Immediate Release (IR) to Sustained Release (SR) Switching Study: Study of Switching From IR Seroquel to SR Seroquel in Outpatients With Schizophrenia
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)
1 other identifier
interventional
454
11 countries
63
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 schizophrenia
Started Nov 2004
Shorter than P25 for phase_3 schizophrenia
63 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 21, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2006
CompletedJanuary 4, 2013
January 1, 2013
1.3 years
September 13, 2005
January 3, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
from randomisation to any visit
Secondary Outcomes (3)
The change in PANSS total score
from randomization to week 6
The change in PANSS positive, negative and general psychopathology symptoms subscale scores respectively
from randomization to week 6
The proportion of patients with a Clinical Global Impressions - Improvement (CGI-I) score greater than or equal to 4
at week 6
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (69)
Research Site
Birmingham, Alabama, United States
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Anaheim, California, United States
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Cerritos, California, United States
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Garden Grove, California, United States
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National City, California, United States
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Pasadena, California, United States
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San Diego, California, United States
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Santa Ana, California, United States
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North Miami, Florida, United States
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Atlanta, Georgia, United States
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Hoffman Estates, Illinois, United States
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New Orleans, Louisiana, United States
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Jackson, Mississippi, United States
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Clementon, New Jersey, United States
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Staten Island, New York, United States
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Austin, Texas, United States
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Houston, Texas, United States
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Richmond, Virginia, United States
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QLD, Australia
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Burgas, Bulgaria
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Radnevo, Bulgaria
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Varna, Bulgaria
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Vancouver, British Columbia, Canada
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Aurora, Ontario, Canada
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Burlington, Ontario, Canada
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Mississauga, Ontario, Canada
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Orléans, Ontario, Canada
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Toronto, Ontario, Canada
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Québec, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Prince Albert, Saskatchewan, Canada
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Põltsamaa, Estonia
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Tallinn, Estonia
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Tartu, Estonia
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Helsinki, Finland
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Mikkeli, Finland
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Turku, Finland
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München, Bavaria, Germany
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Göttingen, Lower Saxony, Germany
Research Center
Aachen, North Rhine-Westphalia, Germany
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Aachen, North Rhine-Westphalia, Germany
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Jena, Thuringia, Germany
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Halle, Germany
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Marburg, Germany
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Budapest, Hungary
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Debrecen, Hungary
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Gyula, Hungary
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Nagykálló, Hungary
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Szeged, Hungary
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Székesfehérvár, Hungary
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Bologna, BO, Italy
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Cagliari, CA, Italy
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Città di Castello, PG, Italy
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Ellera Di Corciano, PG, Italy
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Torino, TO, Italy
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Bassano del Grappa, VI, Italy
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Quartu Sant'Elena, CA, Italy
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Riga, Latvia
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Sigulda, Latvia
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Ziegzdrai, Kaunas County, Lithuania
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Klapeda, Lithuania
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Šiauliai, Lithuania
Research Sitte
Vilnius, Lithuania
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Jerez de la Frontera, Cádiz, Spain
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Alcobendas, Madrid, Spain
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Colmenar Viejo, Madrid, Spain
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Madrid, Madrid, Spain
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Móstoles, Madrid, Spain
Research Site
Villamartín, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
AstraZeneca Seroquel Medical Science Director, MD
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 21, 2005
Study Start
November 1, 2004
Primary Completion
February 1, 2006
Study Completion
February 1, 2006
Last Updated
January 4, 2013
Record last verified: 2013-01