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Completed

NCT Number: NCT00752388

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

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.

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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

30 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Boehringer Ingelheim Investigational Site 1, Achim, Germany

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • PD Patients who only attend the practice to get a prescription and are not seen by the doctor on that day
  • Patients who are not able to understand the questionnaires (e.g. due to mental impairment or language problems).

Treatment and study plan

Primary outcomes

  1. Prevalence of patients with depressive symptoms (based on WHO-5 and MDI) in total and in subgroups

    Time frame: day 1

Secondary outcomes

  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

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Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Application of the WHO-5 Well-being Index (WHO-5) as a Screening Instrument for Depression in Parkinson's Disease

Important dates

Study start
2008
Primary completion
2008
First posted
Sep 15, 2008
Registry last updated
Nov 19, 2013

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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