N/A
N=1,089
Survey on PD Patients With Depressive Symptoms
Parkinson Disease
Bottom Line
View on ClinicalTrials.gov: NCT00614575 ↗Enrolled (actual)
1,089
Serious AEs
2.5%
Results posted
Jul 2011
Primary outcome: Primary: Percentage of Participants With Adverse Events, Adverse Drug Reactions, and Serious Adverse Events — 21.7; 19.2; 2.5 percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Aug 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Adverse Events, Adverse Drug Reactions, and Serious Adverse Events |
21.7; 19.2; 2.5 | — |
| SECONDARY Clinical Global Impression of Improvement |
76; 399; 348; 102; 24 | — |
| SECONDARY Mean Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score |
-7.2 | <0.0001 sig |
| SECONDARY Mean Change From Baseline in Beck's Depression Inventory (BDI) Total Score |
-4.8 | <0.0001 sig |
| SECONDARY Mean Change From Baseline in UPDRS (Unified Parkinson's Disease Rating Scale) Part I Item 3 Score |
-0.7 | <0.0001 sig |
| SECONDARY Mean Change From Baseline in Modified Hoehn & Yahr Rating Scale |
-0.3 | <0.0001 sig |
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
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00614575). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.