Status:
COMPLETED
A NIS Evaluating the Treatment Patterns of Atypical Antipsychotics in Patients Diagnosed With Bipolar I or II Disorder
Lead Sponsor:
AstraZeneca
Conditions:
Bipolar Disorders
Eligibility:
All Genders
18-65 years
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 eval...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2010
Estimated Enrollment :
152 Patients enrolled
Trial Details
Trial ID
NCT00888264
Start Date
May 1 2009
End Date
August 1 2010
Last Update
December 22 2010
Active Locations (45)
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1
Research Site
Aarschot, Belgium
2
Research Site
Afsnee, Belgium
3
Research Site
Antwerp, Belgium
4
Research Site
Asse, Belgium