Clinical trial NCT00206128: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Keywords: Schizophrenia
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-09-21
Enrollment: 454
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: 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
timeFrame: from randomisation to any visit
Secondary outcomes:
measure: The change in PANSS total score
timeFrame: from randomization to week 6
measure: The change in PANSS positive, negative and general psychopathology symptoms subscale scores respectively
timeFrame: from randomization to week 6
measure: The proportion of patients with a Clinical Global Impressions - Improvement (CGI-I) score greater than or equal to 4
timeFrame: at week 6
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Anaheim
country: United States
facility: Research Site
state: California
city: Cerritos
country: United States
facility: Research Site
state: California
city: Garden Grove
country: United States
facility: Research Site
state: California
city: National City
country: United States
facility: Research Site
state: California
city: Pasadena
country: United States
facility: Research Site
state: California
city: San Diego
country: United States
facility: Research Site
state: California
city: Santa Ana
country: United States
facility: Research Site
state: California
city: North Miami
country: United States
facility: Research Site
state: Florida
city: Atlanta
country: United States
facility: Research Site
state: Georgia
city: Hoffman Estates
country: United States
facility: Research Site
state: Illinois
city: New Orleans
country: United States
facility: Research Site
state: Louisiana
city: Jackson
country: United States
facility: Research Site
state: Mississippi
city: Clementon
country: United States
facility: Research Site
state: New Jersey
city: Staten Island
country: United States
facility: Research Site
state: New York
city: Austin
country: United States
facility: Research Site
state: Texas
city: Houston
country: United States
facility: Research Site
state: Texas
city: Richmond
country: United States
facility: Research Site
state: Virginia
city: QLD
country: Australia
facility: Research Site
city: Burgas
country: Bulgaria
facility: Research Site
city: Radnevo
country: Bulgaria
facility: Research Site
city: Varna
country: Bulgaria
facility: Research Site
city: Vancouver
country: Canada
facility: Research Site
state: British Columbia
city: Aurora
country: Canada
facility: Research Site
state: Ontario
city: Burlington
country: Canada
facility: Research Site
state: Ontario
city: Mississauga
country: Canada
facility: Research Site
state: Ontario
city: Orleans
country: Canada
facility: Research Site
state: Ontario
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Sherbrooke
country: Canada
facility: Research Site
state: Quebec
city: Prince Albert
country: Canada
facility: Research Site
state: Saskatchewan
city: Quebec
country: Canada
facility: Research Site
city: Põltsamaa
country: Estonia
facility: Research Site
city: Tallinn
country: Estonia
facility: Research Site
city: Tartu
country: Estonia
facility: Research Site
city: Helsinki
country: Finland
facility: Research Site
city: Mikkeli
country: Finland
facility: Research Site
city: Turku
country: Finland
facility: Research Site
city: München
country: Germany
facility: Research Site
state: Bayern
city: Göttingen
country: Germany
facility: Research Site
state: Niedersachsen
city: Aachen
country: Germany
facility: Research Center
state: Nordrhein-Westfalen
city: Aachen
country: Germany
facility: Research Site
state: Nordrhein-Westfalen
city: Jena
country: Germany
facility: Research Site
state: Thüringen
city: Halle
country: Germany
facility: Research Site
city: Marburg
country: Germany
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Debrecen
country: Hungary
facility: Research Site
city: Gyula
country: Hungary
facility: Research Site
city: Nagykálló
country: Hungary
facility: Research Site
city: Szeged
country: Hungary
facility: Research Site
city: Székesfehérvár
country: Hungary
facility: Research Site
city: Bologna
country: Italy
facility: Research Site
state: BO
city: Cagliari
country: Italy
facility: Research Site
state: CA
city: Citta' di Castello
country: Italy
facility: Research Site
state: PG
city: Ellera di Corciano
country: Italy
facility: Research Site
state: PG
city: Torino
country: Italy
facility: Research Site
state: TO
city: Bassano Del Grappa
country: Italy
facility: Research Site
state: VI
city: Quartu Sant Elena
country: Italy
facility: Research Site
city: Riga
country: Latvia
facility: Research Site
city: Sigulda
country: Latvia
facility: Research Site
city: Ziegzdrai
country: Lithuania
facility: Research Site
state: Kaunas
city: Klapeda
country: Lithuania
facility: Research Site
city: Siauliai
country: Lithuania
facility: Research Site
city: Vilnius
country: Lithuania
facility: Research Sitte
city: Jerez de la Frontera
country: Spain
facility: Research Site
state: Cádiz
city: Alcobendas
country: Spain
facility: Research Site
state: Madrid
city: Colmenar Viejo
country: Spain
facility: Research Site
state: Madrid
city: Mostoles
country: Spain
facility: Research Site
state: Madrid
city: Madrid
country: Spain
facility: Research Site
city: Villamartin
country: Spain
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Seroquel Medical Science Director, MD
role: STUDY_DIRECTOR
References: