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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00752388
Enrollment
1588
Registered
2008-09-15
Start date
2008-11-30
Completion date
Unknown
Last updated
2013-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease

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.

Interventions

None listed

Sponsors

Boehringer Ingelheim
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frame
Prevalence of patients with depressive symptoms (based on WHO-5 and MDI) in total and in subgroupsday 1

Secondary

MeasureTime frame
MDI score (for a subgroup of patients with WHO-5 score < 13 or any WHO-5 item rated with 0 or 1)day 1
WHO-5 score and itemsday 1
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 patientsday 1
Investigator assessment of the applicability of the WHO-5 for screening for depression in PD patientsday 1

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026