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

Bipolar Disorders Clinical Trial

— HARMONY  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00888264
• Other study ID #: NIS-NBE-SER-2008/1
• Status: Completed
• Phase: N/A
• First received: April 24, 2009
• Last updated: December 21, 2010
• Start date: May 2009
• Est. completion date: August 2010

Study information

• Verified date: December 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bipolar Disorder
• Bipolar Disorders
• Disease

Locations

Country	Name	City	State
Belgium	Research Site	Aarschot
Belgium	Research Site	Afsnee
Belgium	Research Site	Antwerpen
Belgium	Research Site	Asse
Belgium	Research Site	Berchem
Belgium	Research Site	Bertrix
Belgium	Research Site	Bierbeek
Belgium	Research Site	Bouge
Belgium	Research Site	Brugge
Belgium	Research Site	Brussels
Belgium	Research Site	Courtrai
Belgium	Research Site	Dave
Belgium	Research Site	Dendermonde
Belgium	Research Site	Elsene
Belgium	Research Site	Erpe Mere
Belgium	Research Site	Geel
Belgium	Research Site	Gent
Belgium	Research Site	Hasselt
Belgium	Research Site	Ixelles
Belgium	Research Site	Kortenberg
Belgium	Research Site	Laeken
Belgium	Research Site	Lebbeke
Belgium	Research Site	Lede
Belgium	Research Site	Leuven
Belgium	Research Site	Libramont
Belgium	Research Site	Liege
Belgium	Research Site	Lierneux
Belgium	Research Site	Lubbeek
Belgium	Research Site	Malle
Belgium	Research Site	Marchienne-au-pont
Belgium	Research Site	Mons
Belgium	Research Site	Montignies-sur-sambre
Belgium	Research Site	Namur
Belgium	Research Site	Ottignies
Belgium	Research Site	Roselaere
Belgium	Research Site	Saint-Servais
Belgium	Research Site	Sint-Josse-ten-Noode
Belgium	Research Site	Sint-Martens-Latem
Belgium	Research Site	Sint-Niklaas
Belgium	Research Site	Sleidinge
Belgium	Research Site	St Denijs Westrem
Belgium	Research Site	St-Truiden
Belgium	Research Site	Tienen
Belgium	Research Site	Tournai
Belgium	Research Site	Zottegem
Belgium	Research Site	Zoutleeuw

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Details of any AAP prescribed 1 to 6 months prior to the first study visit:		4 visits	No
Secondary	Montgomery Asberg Depression Rating Scale (MADRS), a 10-point observer rating scale, used to assess the symptoms and severity of depression.		4 visits	No
Secondary	Young Mania Rating Scale (YMRS), an 11-point observer rating scale, used to assess the symptoms and severity of mania.		4 visits	No
Secondary	Remission rate for the major depressive episode, in progress at inclusion		At completion	No