- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00752388
Non-interventional Observational Study on WHO-5 Questionnaire Application in Parkinson's Disease
November 18, 2013 updated by: Boehringer Ingelheim
Application of the WHO-5 Well-being Index (WHO-5) as a Screening Instrument for Depression in Parkinson's Disease
To assess the predictive value of sequential administration of WHO-5 and MDI (Major Depression Inventory) for the clinical management of Parkinson Disease (PD) patients by
- determination of the prevalence of depression in PD patients, based on MDI severity categories and the self-rating scale WHO-5, where poor well being was indicated.
- exploration of influencing factors (PD status, therapeutic status) on the prevalence of MDI depression categories.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
1588
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
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Achim, Germany
- Boehringer Ingelheim Investigational Site 1
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Achim, Germany
- Boehringer Ingelheim Investigational Site 2
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Altenburg, Germany
- Boehringer Ingelheim Investigational Site
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Altenholz, Germany
- Boehringer Ingelheim Investigational Site
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Alzey, Germany
- Boehringer Ingelheim Investigational Site
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Aue, Germany
- Boehringer Ingelheim Investigational Site
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Bad Driburg, Germany
- Boehringer Ingelheim Investigational Site
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Bad Homburg, Germany
- Boehringer Ingelheim Investigational Site
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Bad Honnef, Germany
- Boehringer Ingelheim Investigational Site
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Bad Neuenahr-Ahrweiler, Germany
- Boehringer Ingelheim Investigational Site
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Bad Soden, Germany
- Boehringer Ingelheim Investigational Site 1
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Bad Soden, Germany
- Boehringer Ingelheim Investigational Site 2
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Bad Sooden-Allendorf, Germany
- Boehringer Ingelheim Investigational Site
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Bergisch Gladbach, Germany
- Boehringer Ingelheim Investigational Site
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Berlin, Germany
- Boehringer Ingelheim Investigational Site 10
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Berlin, Germany
- Boehringer Ingelheim Investigational Site 11
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Berlin, Germany
- Boehringer Ingelheim Investigational Site 14
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Berlin, Germany
- Boehringer Ingelheim Investigational Site 4
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Berlin, Germany
- Boehringer Ingelheim Investigational Site 5
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Berlin, Germany
- Boehringer Ingelheim Investigational Site 8
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Berlin, Germany
- Boehringer Ingelheim Investigational Site 9
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Berlin, Germany
- Boehringer Ingelheim Investigational Site 12
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Berlin, Germany
- Boehringer Ingelheim Investigational Site 13
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Berlin, Germany
- Boehringer Ingelheim Investigational Site 2
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Berlin, Germany
- Boehringer Ingelheim Investigational Site 3
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Berlin, Germany
- Boehringer Ingelheim Investigational Site 6
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Berlin, Germany
- Boehringer Ingelheim Investigational Site 7
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Berlin, Germany
- Boehringer Ingelheim Investigational Site 1
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Bielefeld, Germany
- Boehringer Ingelheim Investigational Site 1
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Bielefeld, Germany
- Boehringer Ingelheim Investigational Site 2
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Bochum, Germany
- Boehringer Ingelheim Investigational Site 1
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Bochum, Germany
- Boehringer Ingelheim Investigational Site 2
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Bochum, Germany
- Boehringer Ingelheim Investigational Site 3
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Bockhorn, Germany
- Boehringer Ingelheim Investigational Site
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Bonn, Germany
- Boehringer Ingelheim Investigational Site
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Braunschweig, Germany
- Boehringer Ingelheim Investigational Site
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Bremen, Germany
- Boehringer Ingelheim Investigational Site
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Bremerhaven, Germany
- Boehringer Ingelheim Investigational Site
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Bretten, Germany
- Boehringer Ingelheim Investigational Site
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Butzbach, Germany
- Boehringer Ingelheim Investigational Site 1
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Butzbach, Germany
- Boehringer Ingelheim Investigational Site 2
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Buxtehude, Germany
- Boehringer Ingelheim Investigational Site
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Castrop-Rauxel, Germany
- Boehringer Ingelheim Investigational Site
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Chemnitz, Germany
- Boehringer Ingelheim Investigational Site
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Cloppenburg, Germany
- Boehringer Ingelheim Investigational Site
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Coesfeld, Germany
- Boehringer Ingelheim Investigational Site
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Cottbus, Germany
- Boehringer Ingelheim Investigational Site 2
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Cottbus, Germany
- Boehringer Ingelheim Investigational Site 1
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Delmenhorst, Germany
- Boehringer Ingelheim Investigational Site
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Dessau, Germany
- Boehringer Ingelheim Investigational Site 1
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Dessau, Germany
- Boehringer Ingelheim Investigational Site 2
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Dietzenbach, Germany
- Boehringer Ingelheim Investigational Site
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Dippoldiswalde, Germany
- Boehringer Ingelheim Investigational Site
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Dortmund, Germany
- Boehringer Ingelheim Investigational Site 1
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Dortmund, Germany
- Boehringer Ingelheim Investigational Site 2
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Dortmund, Germany
- Boehringer Ingelheim Investigational Site 3
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Dresden, Germany
- Boehringer Ingelheim Investigational Site 1
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Dresden, Germany
- Boehringer Ingelheim Investigational Site 2
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Dresden, Germany
- Boehringer Ingelheim Investigational Site 3
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Dresden, Germany
- Boehringer Ingelheim Investigational Site 4
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Duisburg, Germany
- Boehringer Ingelheim Investigational Site 1
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Duisburg, Germany
- Boehringer Ingelheim Investigational Site 2
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Duisburg, Germany
- Boehringer Ingelheim Investigational Site 3
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Duisburg, Germany
- Boehringer Ingelheim Investigational Site 4
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Dülmen, Germany
- Boehringer Ingelheim Investigational Site
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Düsseldorf, Germany
- Boehringer Ingelheim Investigational Site 1
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Düsseldorf, Germany
- Boehringer Ingelheim Investigational Site 2
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Düsseldorf, Germany
- Boehringer Ingelheim Investigational Site 3
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Düsseldorf, Germany
- Boehringer Ingelheim Investigational Site 4
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Düsseldorf, Germany
- Boehringer Ingelheim Investigational Site 5
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Erbach, Germany
- Boehringer Ingelheim Investigational Site 1
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Erbach, Germany
- Boehringer Ingelheim Investigational Site 2
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Erftstadt, Germany
- Boehringer Ingelheim Investigational Site
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Essen, Germany
- Boehringer Ingelheim Investigational Site
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Frankfurt, Germany
- Boehringer Ingelheim Investigational Site 1
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Frankfurt, Germany
- Boehringer Ingelheim Investigational Site 2
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Freiburg, Germany
- Boehringer Ingelheim Investigational Site
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Fürstenwalde, Germany
- Boehringer Ingelheim Investigational Site
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Gelnhausen, Germany
- Boehringer Ingelheim Investigational Site
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Gelsenkirchen, Germany
- Boehringer Ingelheim Investigational Site 1
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Gelsenkirchen, Germany
- Boehringer Ingelheim Investigational Site 2
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Gengenbach, Germany
- Boehringer Ingelheim Investigational Site
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Gera, Germany
- Boehringer Ingelheim Investigational Site
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Gießen, Germany
- Boehringer Ingelheim Investigational Site
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Gifhorn, Germany
- Boehringer Ingelheim Investigational Site
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Gladenbach, Germany
- Boehringer Ingelheim Investigational Site
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Goch, Germany
- Boehringer Ingelheim Investigational Site
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Grünstadt, Germany
- Boehringer Ingelheim Investigational Site
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Göttingen, Germany
- Boehringer Ingelheim Investigational Site
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Güstrow, Germany
- Boehringer Ingelheim Investigational Site 1
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Güstrow, Germany
- Boehringer Ingelheim Investigational Site 2
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Gütersloh, Germany
- Boehringer Ingelheim Investigational Site
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Halle, Germany
- Boehringer Ingelheim Investigational Site 1
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Halle, Germany
- Boehringer Ingelheim Investigational Site 2
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Halle, Germany
- Boehringer Ingelheim Investigational Site 3
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Hamburg, Germany
- Boehringer Ingelheim Investigational Site 3
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Hamburg, Germany
- Boehringer Ingelheim Investigational Site 1
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Hamburg, Germany
- Boehringer Ingelheim Investigational Site 2
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Hamburg, Germany
- Boehringer Ingelheim Investigational Site 4
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Hamburg, Germany
- Boehringer Ingelheim Investigational Site 5
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Hameln, Germany
- Boehringer Ingelheim Investigational Site
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Hannover, Germany
- Boehringer Ingelheim Investigational Site 1
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Hannover, Germany
- Boehringer Ingelheim Investigational Site 2
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Hannover, Germany
- Boehringer Ingelheim Investigational Site 3
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Hannover, Germany
- Boehringer Ingelheim Investigational Site 4
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Heidelberg, Germany
- Boehringer Ingelheim Investigational Site 1
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Heidelberg, Germany
- Boehringer Ingelheim Investigational Site 2
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Heilbronn, Germany
- Boehringer Ingelheim Investigational Site
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Hemmoor, Germany
- Boehringer Ingelheim Investigational Site
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Hennigsdorf, Germany
- Boehringer Ingelheim Investigational Site
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Henstedt-Ulzburg, Germany
- Boehringer Ingelheim Investigational Site
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Herborn, Germany
- Boehringer Ingelheim Investigational Site
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Herzberg, Germany
- Boehringer Ingelheim Investigational Site
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Herzogenrath, Germany
- Boehringer Ingelheim Investigational Site
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Hildesheim, Germany
- Boehringer Ingelheim Investigational Site 1
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Hildesheim, Germany
- Boehringer Ingelheim Investigational Site 2
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Hildesheim, Germany
- Boehringer Ingelheim Investigational Site 3
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Hildesheim, Germany
- Boehringer Ingelheim Investigational Site 4
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Hildesheim, Germany
- Boehringer Ingelheim Investigational Site 5
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Homburg, Germany
- Boehringer Ingelheim Investigational Site
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Hückelhoven, Germany
- Boehringer Ingelheim Investigational Site
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Hürth, Germany
- Boehringer Ingelheim Investigational Site
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Ilmenau, Germany
- Boehringer Ingelheim Investigational Site 1
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Ilmenau, Germany
- Boehringer Ingelheim Investigational Site 2
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Ingelheim, Germany
- Boehringer Ingelheim Investigational Site
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Iserlohn, Germany
- Boehringer Ingelheim Investigational Site
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Itzehoe, Germany
- Boehringer Ingelheim Investigational Site
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Kamen, Germany
- Boehringer Ingelheim Investigational Site
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Kamp-Lintfort, Germany
- Boehringer Ingelheim Investigational Site
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Kandel, Germany
- Boehringer Ingelheim Investigational Site
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Karlstadt, Germany
- Boehringer Ingelheim Investigational Site
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Kassel, Germany
- Boehringer Ingelheim Investigational Site 1
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Kassel, Germany
- Boehringer Ingelheim Investigational Site 2
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Kaufbeuren, Germany
- Boehringer Ingelheim Investigational Site
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Kiel, Germany
- Boehringer Ingelheim Investigational Site
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Kleinblittersdorf, Germany
- Boehringer Ingelheim Investigational Site
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Kleve, Germany
- Boehringer Ingelheim Investigational Site
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Köln, Germany
- Boehringer Ingelheim Investigational Site 1
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Köln, Germany
- Boehringer Ingelheim Investigational Site 2
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Köln, Germany
- Boehringer Ingelheim Investigational Site 3
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Köln, Germany
- Boehringer Ingelheim Investigational Site 4
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Köln, Germany
- Boehringer Ingelheim Investigational Site 5
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Köln, Germany
- Boehringer Ingelheim Investigational Site 6
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Köln, Germany
- Boehringer Ingelheim Investigational Site 7
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Lappersdorf, Germany
- Boehringer Ingelheim Investigational Site
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Lauterbach, Germany
- Boehringer Ingelheim Investigational Site
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Leer, Germany
- Boehringer Ingelheim Investigational Site 1
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Leer, Germany
- Boehringer Ingelheim Investigational Site 2
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Leipzig, Germany
- Boehringer Ingelheim Investigational Site 1
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Leipzig, Germany
- Boehringer Ingelheim Investigational Site 2
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Leipzig, Germany
- Boehringer Ingelheim Investigational Site 3
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Leipzig, Germany
- Boehringer Ingelheim Investigational Site 4
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Leipzig, Germany
- Boehringer Ingelheim Investigational Site 5
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Leverkusen, Germany
- Boehringer Ingelheim Investigational Site 1
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Leverkusen, Germany
- Boehringer Ingelheim Investigational Site 2
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Ludwigsfelde, Germany
- Boehringer Ingelheim Investigational Site
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Ludwigshafen, Germany
- Boehringer Ingelheim Investigational Site 1
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Ludwigshafen, Germany
- Boehringer Ingelheim Investigational Site 2
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Ludwigshafen, Germany
- Boehringer Ingelheim Investigational Site 3
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Ludwigslust, Germany
- Boehringer Ingelheim Investigational Site
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Löbau, Germany
- Boehringer Ingelheim Investigational Site
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Lüdenscheid, Germany
- Boehringer Ingelheim Investigational Site 1
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Lüdenscheid, Germany
- Boehringer Ingelheim Investigational Site 2
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Lüdenscheid, Germany
- Boehringer Ingelheim Investigational Site 3
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Lüdenscheid, Germany
- Boehringer Ingelheim Investigational Site 4
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Lüdenscheid, Germany
- Boehringer Ingelheim Investigational Site 5
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Lüneburg, Germany
- Boehringer Ingelheim Investigational Site 1
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Lüneburg, Germany
- Boehringer Ingelheim Investigational Site 2
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Lünen, Germany
- Boehringer Ingelheim Investigational Site 1
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Lünen, Germany
- Boehringer Ingelheim Investigational Site 2
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Magdeburg, Germany
- Boehringer Ingelheim Investigational Site
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Malente, Germany
- Boehringer Ingelheim Investigational Site
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Mannheim, Germany
- Boehringer Ingelheim Investigational Site 1
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Mannheim, Germany
- Boehringer Ingelheim Investigational Site 2
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Mannheim, Germany
- Boehringer Ingelheim Investigational Site 3
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Mannheim, Germany
- Boehringer Ingelheim Investigational Site 4
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Markkleeberg, Germany
- Boehringer Ingelheim Investigational Site
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Marl, Germany
- Boehringer Ingelheim Investigational Site
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Memmingen, Germany
- Boehringer Ingelheim Investigational Site
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Menden, Germany
- Boehringer Ingelheim Investigational Site
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Mittweida, Germany
- Boehringer Ingelheim Investigational Site
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Mönchengladbach, Germany
- Boehringer Ingelheim Investigational Site 1
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Mönchengladbach, Germany
- Boehringer Ingelheim Investigational Site 2
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Mönchengladbach, Germany
- Boehringer Ingelheim Investigational Site 3
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Mühlacker, Germany
- Boehringer Ingelheim Investigational Site
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Mülheim, Germany
- Boehringer Ingelheim Investigational Site 1
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Mülheim, Germany
- Boehringer Ingelheim Investigational Site 2
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Mülheim, Germany
- Boehringer Ingelheim Investigational Site 3
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Münster, Germany
- Boehringer Ingelheim Investigational Site 1
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Münster, Germany
- Boehringer Ingelheim Investigational Site 2
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Münster, Germany
- Boehringer Ingelheim Investigational Site 3
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Naumburg, Germany
- Boehringer Ingelheim Investigational Site
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Neubrandenburg, Germany
- Boehringer Ingelheim Investigational Site
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Neuenhagen, Germany
- Boehringer Ingelheim Investigational Site
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Neukirchen-Vluyn, Germany
- Boehringer Ingelheim Investigational Site
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Neumünster, Germany
- Boehringer Ingelheim Investigational Site
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Neustadt, Germany
- Boehringer Ingelheim Investigational Site
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Norden, Germany
- Boehringer Ingelheim Investigational Site
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Nordhorn, Germany
- Boehringer Ingelheim Investigational Site
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Nübel, Germany
- Boehringer Ingelheim Investigational Site
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Oberndorf, Germany
- Boehringer Ingelheim Investigational Site
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Offenbach, Germany
- Boehringer Ingelheim Investigational Site
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Oldenburg, Germany
- Boehringer Ingelheim Investigational Site
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Oranienburg, Germany
- Boehringer Ingelheim Investigational Site
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Oschatz, Germany
- Boehringer Ingelheim Investigational Site
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Osnabrück, Germany
- Boehringer Ingelheim Investigational Site
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Paderborn, Germany
- Boehringer Ingelheim Investigational Site
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Pirmasens, Germany
- Boehringer Ingelheim Investigational Site
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Plauen, Germany
- Boehringer Ingelheim Investigational Site
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Potsdam, Germany
- Boehringer Ingelheim Investigational Site
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Quakenbrück, Germany
- Boehringer Ingelheim Investigational Site
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Rastatt, Germany
- Boehringer Ingelheim Investigational Site
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Rathenow, Germany
- Boehringer Ingelheim Investigational Site
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Regensburg, Germany
- Boehringer Ingelheim Investigational Site 1
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Regensburg, Germany
- Boehringer Ingelheim Investigational Site 2
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Remscheid, Germany
- Boehringer Ingelheim Investigational Site
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Rendsburg, Germany
- Boehringer Ingelheim Investigational Site
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Rheine, Germany
- Boehringer Ingelheim Investigational Site
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Ribnitz-Damgarten, Germany
- Boehringer Ingelheim Investigational Site
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Riesa, Germany
- Boehringer Ingelheim Investigational Site
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Rostock, Germany
- Boehringer Ingelheim Investigational Site 1
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Rostock, Germany
- Boehringer Ingelheim Investigational Site 2
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Rostock, Germany
- Boehringer Ingelheim Investigational Site 3
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Rödermark, Germany
- Boehringer Ingelheim Investigational Site
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Rüdersdorf, Germany
- Boehringer Ingelheim Investigational Site
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Rüsselsheim, Germany
- Boehringer Ingelheim Investigational Site
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Salzgitter, Germany
- Boehringer Ingelheim Investigational Site
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Schirgiswalde, Germany
- Boehringer Ingelheim Investigational Site
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Schleiden, Germany
- Boehringer Ingelheim Investigational Site
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Schriesheim, Germany
- Boehringer Ingelheim Investigational Site
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Schwelm, Germany
- Boehringer Ingelheim Investigational Site
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Schwerin, Germany
- Boehringer Ingelheim Investigational Site 1
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Schwerin, Germany
- Boehringer Ingelheim Investigational Site 2
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Seeheim-Jugenheim, Germany
- Boehringer Ingelheim Investigational Site
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Senftenberg, Germany
- Boehringer Ingelheim Investigational Site
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Solingen, Germany
- Boehringer Ingelheim Investigational Site 1
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Solingen, Germany
- Boehringer Ingelheim Investigational Site 2
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Solingen, Germany
- Boehringer Ingelheim Investigational Site 3
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Stade, Germany
- Boehringer Ingelheim Investigational Site 1
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Stade, Germany
- Boehringer Ingelheim Investigational Site 2
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Stollberg, Germany
- Boehringer Ingelheim Investigational Site
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Stralsund, Germany
- Boehringer Ingelheim Investigational Site 1
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Stralsund, Germany
- Boehringer Ingelheim Investigational Site 2
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Strausberg, Germany
- Boehringer Ingelheim Investigational Site
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Sömmerda, Germany
- Boehringer Ingelheim Investigational Site
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Telgte, Germany
- Boehringer Ingelheim Investigational Site
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Teltow, Germany
- Boehringer Ingelheim Investigational Site
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Torgau, Germany
- Boehringer Ingelheim Investigational Site
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Trier, Germany
- Boehringer Ingelheim Investigational Site
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Troisdorf, Germany
- Boehringer Ingelheim Investigational Site
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Vechta, Germany
- Boehringer Ingelheim Investigational Site
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Velen, Germany
- Boehringer Ingelheim Investigational Site 1
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Velen, Germany
- Boehringer Ingelheim Investigational Site 2
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Verden, Germany
- Boehringer Ingelheim Investigational Site 1
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Verden, Germany
- Boehringer Ingelheim Investigational Site 2
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Viersen, Germany
- Boehringer Ingelheim Investigational Site
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Villingen-Schwenningen, Germany
- Boehringer Ingelheim Investigational Site
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Voerde, Germany
- Boehringer Ingelheim Investigational Site
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Warendorf, Germany
- Boehringer Ingelheim Investigational Site 1
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Warendorf, Germany
- Boehringer Ingelheim Investigational Site 2
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Wedel, Germany
- Boehringer Ingelheim Investigational Site
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Weida, Germany
- Boehringer Ingelheim Investigational Site
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Weil am Rhein, Germany
- Boehringer Ingelheim Investigational Site
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Weißenfels, Germany
- Boehringer Ingelheim Investigational Site
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Werdau, Germany
- Boehringer Ingelheim Investigational Site
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Wesseling, Germany
- Boehringer Ingelheim Investigational Site
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Wetzlar, Germany
- Boehringer Ingelheim Investigational Site
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Weyhe, Germany
- Boehringer Ingelheim Investigational Site
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Wismar, Germany
- Boehringer Ingelheim Investigational Site 1
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Wismar, Germany
- Boehringer Ingelheim Investigational Site 2
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Wolfratshausen, Germany
- Boehringer Ingelheim Investigational Site
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Wolgast, Germany
- Boehringer Ingelheim Investigational Site
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Wunstorf, Germany
- Boehringer Ingelheim Investigational Site
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Wuppertal, Germany
- Boehringer Ingelheim Investigational Site 1
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Wuppertal, Germany
- Boehringer Ingelheim Investigational Site 2
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Würzburg, Germany
- Boehringer Ingelheim Investigational Site
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Zella-Mehlis, Germany
- Boehringer Ingelheim Investigational Site
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Zwickau, Germany
- Boehringer Ingelheim Investigational Site
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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
Ages Eligible for Study
30 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
resident physician
Description
Inclusion Criteria:
- PD patients attending one of the participating neurologist practices during 2 fixed weeks in November 2008
- Idiopathic PD with or without fluctuations
- Male or female PD patients aged at least 30
- Ability to reliably complete self-rating scales (WHO-5, MDI) ), according to the physician's judgement.
- Written informed consent by the patient for study participation.
Exclusion Criteria:
- PD Patients who only attend the practice to get a prescription and are not seen by the doctor on that day
- Patients who are not able to understand the questionnaires (e.g. due to mental impairment or language problems).
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Prevalence of patients with depressive symptoms (based on WHO-5 and MDI) in total and in subgroups
Time Frame: day 1
|
day 1
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
WHO-5 score and items
Time Frame: day 1
|
day 1
|
MDI score (for a subgroup of patients with WHO-5 score < 13 or any WHO-5 item rated with 0 or 1)
Time Frame: day 1
|
day 1
|
Correlation of WHO-5 and MDI (for a subgroup of patients with a WHO-5 score < 13 or any WHO-5 item rated with 0 or 1) in PD patients
Time Frame: day 1
|
day 1
|
Investigator assessment of the applicability of the WHO-5 for screening for depression in PD patients
Time Frame: day 1
|
day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
November 1, 2008
Primary Completion (Actual)
November 1, 2008
Study Registration Dates
First Submitted
September 12, 2008
First Submitted That Met QC Criteria
September 12, 2008
First Posted (Estimate)
September 15, 2008
Study Record Updates
Last Update Posted (Estimate)
November 19, 2013
Last Update Submitted That Met QC Criteria
November 18, 2013
Last Verified
November 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 248.658
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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