Efficacy and Safety of Quetiapine Fumarate in the Treatment of Schizophrenic Patients
Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizophrenia
Intervention: Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) (Drug); Chlorpromazine (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s): Niufan Gu, Principal Investigator, Affiliation: Shanghai Mental Health Center Michael Castiglione, Study Director, Affiliation: AstraZeneca
Summary
The primary objective of this study is to evaluate the efficacy of quetiapine fumarate
extended-release (XR) used as mono-therapy, administered once daily, in the treatment of
schizophrenic patient with acute episode.
Clinical Details
Official title: A 6-Week, Multi-centre, Double-blind, Double-dummy, Chlorpromazine-Controlled Randomised Study to Evaluate the Efficacy and Safety of Quetiapine Fumarate Extended-Release in the Treatment of Schizophrenic Patients With Acute Episode
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Change From Baseline of the Positive and Negative Syndrome Scale (PANSS) Total Score at the End of Treatment at Day 42
Secondary outcome: Change From Baseline in PANSS Positive Subscale Score at the End of Treatment at Day 42Change From Baseline in PANSS Negative Subscale Score at the End of Treatment at Day 42 Change From Baseline in PANSS General Psychopathological Subscale Score at the End of Treatment at Day 42 Change From Baseline in PANSS Aggression, Hostility Clusters Score at the End of Treatment at Day 42 Change From Baseline in PANSS Depression Clusters Score at the End of Treatment at Day 42 Number of Patients Achieving a Reduction of at Least 30% From Baseline PANSS Total Score at the End of Treatment at Day 42 Percentage of Patients With Clinical Global Impression (CGI) Global Improvement Rating Less Than or Equal to 3 at the End of Treatment at Day 42 Change in the CGI Severity of Illness Score From Baseline at the End of Treatment at Day 42
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Schizophrenia diagnosis
- Provision of written informed consent before initiation of any study
Exclusion Criteria:
- AIDS and hepatitis B
- History of seizure disorder
- Hospitalisation for schizophrenic more than 1 month immediately before enter into
study
Locations and Contacts
Research Site, Beijing, China
Research Site, Shanghai, China
Research Site, Hunan, Changsha, China
Research Site, Guangzhou, Guangdong, China
Research Site, Baoding, Hebei, China
Research Site, Ha Er Bin, Heilongjiang, China
Research Site, Wuhan, Hubei, China
Research Site, Changsha, Hunan, China
Research Site, Nanjing, Jiangsu, China
Research Site, Xi'an, Shanxi, China
Research Site, Kunming, Yunnan, China
Additional Information
Starting date: April 2009
Last updated: April 16, 2012
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