Non-interventional Observational Study With Pramipexole: Impact on Non-motor Symptoms in Parkinson's Disease

October 31, 2013 updated by: Boehringer Ingelheim

Non-motor Symptoms (Depressive Symptoms) of Parkinson's Disease and Their Course Under Pramipexole Treatment

  • To compare the effect of pramipexole on depressive symptoms in early and advanced PD patients
  • To evaluate the course of depressive symptoms measured with UPDRS Part I (mentation, behavior and mood) and with HADS-D under pramipexole treatment
  • To investigate whether improvement of depressive symptoms is linked to improvement in motor function (UPDRS Part III)

Study Overview

Status

Completed

Conditions

Detailed Description

Study Design:

Study Type

Observational

Enrollment (Actual)

1192

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

      • Aalen, Germany
        • Boehringer Ingelheim
      • Aarbergen, Germany
        • Boehringer Ingelheim
      • Adendorf, Germany
        • Boehringer Ingelheim
      • Aham, Germany
        • Boehringer Ingelheim
      • Ahaus, Germany
        • Boehringer Ingelheim
      • Ahlen, Germany
        • Boehringer Ingelheim
      • Ahorntal, Germany
        • Boehringer Ingelheim
      • Aichach, Germany
        • Boehringer Ingelheim
      • Aislingen, Germany
        • Boehringer Ingelheim
      • Albstadt, Germany
        • Boehringer Ingelheim
      • Aldenhoven, Germany
        • Boehringer Ingelheim
      • Aldingen, Germany
        • Boehringer Ingelheim
      • Alfeld, Germany
        • Boehringer Ingelheim
      • Alpirsbach, Germany
        • Boehringer Ingelheim
      • Alsdorf, Germany
        • Boehringer Ingelheim
      • Altena, Germany
        • Boehringer Ingelheim
      • Altenstadt, Germany
        • Boehringer Ingelheim
      • Altomünster, Germany
        • Boehringer Ingelheim
      • Alveslohe, Germany
        • Boehringer Ingelheim
      • Amberg, Germany
        • Boehringer Ingelheim
      • Ammerbuch, Germany
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      • Andernach, Germany
        • Boehringer Ingelheim
      • Anklam, Germany
        • Boehringer Ingelheim
      • Apolda, Germany
        • Boehringer Ingelheim
      • Armsheim, Germany
        • Boehringer Ingelheim
      • Arzberg, Germany
        • Boehringer Ingelheim
      • Aschaffenburg, Germany
        • Boehringer Ingelheim
      • Aschersleben, Germany
        • Boehringer Ingelheim
      • Aschheim, Germany
        • Boehringer Ingelheim
      • Attendorn, Germany
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      • Auerbach, Germany
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      • Augsburg, Germany
        • Boehringer Ingelheim
      • Aurich, Germany
        • Boehringer Ingelheim
      • Babensham, Germany
        • Boehringer Ingelheim
      • Backnang, Germany
        • Boehringer Ingelheim
      • Bad Arolsen, Germany
        • Boehringer Ingelheim
      • Bad Berleburg, Germany
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      • Bad Bevensen, Germany
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      • Bad Düben, Germany
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      • Bad Dürrenberg, Germany
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      • Bad Dürrheim, Germany
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      • Bad Ems, Germany
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      • Bad Essen, Germany
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      • Bad Kreuznach, Germany
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      • Bad Laasphe, Germany
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      • Bad Langensalza, Germany
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      • Bad Lausick, Germany
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      • Bad Münstereifel, Germany
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      • Bad Oeynhausen, Germany
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      • Bad Salzungen, Germany
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      • Bad Schwalbach, Germany
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      • Bad Schwartau, Germany
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      • Bad Segeberg, Germany
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      • Bad Tennstedt, Germany
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      • Bad Waldsee, Germany
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      • Baden-Baden, Germany
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      • Bahrdorf, Germany
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      • Baltmannsweiler, Germany
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      • Bamberg, Germany
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      • Barleben, Germany
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      • Baunatal, Germany
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      • Bautzen, Germany
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      • Bayreuth, Germany
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      • Beckum, Germany
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      • Beeskow, Germany
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      • Bellheim, Germany
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      • Belm, Germany
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      • Bensheim, Germany
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      • Berching, Germany
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      • Bergfelde, Germany
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      • Bergheim, Germany
        • Boehringer Ingelheim
      • Bergisch Gladbach, Germany
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      • Berkheim, Germany
        • Boehringer Ingelheim
      • Berlin, Germany
        • Boehringer Ingelheim
      • Berne, Germany
        • Boehringer Ingelheim
      • Bernsdorf, Germany
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      • Betzdorf, Germany
        • Boehringer Ingelheim
      • Biebertal, Germany
        • Boehringer Ingelheim
      • Bielefeld, Germany
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      • Bienenbüttel, Germany
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      • Bippen, Germany
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      • Birkenfeld, Germany
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      • Birkenwerder, Germany
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      • Blankenhain, Germany
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      • Blaustein, Germany
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      • Blieskastel, Germany
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      • Bodelshausen, Germany
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      • Bodenkirchen, Germany
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      • Bodenwöhr, Germany
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      • Bodman-Ludwigshafen, Germany
