Study of the Clinical Management of Bipolar Disease (WAVE bd)

May 22, 2012 updated by: AstraZeneca

Multinational Ambispective Study of the Clinical Management and Burden of Bipolar Disorder (WAVE bd Study)

This study is to provide reliable information on the management of bipolar disorders in real every day, clinical practice, to determine the clinical outcomes of such management and use of resources in relation to the disease, and to establish the factors associated with different management patterns and clinical outcomes.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

2965

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

  • Austria
      • Salzburg, Austria
        • Research Site
      • Villach, Austria
        • Research Site
      • Vocklabruck, Austria
        • Research Site
      • Wien, Austria
        • Research Site
      • Wr. Neustadt, Austria
        • Research Site
  • Belgium
      • Asse, Belgium
        • Research Site
      • Begijnendijk, Belgium
        • Research Site
      • Berchem, Belgium
        • Research Site
      • Bredene, Belgium
        • Research Site
      • Brugge, Belgium
        • Research Site
      • Bruxelles, Belgium
        • Research Site
      • Elsene, Belgium
        • Research Site
      • Herstal, Belgium
        • Research Site
      • Houtvenne, Belgium
        • Research Site
      • Jette, Belgium
        • Research Site
      • Keumiee, Belgium
        • Research Site
      • Kontich, Belgium
        • Research Site
      • Kuringen, Belgium
        • Research Site
      • Lebbeke, Belgium
        • Research Site
      • Lede, Belgium
        • Research Site
      • Lembeke, Belgium
        • Research Site
      • Leuven, Belgium
        • Research Site
      • Liege, Belgium
        • Research Site
      • Lubbeek, Belgium
        • Research Site
      • Maldegem, Belgium
        • Research Site
      • Mechelen, Belgium
        • Research Site
      • Mol, Belgium
        • Research Site
      • Monceau-Sur-Sambre, Belgium
        • Research Site
      • Montignies-Sur-Sambre, Belgium
        • Research Site
      • Moorsel, Belgium
        • Research Site
      • Namur, Belgium
        • Research Site
      • Oosteeklo, Belgium
        • Research Site
      • Oostrozebeke, Belgium
        • Research Site
      • Ottignies, Belgium
        • Research Site
      • Pittem, Belgium
        • Research Site
      • Ransart, Belgium
        • Research Site
      • Roeselare, Belgium
        • Research Site
      • Roux, Belgium
        • Research Site
      • Saint-Servais, Belgium
        • Research Site
      • Sint-Denijs-Westrem, Belgium
        • Research Site
      • Sint-Kruis, Belgium
        • Research Site
      • Sint-Martens-Latem, Belgium
        • Research Site
      • Sint-Niklaas, Belgium
        • Research Site
      • Sint-Truiden, Belgium
        • Research Site
      • Spouwen, Belgium
        • Research Site
      • Tienen, Belgium
        • Research Site
      • Tournai, Belgium
        • Research Site
      • Veurne, Belgium
        • Research Site
      • Wezembeek-oppem, Belgium
        • Research Site
      • Willebroek, Belgium
        • Research Site
      • Wilrijk, Belgium
        • Research Site
      • Zeebrugge, Belgium
        • Research Site
      • Zoersel, Belgium
        • Research Site
      • Zomergem, Belgium
        • Research Site
  • Brazil
      • Aparecida de Goiania, Brazil
        • Research Site
      • Belo Horizonte, Brazil
        • Research Site
      • Botucatu, Brazil
        • Research Site
      • Campinas, Brazil
        • Research Site
      • Fortaleza, Brazil
        • Research Site
      • Goiania, Brazil
        • Research Site
      • Itapira, Brazil
        • Research Site
      • Rio de Janeiro, Brazil
        • Research Site
      • Salvador, Brazil
        • Research Site
      • Santo Andre, Brazil
        • Research Site
      • Sao Bernardo, Brazil
        • Research Site
      • Sao Jose, Brazil
        • Research Site
      • Sao Paulo, Brazil
        • Research Site
  • France
      • Ajaccio, France
        • Research Site
      • Albi, France
        • Research Site
      • Alencon Cedex, France
        • Research Site
      • Amiens, France
        • Research Site
      • Appoigny, France
        • Research Site
      • Armentieres, France
        • Research Site
      • Aulnay Sous Bois, France
        • Research Site
      • Bar Le Duc, France
        • Research Site
      • Belfort, France
        • Research Site
      • Bergerac, France
        • Research Site
      • Besancon, France
        • Research Site
      • Blois, France
        • Research Site
      • Bordeaux, France
        • Research Site
      • Bourg En Bresse, France
        • Research Site
      • Bourges, France
        • Research Site
      • Brest, France
        • Research Site
      • Caen Cedex 1, France
        • Research Site
      • Castries, France
        • Research Site
      • Clermmont Ferrand, France
        • Research Site
      • Creteil Cedex, France
        • Research Site
      • Dijon, France
        • Research Site
      • Douai, France
        • Research Site
      • Elancourt, France
        • Research Site
      • Esquerchin, France
        • Research Site
      • Fains Veel, France
        • Research Site
      • Frejus Cedex, France
        • Research Site
      • GAP, France
        • Research Site
      • Grenoble, France
        • Research Site
      • Hauteville Lompnes, France
        • Research Site
      • Hyeres, France
        • Research Site
      • Jarnac, France
        • Research Site
      • La Charite Sur Loire, France
        • Research Site
      • La Roche Sur Foron, France
        • Research Site
      • La Rochelle, France
        • Research Site
