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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00888264
First received: April 24, 2009
Last updated: December 21, 2010
Last verified: December 2010
History of Changes
  Purpose

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
Bipolar Disorders

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Details of any AAP prescribed 1 to 6 months prior to the first study visit: [ Time Frame: 4 visits ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Montgomery Asberg Depression Rating Scale (MADRS), a 10-point observer rating scale, used to assess the symptoms and severity of depression. [ Time Frame: 4 visits ] [ Designated as safety issue: No ]
  • Young Mania Rating Scale (YMRS), an 11-point observer rating scale, used to assess the symptoms and severity of mania. [ Time Frame: 4 visits ] [ Designated as safety issue: No ]
  • Remission rate for the major depressive episode, in progress at inclusion [ Time Frame: At completion ] [ Designated as safety issue: No ]

Estimated Enrollment: 152
Study Start Date: May 2009
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00888264

Locations
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
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Brussels, Belgium
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Courtrai, Belgium
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Dave, Belgium
Research Site
Dendermonde, Belgium
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Elsene, Belgium
Research Site
Erpe Mere, Belgium
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Geel, Belgium
Research Site
Gent, Belgium
Research Site
Hasselt, Belgium
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Ixelles, Belgium
Research Site
Kortenberg, Belgium
Research Site
Laeken, Belgium
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Lebbeke, Belgium
Research Site
Lede, Belgium
Research Site
Leuven, Belgium
Research Site
Libramont, Belgium
Research Site
Liege, Belgium
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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
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Namur, Belgium
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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, Belgium
Sponsors and Collaborators
AstraZeneca
  More Information

No publications provided

Responsible Party: MCMD, AstraZeneca
ClinicalTrials.gov Identifier: NCT00888264     History of Changes
Other Study ID Numbers: NIS-NBE-SER-2008/1
Study First Received: April 24, 2009
Last Updated: December 21, 2010
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by AstraZeneca:
Antipsychotics
Bipolar Disorder
Depressive episodes
Bipolar I or II Disorders

Additional relevant MeSH terms:
Bipolar Disorder
Depression
Depressive Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Behavioral Symptoms
Antipsychotic Agents
 Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on June 18, 2013