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

May 9, 2014 updated by: Boehringer Ingelheim
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

286

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

  • Austria
      • Amstetten, Austria
        • Boehringer Ingelheim Investigational Site
      • Bad Hall, Austria
        • Boehringer Ingelheim Investigational Site
      • Bad Ischl, Austria
        • Boehringer Ingelheim Investigational Site
      • Bad Radkersburg, Austria
        • Boehringer Ingelheim Investigational Site
      • Baden, Austria
        • Boehringer Ingelheim Investigational Site
      • Bregenz, Austria
        • Boehringer Ingelheim Investigational Site
      • Bruck an der Mur, Austria
        • Boehringer Ingelheim Investigational Site
      • Deutschlandsberg, Austria
        • Boehringer Ingelheim Investigational Site
      • Dornbirn, Austria
        • Boehringer Ingelheim Investigational Site
      • Eisenstadt, Austria
        • Boehringer Ingelheim Investigational Site
      • Feldkirch, Austria
        • Boehringer Ingelheim Investigational Site
      • Feldkirchen, Austria
        • Boehringer Ingelheim Investigational Site
      • Gmunden, Austria
        • Boehringer Ingelheim Investigational Site
      • Graz, Austria
        • Boehringer Ingelheim Investigational Site
      • Grieskirchen, Austria
        • Boehringer Ingelheim Investigational Site
      • Gänserndorf, Austria
        • Boehringer Ingelheim Investigational Site
      • Hall in Tirol, Austria
        • Boehringer Ingelheim Investigational Site
      • Hallein, Austria
        • Boehringer Ingelheim Investigational Site
      • Hermagor, Austria
        • Boehringer Ingelheim Investigational Site
      • Hohenems, Austria
        • Boehringer Ingelheim Investigational Site
      • Hollabrunn, Austria
        • Boehringer Ingelheim Investigational Site
      • Horn, Austria
        • Boehringer Ingelheim Investigational Site
      • Imst, Austria
        • Boehringer Ingelheim Investigational Site
      • Innsbruck, Austria
        • Boehringer Ingelheim Investigational Site
      • Judenburg, Austria
        • Boehringer Ingelheim Investigational Site
      • Kapfenberg, Austria
        • Boehringer Ingelheim Investigational Site
      • Klagenfurt, Austria
        • Boehringer Ingelheim Investigational Site
      • Klosterneuburg, Austria
        • Boehringer Ingelheim Investigational Site
      • Knittelfeld, Austria
        • Boehringer Ingelheim Investigational Site
      • Krems, Austria
        • Boehringer Ingelheim Investigational Site
      • Kufstein, Austria
        • Boehringer Ingelheim Investigational Site
      • Leoben, Austria
        • Boehringer Ingelheim Investigational Site
      • Lienz, Austria
        • Boehringer Ingelheim Investigational Site
      • Lilienfeld, Austria
        • Boehringer Ingelheim Investigational Site
      • Linz, Austria
        • Boehringer Ingelheim Investigational Site
      • Melk, Austria
        • Boehringer Ingelheim Investigational Site
      • Neunkirchen, Austria
        • Boehringer Ingelheim Investigational Site
      • Oberwart, Austria
        • Boehringer Ingelheim Investigational Site
      • Ried im Innkreis, Austria
        • Boehringer Ingelheim Investigational Site
      • Salzburg, Austria
        • Boehringer Ingelheim Investigational Site
      • Scheibbs, Austria
        • Boehringer Ingelheim Investigational Site
      • Schwechat, Austria
        • Boehringer Ingelheim Investigational Site
      • Spital an der Drau, Austria
        • Boehringer Ingelheim Investigational Site
      • St. Johann im Pongau, Austria
        • Boehringer Ingelheim Investigational Site
      • St. Pölten, Austria
        • Boehringer Ingelheim Investigational Site
      • St. Veit an der Glan, Austria
        • Boehringer Ingelheim Investigational Site
      • Stegersbach, Austria
        • Boehringer Ingelheim Investigational Site
      • Stockerau, Austria
        • Boehringer Ingelheim Investigational Site
      • Telfs, Austria
        • Boehringer Ingelheim Investigational Site
      • Traun, Austria
        • Boehringer Ingelheim Investigational Site
      • Villach, Austria
        • Boehringer Ingelheim Investigational Site
      • Vöcklabruck, Austria
        • Boehringer Ingelheim Investigational Site
      • W. Neustadt, Austria
        • Boehringer Ingelheim Investigational Site
      • Wels, Austria
        • Boehringer Ingelheim Investigational Site
      • Wien, Austria
        • Boehringer Ingelheim Investigational Site
      • Wolfsberg, Austria
        • Boehringer Ingelheim Investigational Site
      • Wörgl, Austria
        • Boehringer Ingelheim Investigational Site

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:

  • 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

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
Measure Description
Time Frame
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)

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)
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)

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)
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)

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)
Change From Baseline in UPDRS Part III (Motor Examination)
Time Frame: Baseline and Final (visit 3) - Change from baseline (i.e. decrease of score)
14 components rating scale with 27 items scored by 0 (none) - 4 (severe)
Baseline and Final (visit 3) - Change from baseline (i.e. decrease of score)

Collaborators and Investigators

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

Sponsor

Boehringer Ingelheim

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.

Helpful Links

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

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

March 31, 2008

First Submitted That Met QC Criteria

April 1, 2008

First Posted (Estimate)

April 2, 2008

Study Record Updates

Last Update Posted (Estimate)

May 20, 2014

Last Update Submitted That Met QC Criteria

May 9, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

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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