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

NCT ID: NCT00234377

Last Updated: 2013-01-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

550 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2006-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Schizophrenia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Seroquel SR

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Principal Investigators

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AstraZeneca CNS Medical Science Director, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Research Site

Vancouver, British Columbia, Canada

Site Status

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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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Saint-Laurent, Quebec, Canada

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Sherbrooke, Quebec, Canada

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Prince Albert, Saskatchewan, Canada

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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

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Aachen, North Rhine-Westphalia, Germany

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Saarbrücken, Saarland, Germany

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Aachen, , Germany

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Göttingen, , Germany

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Halle, , Germany

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Homburg, , Germany

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Jena, , Germany

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München, , Germany

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Budapest, , Hungary

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Debrecen, , Hungary

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Gyula, , Hungary

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Székesfehérvár, , Hungary

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Countries

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Canada Finland Germany Hungary

References

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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.

Reference Type DERIVED
PMID: 18021496 (View on PubMed)

Other Identifiers

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D1444C00147

Identifier Type: -

Identifier Source: org_study_id

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