      • Lavaur, France
        • Research Site
      • Le Cannet, France
        • Research Site
      • Le Havre, France
        • Research Site
      • Le Puy En Velay, France
        • Research Site
      • Le Vesinet, France
        • Research Site
      • Libourne, France
        • Research Site
      • Lorient, France
        • Research Site
      • Marseille, France
        • Research Site
      • Mayenne Cedex, France
        • Research Site
      • Metz, France
        • Research Site
      • Mont de Marsan, France
        • Research Site
      • Montberon, France
        • Research Site
      • Montpellier, France
        • Research Site
      • Montreuil, France
        • Research Site
      • Mulhouse, France
        • Research Site
      • Nancy, France
        • Research Site
      • Nanterre, France
        • Research Site
      • Nantes, France
        • Research Site
      • Neuilly Sur Marne, France
        • Research Site
      • Nice, France
        • Research Site
      • Orsay, France
        • Research Site
      • PAU, France
        • Research Site
      • Paris, France
        • Research Site
      • Reims, France
        • Research Site
      • Rennes, France
        • Research Site
      • Rodez, France
        • Research Site
      • Sartrouville, France
        • Research Site
      • St Avertin, France
        • Research Site
      • St Brieuc, France
        • Research Site
      • St Dizier, France
        • Research Site
      • St Gratien, France
        • Research Site
      • St Herblain, France
        • Research Site
      • St Nazaire, France
        • Research Site
      • St Pol Sur Ternoise, France
        • Research Site
      • St Quentin, France
        • Research Site
      • Strasbourg, France
        • Research Site
      • Thionville Cedex, France
        • Research Site
      • Thuir Cedex, France
        • Research Site
      • Toulouse, France
        • Research Site
      • Tours, France
        • Research Site
      • Vendome, France
        • Research Site
      • Versailles, France
        • Research Site
      • Wattignies, France
        • Research Site
  • Germany
      • Berlin, Germany
        • Research Site
      • Cham, Germany
        • Research Site
      • Dillingen, Germany
        • Research Site
      • Ettlingen, Germany
        • Research Site
      • Greifswald, Germany
        • Research Site
      • Grunstadt, Germany
        • Research Site
      • Hildesheim, Germany
        • Research Site
      • Karlstadt, Germany
        • Research Site
      • Kiel, Germany
        • Research Site
      • Luneburg, Germany
        • Research Site
      • Munchen, Germany
        • Research Site
      • Regensburg, Germany
        • Research Site
      • Stralsund, Germany
        • Research Site
      • Werneck, Germany
        • Research Site
      • Westerstede, Germany
        • Research Site
  • Portugal
      • Angra do Heroismo, Portugal
        • Research Site
      • Aveiro, Portugal
        • Research Site
      • Braga, Portugal
        • Research Site
      • Carnaxide, Portugal
        • Research Site
      • Coimbra, Portugal
        • Research Site
      • Faro, Portugal
        • Research Site
      • Lisboa, Portugal
        • Research Site
      • Portimao, Portugal
        • Research Site
      • Porto, Portugal
        • Research Site
      • Setubal, Portugal
        • Research Site
      • Tomar, Portugal
        • Research Site
  • Romania
      • Bucuresti, Romania
        • Research Site
      • Cluj, Romania
        • Research Site
      • Craiova, Romania
        • Research Site
      • Iasi, Romania
        • Research Site
  • Turkey
      • Ankara, Turkey
        • Research Site
      • Antalya, Turkey
        • Research Site
      • Aydin, Turkey
        • Research Site
      • Basoglu, Turkey
        • Research Site
      • Bolu, Turkey
        • Research Site
      • Bursa, Turkey
        • Research Site
      • Cankiri, Turkey
        • Research Site
      • D.bakir, Turkey
        • Research Site
      • Denizli, Turkey
        • Research Site
      • Diyarbakir, Turkey
        • Research Site
      • Elazig, Turkey
        • Research Site
      • Eskisehir, Turkey
        • Research Site
      • Hatay, Turkey
        • Research Site
      • Istanbul, Turkey
        • Research Site
      • Izmir, Turkey
        • Research Site
      • Kocaeli, Turkey
        • Research Site
      • Manisa, Turkey
        • Research Site
      • S.urfa, Turkey
        • Research Site
      • Samsun, Turkey
        • Research Site
      • Sanliurfa, Turkey
        • Research Site
      • Sivas, Turkey
        • Research Site
      • Tahsin, Turkey
        • Research Site
      • Tugay, Turkey
        • Research Site
      • Zonguldak, Turkey
        • Research Site
  • Ukraine
      • Dnipropetrovsk, Ukraine
        • Research Site
      • Donetsk, Ukraine
        • Research Site
      • Ivano-Frankivsk, Ukraine
        • Research Site
      • Kharkiv, Ukraine
        • Research Site
      • Kiev, Ukraine
        • Research Site
      • Lugansk, Ukraine
        • Research Site
      • Lviv, Ukraine
        • Research Site
      • Odessa, Ukraine
        • Research Site
      • Simferopol, Ukraine
        • Research Site
      • Vinnitsa, Ukraine
        • Research Site
      • Zaporizhzhya, Ukraine
        • Research Site
  • Venezuela
      • Caracas, Venezuela
        • Research Site
      • Merida, Venezuela
        • Research Site
      • Miranda, Venezuela
        • Research Site
      • San Cristobal, Venezuela
        • 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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Bipolar patients seen in mental health centers, clinics, private settings, hospitals or specialized units

