Study on the Tolerability of Duloxetine in Depressed Patients With Parkinson's Disease

An Open Label Pilot Study on the Tolerability of Duloxetine in the Treatment of Depressed Patients With Parkinson's Disease

This study aims to assess the tolerability of duloxetine, 60mg once daily, in open label fashion, in depressed patients with Parkinson's disease during 12 weeks treatment.

Inclusion Criteria:

• Are outpatients, male or female, 30 through 75 years of age
• Meet diagnostic criteria for major depression episode and a clinical diagnosis of idiopathic Parkinson's disease
• Have a clinician-rated 17-item Hamilton Depression Rating Scale (HAMD17) total score greater than or equal to 15, a Beck Depression Inventory (BDI) total score greater than or equal to 13 and a Clinical Global Impression of Severity (CGI-S) score greater than or equal to 3 at both Visit 1 and Visit 2
• Have satisfactory cognitive function
• Have been held on stable dosage of antiparkinsonian medications for at least 4 weeks immediately prior to Visit 1

Exclusion Criteria:

• Any current primary psychiatric diagnosis other than Major depressive episode, and any personality disorder that could interfere with the compliance with the study protocol
• Atypical or secondary parkinsonism due to drugs or diseases with features of Parkinson's disease
• Motor conditions for which it is to be expected to change the antiparkinsonian treatment during the course of the study
• Clinically significant laboratory abnormalities or serious, unstable medical illness
• Lack of response of current episode to two or more adequate courses of antidepressant therapy