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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.
Information provided by:
AstraZeneca Identifier:
First received: April 24, 2009
Last updated: December 21, 2010
Last verified: December 2010
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.

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:

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)

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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00888264

Research Site
Aarschot, Belgium
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Afsnee, Belgium
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Antwerpen, 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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Brugge, Belgium
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Brussels, Belgium
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Courtrai, Belgium
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Dave, Belgium
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Dendermonde, Belgium
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Elsene, Belgium
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Erpe Mere, Belgium
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Geel, Belgium
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Gent, Belgium
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Hasselt, Belgium
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Ixelles, Belgium
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Kortenberg, Belgium
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Laeken, 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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Liege, Belgium
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Lierneux, 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-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 Denijs Westrem, 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
Research Site
Zoutleeuw, Belgium
Sponsors and Collaborators
  More Information

No publications provided

Responsible Party: MCMD, AstraZeneca 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:
Bipolar Disorder
Depressive episodes
Bipolar I or II Disorders

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mental Disorders
Mood Disorders
Pathologic Processes
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents processed this record on November 25, 2015