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Efficacy & Safety of Quetiapine Fumarate (SEROQUEL) & Placebo in the Treatment of Acutely Ill Patients With Schizophrenia

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Quetiapine Fumarate
Sponsored by
AstraZeneca
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Schizophrenic disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patient is able to provide written informed consent before beginning any study related procedures Patient has a documented clinical diagnosis of schizophrenia Patient is able to understand and comply with the requirements of the study, as judged by a study investigator Exclusion Criteria: Patients with a history of non-compliance as judged by the study investigator Patients with a known lack of response to previous treatment with quetiapine Patients who have participated in another drug study within 4 weeks prior to enrollment into this study Patients who have previously participated in this study or study D1444C00132

Sites / Locations

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Outcomes

Primary Outcome Measures

Change from baseline of the Positive and Negative Syndrome Scale (PANSS) total score at the end of treatment.

Secondary Outcome Measures

Evaluation of secondary PANSS efficacy variables and Clinical Global Impression (CGI) variables at all study visits compared to baseline.

Full Information

First Posted
June 16, 2004
Last Updated
March 24, 2009
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00085891
Brief Title
Efficacy & Safety of Quetiapine Fumarate (SEROQUEL) & Placebo in the Treatment of Acutely Ill Patients With Schizophrenia
Official Title
A 6-Week, Multicenter, Double-Blind, Double-Dummy, Randomized Comparison of the Efficacy and Safety of Sustained-Release Formulation Quetiapine Fumarate (SEROQUEL) and Placebo in the Treatment of Acutely Ill Patients With Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
AstraZeneca

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to demonstrate superior efficacy of sustained release quetiapine compared to placebo in patients with schizophrenia after receiving treatment for up to 6 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, Schizophrenic disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
535 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Quetiapine Fumarate
Primary Outcome Measure Information:
Title
Change from baseline of the Positive and Negative Syndrome Scale (PANSS) total score at the end of treatment.
Secondary Outcome Measure Information:
Title
Evaluation of secondary PANSS efficacy variables and Clinical Global Impression (CGI) variables at all study visits compared to baseline.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient is able to provide written informed consent before beginning any study related procedures Patient has a documented clinical diagnosis of schizophrenia Patient is able to understand and comply with the requirements of the study, as judged by a study investigator Exclusion Criteria: Patients with a history of non-compliance as judged by the study investigator Patients with a known lack of response to previous treatment with quetiapine Patients who have participated in another drug study within 4 weeks prior to enrollment into this study Patients who have previously participated in this study or study D1444C00132
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca Seroquel Medical Science Director, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
Research Site
City
Cerritos
State/Province
California
Country
United States
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Research Site
City
San Diego
State/Province
California
Country
United States
Facility Name
Research Site
City
Santa Ana
State/Province
California
Country
United States
Facility Name
Research Site
City
Washington
State/Province
District of Columbia
Country
United States
Facility Name
Research Site
City
Miami
State/Province
Florida
Country
United States
City
Oak Brook
State/Province
Illinois
Country
United States
Facility Name
Research Site
City
Oakbrook Terrace
State/Province
Illinois
Country
United States
Facility Name
Research Site
City
New Orleans
State/Province
Louisiana
Country
United States
Facility Name
Research Site
City
Rockville
State/Province
Maryland
Country
United States
City
Brighton
State/Province
Massachusetts
Country
United States
Facility Name
Research Site
City
Jackson
State/Province
Mississippi
Country
United States
Facility Name
Research Site
City
St. Louis
State/Province
Missouri
Country
United States
Facility Name
Research Site
City
Holliswood
State/Province
New York
Country
United States
Facility Name
Research Site
City
Lawrence
State/Province
New York
Country
United States
Facility Name
Research Site
City
Staten Island
State/Province
New York
Country
United States
Facility Name
Research Site
City
Medina
State/Province
Ohio
Country
United States
Facility Name
Research Site
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
Research Site
City
Norristown
State/Province
Pennsylvania
Country
United States
Facility Name
Research Site
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Research Site
City
Sioux Falls
State/Province
South Dakota
Country
United States
Facility Name
Research Site
City
Memphis
State/Province
Tennessee
Country
United States
Facility Name
Research Site
City
Austin
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Houston
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Irving
State/Province
Texas
Country
United States
Facility Name
Research Site
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Richmond
State/Province
Virginia
Country
United States
Facility Name
Research Site
City
Kirkland
State/Province
Washington
Country
United States

12. IPD Sharing Statement

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Efficacy & Safety of Quetiapine Fumarate (SEROQUEL) & Placebo in the Treatment of Acutely Ill Patients With Schizophrenia

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