (Quetiapine Fumarate) With Daily Dose 600mg-750mg as Mono-Therapy in the Treatment of Acute Schizophrenic Patients
2 other identifiers
interventional
120
1 country
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 schizophrenia
Started Dec 2006
Shorter than P25 for phase_4 schizophrenia
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2006
CompletedFirst Submitted
Initial submission to the registry
January 29, 2007
CompletedFirst Posted
Study publicly available on registry
January 30, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2007
CompletedMarch 25, 2009
March 1, 2009
9 months
January 29, 2007
March 24, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
Change from baseline in PANSS total score at Day 56 (LOCF)
Secondary Outcomes (4)
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
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- CCMD-3 diagnosis of mental retardation
- Psychosis judged to be the direct physiological effect of an abused medication or substance
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (9)
Research Site
Guangzhou, Guangdong, China
Research Site
Harbin, Heilongjiang, China
Research SIte
Wuhan, Hubei, China
Research Site
Nanjing, Jiangsu, China
Research Site
Jinan, Shandong, China
Research Site
Kunming, Yunnan, China
Research Site
Hangzhou, Zhejiang, China
Research Site
Huzhou, Zhejiang, China
Research Site
Beijing, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jon Zhu, MD
AstraZeneca
- PRINCIPAL INVESTIGATOR
Gang Wang, MD
Beijing An Ding hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 29, 2007
First Posted
January 30, 2007
Study Start
December 1, 2006
Primary Completion
September 1, 2007
Study Completion
September 1, 2007
Last Updated
March 25, 2009
Record last verified: 2009-03