Non-motor Symptoms (Depressive Symptoms) of Parkinson's Disease and Their Course Under Pramipexole Treatment

Boehringer Ingelheim

Status: Completed

Conditions: Parkinson Disease

Treatments: Drug: Pramipexole immediate release

Study type: Observational

Funder types: Industry

Identifiers

NCT00651183

248.649

Details and patient eligibility

About

The objective of this PMS study is the evaluation of depressive symptoms measured with Unified Parkinson's Disease Rating Scale (UPDRS) Part I (mentation, behavior and mood) and with Hospital Anxiety and Depression Scale Depression Subscore (HADS-D) under pramipexole treatment in early and advanced PD patients. In addition it will be investigated whether improvement of depressive symptoms is linked to improvement in motor function (UPDRS Part III). 250 patients diagnosed with Parkinson's disease (PD) will be investigated by 80 specialists (neurologists or neurologists/psychiatrists) across Austria. Pramipexole will be taken orally at an initial dosage of 0.375 mg/day (using a three times daily schedule independently of food intake) and can be titrated upwards, as required, at weekly intervals to a maximum total daily dose of 4,5 mg (TID) as per Summary of Product Characteristics (SPC).

Enrollment: 286 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Idiopathic PD with or without fluctuations
• Indication for treatment with Pramipexole
• Presence of at least mild depressive symptoms (as judged by the treating physician)
• Ability to reliably complete a self-rating scale (Hospital Anxiety and Depression Scale (HADS))

Exclusion criteria

• Any contraindications according to the Summary of Product Characteristics (SPC), hypersensitivity to pramipexole or to any of the excipients
• Ongoing treatment with pramipexole