Clinical trial NCT00437125: Study on the Tolerability of Duloxetine in Depressed Patients With Parkinson's Disease
Official title: An Open Label Pilot Study on the Tolerability of Duloxetine in the Treatment of Depressed Patients With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Major Depressive Disorder
Idiopathic Parkinson Disease
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2007-02-19
Enrollment: 151
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Number of Participants Reporting Serious Adverse Events or Other Adverse Events Leading Either to Discontinuation or to Death
timeFrame: baseline through 12 weeks
Secondary outcomes:
measure: Change From Baseline to 12 Weeks on the Unified Parkinson's Disease Rating Scale (UPDRS) Total Score
timeFrame: baseline, 12 weeks
measure: Change From Baseline to 12 Weeks on the UKU (Udvalg for Kliniske Undersogelser: Committee for Clinical Investigations) Side Effect Rating Scale
timeFrame: baseline, 12 weeks
measure: Change From Baseline on the Pittsburgh Sleep Quality Index (PSQI)
timeFrame: baseline, 4 weeks, 8 weeks, 12 weeks
measure: Change From Baseline to 12 Weeks on the 17-item Hamilton Depression Rating Scale (HAMD-17) Total Score
timeFrame: baseline, 12 weeks
measure: Change From Baseline to 12 Weeks on the Clinical Global Impression-Severity Scale
timeFrame: baseline, 12 weeks
measure: Patient's Global Impression-Improvement at Week 12
timeFrame: 12 weeks
measure: Change From Baseline to 12 Weeks in Beck Depression Inventory (BDI) Total Score
timeFrame: baseline, 12 weeks
measure: Change From Baseline to 12 Weeks in Visual Analog Scale (VAS)
timeFrame: baseline, 12 weeks
measure: Change From Baseline to 12 Weeks in Parkinson Disease Questionnaire - 39 Item Version (PDQ-39) Total Score
timeFrame: baseline, 12 weeks
measure: Average Change From Baseline to 12 Weeks in Blood Pressure
timeFrame: baseline through 12 weeks
measure: Average Change From Baseline to 12 Weeks in Heart Rate
timeFrame: baseline through 12 weeks
measure: Number of Participants With Abnormal Electrocardiograms (ECG) During the 12 Week Study
timeFrame: baseline through 12 weeks
measure: Laboratory Analytes
timeFrame: baseline through 12 weeks
measure: Number of Participants Who Responded to Treatment by 12 Weeks
timeFrame: 12 weeks
measure: Number of Participants Who Reached Remission by 12 Weeks
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Ancona
country: Italy
facility: 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.
city: Brescia
country: Italy
facility: 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.
city: Catania
country: Italy
facility: 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.
city: Genova
country: Italy
facility: 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.
city: Lido Di Camaiore
country: Italy
facility: 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.
city: Messina
country: Italy
facility: 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.
city: Milano
country: Italy
facility: 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.
city: Napoli
country: Italy
facility: 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.
city: Padova
country: Italy
facility: 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.
city: Pisa
country: Italy
facility: 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.
city: Pozzilli
country: Italy
facility: 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.
city: Rome
country: Italy
facility: 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.
city: Torino
country: Italy
facility: 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.
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: