Non-interventional Observational Study on WHO-5 Questionnaire Application in Parkinson's Disease

Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Completed
CT.gov ID
NCT00752388
Collaborator
(none)
1,588
278
5.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    1588 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Application of the WHO-5 Well-being Index (WHO-5) as a Screening Instrument for Depression in Parkinson's Disease
    Study Start Date :
    Nov 1, 2008
    Actual Primary Completion Date :
    Nov 1, 2008

    Outcome Measures

    Primary Outcome Measures

    1. Prevalence of patients with depressive symptoms (based on WHO-5 and MDI) in total and in subgroups [day 1]

    Secondary Outcome Measures

    1. WHO-5 score and items [day 1]

    2. MDI score (for a subgroup of patients with WHO-5 score < 13 or any WHO-5 item rated with 0 or 1) [day 1]

    3. 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 [day 1]

    4. Investigator assessment of the applicability of the WHO-5 for screening for depression in PD patients [day 1]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. PD patients attending one of the participating neurologist practices during 2 fixed weeks in November 2008

    2. Idiopathic PD with or without fluctuations

    3. Male or female PD patients aged at least 30

    4. Ability to reliably complete self-rating scales (WHO-5, MDI) ), according to the physician's judgement.

    5. Written informed consent by the patient for study participation.

    Exclusion Criteria:
    1. PD Patients who only attend the practice to get a prescription and are not seen by the doctor on that day

