Non-interventional Study -Observe Treatment Efficacy in Maintaining Symptoms Control in Schizophrenia With Seroquel XR

NCT ID: NCT00750087

Last Updated: 2010-02-05

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

Total Enrollment

578 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-08-31

Study Completion Date

2009-09-30

Brief Summary

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the primary purpose of the study is to observe symptoms control in schizophrenia for 6 months in patients treated with Seroquel XR.

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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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Schizophrenia patients stabilized on Seroquel XR

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients will have a diagnosis of schizophrenia , as defined by DSM-IV-TR and their symptoms are controlled with Seroquel XR therapy started approximately 1 month before
* All eligible patients will be included in the protocol provided they will receive detailed information in advance and will sign consent to grant access to their own data collected during this programme.

Exclusion Criteria

* All the patients who have a known hypersensitivity to Seroquel XR/quetiapine or any of its excipients will not be included in this study.
* As per valid Romanian SmPC, concomitant medication, that could result in drug interactions and could jeopardise patient safety will be carefully considered before having the patient enrolled.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeenca

Principal Investigators

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Beatrice Costea

Role: STUDY_CHAIR

AstraZeneca

Locations

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Research Site

Alba, , Romania

Site Status

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Arad, , Romania

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Bacau, , Romania

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Baia Mare, , Romania

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Bistriţa, , Romania

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Botoșani, , Romania

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Brasov, , Romania

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Brăila, , Romania

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Bucharest, , Romania

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Câmpina, , Romania

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Călăraşi, , Romania

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Cluj-Napoca, , Romania

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Constanța, , Romania

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Craiova, , Romania

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Deva, , Romania

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Galati, , Romania

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Giurgiu, , Romania

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Horezu, , Romania

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Iași, , Romania

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Oradea, , Romania

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Piteşti, , Romania

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Ploieşti, , Romania

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Râmnicu Vâlcea, , Romania

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Satu Mare, , Romania

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Sibiu, , Romania

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Siret, , Romania

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Slatina, , Romania

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Slobozia, , Romania

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Târgovişte, , Romania

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Târgu Mureş, , Romania

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Timișoara, , Romania

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Zalău, , Romania

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Countries

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Romania

Other Identifiers

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NIS-NRO-SER-2008/1

Identifier Type: -

Identifier Source: org_study_id

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