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

Sponsor
AstraZeneca (Industry)
Overall Status
Completed
CT.gov ID
NCT00750087
Collaborator
(none)
578
Enrollment
33
Locations
13
Duration (Months)
17.5
Patients Per Site
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    578 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Non-interventional Study to Observe Treatment Efficacy in Maintaining Symptoms Control in Patients With Schizophrenia, Treated With Seroquel XR
    Study Start Date :
    Aug 1, 2008
    Actual Primary Completion Date :
    Sep 1, 2009
    Actual Study Completion Date :
    Sep 1, 2009

    Arms and Interventions

    Arm Intervention/Treatment
    1

    Schizophrenia patients stabilized on Seroquel XR

    Outcome Measures

    Primary Outcome Measures

    1. Brief Psychiatric Rating Scale - BPRS [monthly/ at every clinic visit- 7 times]

    Secondary Outcome Measures

    1. Clinical Global Impression Severity of Illness - CGI -S [monthly/ at every clinic visit- 7 times]

    2. Clinical Global Impression Improvement CGI -I [monthly/ at every clinic visit except first visit- 6 times]

    3. Quality of Life Enjoyment & Satisfaction Questionnaire - Short Form ( Q - LES - Q - SF) [twice/first and last clinic visit]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Site Alba Romania
    2 Research Site Arad Romania
    3 Research Site Bacau Romania
    4 Research Site Baia Mare Romania
    5 Research Site Bistrita Romania
    6 Research Site Botosani Romania
    7 Research Site Braila Romania
    8 Research Site Brasov Romania
    9 Research Site Bucuresti Romania
    10 Research Site Calarasi Romania
    11 Research Site Campina Romania
    12 Research Site Cluj Napoca Romania
    13 Research Site Cluj Romania
    14 Research Site Constanta Romania
    15 Research Site Craiova Romania
    16 Research Site Deva Romania
    17 Research Site Galati Romania
    18 Research Site Giurgiu Romania
    19 Research Site Horezu Romania
    20 Research Site Iasi Romania
    21 Research Site Oradea Romania
    22 Research Site Pitesti Romania
    23 Research Site Ploiesti Romania
    24 Research Site Ramnicu Valcea Romania
    25 Research Site Satu Mare Romania
    26 Research Site Sibiu Romania
    27 Research Site Siret Romania
    28 Research Site Slatina Romania
    29 Research Site Slobozia Romania
    30 Research Site Targoviste Romania
    31 Research Site Targu Mures Romania
    32 Research Site Timisoara Romania
    33 Research Site Zalau Romania

    Sponsors and Collaborators

    • AstraZeneca

    Investigators

    • Study Chair: Beatrice Costea, AstraZeneca

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00750087
    Other Study ID Numbers:
    • NIS-NRO-SER-2008/1
    First Posted:
    Sep 10, 2008
    Last Update Posted:
    Feb 5, 2010
    Last Verified:
    Feb 1, 2010
    Keywords provided by , ,
    Schizophrenia
    Additional relevant MeSH terms:
    Schizophrenia

    Study Results

    No Results Posted as of Feb 5, 2010