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HARMONY: A NIS Evaluating the Treatment Patterns of Atypical Antipsychotics in Patients Diagnosed With Bipolar I or II Disorder

Sponsor
AstraZeneca (Industry)
Overall Status
Completed
CT.gov ID
NCT00888264
Collaborator
(none)
152
Enrollment
46
Locations
15
Duration (Months)
3.3
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this NIS is to obtain data on how AAPs are used in DSM-IV-TR Bipolar I and II Disorder, in the course of a major depressive episode. Both the parameters of use of AAPs and clinical evaluation will be recorded and potential differences that may exist due to epidemiological factors or comorbidities will be analyzed.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    152 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A 6 Month Observational Multicentric Prospective Study Observing the Use of Atypical Antipsychotics in Patients Diagnosed With Bipolar I or II Disorder, in the Course of a Major Depressive Episode
    Study Start Date :
    May 1, 2009
    Actual Primary Completion Date :
    Aug 1, 2010
    Actual Study Completion Date :
    Aug 1, 2010

    Outcome Measures

    Primary Outcome Measures

    1. Details of any AAP prescribed 1 to 6 months prior to the first study visit: [4 visits]

    Secondary Outcome Measures

    1. Montgomery Asberg Depression Rating Scale (MADRS), a 10-point observer rating scale, used to assess the symptoms and severity of depression. [4 visits]

    2. Young Mania Rating Scale (YMRS), an 11-point observer rating scale, used to assess the symptoms and severity of mania. [4 visits]

    3. Remission rate for the major depressive episode, in progress at inclusion [At completion]

    Eligibility Criteria

    Criteria

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

    • Outpatients, diagnosed with Bipolar I or II Disorder, having presented or presenting a major depressive episode (according to DSM-IV-TR) with a starting date of 6 months maximum before the inclusion.

    • Current treatment with atypical antipsychotic(s) (AAP(s)) minimal 1 month and maximum 6 months prior to the first study visit

    • Patient takes an AAP at an adequate therapeutic dose as indicated in the local Summary of Product Characteristics (SPC) and current medical practice

    Exclusion Criteria:

    • Patients diagnosed with Bipolar I or II, experiencing a hypomanic, manic or mixed episode at time of inclusion

    • Pregnant or breastfeeding women, or women of childbearing potential not using a medical reliable method of contraception as stated in the SPC of the AAPs

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Site Aarschot Belgium
    2 Research Site Afsnee Belgium
    3 Research Site Antwerpen Belgium
    4 Research Site Asse Belgium
    5 Research Site Berchem Belgium
    6 Research Site Bertrix Belgium
    7 Research Site Bierbeek Belgium
    8 Research Site Bouge Belgium
    9 Research Site Brugge Belgium
    10 Research Site Brussels Belgium
    11 Research Site Courtrai Belgium
    12 Research Site Dave Belgium
    13 Research Site Dendermonde Belgium
    14 Research Site Elsene Belgium
    15 Research Site Erpe Mere Belgium
    16 Research Site Geel Belgium
    17 Research Site Gent Belgium
    18 Research Site Hasselt Belgium
    19 Research Site Ixelles Belgium
    20 Research Site Kortenberg Belgium
    21 Research Site Laeken Belgium
    22 Research Site Lebbeke Belgium
    23 Research Site Lede Belgium
    24 Research Site Leuven Belgium
    25 Research Site Libramont Belgium
    26 Research Site Liege Belgium
    27 Research Site Lierneux Belgium
    28 Research Site Lubbeek Belgium
    29 Research Site Malle Belgium
    30 Research Site Marchienne-au-pont Belgium
    31 Research Site Mons Belgium
    32 Research Site Montignies-sur-sambre Belgium
    33 Research Site Namur Belgium
    34 Research Site Ottignies Belgium
    35 Research Site Roselaere Belgium
    36 Research Site Saint-Servais Belgium
    37 Research Site Sint-Josse-ten-Noode Belgium
    38 Research Site Sint-Martens-Latem Belgium
    39 Research Site Sint-Niklaas Belgium
    40 Research Site Sleidinge Belgium
    41 Research Site St Denijs Westrem Belgium
    42 Research Site St-Truiden Belgium
    43 Research Site Tienen Belgium
    44 Research Site Tournai Belgium
    45 Research Site Zottegem Belgium
    46 Research Site Zoutleeuw Belgium

    Sponsors and Collaborators

    • AstraZeneca

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00888264
    Other Study ID Numbers:
    • NIS-NBE-SER-2008/1
    First Posted:
    Apr 27, 2009
    Last Update Posted:
    Dec 22, 2010
    Last Verified:
    Dec 1, 2010
    Keywords provided by , ,
    Antipsychotics
    Bipolar Disorder
    Depressive episodes
    Bipolar I or II Disorders
    Additional relevant MeSH terms:
    Disease
    Bipolar Disorder

    Study Results

    No Results Posted as of Dec 22, 2010