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

NCT ID: NCT00651183

Last Updated: 2014-05-20

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

286 participants

Study Classification

OBSERVATIONAL

Study Completion Date

2008-04-30

Brief Summary

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The objective of this PMS study is the evaluation of depressive symptoms measured with Unified Parkinson's Disease Rating Scale (UPDRS) Part I (mentation, behavior and mood) and with Hospital Anxiety and Depression Scale Depression Subscore (HADS-D) under pramipexole treatment in early and advanced PD patients. In addition it will be investigated whether improvement of depressive symptoms is linked to improvement in motor function (UPDRS Part III). 250 patients diagnosed with Parkinson's disease (PD) will be investigated by 80 specialists (neurologists or neurologists/psychiatrists) across Austria. Pramipexole will be taken orally at an initial dosage of 0.375 mg/day (using a three times daily schedule independently of food intake) and can be titrated upwards, as required, at weekly intervals to a maximum total daily dose of 4,5 mg (TID) as per Summary of Product Characteristics (SPC).

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Detailed Description

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Conditions

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Parkinson Disease

Study Design

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Study Time Perspective

PROSPECTIVE

Interventions

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Pramipexole immediate release

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Idiopathic PD with or without fluctuations
* Indication for treatment with Pramipexole
* Presence of at least mild depressive symptoms (as judged by the treating physician)
* Ability to reliably complete a self-rating scale (Hospital Anxiety and Depression Scale (HADS))

Exclusion Criteria

* Any contraindications according to the Summary of Product Characteristics (SPC), hypersensitivity to pramipexole or to any of the excipients
* Ongoing treatment with pramipexole
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim Study Coordinator

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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Boehringer Ingelheim Investigational Site

Amstetten, , Austria

Site Status

Boehringer Ingelheim Investigational Site

Bad Hall, , Austria

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Boehringer Ingelheim Investigational Site

Bad Ischl, , Austria

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Boehringer Ingelheim Investigational Site

Bad Radkersburg, , Austria

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Boehringer Ingelheim Investigational Site

Baden, , Austria

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Boehringer Ingelheim Investigational Site

Bregenz, , Austria

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Boehringer Ingelheim Investigational Site

Bruck an der Mur, , Austria

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Boehringer Ingelheim Investigational Site

Deutschlandsberg, , Austria

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Boehringer Ingelheim Investigational Site

Dornbirn, , Austria

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Boehringer Ingelheim Investigational Site

Eisenstadt, , Austria

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Boehringer Ingelheim Investigational Site

Feldkirch, , Austria

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Boehringer Ingelheim Investigational Site

Feldkirchen in Kärnten, , Austria

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Boehringer Ingelheim Investigational Site

Gänserndorf, , Austria

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Boehringer Ingelheim Investigational Site

Gmunden, , Austria

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Boehringer Ingelheim Investigational Site

Graz, , Austria

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Boehringer Ingelheim Investigational Site

Grieskirchen, , Austria

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Boehringer Ingelheim Investigational Site

Hall in Tirol, , Austria

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Boehringer Ingelheim Investigational Site

Hallein, , Austria

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Boehringer Ingelheim Investigational Site

Hermagor, , Austria

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Boehringer Ingelheim Investigational Site

Hohenems, , Austria

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Boehringer Ingelheim Investigational Site

Hollabrunn, , Austria

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Boehringer Ingelheim Investigational Site

Horn, , Austria

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Boehringer Ingelheim Investigational Site

Imst, , Austria

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Boehringer Ingelheim Investigational Site

Innsbruck, , Austria

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Boehringer Ingelheim Investigational Site

Judenburg, , Austria

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Boehringer Ingelheim Investigational Site

Kapfenberg, , Austria

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Boehringer Ingelheim Investigational Site

Klagenfurt, , Austria

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Boehringer Ingelheim Investigational Site

Klosterneuburg, , Austria

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Boehringer Ingelheim Investigational Site

Knittelfeld, , Austria

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Boehringer Ingelheim Investigational Site

Krems, , Austria

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Boehringer Ingelheim Investigational Site

Kufstein, , Austria

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Boehringer Ingelheim Investigational Site

Leoben, , Austria

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Boehringer Ingelheim Investigational Site

Lienz, , Austria

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Boehringer Ingelheim Investigational Site

Lilienfeld, , Austria

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Boehringer Ingelheim Investigational Site

Linz, , Austria

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Boehringer Ingelheim Investigational Site

Melk, , Austria

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Boehringer Ingelheim Investigational Site

Neunkirchen, , Austria

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Boehringer Ingelheim Investigational Site

Oberwart, , Austria

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Boehringer Ingelheim Investigational Site

Ried im Innkreis, , Austria

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Boehringer Ingelheim Investigational Site

Salzburg, , Austria

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Boehringer Ingelheim Investigational Site

Sankt Pölten, , Austria

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Boehringer Ingelheim Investigational Site

Sankt Veit an der Glan, , Austria

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Boehringer Ingelheim Investigational Site

Scheibbs, , Austria

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Boehringer Ingelheim Investigational Site

Schwechat, , Austria

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Boehringer Ingelheim Investigational Site

Spital An Der Drau, , Austria

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Boehringer Ingelheim Investigational Site

St Johann im Pongau, , Austria

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Boehringer Ingelheim Investigational Site

Stegersbach, , Austria

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Boehringer Ingelheim Investigational Site

Stockerau, , Austria

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Boehringer Ingelheim Investigational Site

Telfs, , Austria

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Boehringer Ingelheim Investigational Site

Traun, , Austria

Site Status

Boehringer Ingelheim Investigational Site

Vienna, , Austria

Site Status

Boehringer Ingelheim Investigational Site

Villach, , Austria

Site Status

Boehringer Ingelheim Investigational Site

Vöcklabruck, , Austria

Site Status

Boehringer Ingelheim Investigational Site

W. Neustadt, , Austria

Site Status

Boehringer Ingelheim Investigational Site

Wels, , Austria

Site Status

Boehringer Ingelheim Investigational Site

Wolfsberg, , Austria

Site Status

Boehringer Ingelheim Investigational Site

Wörgl, , Austria

Site Status

Countries

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Austria

Other Identifiers

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248.649

Identifier Type: -

Identifier Source: org_study_id

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