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Trial record 31 of 33 for:    "Depressive Disorder" [DISEASE] AND Behavioral AND BDI | ( Map: Spain )

Profile of Depressive Symptoms in Parkinsons Disease

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ClinicalTrials.gov Identifier: NCT00349310
Recruitment Status : Completed
First Posted : July 6, 2006
Last Update Posted : November 1, 2013
Sponsor:
Information provided by:
Boehringer Ingelheim

Brief 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.

Condition or disease Intervention/treatment
Parkinson Disease Depression Drug: Pramipexole

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Study Type : Observational
Enrollment : 1018 participants
Official Title: Profile of Depressive Symptoms in Parkinson's Disease (PRODEST-PD)
Study Start Date : April 2006
Actual Primary Completion Date : October 2006
Actual Study Completion Date : October 2006

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. HADS, HAMD-17, BDI-1A, FAB (cognitive), DSM-IV (mood- part A, B, C, E) and UPDRS


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00349310


Locations
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Austria
Boehringer Ingelheim Investigational Site
Innsbruck, Austria, 6020
Boehringer Ingelheim Investigational Site
Wien, Austria, 1090
Boehringer Ingelheim Investigational Site
Wien, Austria, 1130
France
Hopital Rangueil
Toulouse cedex 9, France, 31059
Hopital Purpan
Toulouse cedex, France, 31073
Germany
Neurologisches Fachkrankenhaus fur
Beelitz-Heilstatten, Germany, 14547
Universitatsklinikum Carl Gustav Carus Dresden
Dresden, Germany, 01307
Boehringer Ingelheim Investigational Site
Gera, Germany, 07551
Gertrudis-Kliniken Biskirchen
Leun, Germany, 35638
Boehringer Ingelheim Investigational Site
Unterhaching, Germany, 82008
Parkinson Klinik Wolfach
Wolfach, Germany, 77709
Italy
Policlinico di Catania
Catania, Italy, 95125
Azienda Ospedaliera S. Martino
Genova, Italy, 16100
Universita Federico II
Napoli, Italy, 80131
Universita La Sapienza di Roma
Roma, Italy, 00161
Netherlands
Academisch Ziekenhuis Maastricht
Maastricht, Netherlands, 6229 HX
Spain
Hospital de Cruces. Neurology
Baracaldo / Bilbao, Spain, 48903
Hospital Clinic i Provincial. Neurology
Barcelona, Spain, 08036
Hospital Puerta del Mar. Neurology
Cadiz, Spain, 11519
Switzerland
Clinica Hildebrand
Brissago, Switzerland, 6614
Hopital Cantonal (HUG)
Geneve, Switzerland, 1211
Kantonsspital St. Gallen
St.Gallen, Switzerland, 9007
United Kingdom
Boehringer Ingelheim Investigational Site
London, United Kingdom, NW3 2QG
Boehringer Ingelheim Investigational Site
Newark, United Kingdom, NG24 4DE
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Study Coordinator Boehringer Ingelheim BV/Alkmaar

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ClinicalTrials.gov Identifier: NCT00349310     History of Changes
Other Study ID Numbers: 248.597
First Posted: July 6, 2006    Key Record Dates
Last Update Posted: November 1, 2013
Last Verified: October 2013
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Pramipexole
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents