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Completed

NCT Number: NCT00651183

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

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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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Boehringer Ingelheim Investigational Site, Amstetten, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pramipexole Immediate Release

Drug

Primary outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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)

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Important dates

Primary completion
2008
Study completion
2008
First posted
Apr 2, 2008
Registry last updated
May 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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