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

March 24, 2009 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Research Site
    • Guangdong
      • Guangzhou, Guangdong, China
        • Research Site
    • Heilongjiang
      • Harbin, Heilongjiang, China
        • Research Site
    • Hubei
      • Wuhan, Hubei, China
        • Research Site
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Research Site
    • Shandong
      • Jinan, Shandong, China
        • Research Site
    • Yunnan
      • Kunming, Yunnan, China
        • Research Site
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Research Site
      • Huzhou, Zhejiang, China
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change from baseline in PANSS total score at Day 56 (LOCF)

Secondary Outcome Measures

Outcome Measure
Change from baseline in PANSS positive scale score at Day 56 (LOCF)
Change from baseline in PANSS negative scale score at Day 56 (LOCF)
Change from baseline in PANSS EC score at day 56 ,
Change from baseline in MADRS total score at Day 56. etc

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: Jon Zhu, MD, AstraZeneca
  • Principal Investigator: Gang Wang, MD, Beijing An Ding hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (Actual)

September 1, 2007

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

January 29, 2007

First Submitted That Met QC Criteria

January 29, 2007

First Posted (Estimate)

January 30, 2007

Study Record Updates

Last Update Posted (Estimate)

March 25, 2009

Last Update Submitted That Met QC Criteria

March 24, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D1443L00004
  • SOLO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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