- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00651183
Non-motor Symptoms (Depressive Symptoms) of Parkinson's Disease and Their Course Under Pramipexole Treatment
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Amstetten, Austria
- Boehringer Ingelheim Investigational Site
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Bad Hall, Austria
- Boehringer Ingelheim Investigational Site
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Bad Ischl, Austria
- Boehringer Ingelheim Investigational Site
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Bad Radkersburg, Austria
- Boehringer Ingelheim Investigational Site
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Baden, Austria
- Boehringer Ingelheim Investigational Site
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Bregenz, Austria
- Boehringer Ingelheim Investigational Site
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Bruck an der Mur, Austria
- Boehringer Ingelheim Investigational Site
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Deutschlandsberg, Austria
- Boehringer Ingelheim Investigational Site
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Dornbirn, Austria
- Boehringer Ingelheim Investigational Site
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Eisenstadt, Austria
- Boehringer Ingelheim Investigational Site
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Feldkirch, Austria
- Boehringer Ingelheim Investigational Site
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Feldkirchen, Austria
- Boehringer Ingelheim Investigational Site
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Gmunden, Austria
- Boehringer Ingelheim Investigational Site
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Graz, Austria
- Boehringer Ingelheim Investigational Site
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Grieskirchen, Austria
- Boehringer Ingelheim Investigational Site
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Gänserndorf, Austria
- Boehringer Ingelheim Investigational Site
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Hall in Tirol, Austria
- Boehringer Ingelheim Investigational Site
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Hallein, Austria
- Boehringer Ingelheim Investigational Site
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Hermagor, Austria
- Boehringer Ingelheim Investigational Site
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Hohenems, Austria
- Boehringer Ingelheim Investigational Site
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Hollabrunn, Austria
- Boehringer Ingelheim Investigational Site
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Horn, Austria
- Boehringer Ingelheim Investigational Site
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Imst, Austria
- Boehringer Ingelheim Investigational Site
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Innsbruck, Austria
- Boehringer Ingelheim Investigational Site
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Judenburg, Austria
- Boehringer Ingelheim Investigational Site
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Kapfenberg, Austria
- Boehringer Ingelheim Investigational Site
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Klagenfurt, Austria
- Boehringer Ingelheim Investigational Site
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Klosterneuburg, Austria
- Boehringer Ingelheim Investigational Site
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Knittelfeld, Austria
- Boehringer Ingelheim Investigational Site
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Krems, Austria
- Boehringer Ingelheim Investigational Site
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Kufstein, Austria
- Boehringer Ingelheim Investigational Site
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Leoben, Austria
- Boehringer Ingelheim Investigational Site
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Lienz, Austria
- Boehringer Ingelheim Investigational Site
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Lilienfeld, Austria
- Boehringer Ingelheim Investigational Site
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Linz, Austria
- Boehringer Ingelheim Investigational Site
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Melk, Austria
- Boehringer Ingelheim Investigational Site
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Neunkirchen, Austria
- Boehringer Ingelheim Investigational Site
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Oberwart, Austria
- Boehringer Ingelheim Investigational Site
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Ried im Innkreis, Austria
- Boehringer Ingelheim Investigational Site
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Salzburg, Austria
- Boehringer Ingelheim Investigational Site
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Scheibbs, Austria
- Boehringer Ingelheim Investigational Site
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Schwechat, Austria
- Boehringer Ingelheim Investigational Site
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Spital an der Drau, Austria
- Boehringer Ingelheim Investigational Site
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St. Johann im Pongau, Austria
- Boehringer Ingelheim Investigational Site
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St. Pölten, Austria
- Boehringer Ingelheim Investigational Site
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St. Veit an der Glan, Austria
- Boehringer Ingelheim Investigational Site
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Stegersbach, Austria
- Boehringer Ingelheim Investigational Site
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Stockerau, Austria
- Boehringer Ingelheim Investigational Site
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Telfs, Austria
- Boehringer Ingelheim Investigational Site
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Traun, Austria
- Boehringer Ingelheim Investigational Site
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Villach, Austria
- Boehringer Ingelheim Investigational Site
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Vöcklabruck, Austria
- Boehringer Ingelheim Investigational Site
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W. Neustadt, Austria
- Boehringer Ingelheim Investigational Site
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Wels, Austria
- Boehringer Ingelheim Investigational Site
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Wien, Austria
- Boehringer Ingelheim Investigational Site
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Wolfsberg, Austria
- Boehringer Ingelheim Investigational Site
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Wörgl, Austria
- Boehringer Ingelheim Investigational Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part I (Mentation, Behaviour and Mood)
Time Frame: Baseline and Final (visit 3) - Change from baseline (i.e. decrease of score)
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Rating scale scored from 0 (none) - 4 (severe). The UPDRS Part I (Mentation, Behaviour and Mood during the Past Week) consist of 4 items, each of them is scored from 0 (normal) to 4 (severe). Reduction in this score over time is interpreted as improvement. Total UPDRS part I score ranges from 0 = best score to 16 = worst score |
Baseline and Final (visit 3) - Change from baseline (i.e. decrease of score)
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Change From Baseline in Hospital Anxiety and Depression Scale - HADS-D Depression Subscore
Time Frame: Baseline and Final (visit 3) - Change from baseline (i.e. decrease of score)
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Depression Scale - 7 items scored for each individual question from 0 = best and 3 = worst. HADS is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises of 14 items, thereof seven statements describe anxiety and seven statements depression. Each answer is rated on a four-point scale (0-3). All seven answers are summarized and calculated to a total score to the anxiety scale and to the depression scale with a maximum score of 21 points for each scale. |
Baseline and Final (visit 3) - Change from baseline (i.e. decrease of score)
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Change From Baseline in Hospital Anxiety and Depression Scale - HADS-A Anxiety Subscore
Time Frame: Baseline and Final (visit 3) - Change from baseline (i.e. decrease of score)
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Anxiety Scale - 7 items scored for each individual question from 0 = best and 3 = worst. HADS is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises of 14 items, thereof seven statements describe anxiety and seven statements depression. Each answer is rated on a four-point scale (0-3). All seven answers are summarized and calculated to a total score to the anxiety scale and to the depression scale with a maximum score of 21 points for each scale. |
Baseline and Final (visit 3) - Change from baseline (i.e. decrease of score)
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Change From Baseline in UPDRS Part III (Motor Examination)
Time Frame: Baseline and Final (visit 3) - Change from baseline (i.e. decrease of score)
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14 components rating scale with 27 items scored by 0 (none) - 4 (severe)
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Baseline and Final (visit 3) - Change from baseline (i.e. decrease of score)
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Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Movement Disorders
- Synucleinopathies
- Neurodegenerative Diseases
- Depression
- Parkinson Disease
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Protective Agents
- Dopamine Agonists
- Dopamine Agents
- Antioxidants
- Antiparkinson Agents
- Anti-Dyskinesia Agents
- Pramipexole
Other Study ID Numbers
- 248.649
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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