NCT01062607

Brief Summary

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.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network
Enrollment
2,965

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2010

Geographic Reach
10 countries

213 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 27, 2010

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 4, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

May 23, 2012

Status Verified

May 1, 2012

Enrollment Period

1.2 years

First QC Date

January 27, 2010

Last Update Submit

May 22, 2012

Conditions

Keywords

bipolar disorderseveryday settingtreatment adherenceglobal

Outcome Measures

Primary Outcomes (2)

  • Demographic variables

    Once during study

  • 1-year prevalence for each disease phase

    everytime the patient attends the consult

Secondary Outcomes (6)

  • Use of resources

    everytime the patient attends the consult

  • treatments prescribed, EQ5D

    everytime the patient attends the consult

  • treatments prescribed, FAST

    everytime the patient attends the consult

  • treatments prescribed, DAI-10

    everytime the patient attends the consult

  • treatments prescribed, MPR

    everytime the patient attends the consult

  • +1 more secondary outcomes

Study Arms (2)

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 .

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (213)

Research Site

Salzburg, Austria

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Vienna, Austria

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Villach, Austria

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Vöcklabruck, Austria

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Wiener Neustadt, Austria

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Asse, Belgium

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Begijnendijk, Belgium

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Berchem, Belgium

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Bredene, Belgium

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Bruges, Belgium

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Brussels, Belgium

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Herstal, Belgium

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Houtvenne, Belgium

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Ixelles-Elsene, Belgium

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Jette, Belgium

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Keumiée, Belgium

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Kontich, Belgium

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Kuringen, Belgium

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Lebbeke, Belgium

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Lede, Belgium

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Lembeke, Belgium

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Leuven, Belgium

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Liège, Belgium

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Lubbeek, Belgium

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Maldegem, Belgium

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Mechelen, Belgium

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Mol, Belgium

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Monceau-sur-Sambre, Belgium

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Montignies-sur-Sambre, Belgium

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Moorsel, Belgium

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Namur, Belgium

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Oosteeklo, Belgium

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Oostrozebeke, Belgium

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Ottignies, Belgium

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Pittem, Belgium

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Ransart, Belgium

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Roeselare, Belgium

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Roux, Belgium

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Saint-Servais, Belgium

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Sint-Denijs-Westrem, Belgium

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Sint-Kruis, Belgium

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Sint-Martens-Latem, Belgium

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Sint-Niklaas, Belgium

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Sint-Truiden, Belgium

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Spouwen, Belgium

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Tienen, Belgium

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Tournai, Belgium

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Veurne, Belgium

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Wezembeek-Oppem, Belgium

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Willebroek, Belgium

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Wilrijk, Belgium

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Zeebrugge, Belgium

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Zoersel, Belgium

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Zomergem, Belgium

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Aparecida de Goiânia, Brazil

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Belo Horizonte, Brazil

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Botucatu, Brazil

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Campinas, Brazil

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Fortaleza, Brazil

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Goiânia, Brazil

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Itapira, Brazil

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Rio de Janeiro, Brazil

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Salvador, Brazil

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Santo André, Brazil

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São Bernardo, Brazil

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São José, Brazil

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São Paulo, Brazil

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Ajaccio, France

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Albi, France

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Alençon, France

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Amiens, France

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Appoigny, France

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Armentières, France

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Aulnay-sous-Bois, France

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Bar-le-Duc, France

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Belfort, France

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Bergerac, France

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Besançon, France

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Blois, France

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Bordeaux, France

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Bourg-en-Bresse, France

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Bourges, France

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Brest, France

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Caen, France

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Castries, France

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Clermmont Ferrand, France

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Créteil, France

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Dijon, France

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Douai, France

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Esquerchin, France

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Élancourt, France

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Fains-Véel, France

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Fréjus, France

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Gap, France

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Grenoble, France

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Hauteville-Lompnes, France

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Hyères, France

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Jarnac, France

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La Charité-sur-Loire, France

