Study of Efficacy and Safety of Seroquel (Quetiapine Fumarate) as Mono-Therapy for Acute Schizophrenic
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizophrenia
Intervention: Quetiapine Fumarate (Seroquel) (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
Jon Zhu, MD, Study Director, Affiliation: AstraZeneca
Gang Wang, MD, Principal Investigator, Affiliation: Beijing An Ding hospital
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.
Clinical Details
Official title: 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
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Change from baseline in PANSS total score at Day 56 (LOCF)
Secondary outcome: 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
Eligibility
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Both.
Criteria:
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
Exclusion Criteria:
- CCMD-3 diagnosis of mental retardation
- Psychosis judged to be the direct physiological effect of an abused medication or
substance
Locations and Contacts
Research Site, Beijing, China
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, Huzhou, Zhejiang, China
Research Site, Hangzhou, Zhejiang, China
Additional Information
Starting date: December 2006
Ending date: October 2007
Last updated: June 10, 2008
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