Parkinson DiseaseNCT00349310
Profile of Depressive Symptoms in Parkinsons Disease
An observational study of Parkinson Disease and Depression, run by Boehringer Ingelheim at 24 sites in 8 countries.
Trial summary
To explore or establish the relationship between cognitive, mood and motor symptoms in PD to scores on depression rating scales in a naturalistic setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease, Depression
- What is being tested?
- Pramipexole
- How many people
- 1,018 participants
- Where
- 24 sitesin 8 countries
- Study dates
- 1 Apr 2006to 1 Oct 2006
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion_Criteria:
Observation criteria:
- are able to provide written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
- have idiopathic Parkinsons disease according to the United Kingdom Parkinsons Disease Society Brain Bank Diagnostic Criteria for Parkinsons disease
- show no impairment of cognitive function (MMSE score ?24)
- are with or without symptoms of depression (full range)
- are stable on anti-Parkinson/anti-depressive treatment for at least 1 month before entering the study
- are or are not on concomitant antidepressant treatment
- are in the on state during the observation period
- did not previously undergo PD surgery
Trial locations and contacts
24 sites in 8 countries.
24 sites in 8 countries
Germany6 sites
Neurologisches Fachkrankenhaus fur
Beelitz-Heilstätten, 14547
Universitatsklinikum Carl Gustav Carus Dresden
Dresden, 01307
Boehringer Ingelheim Investigational Site
Gera, 07551
Gertrudis-Kliniken Biskirchen
Leun, 35638
Boehringer Ingelheim Investigational Site
Unterhaching, 82008
Parkinson Klinik Wolfach
Wolfach, 77709
Italy4 sites
Policlinico di Catania
Catania, 95125
Azienda Ospedaliera S. Martino
Genova, 16100
Universita Federico II
Naples, 80131
Universita La Sapienza di Roma
Roma, 00161
Austria3 sites
Boehringer Ingelheim Investigational Site
Innsbruck, 6020
Boehringer Ingelheim Investigational Site
Vienna, 1090
Boehringer Ingelheim Investigational Site
Vienna, 1130
Spain3 sites
Hospital de Cruces. Neurology
Baracaldo / Bilbao, 48903
Hospital Clinic i Provincial. Neurology
Barcelona, 08036
Hospital Puerta del Mar. Neurology
Cadiz, 11519
Switzerland3 sites
Clinica Hildebrand
Brissago, 6614
Hopital Cantonal (HUG)
Geneva, 1211
Kantonsspital St. Gallen
Sankt Gallen, 9007
United Kingdom2 sites
Boehringer Ingelheim Investigational Site
London, NW3 2QG
Boehringer Ingelheim Investigational Site
Newark, NG24 4DE
About this study
Official title: Profile of Depressive Symptoms in Parkinson's Disease (PRODEST-PD)
To explore or establish the relationship between cognitive, mood and motor symptoms in PD to scores on depression rating scales in a naturalistic setting.
- Conditions
- Parkinson Disease, Depression
- Being tested
- Pramipexole
- Medical subject headings
- Parkinson Disease, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PramipexoleDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
HADS, HAMD-17, BDI-1A, FAB (cognitive), DSM-IV (mood- part A, B, C, E) and UPDRS
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2006 (estimated)
- Study start1 Apr 2006
- Primary completion1 Oct 2006
- Study completion1 Oct 2006
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
- Enrolment
- 1,018 participants
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim Study Coordinator, Study chair, Boehringer Ingelheim BV/Alkmaar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00349310
- Sponsor's protocol ID
- 248.597
- Status last verified
- Dec 2023
- First submitted
- 5 Jul 2006
- Last updated
- 14 Dec 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Profile of Depressive Symptoms in Parkinson's Disease (PRODEST-PD)
- ClinicalTrials.gov ID
- NCT00349310
- Acronym / sponsor ID
- 248.597
- Conditions
- Parkinson Disease, Depression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,018 participants
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2006 (actual)
- Primary completion
- 1 Oct 2006 (actual)
- Study completion
- 1 Oct 2006 (actual)
- First posted
- 6 Jul 2006 (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 explore or establish the relationship between cognitive, mood and motor symptoms in PD to scores on depression rating scales in a naturalistic setting.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pramipexole | Drug | – |
Primary outcome
HADS, HAMD-17, BDI-1A, FAB (cognitive), DSM-IV (mood- part A, B, C, E) and UPDRS
Time frame: Up to 6 months
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 14 Dec 2023.
- Related InfoLink provided by the sponsor.
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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 Coordinator study chair
Boehringer Ingelheim BV/Alkmaar
24 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease and Depression, run by Boehringer Ingelheim at 24 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 14 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Germany, Italy, Austria, Spain, Switzerland and 3 more countries. 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?
HADS, HAMD-17, BDI-1A, FAB (cognitive), DSM-IV (mood- part A, B, C, E) and UPDRS (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Dec 2023.