Abstract
BackgroundStudies 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.MethodsWAVE-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.DiscussionThis 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 noClinicalTrials.gov: NCT01062607
Highlights
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
Bipolar disorder (BD) is not just a single disorder, but a category of lifelong mood disorders characterised by the presence of one or more recurrent manic, hypomanic and depressive episodes
Study design The WAVE-bd study (NCT01062607) is a multinational, multicentre, observational, longitudinal or cohort study of patients diagnosed with BD type I or II with at least one mood event in the 12 months prior to the study start (Time 0, Figure 1)
Summary
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. Most clinical trials have focused on the manic phase of disease, and not on depression, which is associated with the greatest disease burden. 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. Estimates for lifetime prevalence of any type of BD range from 0.5% to 5%. The lifetime prevalence rate of mania (BD type I) appears to be very similar across studies, with estimates ranging from 0.1-0.2% to 1.8%. There is reasonably consistent evidence that BD-I and BD-II disorders, diagnosed according to criteria in the fourth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) [1], have an estimated 1-year prevalence of approximately 1%, with no major differences by age group and gender [3]
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