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Immediate Release (IR) to Sustained Release (SR) Switching Study: Study of Switching From IR Seroquel to SR Seroquel in Outpatients With Schizophrenia

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Seroquel SR
Sponsored by
AstraZeneca
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia

Eligibility Criteria

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

Inclusion Criteria: A stable dose of quetiapine IR between 300 and 800 mg/day within 4 weeks prior to the enrolment visit (Visit 1) as judged by the investigator. Female patients of childbearing potential must have a negative serum pregnancy test at enrolment and be willing to use a reliable method of birth control, ie, barrier method, oral contraceptive, implant, dermal contraception, long-term injectable contraceptive, intrauterine device, or tubal ligation during the study. Able to understand and comply with the requirements of the study, as judged by the investigator. Exclusion Criteria: Meeting the criteria for any other (than schizophrenia) Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) Axis I diagnosis, concomitant organic mental disorder or mental retardation. Patients with substance abuse or dependence, as defined by DSM-IV, and not in full remission. A urine drug screen test will be performed. The investigator will evaluate the results along with medical history to determine if the patient meets DSM-IV criteria for substance abuse or dependence. Risk of transmitting human immunodeficiency virus (HIV) or hepatitis B, via blood or other body fluids, as judged by the investigator. Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others.

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Outcomes

Primary Outcome Measures

The proportion of patients who discontinue study treatment due to lack of efficacy or whose positive and negative syndrome scale (PANSS) total score increases 20% or more

Secondary Outcome Measures

The change in PANSS total score
The change in PANSS positive, negative and general psychopathology symptoms subscale scores respectively
The proportion of patients with a Clinical Global Impressions - Improvement (CGI-I) score greater than or equal to 4

Full Information

First Posted
September 13, 2005
Last Updated
January 3, 2013
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00206128
Brief Title
Immediate Release (IR) to Sustained Release (SR) Switching Study: Study of Switching From IR Seroquel to SR Seroquel in Outpatients With Schizophrenia
Official Title
6-week Multicenter, Double-blind, Randomized, Parallel-group, Phase 3 Study to Evaluate the Feasibility of Switching From Immediate-release Quetiapine Fumarate (SEROQUEL) to Sustained-release Quetiapine Fumarate in Outpatients With Schizophrenia (Abbreviated)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
February 2006 (Actual)
Study Completion Date
February 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
AstraZeneca

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to determine that the efficacy of the sustained release (SR) formulation of quetiapine (Seroquel) is not inferior to the immediate release (IR) formulation. PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Seroquel SR
Primary Outcome Measure Information:
Title
The proportion of patients who discontinue study treatment due to lack of efficacy or whose positive and negative syndrome scale (PANSS) total score increases 20% or more
Time Frame
from randomisation to any visit
Secondary Outcome Measure Information:
Title
The change in PANSS total score
Time Frame
from randomization to week 6
Title
The change in PANSS positive, negative and general psychopathology symptoms subscale scores respectively
Time Frame
from randomization to week 6
Title
The proportion of patients with a Clinical Global Impressions - Improvement (CGI-I) score greater than or equal to 4
Time Frame
at week 6

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: A stable dose of quetiapine IR between 300 and 800 mg/day within 4 weeks prior to the enrolment visit (Visit 1) as judged by the investigator. Female patients of childbearing potential must have a negative serum pregnancy test at enrolment and be willing to use a reliable method of birth control, ie, barrier method, oral contraceptive, implant, dermal contraception, long-term injectable contraceptive, intrauterine device, or tubal ligation during the study. Able to understand and comply with the requirements of the study, as judged by the investigator. Exclusion Criteria: Meeting the criteria for any other (than schizophrenia) Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) Axis I diagnosis, concomitant organic mental disorder or mental retardation. Patients with substance abuse or dependence, as defined by DSM-IV, and not in full remission. A urine drug screen test will be performed. The investigator will evaluate the results along with medical history to determine if the patient meets DSM-IV criteria for substance abuse or dependence. Risk of transmitting human immunodeficiency virus (HIV) or hepatitis B, via blood or other body fluids, as judged by the investigator. Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others.
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
Anaheim
State/Province
California
Country
United States
Facility Name
Research Site
City
Cerritos
State/Province
California
Country
United States
Facility Name
Research Site
City
Garden Grove
State/Province
California
Country
United States
Facility Name
Research Site
City
National City
State/Province
California
Country
United States
Facility Name
Research Site
City
Pasadena
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
North Miami
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
Research Site
City
Hoffman Estates
State/Province
Illinois
Country
United States
Facility Name
Research Site
City
New Orleans
State/Province
Louisiana
Country
United States
Facility Name
Research Site
City
Jackson
State/Province
Mississippi
Country
United States
Facility Name
Research Site
City
Clementon
State/Province
New Jersey
Country
United States
Facility Name
Research Site
City
Staten Island
State/Province
New York
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
Richmond
State/Province
Virginia
Country
United States
Facility Name
Research Site
City
QLD
Country
Australia
Facility Name
Research Site
City
Burgas
Country
Bulgaria
Facility Name
Research Site
City
Radnevo
Country
Bulgaria
Facility Name
Research Site
City
Varna
Country
Bulgaria
Facility Name
Research Site
City
Vancouver
State/Province
British Columbia
Country
Canada
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Aurora
State/Province
Ontario
Country
Canada
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Burlington
State/Province
Ontario
Country
Canada
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Mississauga
State/Province
Ontario
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Canada
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Orleans
State/Province
Ontario
Country
Canada
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Toronto
State/Province
Ontario
Country
Canada
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City
Sherbrooke
State/Province
Quebec
Country
Canada
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Research Site
City
Prince Albert
State/Province
Saskatchewan
Country
Canada
Facility Name
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City
Quebec
Country
Canada
Facility Name
Research Site
City
Põltsamaa
Country
Estonia
Facility Name
Research Site
City
Tallinn
Country
Estonia
Facility Name
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City
Tartu
Country
Estonia
Facility Name
Research Site
City
Helsinki
Country
Finland
Facility Name
Research Site
City
Mikkeli
Country
Finland
Facility Name
Research Site
City
Turku
Country
Finland
Facility Name
Research Site
City
München
State/Province
Bayern
Country
Germany
Facility Name
Research Site
City
Göttingen
State/Province
Niedersachsen
Country
Germany
Facility Name
Research Center
City
Aachen
State/Province
Nordrhein-Westfalen
Country
Germany
Facility Name
Research Site
City
Aachen
State/Province
Nordrhein-Westfalen
Country
Germany
Facility Name
Research Site
City
Jena
State/Province
Thüringen
Country
Germany
Facility Name
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Halle
Country
Germany
Facility Name
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Marburg
Country
Germany
Facility Name
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City
Budapest
Country
Hungary
Facility Name
Research Site
City
Debrecen
Country
Hungary
Facility Name
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City
Gyula
Country
Hungary
Facility Name
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Nagykálló
Country
Hungary
Facility Name
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Szeged
Country
Hungary
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Székesfehérvár
Country
Hungary
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Bologna
State/Province
BO
Country
Italy
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Cagliari
State/Province
CA
Country
Italy
Facility Name
Research Site
City
Citta' di Castello
State/Province
PG
Country
Italy
Facility Name
Research Site
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Ellera di Corciano
State/Province
PG
Country
Italy
Facility Name
Research Site
City
Torino
State/Province
TO
Country
Italy
Facility Name
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City
Bassano Del Grappa
State/Province
VI
Country
Italy
Facility Name
Research Site
City
Quartu Sant Elena
ZIP/Postal Code
CA
Country
Italy
Facility Name
Research Site
City
Riga
Country
Latvia
Facility Name
Research Site
City
Sigulda
Country
Latvia
Facility Name
Research Site
City
Ziegzdrai
State/Province
Kaunas
Country
Lithuania
Facility Name
Research Site
City
Klapeda
Country
Lithuania
Facility Name
Research Site
City
Siauliai
Country
Lithuania
Facility Name
Research Sitte
City
Vilnius
Country
Lithuania
Facility Name
Research Site
City
Jerez de la Frontera
State/Province
Cádiz
Country
Spain
Facility Name
Research Site
City
Alcobendas
State/Province
Madrid
Country
Spain
Facility Name
Research Site
City
Colmenar Viejo
State/Province
Madrid
Country
Spain
Facility Name
Research Site
City
Mostoles
State/Province
Madrid
Country
Spain
Facility Name
Research Site
City
Madrid
Country
Spain
Facility Name
Research Site
City
Villamartin
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

Immediate Release (IR) to Sustained Release (SR) Switching Study: Study of Switching From IR Seroquel to SR Seroquel in Outpatients With Schizophrenia

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