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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 42

Change 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

Page last updated: August 23, 2015

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