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

NCT00651183 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 286

Last updated 2014-05-20

Study results available
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Summary

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).

Conditions

  • Parkinson Disease

Interventions

DRUG

Pramipexole immediate release

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim Study Coordinator · Boehringer Ingelheim

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Primary Completion
2008-04-30
Completion
2008-04-30

Countries

  • Austria

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00651183 on ClinicalTrials.gov