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

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ClinicalTrials.gov Identifier: NCT00428350
Recruitment Status : Completed
First Posted : January 30, 2007
Last Update Posted : March 25, 2009
Sponsor:
Information provided by:
AstraZeneca

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 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
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources




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


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
Criteria

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

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


Locations
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
China
Research Site
Beijing, China
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Jon Zhu, MD AstraZeneca
Principal Investigator: Gang Wang, MD Beijing An Ding hospital

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

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