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

Completed

• Conditions: Bipolar Disorders

• Registration Number: NCT00888264
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-04-24
• Study First Submitted QC: 2009-04-24
• Study First Posted: 2009-04-27
• Study Start: 2009-05
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Status Verified: 2010-12
• Last Update Submitted: 2010-12-21
• Last Update Posted: 2010-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 152

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Details of any AAP prescribed 1 to 6 months prior to the first study visit:	4 visits

Secondary Outcome Measures

Name	Time	Method
Remission rate for the major depressive episode, in progress at inclusion	At completion
Montgomery Asberg Depression Rating Scale (MADRS), a 10-point observer rating scale, used to assess the symptoms and severity of depression.	4 visits
Young Mania Rating Scale (YMRS), an 11-point observer rating scale, used to assess the symptoms and severity of mania.	4 visits

Trial Locations

Locations (1)

Research Site; 🇧🇪 Zoutleeuw, Belgium