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

NCT ID: NCT00888264

Last Updated: 2010-12-22

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

152 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-05-31

Study Completion Date

2010-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Bipolar Disorders

Keywords

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Antipsychotics Bipolar Disorder Depressive episodes Bipolar I or II Disorders

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
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

Responsible Party

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AstraZeneca

Locations

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Research Site

Aarschot, , Belgium

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Afsnee, , Belgium

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Antwerp, , Belgium

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Asse, , Belgium

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Berchem, , Belgium

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Bertrix, , Belgium

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Bierbeek, , Belgium

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Bouge, , Belgium

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Bruges, , Belgium

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Brussels, , Belgium

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Dave, , Belgium

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Dendermonde, , Belgium

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Erpe Mere, , Belgium

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Geel, , Belgium

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Ghent, , Belgium

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Hasselt, , Belgium

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Ixelles-Elsene, , Belgium

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Kortenberg, , Belgium

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Kortrijk, , Belgium

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Laken, , Belgium

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Lebbeke, , Belgium

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Lede, , Belgium

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Leuven, , Belgium

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Libramont, , Belgium

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Lierneux, , Belgium

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Liège, , Belgium

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Lubbeek, , Belgium

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Malle, , Belgium

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Marchienne-au-Pont, , Belgium

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Mons, , Belgium

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Montignies-sur-Sambre, , Belgium

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Namur, , Belgium

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Ottignies, , Belgium

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Roselaere, , Belgium

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Saint Denijs Westrem, , Belgium

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Saint-Servais, , Belgium

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Sint-Josse-ten-Noode, , Belgium

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Sint-Martens-Latem, , Belgium

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Sint-Niklaas, , Belgium

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Sleidinge, , Belgium

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St-Truiden, , Belgium

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Tienen, , Belgium

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Tournai, , Belgium

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Zottegem, , Belgium

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Zoutleeuw, , Belgium

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Countries

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Belgium

Other Identifiers

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NIS-NBE-SER-2008/1

Identifier Type: -

Identifier Source: org_study_id