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

• Status: Completed
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Duloxetine Hydrochloride

Criteria

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