Profile of Depressive Symptoms in Parkinsons Disease - Full Text View

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

Genetics Home Reference related topics:

familial paroxysmal nonkinesigenic dyskinesia Parkinson disease

MedlinePlus related topics:

Depression Parkinson's Disease

ChemIDplus related topics:

Pramipexol Pramipexole dihydrochloride

U.S. FDA Resources

Study Type:	Observational

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

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
	Universitatsklinikum Carl Gustav Carus Dresden
	Dresden, Germany, 01307
	Boehringer Ingelheim Investigational Site
	Gera, Germany, 07551
	Gertrudis-Kliniken Biskirchen
	Leun, Germany, 35638
	Parkinson Klinik Wolfach
	Wolfach, Germany, 77709
	Neurologisches Fachkrankenhaus fur
	Beelitz-Heilstatten, Germany, 14547
	Boehringer Ingelheim Investigational Site
	Unterhaching, Germany, 82008

Italy
	Universita Federico II
	NAPOLI, Italy, 80131
	Azienda Ospedaliera S. Martino
	GENOVA, Italy, 16100
	Universita La Sapienza di Roma
	ROMA, Italy, 00161
	Policlinico di Catania
	CATANIA, Italy, 95125

Netherlands
	Academisch Ziekenhuis Maastricht
	Maastricht, Netherlands, 6229 HX

Spain
	Hospital Clinic i Provincial. Neurology
	Barcelona, Spain, 08036
	Hospital de Cruces. Neurology
	Baracaldo / Bilbao, Spain, 48903
	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

Related Info This link exits the ClinicalTrials.gov site

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

Study placed in the following topic categories:

Depression

Ganglion Cysts

Basal Ganglia Diseases

Central Nervous System Diseases

Depressive Disorder

Brain Diseases

Neurodegenerative Diseases

Pramipexol

Behavioral Symptoms

Dopamine

Parkinson Disease

Movement Disorders

Parkinsonian Disorders

Additional relevant MeSH terms:

Neurotransmitter Agents

Antioxidants

Molecular Mechanisms of Pharmacological Action

Anti-Dyskinesia Agents

Nervous System Diseases

Physiological Effects of Drugs

Antiparkinson Agents

Dopamine Agonists

Protective Agents

Pharmacologic Actions

Therapeutic Uses

Dopamine Agents

Central Nervous System Agents

ClinicalTrials.gov processed this record on October 10, 2008

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