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

An observational study of Parkinson Disease, run by Boehringer Ingelheim at 278 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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… Read more about this study

Who is it for?: Ages 30 years and older
Conditions the study is for: Parkinson Disease
How many people: 1,588 participants
Where: 278 sitesGermany
Study dates: Nov 2008to Nov 2008
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: resident physician

Who may be able to join

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.

Who cannot join

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).

Trial locations and contacts

278 sites in 1 country.

City, postcode or hospital

278 sites in 1 country

Germany278 sites

Boehringer Ingelheim Investigational Site 1
Achim
Boehringer Ingelheim Investigational Site 2
Achim
Boehringer Ingelheim Investigational Site
Altenburg
Boehringer Ingelheim Investigational Site
Altenholz
Boehringer Ingelheim Investigational Site
Alzey
Boehringer Ingelheim Investigational Site
Aue
Boehringer Ingelheim Investigational Site
Bad Driburg
Boehringer Ingelheim Investigational Site
Bad Homburg
Boehringer Ingelheim Investigational Site
Bad Honnef
Boehringer Ingelheim Investigational Site
Bad Neuenahr-Ahrweiler
Boehringer Ingelheim Investigational Site 1
Bad Soden
Boehringer Ingelheim Investigational Site 2
Bad Soden
Boehringer Ingelheim Investigational Site
Bad Sooden-Allendorf
Boehringer Ingelheim Investigational Site
Bergisch Gladbach
Boehringer Ingelheim Investigational Site 10
Berlin
Boehringer Ingelheim Investigational Site 11
Berlin
Boehringer Ingelheim Investigational Site 12
Berlin
Boehringer Ingelheim Investigational Site 13
Berlin
Boehringer Ingelheim Investigational Site 14
Berlin
Boehringer Ingelheim Investigational Site 1
Berlin
Boehringer Ingelheim Investigational Site 2
Berlin
Boehringer Ingelheim Investigational Site 3
Berlin
Boehringer Ingelheim Investigational Site 4
Berlin
Boehringer Ingelheim Investigational Site 5
Berlin
Boehringer Ingelheim Investigational Site 6
Berlin
Boehringer Ingelheim Investigational Site 7
Berlin
Boehringer Ingelheim Investigational Site 8
Berlin
Boehringer Ingelheim Investigational Site 9
Berlin
Boehringer Ingelheim Investigational Site 1
Bielefeld
Boehringer Ingelheim Investigational Site 2
Bielefeld
Boehringer Ingelheim Investigational Site 1
Bochum
Boehringer Ingelheim Investigational Site 2
Bochum
Boehringer Ingelheim Investigational Site 3
Bochum
Boehringer Ingelheim Investigational Site
Bockhorn
Boehringer Ingelheim Investigational Site
Bonn
Boehringer Ingelheim Investigational Site
Braunschweig
Boehringer Ingelheim Investigational Site
Bremen
Boehringer Ingelheim Investigational Site
Bremerhaven
Boehringer Ingelheim Investigational Site
Bretten
Boehringer Ingelheim Investigational Site 1
Butzbach
Boehringer Ingelheim Investigational Site 2
Butzbach
Boehringer Ingelheim Investigational Site
Buxtehude
Boehringer Ingelheim Investigational Site
Castrop-Rauxel
Boehringer Ingelheim Investigational Site
Chemnitz
Boehringer Ingelheim Investigational Site
Cloppenburg
Boehringer Ingelheim Investigational Site
Coesfeld
Boehringer Ingelheim Investigational Site 1
Cologne
Boehringer Ingelheim Investigational Site 2
Cologne
Boehringer Ingelheim Investigational Site 3
Cologne
Boehringer Ingelheim Investigational Site 4
Cologne
Boehringer Ingelheim Investigational Site 5
Cologne
Boehringer Ingelheim Investigational Site 6
Cologne
Boehringer Ingelheim Investigational Site 7
Cologne
Boehringer Ingelheim Investigational Site 1
Cottbus
Boehringer Ingelheim Investigational Site 2
Cottbus
Boehringer Ingelheim Investigational Site
Delmenhorst
Boehringer Ingelheim Investigational Site 1
Dessau
Boehringer Ingelheim Investigational Site 2
Dessau
Boehringer Ingelheim Investigational Site
Dietzenbach
Boehringer Ingelheim Investigational Site
Dippoldiswalde
Boehringer Ingelheim Investigational Site 1
Dortmund
Boehringer Ingelheim Investigational Site 2
Dortmund
Boehringer Ingelheim Investigational Site 3
Dortmund
Boehringer Ingelheim Investigational Site 1
Dresden
Boehringer Ingelheim Investigational Site 2
Dresden
Boehringer Ingelheim Investigational Site 3
Dresden
Boehringer Ingelheim Investigational Site 4
Dresden
Boehringer Ingelheim Investigational Site 1
Duisburg
Boehringer Ingelheim Investigational Site 2
Duisburg
Boehringer Ingelheim Investigational Site 3
Duisburg
Boehringer Ingelheim Investigational Site 4
Duisburg
Boehringer Ingelheim Investigational Site
Dülmen
Boehringer Ingelheim Investigational Site 1
Düsseldorf
Boehringer Ingelheim Investigational Site 2
Düsseldorf
Boehringer Ingelheim Investigational Site 3
Düsseldorf
Boehringer Ingelheim Investigational Site 4
Düsseldorf
Boehringer Ingelheim Investigational Site 5
Düsseldorf
Boehringer Ingelheim Investigational Site 1
Erbach im Odenwald
Boehringer Ingelheim Investigational Site 2
Erbach im Odenwald
Boehringer Ingelheim Investigational Site
Erftstadt
Boehringer Ingelheim Investigational Site
Essen
Boehringer Ingelheim Investigational Site 1
Frankfurt
Boehringer Ingelheim Investigational Site 2
Frankfurt
Boehringer Ingelheim Investigational Site
Freiburg im Breisgau
Boehringer Ingelheim Investigational Site
Fürstenwalde
Boehringer Ingelheim Investigational Site
Gelnhausen
Boehringer Ingelheim Investigational Site 1
Gelsenkirchen
Boehringer Ingelheim Investigational Site 2
Gelsenkirchen
Boehringer Ingelheim Investigational Site
Gengenbach
Boehringer Ingelheim Investigational Site
Gera
Boehringer Ingelheim Investigational Site
Giessen
Boehringer Ingelheim Investigational Site
Gifhorn
Boehringer Ingelheim Investigational Site
Gladenbach
Boehringer Ingelheim Investigational Site
Goch
Boehringer Ingelheim Investigational Site
Göttingen
Boehringer Ingelheim Investigational Site
Grünstadt
Boehringer Ingelheim Investigational Site 1
Güstrow
Boehringer Ingelheim Investigational Site 2
Güstrow
Boehringer Ingelheim Investigational Site
Gütersloh
Boehringer Ingelheim Investigational Site 1
Halle
Boehringer Ingelheim Investigational Site 2
Halle
Boehringer Ingelheim Investigational Site 3
Halle
Boehringer Ingelheim Investigational Site 1
Hamburg
Boehringer Ingelheim Investigational Site 2
Hamburg
Boehringer Ingelheim Investigational Site 3
Hamburg
Boehringer Ingelheim Investigational Site 4
Hamburg
Boehringer Ingelheim Investigational Site 5
Hamburg
Boehringer Ingelheim Investigational Site
Hamelin
Boehringer Ingelheim Investigational Site 1
Hanover
Boehringer Ingelheim Investigational Site 2
Hanover
Boehringer Ingelheim Investigational Site 3
Hanover
Boehringer Ingelheim Investigational Site 4
Hanover
Boehringer Ingelheim Investigational Site 1
Heidelberg
Boehringer Ingelheim Investigational Site 2
Heidelberg
Boehringer Ingelheim Investigational Site
Heilbronn
Boehringer Ingelheim Investigational Site
Hemmoor
Boehringer Ingelheim Investigational Site
Hennigsdorf
Boehringer Ingelheim Investigational Site
Henstedt-Ulzburg
Boehringer Ingelheim Investigational Site
Herborn
Boehringer Ingelheim Investigational Site
Herzberg
Boehringer Ingelheim Investigational Site
Herzogenrath
Boehringer Ingelheim Investigational Site 1
Hildesheim
Boehringer Ingelheim Investigational Site 2
Hildesheim
Boehringer Ingelheim Investigational Site 3
Hildesheim
Boehringer Ingelheim Investigational Site 4
Hildesheim
Boehringer Ingelheim Investigational Site 5
Hildesheim
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Homburg
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Hückelhoven
Boehringer Ingelheim Investigational Site
Hürth
Boehringer Ingelheim Investigational Site 1
Ilmenau
Boehringer Ingelheim Investigational Site 2
Ilmenau
Boehringer Ingelheim Investigational Site
Ingelheim
Boehringer Ingelheim Investigational Site
Iserlohn
Boehringer Ingelheim Investigational Site
Itzehoe
Boehringer Ingelheim Investigational Site
Kamen
Boehringer Ingelheim Investigational Site
Kamp-Lintfort
Boehringer Ingelheim Investigational Site
Kandel
Boehringer Ingelheim Investigational Site
Karlstadt am Main
Boehringer Ingelheim Investigational Site 1
Kassel
Boehringer Ingelheim Investigational Site 2
Kassel
Boehringer Ingelheim Investigational Site
Kaufbeuren
Boehringer Ingelheim Investigational Site
Kiel
Boehringer Ingelheim Investigational Site
Kleinblittersdorf
Boehringer Ingelheim Investigational Site
Kleve
Boehringer Ingelheim Investigational Site
Lappersdorf
Boehringer Ingelheim Investigational Site
Lauterbach
Boehringer Ingelheim Investigational Site 1
Leer
Boehringer Ingelheim Investigational Site 2
Leer
Boehringer Ingelheim Investigational Site 1
Leipzig
Boehringer Ingelheim Investigational Site 2
Leipzig
Boehringer Ingelheim Investigational Site 3
Leipzig
Boehringer Ingelheim Investigational Site 4
Leipzig
Boehringer Ingelheim Investigational Site 5
Leipzig
Boehringer Ingelheim Investigational Site 1
Leverkusen
Boehringer Ingelheim Investigational Site 2
Leverkusen
Boehringer Ingelheim Investigational Site
Löbau
Boehringer Ingelheim Investigational Site 1
Lüdenscheid
Boehringer Ingelheim Investigational Site 2
Lüdenscheid
Boehringer Ingelheim Investigational Site 3
Lüdenscheid
Boehringer Ingelheim Investigational Site 4
Lüdenscheid
Boehringer Ingelheim Investigational Site 5
Lüdenscheid
Boehringer Ingelheim Investigational Site
Ludwigsfelde
Boehringer Ingelheim Investigational Site 1
Ludwigshafen
Boehringer Ingelheim Investigational Site 2
Ludwigshafen
Boehringer Ingelheim Investigational Site 3
Ludwigshafen
Boehringer Ingelheim Investigational Site
Ludwigslust
Boehringer Ingelheim Investigational Site 1
Lüneburg
Boehringer Ingelheim Investigational Site 2
Lüneburg
Boehringer Ingelheim Investigational Site 1
Lünen
Boehringer Ingelheim Investigational Site 2
Lünen
Boehringer Ingelheim Investigational Site
Magdeburg
Boehringer Ingelheim Investigational Site
Malente
Boehringer Ingelheim Investigational Site 1
Mannheim
Boehringer Ingelheim Investigational Site 2
Mannheim
Boehringer Ingelheim Investigational Site 3
Mannheim
Boehringer Ingelheim Investigational Site 4
Mannheim
Boehringer Ingelheim Investigational Site
Markkleeberg
Boehringer Ingelheim Investigational Site
Marl
Boehringer Ingelheim Investigational Site
Memmingen
Boehringer Ingelheim Investigational Site
Menden
Boehringer Ingelheim Investigational Site
Mittweida
Boehringer Ingelheim Investigational Site 1
