Survey on PD Patients With Depressive Symptoms
- Conditions
- Parkinson Disease
- Registration Number
- NCT00614575
- Lead Sponsor
- Boehringer Ingelheim
- 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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1089
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of Participants With Adverse Events, Adverse Drug Reactions, and Serious Adverse Events for 12 weeks 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
Name Time Method Mean Change From Baseline in Beck's Depression Inventory (BDI) Total Score Baseline and after 12 weeks (or at the time of discontinuation) 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 Modified Hoehn & Yahr Rating Scale After 12 weeks or at the time of discontinuation 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.
Mean Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score Baseline and after 12 weeks (or at the time of discontinuation) 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 UPDRS (Unified Parkinson's Disease Rating Scale) Part I Item 3 Score Baseline and after 12 weeks (or at the time of discontinuation) 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.
Clinical Global Impression of Improvement for 12 weeks after initiation of the treatment 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).
Trial Locations
- Locations (10)
Boehringer Ingelheim Investigational Site 4
🇯🇵Yokohama, Japan
Boehringer Ingelheim Investigational Site 5
🇯🇵Sapporo, Japan
Boehringer Ingelheim Investigational Site 2
🇯🇵Yokohama, Japan
Boehringer Ingelheim Investigational Site
🇯🇵Yoshinogawa, Japan
Boehringer Ingelheim Investigational Site 7
🇯🇵Sapporo, Japan
Boehringer Ingelheim Investigational Site 3
🇯🇵Yokohama, Japan
Boehringer Ingelheim Investigational Site 1
🇯🇵Yokohama, Japan
Boehringer Ingelheim Investigational Site 6
🇯🇵Sapporo, Japan
Boehringer Ingelheim Investigational Site 9
🇯🇵Sapporo, Japan
Boehringer Ingelheim Investigational Site 8
🇯🇵Sapporo, Japan