Depression Clinical Trial
Official title:
Profile of Depressive Symptoms in Parkinson's Disease (PRODEST-PD)
| NCT number | NCT00349310 |
| Other study ID # | 248.597 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | April 1, 2006 |
| Est. completion date | October 1, 2006 |
| Verified date | December 2023 |
| Source | Boehringer Ingelheim |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
To explore or establish the relationship between cognitive, mood and motor symptoms in PD to scores on depression rating scales in a naturalistic setting.
| Status | Completed |
| Enrollment | 1018 |
| Est. completion date | October 1, 2006 |
| Est. primary completion date | October 1, 2006 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Austria | Boehringer Ingelheim Investigational Site | Innsbruck | |
| Austria | Boehringer Ingelheim Investigational Site | Wien | |
| Austria | Boehringer Ingelheim Investigational Site | Wien | |
| France | Hopital Purpan | Toulouse cedex | |
| France | Hopital Rangueil | Toulouse cedex 9 | |
| Germany | Neurologisches Fachkrankenhaus fur | Beelitz-Heilstatten | |
| Germany | Universitatsklinikum Carl Gustav Carus Dresden | Dresden | |
| Germany | Boehringer Ingelheim Investigational Site | Gera | |
| Germany | Gertrudis-Kliniken Biskirchen | Leun | |
| Germany | Boehringer Ingelheim Investigational Site | Unterhaching | |
| Germany | Parkinson Klinik Wolfach | Wolfach | |
| Italy | Policlinico di Catania | Catania | |
| Italy | Azienda Ospedaliera S. Martino | Genova | |
| Italy | Universita Federico II | Napoli | |
| Italy | Universita La Sapienza di Roma | Roma | |
| Netherlands | Academisch Ziekenhuis Maastricht | Maastricht | |
| Spain | Hospital de Cruces. Neurology | Baracaldo / Bilbao | |
| Spain | Hospital Clinic i Provincial. Neurology | Barcelona | |
| Spain | Hospital Puerta del Mar. Neurology | Cadiz | |
| Switzerland | Clinica Hildebrand | Brissago | |
| Switzerland | Hopital Cantonal (HUG) | Geneve | |
| Switzerland | Kantonsspital St. Gallen | St.Gallen | |
| United Kingdom | Boehringer Ingelheim Investigational Site | London | |
| United Kingdom | Boehringer Ingelheim Investigational Site | Newark |
| Lead Sponsor | Collaborator |
|---|---|
| Boehringer Ingelheim |
Austria, France, Germany, Italy, Netherlands, Spain, Switzerland, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | HADS, HAMD-17, BDI-1A, FAB (cognitive), DSM-IV (mood- part A, B, C, E) and UPDRS | Up to 6 months |
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