Profile of Depressive Symptoms in Parkinsons Disease - Full Text View

Sponsor:	Boehringer Ingelheim Pharmaceuticals
Information provided by:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00349310

Purpose

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	Intervention	Phase
Parkinson Disease Depression	Drug: Pramipexole	Phase IV

Study Type:	Observational
Official Title:	Profile of Depressive Symptoms in Parkinson's Disease

Resource links provided by NLM:

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease Perry syndrome

MedlinePlus related topics: Depression Parkinson's Disease

Drug Information available for: Pramipexol Pramipexole dihydrochloride

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:

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

Estimated Enrollment:	1018
Estimated Study Completion Date:	October 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00349310

Locations

Austria
Boehringer Ingelheim Investigational Site
Innsbruck, Austria, 6020
Boehringer Ingelheim Investigational Site
Wien, Austria, 1130
Boehringer Ingelheim Investigational Site
Wien, Austria, 1090
France
Hopital Purpan
Toulouse cedex, France, 31073
Hopital Rangueil
Toulouse cedex 9, France, 31059
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 Pharmaceuticals

Investigators

Study Chair:

Boehringer Ingelheim Study Coordinator

Boehringer Ingelheim BV/Alkmaar

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00349310 History of Changes
Other Study ID Numbers:	248.597
Study First Received:	July 5, 2006
Last Updated:	September 3, 2008
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Additional relevant MeSH terms:

Depression
Depressive Disorder
Parkinson Disease
Behavioral Symptoms
Mood Disorders
Mental Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

Pramipexol
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on February 09, 2012