Mönchengladbach
Boehringer Ingelheim Investigational Site 2
Mönchengladbach
Boehringer Ingelheim Investigational Site 3
Mönchengladbach
Boehringer Ingelheim Investigational Site
Mühlacker
Boehringer Ingelheim Investigational Site 1
Mülheim
Boehringer Ingelheim Investigational Site 2
Mülheim
Boehringer Ingelheim Investigational Site 3
Mülheim
Boehringer Ingelheim Investigational Site 1
Münster
Boehringer Ingelheim Investigational Site 2
Münster
Boehringer Ingelheim Investigational Site 3
Münster
Boehringer Ingelheim Investigational Site
Naumburg
Boehringer Ingelheim Investigational Site
Neubrandenburg
Boehringer Ingelheim Investigational Site
Neuenhagen
Boehringer Ingelheim Investigational Site
Neukirchen-Vluyn
Boehringer Ingelheim Investigational Site
Neumünster
Boehringer Ingelheim Investigational Site
Neustadt
Boehringer Ingelheim Investigational Site
Norden
Boehringer Ingelheim Investigational Site
Nordhorn
Boehringer Ingelheim Investigational Site
Nübel
Boehringer Ingelheim Investigational Site
Oberndorf
Boehringer Ingelheim Investigational Site
Offenbach
Boehringer Ingelheim Investigational Site
Oldenburg
Boehringer Ingelheim Investigational Site
Oranienburg
Boehringer Ingelheim Investigational Site
Oschatz
Boehringer Ingelheim Investigational Site
Osnabrück
Boehringer Ingelheim Investigational Site
Paderborn
Boehringer Ingelheim Investigational Site
Pirmasens
Boehringer Ingelheim Investigational Site
Plauen
Boehringer Ingelheim Investigational Site
Potsdam
Boehringer Ingelheim Investigational Site
Quakenbrück
Boehringer Ingelheim Investigational Site
Rastatt
Boehringer Ingelheim Investigational Site
Rathenow
Boehringer Ingelheim Investigational Site 1
Regensburg
Boehringer Ingelheim Investigational Site 2
Regensburg
Boehringer Ingelheim Investigational Site
Remscheid
Boehringer Ingelheim Investigational Site
Rendsburg
Boehringer Ingelheim Investigational Site
Rheine
Boehringer Ingelheim Investigational Site
Ribnitz-Damgarten
Boehringer Ingelheim Investigational Site
Riesa
Boehringer Ingelheim Investigational Site
Rödermark
Boehringer Ingelheim Investigational Site 1
Rostock
Boehringer Ingelheim Investigational Site 2
Rostock
Boehringer Ingelheim Investigational Site 3
Rostock
Boehringer Ingelheim Investigational Site
Rüdersdorf
Boehringer Ingelheim Investigational Site
Rüsselsheim am Main
Boehringer Ingelheim Investigational Site
Salzgitter
Boehringer Ingelheim Investigational Site
Schirgiswalde
Boehringer Ingelheim Investigational Site
Schleiden
Boehringer Ingelheim Investigational Site
Schriesheim
Boehringer Ingelheim Investigational Site
Schwelm
Boehringer Ingelheim Investigational Site 1
Schwerin
Boehringer Ingelheim Investigational Site 2
Schwerin
Boehringer Ingelheim Investigational Site
Seeheim-Jugenheim
Boehringer Ingelheim Investigational Site
Senftenberg
Boehringer Ingelheim Investigational Site 1
Solingen
Boehringer Ingelheim Investigational Site 2
Solingen
Boehringer Ingelheim Investigational Site 3
Solingen
Boehringer Ingelheim Investigational Site
Sömmerda
Boehringer Ingelheim Investigational Site 1
Stade
Boehringer Ingelheim Investigational Site 2
Stade
Boehringer Ingelheim Investigational Site
Stollberg
Boehringer Ingelheim Investigational Site 1
Stralsund
Boehringer Ingelheim Investigational Site 2
Stralsund
Boehringer Ingelheim Investigational Site
Strausberg
Boehringer Ingelheim Investigational Site
Telgte
Boehringer Ingelheim Investigational Site
Teltow
Boehringer Ingelheim Investigational Site
Torgau
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Trier
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Troisdorf
Boehringer Ingelheim Investigational Site
Vechta
Boehringer Ingelheim Investigational Site 1
Velen
Boehringer Ingelheim Investigational Site 2
Velen
Boehringer Ingelheim Investigational Site 1
Verden an der Aller
Boehringer Ingelheim Investigational Site 2
Verden an der Aller
Boehringer Ingelheim Investigational Site
Viersen
Boehringer Ingelheim Investigational Site
Villingen-Schwenningen
Boehringer Ingelheim Investigational Site
Voerde
Boehringer Ingelheim Investigational Site 1
Warendorf
Boehringer Ingelheim Investigational Site 2
Warendorf
Boehringer Ingelheim Investigational Site
Wedel
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Weida
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Weil am Rhein
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Weißenfels
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Werdau
Boehringer Ingelheim Investigational Site
Wesseling
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Wetzlar
Boehringer Ingelheim Investigational Site
Weyhe
Boehringer Ingelheim Investigational Site 1
Wismar
Boehringer Ingelheim Investigational Site 2
Wismar
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Wolfratshausen
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Wolgast
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Wunstorf
Boehringer Ingelheim Investigational Site 1
Wuppertal
Boehringer Ingelheim Investigational Site 2
Wuppertal
Boehringer Ingelheim Investigational Site
Würzburg
Boehringer Ingelheim Investigational Site
Zella-Mehlis
Boehringer Ingelheim Investigational Site
Zwickau

