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

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Outcomes

Primary Outcome Measures

The proportion of patients who have an improved clinical benefit based on assessment of clinical efficacy in combination with assessment of tolerability

Secondary Outcome Measures

The change from baseline in Clinical Global Impression (CGI)-CB score
Change from baseline in Positive and Negative Syndrome Scale (PANSS) total score

Full Information

First Posted
October 5, 2005
Last Updated
January 3, 2013
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00234377
Brief Title
Seroquel Switching Study: Feasibility of Switching Any Antipsychotic Treatment to Seroquel in Patients With Schizophrenia
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
Study Type
Interventional

2. Study Status

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

3. Sponsor/Collaborators

Name of the Sponsor
AstraZeneca

4. Oversight

5. Study Description

Brief 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.

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
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
550 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Seroquel SR
Primary Outcome Measure Information:
Title
The proportion of patients who have an improved clinical benefit based on assessment of clinical efficacy in combination with assessment of tolerability
Secondary Outcome Measure Information:
Title
The change from baseline in Clinical Global Impression (CGI)-CB score
Title
Change from baseline in Positive and Negative Syndrome Scale (PANSS) total score

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: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca CNS Medical Science Director, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
Research Site
City
Aurora
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Burlington
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Mississauga
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Orleans
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Saint-Laurent
State/Province
Quebec
Country
Canada
Facility Name
Research Site
City
Sherbrooke
State/Province
Quebec
Country
Canada
Facility Name
Research Site
City
Prince Albert
State/Province
Saskatchewan
Country
Canada
Facility Name
Research Site
City
Quebec
Country
Canada
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
Munchen
State/Province
Bayern
Country
Germany
Facility Name
Research Site
City
Gottingen
State/Province
Niedersachsen
Country
Germany
Facility Name
Research Site
City
Aachen
State/Province
Nordrhein-Westfalen
Country
Germany
Facility Name
Research Site
City
Saarbrucken
State/Province
Saarland
Country
Germany
Facility Name
Research Site
City
Aachen
Country
Germany
Facility Name
Research Site
City
Gottingen
Country
Germany
Facility Name
Research Site
City
Halle
Country
Germany
Facility Name
Research Site
City
Homburg
Country
Germany
Facility Name
Research Site
City
Jena
Country
Germany
Facility Name
Research Site
City
Munchen
Country
Germany
Facility Name
Research Site
City
Budapest
Country
Hungary
Facility Name
Research Site
City
Debrecen
Country
Hungary
Facility Name
Research Site
City
Gyula
Country
Hungary
Facility Name
Research Site
City
Szekesfehervar
Country
Hungary

12. IPD Sharing Statement

Citations:
PubMed Identifier
18021496
Citation
Ganesan S, Agambaram V, Randeree F, Eggens I, Huizar K, Meulien D; Study 147 Investigators. Switching from other antipsychotics to once-daily extended release quetiapine fumarate in patients with schizophrenia. Curr Med Res Opin. 2008 Jan;24(1):21-32. doi: 10.1185/030079908x253384.
Results Reference
derived

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

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