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Non-interventional Observational Study on WHO-5 Questionnaire Application in Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT00752388
Recruitment Status : Completed
First Posted : September 15, 2008
Last Update Posted : November 19, 2013
Sponsor:
Information provided by:
Boehringer Ingelheim

Study Description
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Brief Summary:

To assess the predictive value of sequential administration of WHO-5 and MDI (Major Depression Inventory) for the clinical management of Parkinson Disease (PD) patients by

  • determination of the prevalence of depression in PD patients, based on MDI severity categories and the self-rating scale WHO-5, where poor well being was indicated.
  • exploration of influencing factors (PD status, therapeutic status) on the prevalence of MDI depression categories.

Condition or disease
Parkinson Disease

Study Design
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Study Type : Observational
Actual Enrollment : 1588 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Application of the WHO-5 Well-being Index (WHO-5) as a Screening Instrument for Depression in Parkinson's Disease
Study Start Date : November 2008
Actual Primary Completion Date : November 2008

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Prevalence of patients with depressive symptoms (based on WHO-5 and MDI) in total and in subgroups [ Time Frame: day 1 ]

Secondary Outcome Measures :
  1. WHO-5 score and items [ Time Frame: day 1 ]
  2. MDI score (for a subgroup of patients with WHO-5 score < 13 or any WHO-5 item rated with 0 or 1) [ Time Frame: day 1 ]
  3. Correlation of WHO-5 and MDI (for a subgroup of patients with a WHO-5 score < 13 or any WHO-5 item rated with 0 or 1) in PD patients [ Time Frame: day 1 ]
  4. Investigator assessment of the applicability of the WHO-5 for screening for depression in PD patients [ Time Frame: day 1 ]

Eligibility Criteria
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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
resident physician
Criteria

Inclusion Criteria:

  1. PD patients attending one of the participating neurologist practices during 2 fixed weeks in November 2008
  2. Idiopathic PD with or without fluctuations
  3. Male or female PD patients aged at least 30
  4. Ability to reliably complete self-rating scales (WHO-5, MDI) ), according to the physician's judgement.
  5. Written informed consent by the patient for study participation.

Exclusion Criteria:

  1. PD Patients who only attend the practice to get a prescription and are not seen by the doctor on that day
  2. Patients who are not able to understand the questionnaires (e.g. due to mental impairment or language problems).
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00752388


Locations
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Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
More Information
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Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00752388    
Other Study ID Numbers: 248.658
First Posted: September 15, 2008    Key Record Dates
Last Update Posted: November 19, 2013
Last Verified: November 2013
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases