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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00651183
First received: March 31, 2008
Last updated: May 9, 2014
Last verified: May 2014
  Purpose

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).


Condition Intervention Phase
Parkinson Disease
Drug: Pramipexole immediate release
Phase 4

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Non-motor Symptoms (Depressive Symptoms) of Parkinson's Disease and Their Course Under Pramipexole Treatment

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

    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 [ Time Frame: Baseline and Final (visit 3) - Change from baseline (i.e. decrease of score) ] [ Designated as safety issue: No ]

    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 [ Time Frame: Baseline and Final (visit 3) - Change from baseline (i.e. decrease of score) ] [ Designated as safety issue: No ]

    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) [ Time Frame: Baseline and Final (visit 3) - Change from baseline (i.e. decrease of score) ] [ Designated as safety issue: No ]
    14 components rating scale with 27 items scored by 0 (none) - 4 (severe)


Enrollment: 286
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

PD patients

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00651183

  Show 57 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Study Coordinator Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00651183     History of Changes
Other Study ID Numbers: 248.649
Study First Received: March 31, 2008
Results First Received: December 14, 2009
Last Updated: May 9, 2014
Health Authority: Austria: Bundesamt für Sicherheit im Gesundheitswesen
United States: Food and Drug Administration

Additional relevant MeSH terms:
Parkinson Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Parkinsonian Disorders
Pramipexole
Anti-Dyskinesia Agents
Antioxidants
Antiparkinson Agents
Central Nervous System Agents
Dopamine Agents
Dopamine Agonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014