Study of the Clinical Management of Bipolar Disease

Bipolar Disorders Clinical Trial

— WAVE bd  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01062607
• Other study ID #: NIS-NEU-DUM-2009/1
• Status: Completed
• Phase: N/A
• First received: January 27, 2010
• Last updated: May 22, 2012
• Start date: April 2010
• Est. completion date: June 2011

Study information

• Verified date: May 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: EthikkommissionBelgium: Institutional Review BoardFrance: French Data Protection AuthorityFrance: Institutional Ethical CommitteeTurkey: Ministry of HealthGermany: Ethics CommissionPortugal: Ethics Committee for Clinical ResearchSpain: Ethics CommitteeBrazil: Ethics CommitteeBrazil: National Committee of Ethics in ResearchVenezuela: Ethics CommitteeRomania: Ministry of Public HealthUkraine: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2965
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Bipolar Disorder
• Bipolar Disorders

Locations

Country	Name	City	State
Austria	Research Site	Salzburg
Austria	Research Site	Villach
Austria	Research Site	Vocklabruck
Austria	Research Site	Wien
Austria	Research Site	Wr. Neustadt
Belgium	Research Site	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
Brazil	Research Site	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
France	Research Site	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	Paris
France	Research Site	PAU
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
Germany	Research Site	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
Portugal	Research Site	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
Romania	Research Site	Bucuresti
Romania	Research Site	Cluj
Romania	Research Site	Craiova
Romania	Research Site	Iasi
Turkey	Research Site	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
Ukraine	Research Site	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
Venezuela	Research Site	Caracas
Venezuela	Research Site	Merida
Venezuela	Research Site	Miranda
Venezuela	Research Site	San Cristobal

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Austria,  Belgium,  Brazil,  France,  Germany,  Portugal,  Romania,  Turkey,  Ukraine,  Venezuela, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Demographic variables		Once during study	No
Primary	1-year prevalence for each disease phase		everytime the patient attends the consult	No
Secondary	Use of resources		everytime the patient attends the consult	No
Secondary	treatments prescribed, EQ5D		everytime the patient attends the consult	No
Secondary	treatments prescribed, FAST		everytime the patient attends the consult	No
Secondary	treatments prescribed, DAI-10		everytime the patient attends the consult	No
Secondary	treatments prescribed, MPR		everytime the patient attends the consult	No
Secondary	treatments prescribed, BAS		Once during the prospective part (only if patient attends with a caregiver)	No