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Study of Efficacy and Safety of Seroquel (Quetiapine Fumarate) as Mono-Therapy for Acute Schizophrenic

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00428350
Recruitment Status : Completed
First Posted : January 30, 2007
Last Update Posted : March 25, 2009
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Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Quetiapine Fumarate (Seroquel) Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : December 2006
Primary Completion Date : September 2007
Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. Change from baseline in PANSS total score at Day 56 (LOCF)

Secondary Outcome Measures :
  1. Change from baseline in PANSS positive scale score at Day 56 (LOCF)
  2. Change from baseline in PANSS negative scale score at Day 56 (LOCF)
  3. Change from baseline in PANSS EC score at day 56 ,
  4. Change from baseline in MADRS total score at Day 56. etc

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00428350

China, Guangdong
Research Site
Guangzhou, Guangdong, China
China, Heilongjiang
Research Site
Harbin, Heilongjiang, China
China, Hubei
Research SIte
Wuhan, Hubei, China
China, Jiangsu
Research Site
Nanjing, Jiangsu, China
China, Shandong
Research Site
Jinan, Shandong, China
China, Yunnan
Research Site
Kunming, Yunnan, China
China, Zhejiang
Research Site
Hangzhou, Zhejiang, China
Research Site
Huzhou, Zhejiang, China
Research Site
Beijing, China
Sponsors and Collaborators
Study Director: Jon Zhu, MD AstraZeneca
Principal Investigator: Gang Wang, MD Beijing An Ding hospital
More Information

ClinicalTrials.gov Identifier: NCT00428350     History of Changes
Other Study ID Numbers: D1443L00004
First Posted: January 30, 2007    Key Record Dates
Last Update Posted: March 25, 2009
Last Verified: March 2009

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Quetiapine Fumarate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs