ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00437125
Recruitment Status : Completed
First Posted : February 19, 2007
Results First Posted : August 16, 2010
Last Update Posted : September 8, 2010
Sponsor:
Information provided by:
Eli Lilly and Company

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Major Depressive Disorder
Idiopathic Parkinson Disease
Intervention: Drug: Duloxetine hydrochloride

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
167 participants were screened and 16 participants were screen failures

Reporting Groups
  Description
Duloxetine Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks

Participant Flow:   Overall Study
    Duloxetine
STARTED   151 
COMPLETED   119 
NOT COMPLETED   32 
Adverse Event                12 
Death                1 
Clinical Relapse                1 
Lack of Efficacy                1 
Lost to Follow-up                1 
Withdrawal by Subject                13 
Withdrawal by Caregiver                2 
Physician Decision                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Duloxetine Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks

Baseline Measures
   Duloxetine 
Overall Participants Analyzed 
[Units: Participants]
 151 
Age 
[Units: Years]
Mean (Standard Deviation)
 63.6  (8.9) 
Gender 
[Units: Participants]
 
Female   85 
Male   66 
Race/Ethnicity, Customized 
[Units: Participants]
 
Caucasian   151 
Region of Enrollment 
[Units: Participants]
 
Italy   151 
Current alcohol consumption by participants 
[Units: Participants]
 
no   130 
yes   21 
Current use of tobacco products by participants 
[Units: Participants]
 
no   140 
yes   11 
Depression in a distant relative of the participant 
[Units: Participants]
 
no   120 
yes   1 
unknown   30 
Depression in a second degree relative of the participant 
[Units: Participants]
 
no   126 
yes   25 
Depression in mother or father of participant 
[Units: Participants]
 
no   149 
yes   1 
unknown   1 
Depression in sibling or child of participant 
[Units: Participants]
 
no   150 
yes   1 
Disease stage of the modified Hoen and Yahr staging scale [1] 
[Units: Participants]
 
unilateral disease   23 
unilateral plus axial involvement   16 
bilateral disease, without impairment of balance   63 
mild bilateral disease   40 
mild to moderate bilateral disease   9 
[1] Stage 1: unilateral disease; stage 1.5: unilateral plus axial involvement; Stage 2: bilateral disease, without impairment of balance; Stage 2.5: mild bilateral disease with recovery on pull test; Stage 3: mild to moderate bilateral disease, some postural instability, physically independent; Stage 4: severe disability, still able to walk or stand unassisted; Stage 5: wheelchair or bedridden unless aided.
Other Axis 1 disorder in distant relative of participant [1] 
[Units: Participants]
 
no   119 
yes   32 
[1] Any axis 1 disorder except depressive disorder.
Other Axis 1 disorder in parents of participant [1] 
[Units: Participants]
 
no   149 
yes   1 
unknown   1 
[1] Any axis 1 disorder except depressive disorder.
Other Axis 1 disorder in second degree relative of participant [1] 
[Units: Participants]
 
no   127 
yes   24 
[1] Any axis 1 disorder except depressive disorder.
Other Axis 1 disorder in sibling or child of participant [1] 
[Units: Participants]
 
no   150 
yes   1 
[1] Any axis 1 disorder except depressive disorder.
Presence of major depressive episode diagnosed with Mini International Neuropsychiatric Interview [1] 
[Units: Participants]
 
no   2 
yes   149 
[1] The Mini International Neuropsychiatric Interview (MINI) is a standardized diagnostic interview based on Diagnostic and Statistical Manual of Mental Disorders version 4 (DSM-IV) criteria. It was developed as a more concise and easily administered alternative to the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID).
Mini Mental State Examination (MMSE) Total Score [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 28.3  (1.8) 
[1] The MMSE is used to screen cognitive functioning and provides measures of orientation, registration (immediate memory), memory, and language functioning. The score range is 0-30; normal: 25-30; mild impairment: 21-24; moderate impairment: 10-20; severe impairment: <10.


  Outcome Measures

1.  Primary:   Number of Participants Reporting Serious Adverse Events or Other Adverse Events Leading Either to Discontinuation or to Death   [ Time Frame: baseline through 12 weeks ]

2.  Secondary:   Change From Baseline to 12 Weeks on the Unified Parkinson's Disease Rating Scale (UPDRS) Total Score   [ Time Frame: baseline, 12 weeks ]

3.  Secondary:   Change From Baseline to 12 Weeks on the UKU (Udvalg for Kliniske Undersogelser: Committee for Clinical Investigations) Side Effect Rating Scale   [ Time Frame: baseline, 12 weeks ]

4.  Secondary:   Change From Baseline on the Pittsburgh Sleep Quality Index (PSQI)   [ Time Frame: baseline, 4 weeks, 8 weeks, 12 weeks ]

5.  Secondary:   Change From Baseline to 12 Weeks on the 17-item Hamilton Depression Rating Scale (HAMD-17) Total Score   [ Time Frame: baseline, 12 weeks ]

6.  Secondary:   Change From Baseline to 12 Weeks on the Clinical Global Impression-Severity Scale   [ Time Frame: baseline, 12 weeks ]

7.  Secondary:   Patient's Global Impression-Improvement at Week 12   [ Time Frame: 12 weeks ]

8.  Secondary:   Change From Baseline to 12 Weeks in Beck Depression Inventory (BDI) Total Score   [ Time Frame: baseline, 12 weeks ]

9.  Secondary:   Change From Baseline to 12 Weeks in Visual Analog Scale (VAS)   [ Time Frame: baseline, 12 weeks ]

10.  Secondary:   Change From Baseline to 12 Weeks in Parkinson Disease Questionnaire - 39 Item Version (PDQ-39) Total Score   [ Time Frame: baseline, 12 weeks ]

11.  Secondary:   Average Change From Baseline to 12 Weeks in Blood Pressure   [ Time Frame: baseline through 12 weeks ]

12.  Secondary:   Average Change From Baseline to 12 Weeks in Heart Rate   [ Time Frame: baseline through 12 weeks ]

13.  Secondary:   Number of Participants With Abnormal Electrocardiograms (ECG) During the 12 Week Study   [ Time Frame: baseline through 12 weeks ]

14.  Secondary:   Laboratory Analytes   [ Time Frame: baseline through 12 weeks ]

15.  Secondary:   Number of Participants Who Responded to Treatment by 12 Weeks   [ Time Frame: 12 weeks ]

16.  Secondary:   Number of Participants Who Reached Remission by 12 Weeks   [ Time Frame: 12 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 800-545-5979



Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00437125     History of Changes
Other Study ID Numbers: 11127
F1J-IT-HMFQ ( Other Identifier: Eli Lilly and Company )
First Submitted: February 16, 2007
First Posted: February 19, 2007
Results First Submitted: July 16, 2010
Results First Posted: August 16, 2010
Last Update Posted: September 8, 2010