Survey on PD Patients With Depressive Symptoms

Study Overview
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Brief Summary
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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

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

Conditions
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Parkinson Disease

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| BI-Sifrol® Tablets (Pramipexole)<br>BI-Sifrol® Tablets, pramipexole dose: 0.125 mg, 0.5 mg, No reference therapy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Adverse Events, Adverse Drug Reactions, and Serious Adverse Events | 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. | for 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impression of Improvement | 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). | for 12 weeks after initiation of the treatment | 
| Mean Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score | 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. | Baseline and after 12 weeks (or at the time of discontinuation) | 
| Mean Change From Baseline in Beck's Depression Inventory (BDI) Total Score | The degree of severity in depressive state are scored between 0-63 in BDI. A decrease in the score means improvement. | Baseline and after 12 weeks (or at the time of discontinuation) | 
| Mean Change From Baseline in UPDRS (Unified Parkinson's Disease Rating Scale) Part I Item 3 Score | 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. | Baseline and after 12 weeks (or at the time of discontinuation) | 
| Mean Change From Baseline in Modified Hoehn & Yahr Rating Scale | 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. | After 12 weeks or at the time of discontinuation |