Survey on PD Patients With Depressive Symptoms - Tabular View

Tracking Information

First Received Date ^ICMJE

January 31, 2008

Last Updated Date

March 2, 2010

Start Date ^ICMJE

January 2007

Primary Completion Date

August 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT00614575 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

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

Descriptive Information

Brief Title ^ICMJE

Survey on PD Patients With Depressive Symptoms

Official Title ^ICMJE

BI_Sifrol Tablets Special Drug Use Surveillance(Survey on the Safety and Efficacy in Parkinson's Disease Patients With Depressive Symptoms)

Brief Summary

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

Detailed Description

Study Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Condition ^ICMJE

Parkinson Disease

Intervention ^ICMJE

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

1087

Completion Date

Primary Completion Date

August 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

20 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Japan

Administrative Information

NCT ID ^ICMJE

NCT00614575

Responsible Party

Boehringer Ingelheim, Study Chair, Boehringer Ingelheim

Study ID Numbers ^ICMJE

248.635

Study Sponsor ^ICMJE

Boehringer Ingelheim Pharmaceuticals

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

Information Provided By

Boehringer Ingelheim Pharmaceuticals

Verification Date

March 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP