WAVE bd: Study of the Clinical Management of Bipolar Disease
Sponsor
AstraZeneca (Industry)
Overall Status
Completed
CT.gov ID
NCT01062607
Collaborator
(none)
2,965
213
14
13.9
1
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
2965 participants
Observational Model:
Cohort
Official Title:
Multinational Ambispective Study of the Clinical Management and Burden of Bipolar Disorder (WAVE bd Study)
Study Start Date
:
Apr 1, 2010
Actual Primary Completion Date
:
Jun 1, 2011
Actual Study Completion Date
:
Jun 1, 2011
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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 . |
Outcome Measures
Primary Outcome Measures
- Demographic variables [Once during study]
- 1-year prevalence for each disease phase [everytime the patient attends the consult]
Secondary Outcome Measures
- Use of resources [everytime the patient attends the consult]
- treatments prescribed, EQ5D [everytime the patient attends the consult]
- treatments prescribed, FAST [everytime the patient attends the consult]
- treatments prescribed, DAI-10 [everytime the patient attends the consult]
- treatments prescribed, MPR [everytime the patient attends the consult]
- treatments prescribed, BAS [Once during the prospective part (only if patient attends with a caregiver)]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Research Site | Salzburg | Austria | ||
| 2 | Research Site | Villach | Austria | ||
| 3 | Research Site | Vocklabruck | Austria | ||
| 4 | Research Site | Wien | Austria | ||
| 5 | Research Site | Wr. Neustadt | Austria | ||
| 6 | Research Site | Asse | Belgium | ||
| 7 | Research Site | Begijnendijk | Belgium | ||
| 8 | Research Site | Berchem | Belgium | ||
| 9 | Research Site | Bredene | Belgium | ||
| 10 | Research Site | Brugge | Belgium | ||
| 11 | Research Site | Bruxelles | Belgium | ||
| 12 | Research Site | Elsene | Belgium | ||
| 13 | Research Site | Herstal | Belgium | ||
| 14 | Research Site | Houtvenne | Belgium | ||
| 15 | Research Site | Jette | Belgium | ||
| 16 | Research Site | Keumiee | Belgium | ||
| 17 | Research Site | Kontich | Belgium | ||
| 18 | Research Site | Kuringen | Belgium | ||
| 19 | Research Site | Lebbeke | Belgium | ||
| 20 | Research Site | Lede | Belgium | ||
| 21 | Research Site | Lembeke | Belgium | ||
| 22 | Research Site | Leuven | Belgium | ||
| 23 | Research Site | Liege | Belgium | ||
| 24 | Research Site | Lubbeek | Belgium | ||
| 25 | Research Site | Maldegem | Belgium | ||
| 26 | Research Site | Mechelen | Belgium | ||
| 27 | Research Site | Mol | Belgium | ||
| 28 | Research Site | Monceau-Sur-Sambre | Belgium | ||
| 29 | Research Site | Montignies-Sur-Sambre | Belgium | ||
| 30 | Research Site | Moorsel | Belgium | ||
| 31 | Research Site | Namur | Belgium | ||
| 32 | Research Site | Oosteeklo | Belgium | ||
| 33 | Research Site | Oostrozebeke | Belgium | ||
| 34 | Research Site | Ottignies | Belgium | ||
| 35 | Research Site | Pittem | Belgium | ||
| 36 | Research Site | Ransart | Belgium | ||
| 37 | Research Site | Roeselare | Belgium | ||
| 38 | Research Site | Roux | Belgium | ||
| 39 | Research Site | Saint-Servais | Belgium | ||
| 40 | Research Site | Sint-Denijs-Westrem | Belgium | ||
| 41 | Research Site | Sint-Kruis | Belgium | ||
| 42 | Research Site | Sint-Martens-Latem | Belgium | ||
| 43 | Research Site | Sint-Niklaas | Belgium | ||
| 44 | Research Site | Sint-Truiden | Belgium | ||
| 45 | Research Site | Spouwen | Belgium | ||
| 46 | Research Site | Tienen | Belgium | ||
| 47 | Research Site | Tournai | Belgium | ||
| 48 | Research Site | Veurne | Belgium | ||
| 49 | Research Site | Wezembeek-oppem | Belgium | ||
| 50 | Research Site | Willebroek | Belgium | ||
| 51 | Research Site | Wilrijk | Belgium | ||
| 52 | Research Site | Zeebrugge | Belgium | ||
| 53 | Research Site | Zoersel | Belgium | ||
| 54 | Research Site | Zomergem | Belgium | ||
| 55 | Research Site | Aparecida de Goiania | Brazil | ||
