Clinical trial NCT01062607: Study of the Clinical Management of Bipolar Disease
Official title: Multinational Ambispective Study of the Clinical Management and Burden of Bipolar Disorder (WAVE bd Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bipolar Disorders
Keywords: bipolar disorders
everyday setting
treatment adherence
global
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-02-04
Enrollment: 2965
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: PROBABILITY_SAMPLE
Study population: Bipolar patients seen in mental health centers, clinics, private settings, hospitals or specialized units

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Demographic variables
timeFrame: Once during study
measure: 1-year prevalence for each disease phase
timeFrame: everytime the patient attends the consult
Secondary outcomes:
measure: Use of resources
timeFrame: everytime the patient attends the consult
measure: treatments prescribed, EQ5D
timeFrame: everytime the patient attends the consult
measure: treatments prescribed, FAST
timeFrame: everytime the patient attends the consult
measure: treatments prescribed, DAI-10
timeFrame: everytime the patient attends the consult
measure: treatments prescribed, MPR
timeFrame: everytime the patient attends the consult
measure: treatments prescribed, BAS
timeFrame: Once during the prospective part (only if patient attends with a caregiver)
Other outcomes:
Locations:
city: Salzburg
country: Austria
facility: Research Site
city: Villach
country: Austria
facility: Research Site
city: Vocklabruck
country: Austria
facility: Research Site
city: Wien
country: Austria
facility: Research Site
city: Wr. Neustadt
country: Austria
facility: Research Site
city: Asse
country: Belgium
facility: Research Site
city: Begijnendijk
country: Belgium
facility: Research Site
city: Berchem
country: Belgium
facility: Research Site
city: Bredene
country: Belgium
facility: Research Site
city: Brugge
country: Belgium
facility: Research Site
city: Bruxelles
country: Belgium
facility: Research Site
city: Elsene
country: Belgium
facility: Research Site
city: Herstal
country: Belgium
facility: Research Site
city: Houtvenne
country: Belgium
facility: Research Site
city: Jette
country: Belgium
facility: Research Site
city: Keumiee
country: Belgium
facility: Research Site
city: Kontich
country: Belgium
facility: Research Site
city: Kuringen
country: Belgium
facility: Research Site
city: Lebbeke
country: Belgium
facility: Research Site
city: Lede
country: Belgium
facility: Research Site
city: Lembeke
country: Belgium
facility: Research Site
city: Leuven
country: Belgium
facility: Research Site
city: Liege
country: Belgium
facility: Research Site
city: Lubbeek
country: Belgium
facility: Research Site
city: Maldegem
country: Belgium
facility: Research Site
city: Mechelen
country: Belgium
facility: Research Site
city: Mol
country: Belgium
facility: Research Site
city: Monceau-Sur-Sambre
country: Belgium
facility: Research Site
city: Montignies-Sur-Sambre
country: Belgium
facility: Research Site
city: Moorsel
country: Belgium
facility: Research Site
city: Namur
country: Belgium
facility: Research Site
city: Oosteeklo
country: Belgium
facility: Research Site
city: Oostrozebeke
country: Belgium
facility: Research Site
city: Ottignies
country: Belgium
facility: Research Site
city: Pittem
country: Belgium
facility: Research Site
city: Ransart
country: Belgium
facility: Research Site
city: Roeselare
country: Belgium
facility: Research Site
city: Roux
country: Belgium
facility: Research Site
city: Saint-Servais
country: Belgium
facility: Research Site
city: Sint-Denijs-Westrem
country: Belgium
facility: Research Site
city: Sint-Kruis
country: Belgium
facility: Research Site
city: Sint-Martens-Latem
country: Belgium
facility: Research Site
city: Sint-Niklaas
country: Belgium
facility: Research Site
city: Sint-Truiden
country: Belgium
facility: Research Site
city: Spouwen
country: Belgium
facility: Research Site
city: Tienen
country: Belgium
facility: Research Site
city: Tournai
country: Belgium
facility: Research Site
city: Veurne
country: Belgium
facility: Research Site
city: Wezembeek-oppem
country: Belgium
facility: Research Site
city: Willebroek
country: Belgium
facility: Research Site
city: Wilrijk
country: Belgium
facility: Research Site
city: Zeebrugge
country: Belgium
facility: Research Site
city: Zoersel
country: Belgium
facility: Research Site
city: Zomergem
country: Belgium
facility: Research Site
city: Aparecida de Goiania
country: Brazil
facility: Research Site
city: Belo Horizonte
country: Brazil
facility: Research Site
city: Botucatu
country: Brazil
facility: Research Site
city: Campinas
country: Brazil
facility: Research Site
city: Fortaleza
country: Brazil
facility: Research Site
city: Goiania
country: Brazil
facility: Research Site
city: Itapira
country: Brazil
facility: Research Site
city: Rio de Janeiro
country: Brazil
facility: Research Site
city: Salvador
country: Brazil
facility: Research Site
city: Santo Andre
country: Brazil
facility: Research Site
city: Sao Bernardo
country: Brazil
facility: Research Site
city: Sao Jose
country: Brazil
facility: Research Site
city: Sao Paulo
country: Brazil
facility: Research Site
city: Ajaccio
country: France
facility: Research Site
city: Albi
country: France
facility: Research Site
city: Alencon Cedex
country: France
facility: Research Site
city: Amiens
country: France
facility: Research Site
city: Appoigny
country: France
facility: Research Site
city: Armentieres
country: France
facility: Research Site
city: Aulnay Sous Bois
country: France
facility: Research Site
city: Bar Le Duc
country: France
facility: Research Site
city: Belfort
country: France
facility: Research Site
city: Bergerac
country: France
facility: Research Site
city: Besancon
country: France
facility: Research Site
city: Blois
country: France
facility: Research Site
city: Bordeaux
country: France
facility: Research Site
city: Bourg En Bresse
country: France
facility: Research Site
city: Bourges
country: France
facility: Research Site
city: Brest
country: France
facility: Research Site
city: Caen Cedex 1
country: France
facility: Research Site
city: Castries
country: France
facility: Research Site
city: Clermmont Ferrand
country: France
facility: Research Site
city: Creteil Cedex
country: France
facility: Research Site
city: Dijon
country: France
facility: Research Site
city: Douai
country: France
facility: Research Site
city: Elancourt
country: France
facility: Research Site
city: Esquerchin
country: France
facility: Research Site
city: Fains Veel
country: France
facility: Research Site
city: Frejus Cedex
country: France
facility: Research Site
city: GAP
country: France
facility: Research Site
city: Grenoble
country: France
facility: Research Site
city: Hauteville Lompnes
country: France
facility: Research Site
city: Hyeres
country: France
facility: Research Site
city: Jarnac
country: France
facility: Research Site
city: La Charite Sur Loire
country: France
facility: Research Site
city: La Roche Sur Foron
country: France
facility: Research Site
city: La Rochelle
country: France
facility: Research Site
city: Lavaur
country: France
facility: Research Site
city: Le Cannet
country: France
facility: Research Site
city: Le Havre
country: France
facility: Research Site
city: Le Puy En Velay
country: France
facility: Research Site
city: Le Vesinet
country: France
facility: Research Site
city: Libourne
country: France
facility: Research Site
city: Lorient
country: France
facility: Research Site
city: Marseille
country: France
facility: Research Site
city: Mayenne Cedex
country: France
facility: Research Site
city: Metz
country: France
facility: Research Site
city: Mont de Marsan
country: France
facility: Research Site
city: Montberon
country: France
facility: Research Site
city: Montpellier
country: France
facility: Research Site
city: Montreuil
country: France
facility: Research Site
city: Mulhouse
country: France
facility: Research Site
city: Nancy
country: France
facility: Research Site
city: Nanterre
country: France
facility: Research Site
city: Nantes
country: France
facility: Research Site
city: Neuilly Sur Marne
country: France
facility: Research Site
city: Nice
country: France
facility: Research Site
city: Orsay
country: France
facility: Research Site
city: Paris
country: France
facility: Research Site
city: PAU
country: France
facility: Research Site
city: Reims
country: France
facility: Research Site
city: Rennes
country: France
facility: Research Site
city: Rodez
country: France
facility: Research Site
city: Sartrouville
country: France
facility: Research Site
city: St Avertin
country: France
facility: Research Site
city: St Brieuc
country: France
facility: Research Site
city: St Dizier
country: France
facility: Research Site
city: St Gratien
country: France
facility: Research Site
city: St Herblain
country: France
facility: Research Site
city: St Nazaire
country: France
facility: Research Site
city: St Pol Sur Ternoise
country: France
facility: Research Site
city: St Quentin
country: France
facility: Research Site
city: Strasbourg
country: France
facility: Research Site
city: Thionville Cedex
country: France
facility: Research Site
city: Thuir Cedex
country: France
facility: Research Site
city: Toulouse
country: France
facility: Research Site
city: Tours
country: France
facility: Research Site
city: Vendome
country: France
facility: Research Site
city: Versailles
country: France
facility: Research Site
city: Wattignies
country: France
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Cham
country: Germany
facility: Research Site
city: Dillingen
country: Germany
facility: Research Site
city: Ettlingen
country: Germany
facility: Research Site
city: Greifswald
country: Germany
facility: Research Site
city: Grunstadt
country: Germany
facility: Research Site
city: Hildesheim
country: Germany
facility: Research Site
city: Karlstadt
country: Germany
facility: Research Site
city: Kiel
country: Germany
facility: Research Site
city: Luneburg
country: Germany
facility: Research Site
city: Munchen
country: Germany
facility: Research Site
city: Regensburg
country: Germany
facility: Research Site
city: Stralsund
country: Germany
facility: Research Site
city: Werneck
country: Germany
facility: Research Site
city: Westerstede
country: Germany
facility: Research Site
city: Angra do Heroismo
country: Portugal
facility: Research Site
city: Aveiro
country: Portugal
facility: Research Site
city: Braga
country: Portugal
facility: Research Site
city: Carnaxide
country: Portugal
facility: Research Site
city: Coimbra
country: Portugal
facility: Research Site
city: Faro
country: Portugal
facility: Research Site
city: Lisboa
country: Portugal
facility: Research Site
city: Portimao
country: Portugal
facility: Research Site
city: Porto
country: Portugal
facility: Research Site
city: Setubal
country: Portugal
facility: Research Site
city: Tomar
country: Portugal
facility: Research Site
city: Bucuresti
country: Romania
facility: Research Site
city: Cluj
country: Romania
facility: Research Site
city: Craiova
country: Romania
facility: Research Site
city: Iasi
country: Romania
facility: Research Site
city: Ankara
country: Turkey
facility: Research Site
city: Antalya
country: Turkey
facility: Research Site
city: Aydin
country: Turkey
facility: Research Site
city: Basoglu
country: Turkey
facility: Research Site
city: Bolu
country: Turkey
facility: Research Site
city: Bursa
country: Turkey
facility: Research Site
city: Cankiri
country: Turkey
facility: Research Site
city: D.bakir
country: Turkey
facility: Research Site
city: Denizli
country: Turkey
facility: Research Site
city: Diyarbakir
country: Turkey
facility: Research Site
city: Elazig
country: Turkey
facility: Research Site
city: Eskisehir
country: Turkey
facility: Research Site
city: Hatay
country: Turkey
facility: Research Site
city: Istanbul
country: Turkey
facility: Research Site
city: Izmir
country: Turkey
facility: Research Site
city: Kocaeli
country: Turkey
facility: Research Site
city: Manisa
country: Turkey
facility: Research Site
city: S.urfa
country: Turkey
facility: Research Site
city: Samsun
country: Turkey
facility: Research Site
city: Sanliurfa
country: Turkey
facility: Research Site
city: Sivas
country: Turkey
facility: Research Site
city: Tahsin
country: Turkey
facility: Research Site
city: Tugay
country: Turkey
facility: Research Site
city: Zonguldak
country: Turkey
facility: Research Site
city: Dnipropetrovsk
country: Ukraine
facility: Research Site
city: Donetsk
country: Ukraine
facility: Research Site
city: Ivano-Frankivsk
country: Ukraine
facility: Research Site
city: Kharkiv
country: Ukraine
facility: Research Site
city: Kiev
country: Ukraine
facility: Research Site
city: Lugansk
country: Ukraine
facility: Research Site
city: Lviv
country: Ukraine
facility: Research Site
city: Odessa
country: Ukraine
facility: Research Site
city: Simferopol
country: Ukraine
facility: Research Site
city: Vinnitsa
country: Ukraine
facility: Research Site
city: Zaporizhzhya
country: Ukraine
facility: Research Site
city: Caracas
country: Venezuela
facility: Research Site
city: Merida
country: Venezuela
facility: Research Site
city: Miranda
country: Venezuela
facility: Research Site
city: San Cristobal
country: Venezuela
facility: Research Site
Study officials:
affiliation: Medical Department.AstraZeneca Spain
name: Esteban Medina
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.