Study on the Tolerability of Duloxetine in Depressed Patients With Parkinson's Disease
Information source: Eli Lilly and Company
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Major Depressive Disorder; Idiopathic Parkinson Disease
Intervention: Duloxetine hydrochloride (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Eli Lilly and Company Official(s) and/or principal investigator(s):
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study Director, Affiliation: Eli Lilly and Company
Overall contact:
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or, Phone: 1-317-615-4559
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.
Clinical Details
Official title: An Open Label Pilot Study on the Tolerability of Duloxetine in the Treatment of Depressed Patients With Parkinson's Disease
Study design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Discontinuation due to adverse events
Secondary outcome: Unified Parkinson's disease rating scale (UPDRS)Udvalg for Kliniske Undersogelser (UKU) Side effect rating scale Pittsburgh Sleep Quality Index (PSQI) 17- Hamilton Depression Rating Scale Clinical Global Impression-severity scale Patient's Global Impression-improvement Beck Depression Inventory (BDI) Visual Analog Scale Parkinson Disease Questionnaire -39 item version (PDQ-39) Treatment emergent adverse events Vital signs Electrocardiograms Laboratory analytes HAMD17 response rate defined as 50% reduction HAMD17 Remission rates
Eligibility
Minimum age: 30 Years.
Maximum age: 75 Years.
Gender(s): Both.
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 HAMD17 total score greater than or equal to 15, a BDI total
score greater than or equal to 13 and a 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
Locations and Contacts
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or, Phone: 1-317-615-4559
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 60124, Italy; Recruiting
Eli Lilly
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 25100, Italy; Recruiting
Eli Lilly
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 95125, Italy; Recruiting
Eli Lilly
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 16132, Italy; Recruiting
Eli Lilly
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., Lido Di Camaiore 55000, Italy; Recruiting
Eli Lilly
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., Messina 98122, Italy; Recruiting
Eli Lilly
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., Milano 20157, Italy; Recruiting
Eli Lilly
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., Napoli 80131, Italy; Recruiting
Eli Lilly
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., Padova 35100, Italy; Recruiting
Eli Lilly
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., Pisa 56100, Italy; Recruiting
Eli Lilly
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., Pozzilli 86077, Italy; Recruiting
Eli Lilly
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., Rome 00179, Italy; Recruiting
Eli Lilly
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., Torino 10126, Italy; Recruiting
Eli Lilly
Additional Information
Lilly Clinical Trial Registry
Starting date: March 2007
Ending date: May 2009
Last updated: September 26, 2008
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