Other trials in Germany

About this study

Official title: Application of the WHO-5 Well-being Index (WHO-5) as a Screening Instrument for Depression 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.

Conditions: Parkinson Disease
Medical subject headings: Parkinson Disease

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (4)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2008Nov 2008

First posted15 Sep 2008 (estimated)
Study startNov 2008
Primary completionNov 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 1,588 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00752388
Sponsor's protocol ID: 248.658
Status last verified: Nov 2013
First submitted: 12 Sep 2008
Last updated: 19 Nov 2013
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Parkinson Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Application of the WHO-5 Well-being Index (WHO-5) as a Screening Instrument for Depression in Parkinson's Disease
ClinicalTrials.gov ID: NCT00752388
Acronym / sponsor ID: 248.658
Conditions: Parkinson Disease
Study type: Observational
Recruitment status: Completed
Enrolment: 1,588 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Nov 2008
Primary completion: Nov 2008 (actual)
First posted: 15 Sep 2008 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: 30 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: resident physician

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (2 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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

4 secondary outcomes

WHO-5 score and items
Time frame: day 1
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
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
Investigator assessment of the applicability of the WHO-5 for screening for depression in PD patients
Time frame: day 1

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2013.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

278 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Parkinson Disease, run by Boehringer Ingelheim at 278 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 278 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevalence of patients with depressive symptoms (based on WHO-5 and MDI) in total and in subgroups (time frame: day 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00752388.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2013.