Study of the Clinical Management of Bipolar Disease

NCT ID: NCT01062607

Last Updated: 2012-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2965 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-04-30

Study Completion Date

2011-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Bipolar Disorders

Study Design

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Observational Model Type

COHORT

Study Groups

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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.

No interventions assigned to this group

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 .

No interventions assigned to this group

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Esteban Medina

Role: STUDY_DIRECTOR

Medical Department.AstraZeneca Spain

Locations

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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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Countries

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Austria Belgium Brazil France Germany Portugal Romania Turkey (Türkiye) Ukraine Venezuela

References

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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.

Reference Type DERIVED
PMID: 23663490 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21481244 (View on PubMed)

Other Identifiers

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NIS-NEU-DUM-2009/1

Identifier Type: -

Identifier Source: org_study_id

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