Clinical trial NCT00882518: Efficacy and Safety of Quetiapine Fumarate in the Treatment of Schizophrenic Patients
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Keywords: Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)
qualified PANSS assessment
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-04-16
Enrollment: 388
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Change From Baseline of the Positive and Negative Syndrome Scale (PANSS) Total Score at the End of Treatment at Day 42
timeFrame: Baseline and 6 weeks
Secondary outcomes:
measure: Change From Baseline in PANSS Positive Subscale Score at the End of Treatment at Day 42
timeFrame: Baseline and 6 weeks
measure: Change From Baseline in PANSS Negative Subscale Score at the End of Treatment at Day 42
timeFrame: Baseline and 6 weeks
measure: Change From Baseline in PANSS General Psychopathological Subscale Score at the End of Treatment at Day 42
timeFrame: Baseline and 6 weeks
measure: Change From Baseline in PANSS Aggression, Hostility Clusters Score at the End of Treatment at Day 42
timeFrame: Baseline and 6 weeks
measure: Change From Baseline in PANSS Depression Clusters Score at the End of Treatment at Day 42
timeFrame: Baseline and 6 weeks
measure: Number of Patients Achieving a Reduction of at Least 30% From Baseline PANSS Total Score at the End of Treatment at Day 42
timeFrame: Baseline and 6 weeks
measure: 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
timeFrame: Baseline and 6 weeks
measure: Change in the CGI Severity of Illness Score From Baseline at the End of Treatment at Day 42
timeFrame: Baseline and 6 weeks
Other outcomes:
Locations:
city: Hunan
country: China
facility: Research Site
state: Changsha
city: Guangzhou
country: China
facility: Research Site
state: Guangdong
city: Baoding
country: China
facility: Research Site
state: Hebei
city: Ha Er Bin
country: China
facility: Research Site
state: Heilongjiang
city: Wuhan
country: China
facility: Research Site
state: Hubei
city: Changsha
country: China
facility: Research Site
state: Hunan
city: Nanjing
country: China
facility: Research Site
state: Jiangsu
city: Xi'an
country: China
facility: Research Site
state: Shanxi
city: Kunming
country: China
facility: Research Site
state: Yunnan
city: Beijing
country: China
facility: Research Site
city: Shanghai
country: China
facility: Research Site
Study officials:
affiliation: Shanghai Mental Health Center
name: Niufan Gu
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca
name: Michael Castiglione
role: STUDY_DIRECTOR
References: