Survey on PD Patients With Depressive Symptoms - Full Text View

Sponsor:	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

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

Resource links provided by NLM:

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

MedlinePlus related topics: Parkinson's Disease

U.S. FDA Resources

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 ]

Enrollment:	1087
Study Start Date:	January 2007
Primary Completion Date:	August 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
Sampling Method:	Non-Probability Sample

Study Population

PD patients with depressive symptoms

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

Show 238 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:	October 29, 2009
ClinicalTrials.gov Identifier:	NCT00614575 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

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 November 22, 2009