Seroquel Switching Study: Feasibility of Switching Any Antipsychotic Treatment to Seroquel in Patients With Schizophrenia

Schizophrenia Clinical Trial

Official title:

A 12-week International, Multicenter, Open Label, Non-comparative Study to Evaluate the Feasibility of Switching Any Antipsychotic Treatment to Sustained-release Quetiapine Fumarate (SEROQUEL®) in Patients With Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00234377
• Other study ID #: D1444C00147
• Status: Completed
• Phase: Phase 3
• First received: October 5, 2005
• Last updated: January 3, 2013
• Start date: November 2004
• Est. completion date: May 2006

Study information

• Verified date: January 2013
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines AgencyAustralia: Department of Health and Ageing Therapeutic Goods AdministrationCanada: Health CanadaGermany: Federal Institute for Drugs and Medical DevicesHungary: National Institute of PharmacyMalaysia: Ministry of HealthSouth Africa: Medicines Control CouncilSpain: Spanish Agency of MedicinesItaly: National Monitoring Centre for Clinical Trials - Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to document the clinical benefit of quetiapine (Seroquel) sustained release (SR) after switching from another ongoing antipsychotic treatment, regardless of the reason for the switch.

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: 550
• Est. completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients who in their own and/or in the Investigator's opinion, consider ongoing antipsychotic treatment inadequate, because of insufficient efficacy and/or tolerability.

• 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.

• 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: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Seroquel SR

Locations

Country	Name	City	State
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	Saint-Laurent	Quebec
Canada	Research Site	Sherbrooke	Quebec
Canada	Research Site	Toronto	Ontario
Canada	Research Site	Vancouver	British Columbia
Finland	Research Site	Helsinki
Finland	Research Site	Mikkeli
Finland	Research Site	Turku
Germany	Research Site	Aachen
Germany	Research Site	Aachen	Nordrhein-Westfalen
Germany	Research Site	Gottingen	Niedersachsen
Germany	Research Site	Gottingen
Germany	Research Site	Halle
Germany	Research Site	Homburg
Germany	Research Site	Jena
Germany	Research Site	Munchen
Germany	Research Site	Munchen	Bayern
Germany	Research Site	Saarbrucken	Saarland
Hungary	Research Site	Budapest
Hungary	Research Site	Debrecen
Hungary	Research Site	Gyula
Hungary	Research Site	Szekesfehervar

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Canada,  Finland,  Germany,  Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of patients who have an improved clinical benefit based on assessment of clinical efficacy in combination with assessment of tolerability
Secondary	The change from baseline in Clinical Global Impression (CGI)-CB score
Secondary	Change from baseline in Positive and Negative Syndrome Scale (PANSS) total score