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: May 18, 2012
Last verified: May 2012
  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. Therefore efficacy evaluation is not primary endpoint.


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 CGI (clinical global impression) with 5 categories (very much improved, much improved, minimally improved, no effect, and unassessable).

  • Change From Baseline in UPDRS (Unified Parkinson's Disease Rating Scale) Part III Total Score [ Time Frame: Baseline and after 12 weeks (or at the time of discontinuation) ] [ Designated as safety issue: No ]
    Motor examination are scored between 0-108 in UPDRS Part III. A decrease in the score means improvement.

  • Change From Baseline in BDI (Beck's Depression Inventory) 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.

  • Change From Baseline in UPDRS (Unified Parkinson's Disease Rating Scale) Part I item3 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 0-4 in UPDRS Part I item3 score. A decrease in the score means improvement.

  • Percentage of Participants Whose BDI (Beck's Depression Inventory) Total Score Decreased More Than 50% From Baseline [ Time Frame: After 12 weeks or at the time of discontinuation ] [ Designated as safety issue: No ]
    The percentage of BDI responders defined as patients whose BDI total score decreased by more than 50% from baseline.


Enrollment: 1089
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
  • PD patients with suicidal ideation
  • PD patients with the past history of suicidal tendency
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00614575

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Locations
Japan
Boehringer Ingelheim Investigational Site
Akashi, Japan
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Akita, Japan
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Akita, Japan
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Asahikawa, Japan
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Ashikaga, Japan
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Awaji, Japan
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Chitose, Japan
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Chuo, Japan
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Fuchu, Japan
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Fuchu, Japan
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Fuefuki, Japan
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Fuehuki, Japan
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Fujioka, Japan
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Fujisaki, Japan
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Fujisawa, Japan
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Fukaya, Japan
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Fukuoka, Japan
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Fukushima, Japan
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Fukushima, Japan
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Gifu, Japan
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Gifu, Japan
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Hamamatsu, Japan
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Musashino, Japan
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Tokyo Minato-ku, Japan
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Tokyo Ota-ku, Japan
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Tokyo Shinagawa-ku, Japan
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Tokyo Shinjyuku-ku, Japan
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Tokyo Shinjyuku-ku, Japan
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Toride, Japan
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Tosu, Japan
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Toyama, Japan
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Wakayama, Japan
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Yoichi, Japan
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Yokohama, Japan
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Yokohama, Japan
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Yokohama, Japan
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Yokohama, Japan
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Yokosuka, Japan
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Yoshinogawa, Japan
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: May 18, 2012
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 April 22, 2014