    2. Patients who are not able to understand the questionnaires (e.g. due to mental impairment or language problems).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Boehringer Ingelheim Investigational Site 1 Achim Germany
    2 Boehringer Ingelheim Investigational Site 2 Achim Germany
    3 Boehringer Ingelheim Investigational Site Altenburg Germany
    4 Boehringer Ingelheim Investigational Site Altenholz Germany
    5 Boehringer Ingelheim Investigational Site Alzey Germany
    6 Boehringer Ingelheim Investigational Site Aue Germany
    7 Boehringer Ingelheim Investigational Site Bad Driburg Germany
    8 Boehringer Ingelheim Investigational Site Bad Homburg Germany
    9 Boehringer Ingelheim Investigational Site Bad Honnef Germany
    10 Boehringer Ingelheim Investigational Site Bad Neuenahr-Ahrweiler Germany
    11 Boehringer Ingelheim Investigational Site 1 Bad Soden Germany
    12 Boehringer Ingelheim Investigational Site 2 Bad Soden Germany
    13 Boehringer Ingelheim Investigational Site Bad Sooden-Allendorf Germany
    14 Boehringer Ingelheim Investigational Site Bergisch Gladbach Germany
    15 Boehringer Ingelheim Investigational Site 10 Berlin Germany
    16 Boehringer Ingelheim Investigational Site 11 Berlin Germany
    17 Boehringer Ingelheim Investigational Site 12 Berlin Germany
    18 Boehringer Ingelheim Investigational Site 13 Berlin Germany
    19 Boehringer Ingelheim Investigational Site 14 Berlin Germany
    20 Boehringer Ingelheim Investigational Site 1 Berlin Germany
    21 Boehringer Ingelheim Investigational Site 2 Berlin Germany
    22 Boehringer Ingelheim Investigational Site 3 Berlin Germany
    23 Boehringer Ingelheim Investigational Site 4 Berlin Germany
    24 Boehringer Ingelheim Investigational Site 5 Berlin Germany
    25 Boehringer Ingelheim Investigational Site 6 Berlin Germany
    26 Boehringer Ingelheim Investigational Site 7 Berlin Germany
    27 Boehringer Ingelheim Investigational Site 8 Berlin Germany
    28 Boehringer Ingelheim Investigational Site 9 Berlin Germany
    29 Boehringer Ingelheim Investigational Site 1 Bielefeld Germany
    30 Boehringer Ingelheim Investigational Site 2 Bielefeld Germany
    31 Boehringer Ingelheim Investigational Site 1 Bochum Germany
    32 Boehringer Ingelheim Investigational Site 2 Bochum Germany
    33 Boehringer Ingelheim Investigational Site 3 Bochum Germany
    34 Boehringer Ingelheim Investigational Site Bockhorn Germany
    35 Boehringer Ingelheim Investigational Site Bonn Germany
    36 Boehringer Ingelheim Investigational Site Braunschweig Germany
    37 Boehringer Ingelheim Investigational Site Bremen Germany
    38 Boehringer Ingelheim Investigational Site Bremerhaven Germany
    39 Boehringer Ingelheim Investigational Site Bretten Germany
    40 Boehringer Ingelheim Investigational Site 1 Butzbach Germany
    41 Boehringer Ingelheim Investigational Site 2 Butzbach Germany
    42 Boehringer Ingelheim Investigational Site Buxtehude Germany
    43 Boehringer Ingelheim Investigational Site Castrop-Rauxel Germany
    44 Boehringer Ingelheim Investigational Site Chemnitz Germany
    45 Boehringer Ingelheim Investigational Site Cloppenburg Germany
    46 Boehringer Ingelheim Investigational Site Coesfeld Germany
    47 Boehringer Ingelheim Investigational Site 1 Cottbus Germany
    48 Boehringer Ingelheim Investigational Site 2 Cottbus Germany
    49 Boehringer Ingelheim Investigational Site Delmenhorst Germany
    50 Boehringer Ingelheim Investigational Site 1 Dessau Germany
    51 Boehringer Ingelheim Investigational Site 2 Dessau Germany
    52 Boehringer Ingelheim Investigational Site Dietzenbach Germany
    53 Boehringer Ingelheim Investigational Site Dippoldiswalde Germany
    54 Boehringer Ingelheim Investigational Site 1 Dortmund Germany
    55 Boehringer Ingelheim Investigational Site 2 Dortmund Germany
