Survey on PD Patients With Depressive Symptoms

Boehringer Ingelheim

Status: Completed

Conditions: Parkinson Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT00614575

248.635

Details and patient eligibility

About

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

Enrollment: 1,089 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1,089 participants in 1 patient group

BI-Sifrol® Tablets (Pramipexole)

Description:

BI-Sifrol® Tablets, pramipexole dose: 0.125 mg, 0.5 mg, No reference therapy