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

Schizophrenia Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00206128
• Other study ID #: D1444C00146
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: January 3, 2013
• Start date: November 2004
• Est. completion date: February 2006

Study information

• Verified date: January 2013
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 454
• Est. completion date: February 2006
• Est. primary completion date: February 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Seroquel SR

Locations

Country	Name	City	State
Australia	Research Site	QLD
Bulgaria	Research Site	Burgas
Bulgaria	Research Site	Radnevo
Bulgaria	Research Site	Varna
Canada	Research Site	Aurora	Ontario
Canada	Research Site	Burlington	Ontario
Canada	Research Site	Mississauga	Ontario
Canada	Research Site	Orleans	Ontario
Canada	Research Site	Prince Albert	Saskatchewan
Canada	Research Site	Quebec
Canada	Research Site	Sherbrooke	Quebec
Canada	Research Site	Toronto	Ontario
Canada	Research Site	Vancouver	British Columbia
Estonia	Research Site	Põltsamaa
Estonia	Research Site	Tallinn
Estonia	Research Site	Tartu
Finland	Research Site	Helsinki
Finland	Research Site	Mikkeli
Finland	Research Site	Turku
Germany	Research Center	Aachen	Nordrhein-Westfalen
Germany	Research Site	Aachen	Nordrhein-Westfalen
Germany	Research Site	Göttingen	Niedersachsen
Germany	Research Site	Halle
Germany	Research Site	Jena	Thüringen
Germany	Research Site	Marburg
Germany	Research Site	München	Bayern
Hungary	Research Site	Budapest
Hungary	Research Site	Debrecen
Hungary	Research Site	Gyula
Hungary	Research Site	Nagykálló
Hungary	Research Site	Szeged
Hungary	Research Site	Székesfehérvár
Italy	Research Site	Bassano Del Grappa	VI
Italy	Research Site	Bologna	BO
Italy	Research Site	Cagliari	CA
Italy	Research Site	Citta' di Castello	PG
Italy	Research Site	Ellera di Corciano	PG
Italy	Research Site	Quartu Sant Elena
Italy	Research Site	Torino	TO
Latvia	Research Site	Riga
Latvia	Research Site	Sigulda
Lithuania	Research Site	Klapeda
Lithuania	Research Site	Siauliai
Lithuania	Research Sitte	Vilnius
Lithuania	Research Site	Ziegzdrai	Kaunas
Spain	Research Site	Alcobendas	Madrid
Spain	Research Site	Colmenar Viejo	Madrid
Spain	Research Site	Jerez de la Frontera	Cádiz
Spain	Research Site	Madrid
Spain	Research Site	Mostoles	Madrid
Spain	Research Site	Villamartin
United States	Research Site	Anaheim	California
United States	Research Site	Atlanta	Georgia
United States	Research Site	Austin	Texas
United States	Research Site	Birmingham	Alabama
United States	Research Site	Cerritos	California
United States	Research Site	Clementon	New Jersey
United States	Research Site	Garden Grove	California
United States	Research Site	Hoffman Estates	Illinois
United States	Research Site	Houston	Texas
United States	Research Site	Jackson	Mississippi
United States	Research Site	National City	California
United States	Research Site	New Orleans	Louisiana
United States	Research Site	North Miami	Florida
United States	Research Site	Pasadena	California
United States	Research Site	Richmond	Virginia
United States	Research Site	San Diego	California
United States	Research Site	Santa Ana	California
United States	Research Site	Staten Island	New York

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Australia,  Bulgaria,  Canada,  Estonia,  Finland,  Germany,  Hungary,  Italy,  Latvia,  Lithuania,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	The change in PANSS total score		from randomization to week 6	No
Secondary	The change in PANSS positive, negative and general psychopathology symptoms subscale scores respectively		from randomization to week 6	No
Secondary	The proportion of patients with a Clinical Global Impressions - Improvement (CGI-I) score greater than or equal to 4		at week 6	No