    56 Boehringer Ingelheim Investigational Site 3 Dortmund Germany
    57 Boehringer Ingelheim Investigational Site 1 Dresden Germany
    58 Boehringer Ingelheim Investigational Site 2 Dresden Germany
    59 Boehringer Ingelheim Investigational Site 3 Dresden Germany
    60 Boehringer Ingelheim Investigational Site 4 Dresden Germany
    61 Boehringer Ingelheim Investigational Site 1 Duisburg Germany
    62 Boehringer Ingelheim Investigational Site 2 Duisburg Germany
    63 Boehringer Ingelheim Investigational Site 3 Duisburg Germany
    64 Boehringer Ingelheim Investigational Site 4 Duisburg Germany
    65 Boehringer Ingelheim Investigational Site Dülmen Germany
    66 Boehringer Ingelheim Investigational Site 1 Düsseldorf Germany
    67 Boehringer Ingelheim Investigational Site 2 Düsseldorf Germany
    68 Boehringer Ingelheim Investigational Site 3 Düsseldorf Germany
    69 Boehringer Ingelheim Investigational Site 4 Düsseldorf Germany
    70 Boehringer Ingelheim Investigational Site 5 Düsseldorf Germany
    71 Boehringer Ingelheim Investigational Site 1 Erbach Germany
    72 Boehringer Ingelheim Investigational Site 2 Erbach Germany
    73 Boehringer Ingelheim Investigational Site Erftstadt Germany
    74 Boehringer Ingelheim Investigational Site Essen Germany
    75 Boehringer Ingelheim Investigational Site 1 Frankfurt Germany
    76 Boehringer Ingelheim Investigational Site 2 Frankfurt Germany
    77 Boehringer Ingelheim Investigational Site Freiburg Germany
    78 Boehringer Ingelheim Investigational Site Fürstenwalde Germany
    79 Boehringer Ingelheim Investigational Site Gelnhausen Germany
    80 Boehringer Ingelheim Investigational Site 1 Gelsenkirchen Germany
    81 Boehringer Ingelheim Investigational Site 2 Gelsenkirchen Germany
    82 Boehringer Ingelheim Investigational Site Gengenbach Germany
    83 Boehringer Ingelheim Investigational Site Gera Germany
    84 Boehringer Ingelheim Investigational Site Gießen Germany
    85 Boehringer Ingelheim Investigational Site Gifhorn Germany
    86 Boehringer Ingelheim Investigational Site Gladenbach Germany
    87 Boehringer Ingelheim Investigational Site Goch Germany
    88 Boehringer Ingelheim Investigational Site Grünstadt Germany
    89 Boehringer Ingelheim Investigational Site Göttingen Germany
    90 Boehringer Ingelheim Investigational Site 1 Güstrow Germany
    91 Boehringer Ingelheim Investigational Site 2 Güstrow Germany
    92 Boehringer Ingelheim Investigational Site Gütersloh Germany
    93 Boehringer Ingelheim Investigational Site 1 Halle Germany
    94 Boehringer Ingelheim Investigational Site 2 Halle Germany
    95 Boehringer Ingelheim Investigational Site 3 Halle Germany
    96 Boehringer Ingelheim Investigational Site 1 Hamburg Germany
    97 Boehringer Ingelheim Investigational Site 2 Hamburg Germany
    98 Boehringer Ingelheim Investigational Site 3 Hamburg Germany
    99 Boehringer Ingelheim Investigational Site 4 Hamburg Germany
    100 Boehringer Ingelheim Investigational Site 5 Hamburg Germany
    101 Boehringer Ingelheim Investigational Site Hameln Germany
    102 Boehringer Ingelheim Investigational Site 1 Hannover Germany
    103 Boehringer Ingelheim Investigational Site 2 Hannover Germany
    104 Boehringer Ingelheim Investigational Site 3 Hannover Germany
    105 Boehringer Ingelheim Investigational Site 4 Hannover Germany
    106 Boehringer Ingelheim Investigational Site 1 Heidelberg Germany
    107 Boehringer Ingelheim Investigational Site 2 Heidelberg Germany
    108 Boehringer Ingelheim Investigational Site Heilbronn Germany
    109 Boehringer Ingelheim Investigational Site Hemmoor Germany
    110 Boehringer Ingelheim Investigational Site Hennigsdorf Germany
    111 Boehringer Ingelheim Investigational Site Henstedt-Ulzburg Germany
    112 Boehringer Ingelheim Investigational Site Herborn Germany
    113 Boehringer Ingelheim Investigational Site Herzberg Germany
    114 Boehringer Ingelheim Investigational Site Herzogenrath Germany
    115 Boehringer Ingelheim Investigational Site 1 Hildesheim Germany
    116 Boehringer Ingelheim Investigational Site 2 Hildesheim Germany
    117 Boehringer Ingelheim Investigational Site 3 Hildesheim Germany
    118 Boehringer Ingelheim Investigational Site 4 Hildesheim Germany
    119 Boehringer Ingelheim Investigational Site 5 Hildesheim Germany
    120 Boehringer Ingelheim Investigational Site Homburg Germany
    121 Boehringer Ingelheim Investigational Site Hückelhoven Germany
    122 Boehringer Ingelheim Investigational Site Hürth Germany
    123 Boehringer Ingelheim Investigational Site 1 Ilmenau Germany
    124 Boehringer Ingelheim Investigational Site 2 Ilmenau Germany
    125 Boehringer Ingelheim Investigational Site Ingelheim Germany
    126 Boehringer Ingelheim Investigational Site Iserlohn Germany
    127 Boehringer Ingelheim Investigational Site Itzehoe Germany
    128 Boehringer Ingelheim Investigational Site Kamen Germany
    129 Boehringer Ingelheim Investigational Site Kamp-Lintfort Germany
    130 Boehringer Ingelheim Investigational Site Kandel Germany
    131 Boehringer Ingelheim Investigational Site Karlstadt Germany
    132 Boehringer Ingelheim Investigational Site 1 Kassel Germany
    133 Boehringer Ingelheim Investigational Site 2 Kassel Germany
    134 Boehringer Ingelheim Investigational Site Kaufbeuren Germany
    135 Boehringer Ingelheim Investigational Site Kiel Germany
    136 Boehringer Ingelheim Investigational Site Kleinblittersdorf Germany
    137 Boehringer Ingelheim Investigational Site Kleve Germany
    138 Boehringer Ingelheim Investigational Site 1 Köln Germany
    139 Boehringer Ingelheim Investigational Site 2 Köln Germany
    140 Boehringer Ingelheim Investigational Site 3 Köln Germany
    141 Boehringer Ingelheim Investigational Site 4 Köln Germany
    142 Boehringer Ingelheim Investigational Site 5 Köln Germany
    143 Boehringer Ingelheim Investigational Site 6 Köln Germany
    144 Boehringer Ingelheim Investigational Site 7 Köln Germany
    145 Boehringer Ingelheim Investigational Site Lappersdorf Germany
    146 Boehringer Ingelheim Investigational Site Lauterbach Germany
    147 Boehringer Ingelheim Investigational Site 1 Leer Germany
    148 Boehringer Ingelheim Investigational Site 2 Leer Germany
    149 Boehringer Ingelheim Investigational Site 1 Leipzig Germany
    150 Boehringer Ingelheim Investigational Site 2 Leipzig Germany
    151 Boehringer Ingelheim Investigational Site 3 Leipzig Germany
    152 Boehringer Ingelheim Investigational Site 4 Leipzig Germany
    153 Boehringer Ingelheim Investigational Site 5 Leipzig Germany
    154 Boehringer Ingelheim Investigational Site 1 Leverkusen Germany
    155 Boehringer Ingelheim Investigational Site 2 Leverkusen Germany
    156 Boehringer Ingelheim Investigational Site Ludwigsfelde Germany
    157 Boehringer Ingelheim Investigational Site 1 Ludwigshafen Germany
    158 Boehringer Ingelheim Investigational Site 2 Ludwigshafen Germany
    159 Boehringer Ingelheim Investigational Site 3 Ludwigshafen Germany
    160 Boehringer Ingelheim Investigational Site Ludwigslust Germany
    161 Boehringer Ingelheim Investigational Site Löbau Germany
    162 Boehringer Ingelheim Investigational Site 1 Lüdenscheid Germany
    163 Boehringer Ingelheim Investigational Site 2 Lüdenscheid Germany
    164 Boehringer Ingelheim Investigational Site 3 Lüdenscheid Germany
    165 Boehringer Ingelheim Investigational Site 4 Lüdenscheid Germany
    166 Boehringer Ingelheim Investigational Site 5 Lüdenscheid Germany
    167 Boehringer Ingelheim Investigational Site 1 Lüneburg Germany
    168 Boehringer Ingelheim Investigational Site 2 Lüneburg Germany
    169 Boehringer Ingelheim Investigational Site 1 Lünen Germany
    170 Boehringer Ingelheim Investigational Site 2 Lünen Germany
    171 Boehringer Ingelheim Investigational Site Magdeburg Germany
    172 Boehringer Ingelheim Investigational Site Malente Germany
    173 Boehringer Ingelheim Investigational Site 1 Mannheim Germany
    174 Boehringer Ingelheim Investigational Site 2 Mannheim Germany
    175 Boehringer Ingelheim Investigational Site 3 Mannheim Germany
    176 Boehringer Ingelheim Investigational Site 4 Mannheim Germany
    177 Boehringer Ingelheim Investigational Site Markkleeberg Germany
    178 Boehringer Ingelheim Investigational Site Marl Germany
    179 Boehringer Ingelheim Investigational Site Memmingen Germany
    180 Boehringer Ingelheim Investigational Site Menden Germany
    181 Boehringer Ingelheim Investigational Site Mittweida Germany
    182 Boehringer Ingelheim Investigational Site 1 Mönchengladbach Germany
    183 Boehringer Ingelheim Investigational Site 2 Mönchengladbach Germany
    184 Boehringer Ingelheim Investigational Site 3 Mönchengladbach Germany
    185 Boehringer Ingelheim Investigational Site Mühlacker Germany
    186 Boehringer Ingelheim Investigational Site 1 Mülheim Germany
    187 Boehringer Ingelheim Investigational Site 2 Mülheim Germany
    188 Boehringer Ingelheim Investigational Site 3 Mülheim Germany
    189 Boehringer Ingelheim Investigational Site 1 Münster Germany
    190 Boehringer Ingelheim Investigational Site 2 Münster Germany
    191 Boehringer Ingelheim Investigational Site 3 Münster Germany
    192 Boehringer Ingelheim Investigational Site Naumburg Germany
    193 Boehringer Ingelheim Investigational Site Neubrandenburg Germany
    194 Boehringer Ingelheim Investigational Site Neuenhagen Germany
    195 Boehringer Ingelheim Investigational Site Neukirchen-Vluyn Germany
    196 Boehringer Ingelheim Investigational Site Neumünster Germany
    197 Boehringer Ingelheim Investigational Site Neustadt Germany
    198 Boehringer Ingelheim Investigational Site Norden Germany
    199 Boehringer Ingelheim Investigational Site Nordhorn Germany
    200 Boehringer Ingelheim Investigational Site Nübel Germany
    201 Boehringer Ingelheim Investigational Site Oberndorf Germany
    202 Boehringer Ingelheim Investigational Site Offenbach Germany
    203 Boehringer Ingelheim Investigational Site Oldenburg Germany
    204 Boehringer Ingelheim Investigational Site Oranienburg Germany
    205 Boehringer Ingelheim Investigational Site Oschatz Germany
    206 Boehringer Ingelheim Investigational Site Osnabrück Germany
    207 Boehringer Ingelheim Investigational Site Paderborn Germany
    208 Boehringer Ingelheim Investigational Site Pirmasens Germany
    209 Boehringer Ingelheim Investigational Site Plauen Germany
    210 Boehringer Ingelheim Investigational Site Potsdam Germany
    211 Boehringer Ingelheim Investigational Site Quakenbrück Germany
    212 Boehringer Ingelheim Investigational Site Rastatt Germany
    213 Boehringer Ingelheim Investigational Site Rathenow Germany
    214 Boehringer Ingelheim Investigational Site 1 Regensburg Germany
    215 Boehringer Ingelheim Investigational Site 2 Regensburg Germany
    216 Boehringer Ingelheim Investigational Site Remscheid Germany
    217 Boehringer Ingelheim Investigational Site Rendsburg Germany
    218 Boehringer Ingelheim Investigational Site Rheine Germany
    219 Boehringer Ingelheim Investigational Site Ribnitz-Damgarten Germany
    220 Boehringer Ingelheim Investigational Site Riesa Germany
    221 Boehringer Ingelheim Investigational Site 1 Rostock Germany
    222 Boehringer Ingelheim Investigational Site 2 Rostock Germany
    223 Boehringer Ingelheim Investigational Site 3 Rostock Germany
    224 Boehringer Ingelheim Investigational Site Rödermark Germany
    225 Boehringer Ingelheim Investigational Site Rüdersdorf Germany
    226 Boehringer Ingelheim Investigational Site Rüsselsheim Germany
    227 Boehringer Ingelheim Investigational Site Salzgitter Germany
    228 Boehringer Ingelheim Investigational Site Schirgiswalde Germany
    229 Boehringer Ingelheim Investigational Site Schleiden Germany
    230 Boehringer Ingelheim Investigational Site Schriesheim Germany
    231 Boehringer Ingelheim Investigational Site Schwelm Germany
    232 Boehringer Ingelheim Investigational Site 1 Schwerin Germany
    233 Boehringer Ingelheim Investigational Site 2 Schwerin Germany
    234 Boehringer Ingelheim Investigational Site Seeheim-Jugenheim Germany
    235 Boehringer Ingelheim Investigational Site Senftenberg Germany
    236 Boehringer Ingelheim Investigational Site 1 Solingen Germany
    237 Boehringer Ingelheim Investigational Site 2 Solingen Germany
    238 Boehringer Ingelheim Investigational Site 3 Solingen Germany
    239 Boehringer Ingelheim Investigational Site 1 Stade Germany
    240 Boehringer Ingelheim Investigational Site 2 Stade Germany
    241 Boehringer Ingelheim Investigational Site Stollberg Germany
    242 Boehringer Ingelheim Investigational Site 1 Stralsund Germany
    243 Boehringer Ingelheim Investigational Site 2 Stralsund Germany
    244 Boehringer Ingelheim Investigational Site Strausberg Germany
    245 Boehringer Ingelheim Investigational Site Sömmerda Germany
    246 Boehringer Ingelheim Investigational Site Telgte Germany
    247 Boehringer Ingelheim Investigational Site Teltow Germany
    248 Boehringer Ingelheim Investigational Site Torgau Germany
    249 Boehringer Ingelheim Investigational Site Trier Germany
    250 Boehringer Ingelheim Investigational Site Troisdorf Germany
    251 Boehringer Ingelheim Investigational Site Vechta Germany
    252 Boehringer Ingelheim Investigational Site 1 Velen Germany
    253 Boehringer Ingelheim Investigational Site 2 Velen Germany
    254 Boehringer Ingelheim Investigational Site 1 Verden Germany
    255 Boehringer Ingelheim Investigational Site 2 Verden Germany
    256 Boehringer Ingelheim Investigational Site Viersen Germany
    257 Boehringer Ingelheim Investigational Site Villingen-Schwenningen Germany
    258 Boehringer Ingelheim Investigational Site Voerde Germany
    259 Boehringer Ingelheim Investigational Site 1 Warendorf Germany
    260 Boehringer Ingelheim Investigational Site 2 Warendorf Germany
    261 Boehringer Ingelheim Investigational Site Wedel Germany
    262 Boehringer Ingelheim Investigational Site Weida Germany
    263 Boehringer Ingelheim Investigational Site Weil am Rhein Germany
    264 Boehringer Ingelheim Investigational Site Weißenfels Germany
    265 Boehringer Ingelheim Investigational Site Werdau Germany
    266 Boehringer Ingelheim Investigational Site Wesseling Germany
    267 Boehringer Ingelheim Investigational Site Wetzlar Germany
    268 Boehringer Ingelheim Investigational Site Weyhe Germany
    269 Boehringer Ingelheim Investigational Site 1 Wismar Germany
    270 Boehringer Ingelheim Investigational Site 2 Wismar Germany
    271 Boehringer Ingelheim Investigational Site Wolfratshausen Germany
    272 Boehringer Ingelheim Investigational Site Wolgast Germany
    273 Boehringer Ingelheim Investigational Site Wunstorf Germany
    274 Boehringer Ingelheim Investigational Site 1 Wuppertal Germany
    275 Boehringer Ingelheim Investigational Site 2 Wuppertal Germany
    276 Boehringer Ingelheim Investigational Site Würzburg Germany
    277 Boehringer Ingelheim Investigational Site Zella-Mehlis Germany
    278 Boehringer Ingelheim Investigational Site Zwickau Germany

    Sponsors and Collaborators

    • Boehringer Ingelheim

    Investigators

    • Study Chair: Boehringer Ingelheim, Boehringer Ingelheim

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00752388
    Other Study ID Numbers:
    • 248.658
    First Posted:
    Sep 15, 2008
    Last Update Posted:
    Nov 19, 2013
    Last Verified:
    Nov 1, 2013
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 19, 2013