Study of the Clinical Management of Bipolar Disease (WAVE bd)

May 22, 2012 updated by: AstraZeneca

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2965

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Salzburg, Austria
        • Research Site
      • Villach, Austria
        • Research Site
      • Vocklabruck, Austria
        • Research Site
      • Wien, Austria
        • Research Site
      • Wr. Neustadt, Austria
        • Research Site
  • Belgium
      • 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
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      • 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
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      • Lubbeek, Belgium
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      • 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
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      • Ottignies, Belgium
        • Research Site
      • Pittem, Belgium
        • Research Site
      • Ransart, Belgium
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      • Roeselare, Belgium
        • Research Site
      • Roux, Belgium
        • Research Site
      • 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
        • 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
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      • Willebroek, Belgium
        • Research Site
      • Wilrijk, Belgium
        • Research Site
      • Zeebrugge, Belgium
        • Research Site
      • Zoersel, Belgium
        • Research Site
      • Zomergem, Belgium
        • Research Site
  • Brazil
      • 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
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      • Sao Jose, Brazil
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      • Sao Paulo, Brazil
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  • France
      • Ajaccio, France
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      • 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
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      • Le Havre, France
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      • 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
      • PAU, France
        • Research Site
      • Paris, 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
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      • Thuir Cedex, France
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      • Toulouse, France
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      • Tours, France
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      • Vendome, France
        • Research Site
      • Versailles, France
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      • Wattignies, France
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  • Germany
      • Berlin, Germany
        • Research Site
      • Cham, Germany
        • Research Site
      • Dillingen, Germany
        • Research Site
      • Ettlingen, Germany
        • Research Site
      • Greifswald, Germany
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      • Grunstadt, Germany
        • Research Site
      • Hildesheim, Germany
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      • 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, Germany
        • Research Site
  • Portugal
      • 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, Portugal
        • Research Site
  • Romania
      • Bucuresti, Romania
        • Research Site
      • Cluj, Romania
        • Research Site
      • Craiova, Romania
        • Research Site
      • Iasi, Romania
        • Research Site
  • Turkey
      • 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, Turkey
        • Research Site
  • Ukraine
      • 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, Ukraine
        • Research Site
  • Venezuela
      • Caracas, Venezuela
        • Research Site
      • Merida, Venezuela
        • Research Site
      • Miranda, Venezuela
        • Research Site
      • San Cristobal, Venezuela
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Bipolar patients seen in mental health centers, clinics, private settings, hospitals or specialized units

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
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 .

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Demographic variables
Time Frame: Once during study
Once during study
1-year prevalence for each disease phase
Time Frame: everytime the patient attends the consult
everytime the patient attends the consult

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Use of resources
Time Frame: everytime the patient attends the consult
everytime the patient attends the consult
treatments prescribed, EQ5D
Time Frame: everytime the patient attends the consult
everytime the patient attends the consult
treatments prescribed, FAST
Time Frame: everytime the patient attends the consult
everytime the patient attends the consult
treatments prescribed, DAI-10
Time Frame: everytime the patient attends the consult
everytime the patient attends the consult
treatments prescribed, MPR
Time Frame: everytime the patient attends the consult
everytime the patient attends the consult
treatments prescribed, BAS
Time Frame: Once during the prospective part (only if patient attends with a caregiver)
Once during the prospective part (only if patient attends with a caregiver)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Esteban Medina, Medical Department.AstraZeneca Spain

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 27, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 3, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 4, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 23, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NIS-NEU-DUM-2009/1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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