Efficacy and Safety of Quetiapine Fumarate in the Treatment of Schizophrenic Patients

NCT ID: NCT00882518

Last Updated: 2012-05-15

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

388 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2010-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1-Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)

Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) extended-release (300 mg/1st day, 600 mg/2nd day, 400 or 600 or 800 mg/3-42 day)

Group Type EXPERIMENTAL

Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)

Intervention Type DRUG

200 mg or 300 mg, oral, single dose

2-Chlorpromazine

Chlorpromazine (50 or 100 mg/1st day; 100-200 mg/2nd day; 150-300 mg/3rd day; 200-400 mg/4th day; 300 or 400 or 500 or 600 mg/5-42 days)

Group Type ACTIVE_COMPARATOR

Chlorpromazine

Intervention Type DRUG

50 mg, oral, double dose

Interventions

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Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)

200 mg or 300 mg, oral, single dose

Intervention Type DRUG

Chlorpromazine

50 mg, oral, double dose

Intervention Type DRUG

Other Intervention Names

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Seroquel_XR (Quetiapine Fumarate XR)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Niufan Gu

Role: PRINCIPAL_INVESTIGATOR

Shanghai Mental Health Center

Michael Castiglione

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Research Site

Hunan, Changsha, China

Site Status

Research Site

Guangzhou, Guangdong, China

Site Status

Research Site

Baoding, Hebei, China

Site Status

Research Site

Harbin, Heilongjiang, China

Site Status

Research Site

Wuhan, Hubei, China

Site Status

Research Site

Changsha, Hunan, China

Site Status

Research Site

Nanjing, Jiangsu, China

Site Status

Research Site

Xi’an, Shanxi, China

Site Status

Research Site

Kunming, Yunnan, China

Site Status

Research Site

Beijing, , China

Site Status

Research Site

Shanghai, , China

Site Status

Countries

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China

Other Identifiers

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D1444C00008

Identifier Type: -

Identifier Source: org_study_id

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