Survey on Parkinson's Disease (PD) Patients With Depressive Symptoms - Full Text View

Survey on Parkinson's Disease (PD) Patients With Depressive Symptoms

This study is currently recruiting participants.
Verified by Boehringer Ingelheim Pharmaceuticals, July 2008

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	Phase
Parkinson Disease	Phase IV

Genetics Home Reference related topics:

familial paroxysmal nonkinesigenic dyskinesia Parkinson disease

MedlinePlus related topics:

Parkinson's Disease

ChemIDplus related topics:

Pramipexol Pramipexole dihydrochloride

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:

Primary Outcome Measures:

Safety i. Incidence & severity of AEs, ii. Drop outs, iii. Days from treatment start to hallucination onset Efficacy i. Changes in UPDRS Part I (Item 3) & III scores, ii. Change in BDI total score at Week 12 [ Time Frame: 12 Weeks ]

Secondary Outcome Measures:

Efficacy i. Percentage of patients with 50% decrease in the BDI score from baseline [ Time Frame: 12 Weeks ]

Estimated Enrollment:	1000
Estimated Study Completion Date:	March 2009

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		clintriage@rdg.boehringer-ingelheim.com

Show 245 Study Locations

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Investigators


Study Chair:	Boehringer Ingelheim Study Coordinator	Nippon Boehringer Ingelheim Co., Ltd.

More Information

Study ID Numbers:	248.635
First Received:	January 31, 2008
Last Updated:	July 25, 2008
ClinicalTrials.gov Identifier:	NCT00614575
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:

Nervous System Diseases

ClinicalTrials.gov processed this record on October 10, 2008