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

December 21, 2010 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

Bipolar Disorders

Study Type

Observational

Enrollment (Anticipated)

152

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Belgium
- - 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, Belgium
    - Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Details of any AAP prescribed 1 to 6 months prior to the first study visit: Time Frame: 4 visits	4 visits

Secondary Outcome Measures

Outcome Measure	Time Frame
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	4 visits
Young Mania Rating Scale (YMRS), an 11-point observer rating scale, used to assess the symptoms and severity of mania. Time Frame: 4 visits	4 visits
Remission rate for the major depressive episode, in progress at inclusion Time Frame: At completion	At completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

April 24, 2009

First Submitted That Met QC Criteria