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La Roche-sur-Foron, France

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La Rochelle, France

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Lavaur, France

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Le Cannet, France

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Le Havre, France

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Le Puy-en-Velay, France

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Le Vésinet, France

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Libourne, France

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Lorient, France

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Marseille, France

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Mayenne, France

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Metz, France

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Mont-de-Marsan, France

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Montberon, France

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Montpellier, France

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Montreuil, France

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Mulhouse, France

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Nancy, France

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Nanterre, France

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Nantes, France

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Neuilly-sur-Marne, France

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Nice, France

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Orsay, France

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Paris, France

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Pau, France

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Reims, France

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Rennes, France

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Rodez, France

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Saint-Avertin, France

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Saint-Brieuc, France

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Saint-Dizier, France

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Saint-Gratien, France

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Saint-Herblain, France

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Saint-Nazaire, France

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Saint-Pol-sur-Ternoise, France

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Saint-Quentin, France

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Sartrouville, France

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Strasbourg, France

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Thionville, France

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Thuir, France

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Toulouse, France

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Tours, France

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Vendôme, France

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Versailles, France

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Wattignies, France

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Berlin, Germany

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Cham, Germany

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Dillingen, Germany

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Ettlingen, Germany

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Greifswald, Germany

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Grünstadt, Germany

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Hildesheim, Germany

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Karlstadt am Main, Germany

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Kiel, Germany

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Lüneburg, Germany

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München, Germany

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Regensburg, Germany

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Stralsund, Germany

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Werneck, Germany

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Westerstede, Germany

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Angra do Heroísmo, Portugal

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Aveiro, Portugal

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Braga, Portugal

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Carnaxide, Portugal

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Coimbra, Portugal

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Faro, Portugal

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Lisbon, Portugal

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Portimão, Portugal

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Porto, Portugal

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Setúbal, Portugal

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Tomar, Portugal

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Bucharest, Romania

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Cluj-Napoca, Romania

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Craiova, Romania

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Iași, Romania

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Ankara, Turkey (Türkiye)

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Antalya, Turkey (Türkiye)

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Aydin, Turkey (Türkiye)

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Başoğlu, Turkey (Türkiye)

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Bolu, Turkey (Türkiye)

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Bursa, Turkey (Türkiye)

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Çankırı, Turkey (Türkiye)

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D.bakir, Turkey (Türkiye)

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Denizli, Turkey (Türkiye)

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Diyarbakır, Turkey (Türkiye)

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Elâzığ, Turkey (Türkiye)

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Eskişehir, Turkey (Türkiye)

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Hatay, Turkey (Türkiye)

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Istanbul, Turkey (Türkiye)

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Izmir, Turkey (Türkiye)

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Kocaeli, Turkey (Türkiye)

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Manisa, Turkey (Türkiye)

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S.urfa, Turkey (Türkiye)

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Samsun, Turkey (Türkiye)

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Sanliurfa, Turkey (Türkiye)

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Sivas, Turkey (Türkiye)

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Tugay, Turkey (Türkiye)

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Yağlıca, Turkey (Türkiye)

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Zonguldak, Turkey (Türkiye)

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Dnipropetrovsk, Ukraine

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Donetsk, Ukraine

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Ivano-Frankivsk, Ukraine

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Kharkiv, Ukraine

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Kiev, Ukraine

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Luhansk, Ukraine

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Lviv, Ukraine

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Odesa, Ukraine

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Simferopol, Ukraine

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Vinnitsa, Ukraine

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Zaporizhzhya, Ukraine

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Caracas, Venezuela

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Mérida, Venezuela

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Miranda, Venezuela

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San Cristóbal, Venezuela

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Related Publications (2)

  • Vieta E, Langosch JM, Figueira ML, Souery D, Blasco-Colmenares E, Medina E, Moreno-Manzanaro M, Gonzalez MA, Bellivier F. Clinical management and burden of bipolar disorder: results from a multinational longitudinal study (WAVE-bd). Int J Neuropsychopharmacol. 2013 Sep;16(8):1719-32. doi: 10.1017/S1461145713000278. Epub 2013 May 13.

  • Vieta E, Blasco-Colmenares E, Figueira ML, Langosch JM, Moreno-Manzanaro M, Medina E; WAVE-bd Study Group. Clinical management and burden of bipolar disorder: a multinational longitudinal study (WAVE-bd study). BMC Psychiatry. 2011 Apr 11;11:58. doi: 10.1186/1471-244X-11-58.

MeSH Terms

Conditions

Bipolar DisorderTreatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental DisordersHealth BehaviorBehavior

Study Officials

  • Esteban Medina

    Medical Department.AstraZeneca Spain

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2010

First Posted

February 4, 2010

Study Start

April 1, 2010

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

May 23, 2012

Record last verified: 2012-05

Locations