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      • Bollendorf, Germany
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      • Bonn, Germany
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      • Borna, Germany
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      • Bornheim, Germany
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      • Bottmersdorf, Germany
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      • Bottrop, Germany
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      • Bovenden, Germany
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      • Brake, Germany
        • Boehringer Ingelheim
      • Brandenburg, Germany
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      • Brannenburg, Germany
        • Boehringer Ingelheim
      • Braunschweig, Germany
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      • Brechen, Germany
        • Boehringer Ingelheim
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      • Bremerhaven, Germany
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      • Büttelborn, Germany
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      • Cadolzburg, Germany
        • Boehringer Ingelheim
      • Calbe, Germany
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      • Calberlah, Germany
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      • Castrop-Rauxel, Germany
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      • Celle, Germany
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      • Chemnitz, Germany
        • Boehringer Ingelheim
      • Cochem, Germany
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      • Coppenbrügge, Germany
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      • Crimmitschau, Germany
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      • Crivitz, Germany
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      • Cuxhaven, Germany
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      • Dabel, Germany
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      • Darmstadt, Germany
        • Boehringer Ingelheim
      • Dassow, Germany
        • Boehringer Ingelheim
      • Datteln, Germany
        • Boehringer Ingelheim
      • Daun, Germany
        • Boehringer Ingelheim
      • Deggendorf, Germany
        • Boehringer Ingelheim
      • Deidesheim, Germany
        • Boehringer Ingelheim
      • Deining, Germany
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      • Delitzsch, Germany
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      • Demen, Germany
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      • Denkendorf, Germany
        • Boehringer Ingelheim
      • Dessau, Germany
        • Boehringer Ingelheim
      • Detmold, Germany
        • Boehringer Ingelheim
      • Dettenheim, Germany
        • Boehringer Ingelheim
      • Deuben, Germany
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      • Deutzen, Germany
        • Boehringer Ingelheim
      • Diepholz, Germany
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      • Dillingen, Germany
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      • Dingolfing, Germany
        • Boehringer Ingelheim
      • Dinkelsbühl, Germany
        • Boehringer Ingelheim
      • Dinslaken, Germany
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      • Dissen, Germany
        • Boehringer Ingelheim
      • Dogern, Germany
        • Boehringer Ingelheim
      • Dollern, Germany
        • Boehringer Ingelheim
      • Donaueschingen, Germany
        • Boehringer Ingelheim
      • Dormagen, Germany
        • Boehringer Ingelheim
      • Dornstetten, Germany
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      • Dorsten, Germany
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      • Dortmund, Germany
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      • Dreieich, Germany
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      • Drensteinfurt, Germany
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      • Dresden, Germany
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      • Driedorf, Germany
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      • Duderstadt, Germany
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      • Duisburg, Germany
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      • Dummerstorf, Germany
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      • Dörentrup, Germany
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      • Dörpen, Germany
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      • Düren, Germany
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      • Düsseldorf, Germany
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      • Ebergötzen, Germany
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      • Ebermannstadt, Germany
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      • Eberstadt, Germany
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      • Ebhausen, Germany
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      • Edewecht, Germany
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      • Edling, Germany
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      • Egelsbach, Germany
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      • Ehingen, Germany
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      • Eilenburg, Germany
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      • Eisenhüttenstadt, Germany
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      • Eiterfeld, Germany
        • Boehringer Ingelheim
      • Eitorf, Germany
        • Boehringer Ingelheim
      • Ellwangen, Germany
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      • Elmshorn, Germany
        • Boehringer Ingelheim
      • Emersacker, Germany
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      • Emmendingen, Germany
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      • Emsdetten, Germany
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      • Enger, Germany
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      • Enkenbach-Alsenborn, Germany
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      • Ennepetal, Germany
        • Boehringer Ingelheim
      • Ennigerloh, Germany
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      • Eppstein, Germany
        • Boehringer Ingelheim
      • Erding, Germany
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      • Erftstadt, Germany
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      • Erkrath, Germany
        • Boehringer Ingelheim
      • Erligheim, Germany
        • Boehringer Ingelheim
      • Erndtebrück, Germany
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      • Erolzheim, Germany
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      • Eschborn, Germany
        • Boehringer Ingelheim
      • Eschelbronn, Germany
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      • Eschweiler, Germany
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      • Eslohe, Germany
        • Boehringer Ingelheim
      • Espenhain, Germany
        • Boehringer Ingelheim
      • Essen, Germany
        • Boehringer Ingelheim
      • Esslingen, Germany
        • Boehringer Ingelheim
      • Euskirchen, Germany
        • Boehringer Ingelheim
      • Filderstadt, Germany
        • Boehringer Ingelheim
      • Floh-Seligenthal, Germany
        • Boehringer Ingelheim
      • Flöha, Germany
        • Boehringer Ingelheim
      • Forbach, Germany
        • Boehringer Ingelheim
      • Forchheim, Germany
        • Boehringer Ingelheim
      • Frankenberg, Germany
        • Boehringer Ingelheim
      • Frankenthal, Germany
        • Boehringer Ingelheim
      • Frankfurt, Germany
        • Boehringer Ingelheim
      • Freiberg, Germany
        • Boehringer Ingelheim
      • Freiburg, Germany
        • Boehringer Ingelheim
      • Freigericht, Germany
        • Boehringer Ingelheim
      • Freudenstadt, Germany
        • Boehringer Ingelheim
      • Freyung, Germany
        • Boehringer Ingelheim
      • Friedland, Germany
        • Boehringer Ingelheim
      • Friedrichshafen, Germany
        • Boehringer Ingelheim
      • Friedrichsthal, Germany
        • Boehringer Ingelheim
      • Frohburg, Germany
        • Boehringer Ingelheim
      • Fulda, Germany
        • Boehringer Ingelheim
      • Furtwangen, Germany
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      • Fürstenwalde, Germany
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      • Füssen, Germany
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      • Gangelt, Germany
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      • Gardelegen, Germany
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      • Garmisch-Partenkirchen, Germany
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      • Gars, Germany
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      • Gaußig, Germany
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      • Gebesee, Germany
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      • Geesthacht, Germany
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      • Gelbensande, Germany
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      • Gelsenkirchen, Germany
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      • Gensingen, Germany
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      • Georgsmarienhütte, Germany
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      • Gera, Germany
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      • Gerbstedt, Germany
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      • Germaringen, Germany
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      • Germering, Germany
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      • Germersheim, Germany
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      • Gevelsberg, Germany
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      • Gießen, Germany
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      • Gifhorn, Germany
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      • Gilserberg, Germany
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      • Gladbeck, Germany
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      • Gleichen, Germany
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      • Goch, Germany
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      • Gochsheim, Germany
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      • Gomaringen, Germany
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      • Grafenau, Germany
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      • Gransee, Germany
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      • Grassau, Germany
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      • Grevesmühlen, Germany
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      • Groß Grönau, Germany
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      • Groß Quenstedt, Germany
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      • Groß-Zimmern, Germany
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      • Großalmerode, Germany
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      • Großbottwar, Germany
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      • Großefehn, Germany
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      • Großhabersdorf, Germany
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      • Großkorbetha, Germany
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      • Großlangheim, Germany
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      • Grömitz, Germany
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      • Grünbach, Germany
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      • Gummersbach, Germany
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      • Göllheim, Germany
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      • Göllingen, Germany
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      • Göttingen, Germany
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      • Güstrow, Germany
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      • Haag, Germany
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      • Hagen, Germany
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      • Haigerloch, Germany
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      • Haldensleben, Germany
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      • Halle, Germany
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      • Hamburg, Germany
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      • Hamm, Germany
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      • Hamminkeln, Germany
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      • Hanau, Germany
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      • Hanerau-Hademarschen, Germany
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      • Hannover, Germany
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      • Harpstedt, Germany
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      • Harsefeld, Germany
        • Boehringer Ingelheim
      • Harsewinkel, Germany
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      • Haselünne, Germany
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      • Hattersheim, Germany
        • Boehringer Ingelheim
      • Hattingen, Germany
        • Boehringer Ingelheim
      • Havixbeck, Germany
        • Boehringer Ingelheim
      • Hedersleben, Germany
        • Boehringer Ingelheim
      • Heek, Germany
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      • Heide, Germany
        • Boehringer Ingelheim
      • Heidelberg, Germany
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      • Heilbronn, Germany
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      • Heimsheim, Germany
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      • Heinsberg, Germany
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      • Hellenthal, Germany
        • Boehringer Ingelheim

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

PD patients

Description

Inclusion criteria:

  1. Idiopathic Parkinsons disease with or without fluctuations
  2. Indication for treatment with Sifrol®
  3. Male or female patients of age
  4. Presence of at least mild depressive symptoms (as judged by the treating physician)
  5. Ability to reliably complete a self-rating scale (HADS)

Exclusion criteria:

  1. Any contraindications according to the Summary of Product Characteristics (SPC): hypersensitivity to pramipexole or to any of the excipients.
  2. Ongoing treatment with Sifrol®.

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
Improvement of depressive symptoms (UPDRS item 3, HADS-D) compared to baseline in early and advanced Parkinsons's disease
Time Frame: 9-16 weeks
9-16 weeks
Change in sum scores of UPDRS Part III (motor examination) from baseline and UPDRS Part I (mentation, behavior and mood) from baseline
Time Frame: 9-16 weeks
9-16 weeks
Change in HADS subscores (anxiety and depression) from baseline
Time Frame: 9-16 weeks
9-16 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Baseline pattern of patient rated symptom list (HADS)
Time Frame: 9-16 weeks
9-16 weeks
Correlation of the change in UPDRS Part I and UPDRS Part III at the final visit
Time Frame: 9-16 weeks
9-16 weeks
Frequency of adverse events
Time Frame: 9-16 weeks
9-16 weeks

Collaborators and Investigators

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

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.

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

March 1, 2007

Primary Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

September 28, 2007

First Submitted That Met QC Criteria

October 2, 2007

First Posted (Estimate)

October 4, 2007

Study Record Updates

Last Update Posted (Estimate)

November 1, 2013

Last Update Submitted That Met QC Criteria

October 31, 2013

Last Verified

October 1, 2013

More Information

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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