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

Completed

• Conditions: Parkinson Disease

• Registration Number: NCT00651183
• Lead Sponsor: Boehringer Ingelheim

Brief 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).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2008-03-31
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Study First Submitted QC: 2008-04-01
• Study First Posted: 2008-04-02
• Results First Submitted: 2009-12-14
• Results First Submitted QC: 2010-02-11
• Results First Posted: 2010-03-03
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-09
• Last Update Posted: 2014-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 286

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))

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part I (Mentation, Behaviour and Mood)	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
Change From Baseline in Hospital Anxiety and Depression Scale - HADS-D Depression Subscore	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.
Change From Baseline in Hospital Anxiety and Depression Scale - HADS-A Anxiety Subscore	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.
Change From Baseline in UPDRS Part III (Motor Examination)	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)

Trial Locations

Locations (1)

Boehringer Ingelheim Investigational Site; 🇦🇹 Wörgl, Austria