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Xperience: Evaluating Subjective Well-being in Schizophrenic Patients Treated With quetiapineXR® and Other Atypical Antipsychotics

Sponsor
AstraZeneca (Industry)
Overall Status
Completed
CT.gov ID
NCT00689325
Collaborator
(none)
158
Enrollment
37
Locations
21
Duration (Months)
4.3
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To evaluate the QOL (subjective effectiveness) in patients with schizophrenia, treated with atypical antipsychotics.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    158 participants
    Time Perspective:
    Prospective
    Official Title:
    A Non-interventional Study Evaluating Well-being/Quality of Life in Schizophrenic Patients Treated With Seroquel XR® (Quetiapine) and Other Atypical Antipsychotics.A 9-month, Observational, Multicentric Prospective Study.
    Study Start Date :
    Apr 1, 2008
    Actual Primary Completion Date :
    Jan 1, 2010
    Actual Study Completion Date :
    Jan 1, 2010

    Outcome Measures

    Primary Outcome Measures

    1. Subjective Wellbeing under Neuroleptics' SWN-K-score; Change from baseline of QoL assessed by the SWN-K after 9 months of treatment with atypical antipsychotics. [At baseline (Visit 1), and after ~3 months, ~6 months, ~9 months after V1, or at premature discontinuation]

    Secondary Outcome Measures

    1. Positive And Negative Syndrome Scale-PANSS-8score [At baseline (Visit 1), and after ~3 months, ~6 months, ~9 months after V1, or at premature discontinuation]

    2. Global Assessment of Functioning 'GAF' scale [At baseline (Visit 1), and after ~3 months, ~6 months, ~9 months after V1, or at premature discontinuation]

    3. Disease insight; G-12 item of PANSS [At baseline (Visit 1), and after ~3 months, ~6 months, ~9 months after V1, or at premature discontinuation]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Diagnosis of schizophrenia

    • Treatment with one atypical antipsychotic* (for a first/new episode or a switch of therapy) for at least 2 weeks and maximum 8 weeks prior to the first study visit.

    • Patient takes an AAP according to local SPC and current medical practice

    • The patient must be able to understand and comply with the study requirements as judged by the investigator, e.g. patient must be able to read and write

    Exclusion Criteria:

    • Treatment with an additional AAP or AP to the initial prescribed AAP within the 2-8 weeks before the patient is included in the study

    • Since the use of clozapine is limited, due to, among other things, the risk for agranulocytosis, patients on treatment with this '2nd line'AAP are excluded.

    • Previous enrolment or treatment in the present NIS

    • Known allergy to the prescribed AAP or any of its substances

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Site Alphen Netherlands
    2 Research Site Amersfoort Netherlands
    3 Research Site Amstelveen Netherlands
    4 Research Site Amsterdam Netherlands
    5 Research Site Arnhem Netherlands
    6 Research Site Bennebroek Netherlands
    7 Research Site Boxmeer Netherlands
    8 Research Site Breda Netherlands
    9 Research Site Doetinchem Netherlands
    10 Research Site Echt Netherlands
    11 Research Site Enkhuizen Netherlands
    12 Research Site Enschede Netherlands
    13 Research Site Haarlem Netherlands
    14 Research Site Halsteren Netherlands
    15 Research Site Helmond Netherlands
    16 Research Site Heythuizen Netherlands
    17 Research Site Hoorn Netherlands
    18 Research Site Kerkrade Netherlands
    19 Research Site Kloetinge Netherlands
    20 Research Site Leeuwarden Netherlands
    21 Research Site Maastricht Netherlands
    22 Research Site Nijmegen Netherlands
    23 Research Site Oegstgeest Netherlands
    24 Research Site Raalte Netherlands
    25 Research Site Roermond Netherlands
    26 Research Site Rotterdam Netherlands
    27 Research Site Sluis Netherlands
    28 Research Site Tiel Netherlands
    29 Research Site Tilburg Netherlands
    30 Research Site Utrecht Netherlands
    31 Research Site Veenendaal Netherlands
    32 Research Site Venray Netherlands
    33 Research Site Vlaardingen Netherlands
    34 Research Site Weert Netherlands
    35 Research Site Zaandam Netherlands
    36 Research Site Zoetermeer Netherlands
    37 Research Site Zwolle Netherlands

    Sponsors and Collaborators

    • AstraZeneca

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00689325
    Other Study ID Numbers:
    • NIS-NNL-SER-2008/1
    First Posted:
    Jun 3, 2008
    Last Update Posted:
    Oct 27, 2010
    Last Verified:
    Oct 1, 2010
    Keywords provided by , ,
    Schizophrenia
    remission
    subjective well-being and effectiveness
    Quality of Life
    Additional relevant MeSH terms:
    Schizophrenia

    Study Results

    No Results Posted as of Oct 27, 2010