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

Completed

• Conditions: Parkinson Disease

• Registration Number: NCT00752388
• Lead Sponsor: Boehringer Ingelheim

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-09-12
• Study First Submitted QC: 2008-09-12
• Study First Posted: 2008-09-15
• Study Start: 2008-11
• Primary Completion: 2008-11
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-18
• Last Update Posted: 2013-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1588

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of patients with depressive symptoms (based on WHO-5 and MDI) in total and in subgroups	day 1

Secondary Outcome Measures

Name	Time	Method
WHO-5 score and items	day 1
MDI score (for a subgroup of patients with WHO-5 score < 13 or any WHO-5 item rated with 0 or 1)	day 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 patients	day 1
Investigator assessment of the applicability of the WHO-5 for screening for depression in PD patients	day 1

Trial Locations

Locations (15)

Boehringer Ingelheim Investigational Site 2; 🇩🇪 Wuppertal, Germany

Boehringer Ingelheim Investigational Site 13; 🇩🇪 Berlin, Germany

Boehringer Ingelheim Investigational Site 14; 🇩🇪 Berlin, Germany

Boehringer Ingelheim Investigational Site 1; 🇩🇪 Wuppertal, Germany

Boehringer Ingelheim Investigational Site 6; 🇩🇪 Köln, Germany

Boehringer Ingelheim Investigational Site 9; 🇩🇪 Berlin, Germany

Boehringer Ingelheim Investigational Site 8; 🇩🇪 Berlin, Germany

Boehringer Ingelheim Investigational Site; 🇩🇪 Zwickau, Germany

Boehringer Ingelheim Investigational Site 10; 🇩🇪 Berlin, Germany

Boehringer Ingelheim Investigational Site 11; 🇩🇪 Berlin, Germany

Boehringer Ingelheim Investigational Site 12; 🇩🇪 Berlin, Germany

Boehringer Ingelheim Investigational Site 4; 🇩🇪 Mannheim, Germany

Boehringer Ingelheim Investigational Site 5; 🇩🇪 Lüdenscheid, Germany

Boehringer Ingelheim Investigational Site 3; 🇩🇪 Solingen, Germany

Boehringer Ingelheim Investigational Site 7; 🇩🇪 Köln, Germany