Status:
COMPLETED
Study on the Tolerability of Duloxetine in Depressed Patients With Parkinson's Disease
Lead Sponsor:
Eli Lilly and Company
Conditions:
Major Depressive Disorder
Idiopathic Parkinson Disease
Eligibility:
All Genders
30-75 years
Phase:
PHASE4
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
151 Patients enrolled
Trial Details
Trial ID
NCT00437125
Start Date
March 1 2007
End Date
July 1 2009
Last Update
September 8 2010
Active Locations (13)
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1
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Ancona, Italy, 60124
2
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Brescia, Italy, 25100
3
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Catania, Italy, 95125
4
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Genova, Italy, 16132