Bipolar DisordersWAVE bdNCT01062607

Study of the Clinical Management of Bipolar Disease

An observational study of Bipolar Disorders, run by AstraZeneca at 213 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Bipolar Disorders
Type of treatment: Injection or infusion
How many people: 2,965 participants
Where: 213 sitesin 10 countries
Study dates: Apr 2010to Jun 2011
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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

Who may be able to join

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

Who cannot join

Patients who had the index mood event during the 3 months before the beginning of the study (Time 0).

Trial locations and contacts

213 sites in 10 countries.

Country

City, postcode or hospital

213 sites in 10 countries

France77 sites

Research Site
Ajaccio
Research Site
Albi
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Alençon
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Amiens
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Appoigny
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Armentières
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Aulnay-sous-Bois
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Bar-le-Duc
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Belfort
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Bergerac
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Besançon
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Blois
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Bordeaux
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Bourg-en-Bresse
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Bourges
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Brest
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Caen
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Castries
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Clermmont Ferrand
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Créteil
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Dijon
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Douai
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Élancourt
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Esquerchin
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Fains-Véel
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Fréjus
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Gap
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Grenoble
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Hauteville-Lompnes
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Hyères
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Jarnac
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La Charité-sur-Loire
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La Roche-sur-Foron
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La Rochelle
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Lavaur
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Le Cannet
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Le Havre
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Le Puy-en-Velay
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Le Vésinet
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Libourne
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Lorient
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Marseille
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Mayenne
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Metz
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Mont-de-Marsan
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Montberon
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Montpellier
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Montreuil
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Mulhouse
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Nancy
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Nanterre
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Nantes
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Neuilly-sur-Marne
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Nice
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Orsay
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Paris
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Pau
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Reims
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Rennes
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Rodez
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Saint-Avertin
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Saint-Brieuc
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Saint-Dizier
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Saint-Gratien
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Saint-Herblain
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Saint-Nazaire
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Saint-Pol-sur-Ternoise
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Saint-Quentin
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Sartrouville
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Strasbourg
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Thionville
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Thuir
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Toulouse
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Tours
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Vendôme
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Versailles
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Wattignies

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Belgium49 sites

Research Site
Asse
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Begijnendijk
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Berchem
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Bredene
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Bruges
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Brussels
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Herstal
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Houtvenne
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Ixelles-Elsene
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Jette
Research Site
Keumiée
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Kontich
Research Site
Kuringen
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Lebbeke
Research Site
Lede
Research Site
Lembeke
Research Site
Leuven
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Liège
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Lubbeek
Research Site
Maldegem
Research Site
Mechelen
Research Site
Mol
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Monceau-sur-Sambre
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Montignies-sur-Sambre
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Moorsel
Research Site
Namur
Research Site
Oosteeklo
Research Site
Oostrozebeke
Research Site
Ottignies
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Pittem
Research Site
Ransart
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Roeselare
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Roux
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Saint-Servais
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Sint-Denijs-Westrem
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Sint-Kruis
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Sint-Martens-Latem
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Sint-Niklaas
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Sint-Truiden
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Spouwen
Research Site
Tienen
Research Site
Tournai
Research Site
Veurne
Research Site
Wezembeek-Oppem
Research Site
Willebroek
Research Site
Wilrijk
Research Site
Zeebrugge
Research Site
Zoersel
Research Site
Zomergem

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Turkey (Türkiye)24 sites

Research Site
Ankara
Research Site
Antalya
Research Site
Aydin
Research Site
Başoğlu
Research Site
Bolu
Research Site
Bursa
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Çankırı
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D.bakir
Research Site
Denizli
Research Site
Diyarbakır
Research Site
Elâzığ
Research Site
Eskişehir
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Hatay
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Istanbul
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Izmir
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Kocaeli
Research Site
Manisa
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S.urfa
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Samsun
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Sanliurfa
Research Site
Sivas
Research Site
Tugay
Research Site
Yağlıca
Research Site
Zonguldak

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Germany15 sites

Research Site
Berlin
Research Site
Cham
Research Site
Dillingen
Research Site
Ettlingen
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Greifswald
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Grünstadt
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Hildesheim
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Karlstadt am Main
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Kiel
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Lüneburg
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München
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Regensburg
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Stralsund
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Werneck
Research Site
Westerstede

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Brazil13 sites

Research Site
Aparecida de Goiânia
Research Site
Belo Horizonte
Research Site
Botucatu
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Campinas
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Fortaleza
Research Site
Goiânia
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Itapira
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Rio de Janeiro
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Salvador
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Santo André
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São Bernardo
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São José
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São Paulo

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Portugal11 sites

Research Site
Angra do Heroísmo
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Aveiro
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Braga
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Carnaxide
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Coimbra
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Faro
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Lisbon
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Portimão
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Porto
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Setúbal
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Tomar

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Ukraine11 sites

Research Site
Dnipropetrovsk
Research Site
Donetsk
Research Site
Ivano-Frankivsk
Research Site
Kharkiv
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Kiev
Research Site
Luhansk
Research Site
Lviv
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Odesa
Research Site
Simferopol
Research Site
Vinnitsa
Research Site
Zaporizhzhya

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Austria5 sites

Research Site
Salzburg
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Vienna
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Villach
Research Site
Vöcklabruck
Research Site
Wiener Neustadt

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Romania4 sites

Research Site
Bucharest
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Cluj-Napoca
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Craiova
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Iași

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Venezuela4 sites

Research Site
Caracas
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Mérida
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Miranda
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San Cristóbal

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About this study

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

Conditions: Bipolar Disorders
Keywords: bipolar disorders, everyday setting, treatment adherence, global
Medical subject headings: Bipolar Disorder, Treatment Adherence and Compliance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01062607
Study group	Role	What they receive
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 being measured

The primary outcome is the main question the study is designed to answer.

Demographic variables
Measured: Once during study
1-year prevalence for each disease phase
Measured: everytime the patient attends the consult

Secondary outcomes (6)

Use of resources
Measured: everytime the patient attends the consult
treatments prescribed, EQ5D
Measured: everytime the patient attends the consult
treatments prescribed, FAST
Measured: everytime the patient attends the consult
treatments prescribed, DAI-10
Measured: everytime the patient attends the consult
treatments prescribed, MPR
Measured: everytime the patient attends the consult
treatments prescribed, BAS
Measured: Once during the prospective part (only if patient attends with a caregiver)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2010Jun 2011

First posted4 Feb 2010 (estimated)
Study startApr 2010
Primary completionJun 2011
Study completionJun 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Bipolar DisordersStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Enrolment: 2,965 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01062607
Sponsor's protocol ID: NIS-NEU-DUM-2009/1
Acronym: WAVE bd
Status last verified: May 2012
First submitted: 27 Jan 2010
Last updated: 23 May 2012
Results posted: No
Data monitoring committee: No

Publications

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.
PubMed 23663490
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.
PubMed 21481244

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Recruiting
Safety and Feasibility of DBS for Bipolar Depression
Bipolar I Disorder, Bipolar Depression
Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
PARKINSON DISEASE (Disorder), Bipolar 1 Disorder
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Recruiting
Affective Cognitive Training in Mood Disorders and High-risk Relatives
Major Depressive Disorder (MDD), Bipolar Disorder (BD)

All Bipolar Disorders trials

Study at a glance

From the registry record, last updated by the sponsor on 23 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multinational Ambispective Study of the Clinical Management and Burden of Bipolar Disorder (WAVE bd Study)
ClinicalTrials.gov ID: NCT01062607
Acronym / sponsor ID: WAVE bd / NIS-NEU-DUM-2009/1
Conditions: Bipolar Disorders
Keywords: bipolar disorders, everyday setting, treatment adherence, global
Study type: Observational
Recruitment status: Completed
Enrolment: 2,965 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Apr 2010
Primary completion: Jun 2011 (actual)
Study completion: Jun 2011 (actual)
First posted: 4 Feb 2010 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Number of arms: 2

Arm	Type	Receives
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 .

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Bipolar patients seen in mental health centers, clinics, private settings, hospitals or specialized units

Key inclusion criteria (2 listed)

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

Key exclusion criteria (1 listed)

Patients who had the index mood event during the 3 months before the beginning of the study (Time 0).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Demographic variables
Time frame: Once during study
1-year prevalence for each disease phase
Time frame: everytime the patient attends the consult

6 secondary outcomes

Use of resources
Time frame: everytime the patient attends the consult
treatments prescribed, EQ5D
Time frame: everytime the patient attends the consult
treatments prescribed, FAST
Time frame: everytime the patient attends the consult
treatments prescribed, DAI-10
Time frame: everytime the patient attends the consult
treatments prescribed, MPR
Time frame: everytime the patient attends the consult
treatments prescribed, BAS
Time frame: Once during the prospective part (only if patient attends with a caregiver)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2012.
Derived from this study: PubMed 23663490Vieta 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.
Derived from this study: PubMed 21481244Vieta 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.

Related trials for Bipolar Disorders

Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Recruiting
Safety and Feasibility of DBS for Bipolar Depression
Bipolar I Disorder, Bipolar Depression
Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
PARKINSON DISEASE (Disorder), Bipolar 1 Disorder
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Recruiting
Affective Cognitive Training in Mood Disorders and High-risk Relatives
Major Depressive Disorder (MDD), Bipolar Disorder (BD)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Esteban Medina study director

Medical Department.AstraZeneca Spain

213 sites in 10 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Bipolar Disorders, run by AstraZeneca at 213 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 May 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 213 sites in France, Belgium, Turkey (Türkiye), Germany, Brazil and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Demographic variables (time frame: Once during study). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01062607, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2012.