Survey on PD Patients With Depressive Symptoms

This study is currently recruiting participants.

Verified by Boehringer Ingelheim Pharmaceuticals, March 2009

First Received: January 31, 2008 Last Updated: March 4, 2009 History of Changes

Sponsored by:	Boehringer Ingelheim Pharmaceuticals
Information provided by:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00614575

Purpose

The primary objective of this investigation is to conduct a 12-week prospective survey in PD patients with depressive symptoms treated with BI Sifrol Tablets (hereinafter referred to as this drug) in the routine clinical settings to determine the following items related to the safety and efficacy.

i. Adverse drug reaction symptoms, incidence, and severity ii. Motor capacity during the investigation iii. Depressive symptoms during the investigation

Condition
Parkinson Disease

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

MedlinePlus related topics: Parkinson's Disease

U.S. FDA Resources

Study Type:	Observational
Official Title:	BI_Sifrol Tablets Special Drug Use Surveillance(Survey on the Safety and Efficacy in Parkinson's Disease Patients With Depressive Symptoms)

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Estimated Enrollment:	1000
Study Start Date:	January 2007
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

PD patients with depressive symptoms
Patients who have not received pramipexole hydrochloride hydrate preparations within 1 month before survey entrance.

Exclusion Criteria:

PD patients with the past history of suicidal attempt, suicidal ideation or tendency

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00614575

Contacts

Contact: Boehringer Ingelheim Study Coordinator

1-800-243-0127

clintriage.rdg@boehringer-ingelheim.com

Show 245 Study Locations

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Investigators

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

More Information

No publications provided

Responsible Party:	Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers:	248.635
Study First Received:	January 31, 2008
Last Updated:	March 4, 2009
ClinicalTrials.gov Identifier:	NCT00614575 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Study placed in the following topic categories:

Ganglion Cysts
Depression
Movement Disorders
Parkinson Disease
Basal Ganglia Diseases
Central Nervous System Diseases

Parkinsonian Disorders
Neurodegenerative Diseases
Brain Diseases
Depressive Disorder
Pramipexol
Behavioral Symptoms

Additional relevant MeSH terms:

Depression
Movement Disorders
Parkinson Disease
Nervous System Diseases
Basal Ganglia Diseases

Central Nervous System Diseases
Parkinsonian Disorders
Neurodegenerative Diseases
Brain Diseases
Behavioral Symptoms

ClinicalTrials.gov processed this record on May 07, 2009