Description

Inclusion Criteria:

  • Diagnosis of Bipolar Disorder I or II (DSM-IV TR) in any phase of the disorder
  • Patients who had at least one mood event (depression, mania, hypomania or mixed) according to DSM-IV TR definition during the 12 months prior to the beginning of the study

Exclusion Criteria:

  • Patients who had the index mood event during the 3 months before the beginning of the study (Time 0).

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

Cohorts and Interventions

Group / Cohort
1
Patients diagnosed with Bipolar Disorder I or II (DSM-IV-TR) at any phase of the disorder with at least one mood event during the 12 months before the study start.
2
Patients diagnosed with Bipolar Disorder I or II (DSM-IV-TR) at any phase of the disorder with at least one mood event during the 12 months before the study start receiving Seroquel extended release at some point during the retrospective period .

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Demographic variables
Time Frame: Once during study
Once during study
1-year prevalence for each disease phase
Time Frame: everytime the patient attends the consult
everytime the patient attends the consult

Secondary Outcome Measures

Outcome Measure
Time Frame
Use of resources
Time Frame: everytime the patient attends the consult
everytime the patient attends the consult
treatments prescribed, EQ5D
Time Frame: everytime the patient attends the consult
everytime the patient attends the consult
treatments prescribed, FAST
Time Frame: everytime the patient attends the consult
everytime the patient attends the consult
treatments prescribed, DAI-10
Time Frame: everytime the patient attends the consult
everytime the patient attends the consult
treatments prescribed, MPR
Time Frame: everytime the patient attends the consult
everytime the patient attends the consult
treatments prescribed, BAS
Time Frame: Once during the prospective part (only if patient attends with a caregiver)
Once during the prospective part (only if patient attends with a caregiver)

Collaborators and Investigators

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

Sponsor

AstraZeneca

Investigators

  • Study Director: Esteban Medina, Medical Department.AstraZeneca Spain

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

April 1, 2010

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

January 27, 2010

First Submitted That Met QC Criteria

February 3, 2010

First Posted (Estimate)

February 4, 2010

Study Record Updates

Last Update Posted (Estimate)

May 23, 2012

Last Update Submitted That Met QC Criteria

May 22, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS-NEU-DUM-2009/1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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