Survey on PD Patients With Depressive Symptoms

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00614575
First received: January 31, 2008
Last updated: August 1, 2014
Last verified: August 2014
  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: Observational Model: Cohort
Time Perspective: 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:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Percentage of Participants With Adverse Events, Adverse Drug Reactions, and Serious Adverse Events [ Time Frame: for 12 weeks ] [ Designated as safety issue: No ]
    The aim of this Post Marketing Surveillance (PMS) was to obtain safety data with treatment of pramipexole in Parkinson's disease patients with depressive symptoms. The percentage of participants with adverse events, adverse drug reactions, and serious adverse events are presented.


Secondary Outcome Measures:
  • Clinical Global Impression of Improvement [ Time Frame: for 12 weeks after initiation of the treatment ] [ Designated as safety issue: No ]
    Investigators evaluation of the Parkinson's disease (PD) symptoms on the Clinical Global Impression (CGI) with 5 categories (very much improved, much improved, minimally improved, no effect, and unassessable).

  • Mean Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score [ Time Frame: Baseline and after 12 weeks (or at the time of discontinuation) ] [ Designated as safety issue: No ]
    Part III of the UPDRS contains the clinician-scored motor evaluation, and includes 14 individual items each scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 56. A negative change in the Part III total score indicates improvement.

  • Mean Change From Baseline in Beck's Depression Inventory (BDI) Total Score [ Time Frame: Baseline and after 12 weeks (or at the time of discontinuation) ] [ Designated as safety issue: No ]
    The degree of severity in depressive state are scored between 0-63 in BDI. A decrease in the score means improvement.

  • Mean Change From Baseline in UPDRS (Unified Parkinson's Disease Rating Scale) Part I Item 3 Score [ Time Frame: Baseline and after 12 weeks (or at the time of discontinuation) ] [ Designated as safety issue: No ]
    Unified Parkinson's Disease Rating Scale Part I Item 3 assesses the participant for symptoms of depression. Item 3 scores range from 0 (None) to 4 (Sustained depression with suicidal thoughts or intent). A higher score indicates more severe depression symptoms. A negative change in the item 3 score indicates improvement.

  • Mean Change From Baseline in Modified Hoehn & Yahr Rating Scale [ Time Frame: After 12 weeks or at the time of discontinuation ] [ Designated as safety issue: No ]
    This scale is an investigator-completed assessment of the degree of complications arising from Parkinson's disease. The scale ranges from 0 (No signs) to 5 (Bedridden). A negative change in the Yahr rating scale indicates improvement.


Enrollment: 1089
Study Start Date: January 2007
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
BI-Sifrol® Tablets (Pramipexole)
BI-Sifrol® Tablets, pramipexole dose: 0.125 mg, 0.5 mg, No reference therapy

  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
  • PD patients with suicidal ideation
  • PD patients with the past history of suicidal tendency
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 238 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00614575     History of Changes
Other Study ID Numbers: 248.635
Study First Received: January 31, 2008
Results First Received: February 23, 2011
Last Updated: August 1, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Parkinson Disease
Depression
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Behavioral Symptoms

ClinicalTrials.gov processed this record on September 14, 2014