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Logo of bmcpsycBioMed Centralsearchsubmit a manuscriptregisterthis articleBMC Psychiatry
 
BMC Psychiatry. 2011; 11: 58.
Published online Apr 11, 2011. doi:  10.1186/1471-244X-11-58
PMCID: PMC3087674
Clinical management and burden of bipolar disorder: a multinational longitudinal study (WAVE-bd Study)
Eduard Vieta,#1 Elena Blasco-Colmenares,#2 Maria Luisa Figueira,#3 Jens M Langosch,#4 Miriam Moreno-Manzanaro,#5 and Esteban Medinacorresponding author#5, WAVE-bd Study Group les.steele@fishawack.com
1Bipolar Disorders Programme, Hospital Clínic, University of Barcelona, IDIBAPS, CIBERSAM, Villarroel 170, 08036 Barcelona, Spain
2Welch Center for Prevention, Epidemiology, and Clinical Research. Johns Hopkins Bloomberg School of Public Health, 2024 E. Monument St., Baltimore, MD 21205, USA
3Psychiatric Department, Hospital Santa Maria, Faculty of Medicine, University of Lisbon, Av. Prof. Egas Moniz, 1640-035 Lisboa, Portugal
4Bethanien Hospital for Psychiatry, Psychosomatics, and Psychotherapy, Gützkower Landstraße 69, 17489 Greifswald, Germany
5Medical Department, AstraZeneca Pharmaceuticals, Serrano Galvache 56, 28033 Madrid, Spain
corresponding authorCorresponding author.
#Contributed equally.
Eduard Vieta: evieta/at/clinic.ub.es; Elena Blasco-Colmenares: eblasco/at/jhsph.edu; Maria Luisa Figueira: ml.figueira/at/hsm.min-saude.pt; Jens M Langosch: langosch/at/odebrecht-stiftung.de; Miriam Moreno-Manzanaro: Miriam.moreno-manzanaro/at/astrazeneca.com; Esteban Medina: esteban.medina/at/astrazeneca.com
Received November 25, 2010; Accepted April 11, 2011.
Abstract
Background
Studies in bipolar disorder (BD) to date are limited in their ability to provide a whole-disease perspective - their scope has generally been confined to a single disease phase and/or a specific treatment. Moreover, most clinical trials have focused on the manic phase of disease, and not on depression, which is associated with the greatest disease burden. There are few longitudinal studies covering both types of patients with BD (I and II) and the whole course of the disease, regardless of patients' symptomatology. Therefore, the Wide AmbispectiVE study of the clinical management and burden of Bipolar Disorder (WAVE-bd) (NCT01062607) aims to provide reliable information on the management of patients with BD in daily clinical practice. It also seeks to determine factors influencing clinical outcomes and resource use in relation to the management of BD.
Methods
WAVE-bd is a multinational, multicentre, non-interventional, longitudinal study. Approximately 3000 patients diagnosed with BD type I or II with at least one mood event in the preceding 12 months were recruited at centres in Austria, Belgium, Brazil, France, Germany, Portugal, Romania, Turkey, Ukraine and Venezuela. Site selection methodology aimed to provide a balanced cross-section of patients cared for by different types of providers of medical aid (e.g. academic hospitals, private practices) in each country. Target recruitment percentages were derived either from scientific publications or from expert panels in each participating country. The minimum follow-up period will be 12 months, with a maximum of 27 months, taking into account the retrospective and the prospective parts of the study. Data on demographics, diagnosis, medical history, clinical management, clinical and functional outcomes (CGI-BP and FAST scales), adherence to treatment (DAI-10 scale and Medication Possession Ratio), quality of life (EQ-5D scale), healthcare resources, and caregiver burden (BAS scale) will be collected. Descriptive analysis with common statistics will be performed.
Discussion
This study will provide detailed descriptions of the management of BD in different countries, particularly in terms of clinical outcomes and resources used. Thus, it should provide psychiatrists with reliable and up-to-date information about those factors associated with different management patterns of BD.
Trial registration no
ClinicalTrials.gov: NCT01062607
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