| 56 | Research Site | Belo Horizonte | Brazil | ||
| 57 | Research Site | Botucatu | Brazil | ||
| 58 | Research Site | Campinas | Brazil | ||
| 59 | Research Site | Fortaleza | Brazil | ||
| 60 | Research Site | Goiania | Brazil | ||
| 61 | Research Site | Itapira | Brazil | ||
| 62 | Research Site | Rio de Janeiro | Brazil | ||
| 63 | Research Site | Salvador | Brazil | ||
| 64 | Research Site | Santo Andre | Brazil | ||
| 65 | Research Site | Sao Bernardo | Brazil | ||
| 66 | Research Site | Sao Jose | Brazil | ||
| 67 | Research Site | Sao Paulo | Brazil | ||
| 68 | Research Site | Ajaccio | France | ||
| 69 | Research Site | Albi | France | ||
| 70 | Research Site | Alencon Cedex | France | ||
| 71 | Research Site | Amiens | France | ||
| 72 | Research Site | Appoigny | France | ||
| 73 | Research Site | Armentieres | France | ||
| 74 | Research Site | Aulnay Sous Bois | France | ||
| 75 | Research Site | Bar Le Duc | France | ||
| 76 | Research Site | Belfort | France | ||
| 77 | Research Site | Bergerac | France | ||
| 78 | Research Site | Besancon | France | ||
| 79 | Research Site | Blois | France | ||
| 80 | Research Site | Bordeaux | France | ||
| 81 | Research Site | Bourg En Bresse | France | ||
| 82 | Research Site | Bourges | France | ||
| 83 | Research Site | Brest | France | ||
| 84 | Research Site | Caen Cedex 1 | France | ||
| 85 | Research Site | Castries | France | ||
| 86 | Research Site | Clermmont Ferrand | France | ||
| 87 | Research Site | Creteil Cedex | France | ||
| 88 | Research Site | Dijon | France | ||
| 89 | Research Site | Douai | France | ||
| 90 | Research Site | Elancourt | France | ||
| 91 | Research Site | Esquerchin | France | ||
| 92 | Research Site | Fains Veel | France | ||
| 93 | Research Site | Frejus Cedex | France | ||
| 94 | Research Site | GAP | France | ||
| 95 | Research Site | Grenoble | France | ||
| 96 | Research Site | Hauteville Lompnes | France | ||
| 97 | Research Site | Hyeres | France | ||
| 98 | Research Site | Jarnac | France | ||
| 99 | Research Site | La Charite Sur Loire | France | ||
| 100 | Research Site | La Roche Sur Foron | France | ||
| 101 | Research Site | La Rochelle | France | ||
| 102 | Research Site | Lavaur | France | ||
| 103 | Research Site | Le Cannet | France | ||
| 104 | Research Site | Le Havre | France | ||
| 105 | Research Site | Le Puy En Velay | France | ||
| 106 | Research Site | Le Vesinet | France | ||
| 107 | Research Site | Libourne | France | ||
| 108 | Research Site | Lorient | France | ||
| 109 | Research Site | Marseille | France | ||
| 110 | Research Site | Mayenne Cedex | France | ||
| 111 | Research Site | Metz | France | ||
| 112 | Research Site | Mont de Marsan | France | ||
| 113 | Research Site | Montberon | France | ||
| 114 | Research Site | Montpellier | France | ||
| 115 | Research Site | Montreuil | France | ||
| 116 | Research Site | Mulhouse | France | ||
| 117 | Research Site | Nancy | France | ||
| 118 | Research Site | Nanterre | France | ||
| 119 | Research Site | Nantes | France | ||
| 120 | Research Site | Neuilly Sur Marne | France | ||
| 121 | Research Site | Nice | France | ||
| 122 | Research Site | Orsay | France | ||
| 123 | Research Site | Paris | France | ||
| 124 | Research Site | PAU | France | ||
| 125 | Research Site | Reims | France | ||
| 126 | Research Site | Rennes | France | ||
| 127 | Research Site | Rodez | France | ||
| 128 | Research Site | Sartrouville | France | ||
| 129 | Research Site | St Avertin | France | ||
| 130 | Research Site | St Brieuc | France | ||
| 131 | Research Site | St Dizier | France | ||
| 132 | Research Site | St Gratien | France | ||
| 133 | Research Site | St Herblain | France | ||
| 134 | Research Site | St Nazaire | France | ||
| 135 | Research Site | St Pol Sur Ternoise | France | ||
| 136 | Research Site | St Quentin | France | ||
| 137 | Research Site | Strasbourg | France | ||
| 138 | Research Site | Thionville Cedex | France | ||
| 139 | Research Site | Thuir Cedex | France | ||
| 140 | Research Site | Toulouse | France | ||
| 141 | Research Site | Tours | France | ||
| 142 | Research Site | Vendome | France | ||
| 143 | Research Site | Versailles | France | ||
| 144 | Research Site | Wattignies | France | ||
| 145 | Research Site | Berlin | Germany | ||
| 146 | Research Site | Cham | Germany | ||
| 147 | Research Site | Dillingen | Germany | ||
| 148 | Research Site | Ettlingen | Germany | ||
| 149 | Research Site | Greifswald | Germany | ||
| 150 | Research Site | Grunstadt | Germany | ||
| 151 | Research Site | Hildesheim | Germany | ||
| 152 | Research Site | Karlstadt | Germany | ||
| 153 | Research Site | Kiel | Germany | ||
| 154 | Research Site | Luneburg | Germany | ||
| 155 | Research Site | Munchen | Germany | ||
| 156 | Research Site | Regensburg | Germany | ||
| 157 | Research Site | Stralsund | Germany | ||
| 158 | Research Site | Werneck | Germany | ||
| 159 | Research Site | Westerstede | Germany | ||
| 160 | Research Site | Angra do Heroismo | Portugal | ||
| 161 | Research Site | Aveiro | Portugal | ||
| 162 | Research Site | Braga | Portugal | ||
| 163 | Research Site | Carnaxide | Portugal | ||
| 164 | Research Site | Coimbra | Portugal | ||
| 165 | Research Site | Faro | Portugal | ||
| 166 | Research Site | Lisboa | Portugal | ||
| 167 | Research Site | Portimao | Portugal | ||
| 168 | Research Site | Porto | Portugal | ||
| 169 | Research Site | Setubal | Portugal | ||
| 170 | Research Site | Tomar | Portugal | ||
| 171 | Research Site | Bucuresti | Romania | ||
| 172 | Research Site | Cluj | Romania | ||
| 173 | Research Site | Craiova | Romania | ||
| 174 | Research Site | Iasi | Romania | ||
| 175 | Research Site | Ankara | Turkey | ||
| 176 | Research Site | Antalya | Turkey | ||
| 177 | Research Site | Aydin | Turkey | ||
| 178 | Research Site | Basoglu | Turkey | ||
| 179 | Research Site | Bolu | Turkey | ||
| 180 | Research Site | Bursa | Turkey | ||
| 181 | Research Site | Cankiri | Turkey | ||
| 182 | Research Site | D.bakir | Turkey | ||
| 183 | Research Site | Denizli | Turkey | ||
| 184 | Research Site | Diyarbakir | Turkey | ||
| 185 | Research Site | Elazig | Turkey | ||
| 186 | Research Site | Eskisehir | Turkey | ||
| 187 | Research Site | Hatay | Turkey | ||
| 188 | Research Site | Istanbul | Turkey | ||
| 189 | Research Site | Izmir | Turkey | ||
| 190 | Research Site | Kocaeli | Turkey | ||
| 191 | Research Site | Manisa | Turkey | ||
| 192 | Research Site | S.urfa | Turkey | ||
| 193 | Research Site | Samsun | Turkey | ||
| 194 | Research Site | Sanliurfa | Turkey | ||
| 195 | Research Site | Sivas | Turkey | ||
| 196 | Research Site | Tahsin | Turkey | ||
| 197 | Research Site | Tugay | Turkey | ||
| 198 | Research Site | Zonguldak | Turkey | ||
| 199 | Research Site | Dnipropetrovsk | Ukraine | ||
| 200 | Research Site | Donetsk | Ukraine | ||
| 201 | Research Site | Ivano-Frankivsk | Ukraine | ||
| 202 | Research Site | Kharkiv | Ukraine | ||
| 203 | Research Site | Kiev | Ukraine | ||
| 204 | Research Site | Lugansk | Ukraine | ||
| 205 | Research Site | Lviv | Ukraine | ||
| 206 | Research Site | Odessa | Ukraine | ||
| 207 | Research Site | Simferopol | Ukraine | ||
| 208 | Research Site | Vinnitsa | Ukraine | ||
| 209 | Research Site | Zaporizhzhya | Ukraine | ||
| 210 | Research Site | Caracas | Venezuela | ||
| 211 | Research Site | Merida | Venezuela | ||
| 212 | Research Site | Miranda | Venezuela | ||
| 213 | Research Site | San Cristobal | Venezuela |
Sponsors and Collaborators
- AstraZeneca
Investigators
- Study Director: Esteban Medina, Medical Department.AstraZeneca Spain
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01062607
Other Study ID Numbers:
- NIS-NEU-DUM-2009/1
First Posted:
Feb 4, 2010
Last Update Posted:
May 23, 2012
Last Verified:
May 1, 2012
Keywords provided by AstraZeneca
Additional relevant MeSH terms: