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

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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
Enrollment 151
Recruitment Details  
Pre-assignment Details 167 participants were screened and 16 participants were screen failures
Arm/Group Title Duloxetine
Hide Arm/Group Description Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
Period Title: Overall Study
Started 151
Completed 119
Not Completed 32
Reason Not Completed
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
Arm/Group Title Duloxetine
Hide Arm/Group Description Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
Overall Number of Baseline Participants 151
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 151 participants
63.6  (8.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 151 participants
Female
85
  56.3%
Male
66
  43.7%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Caucasian Number Analyzed 151 participants
151
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Italy Number Analyzed 151 participants
151
Current alcohol consumption by participants  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 151 participants
no 130
yes 21
Current use of tobacco products by participants  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 151 participants
no 140
yes 11
Depression in a distant relative of the participant  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 151 participants
no 120
yes 1
unknown 30
Depression in a second degree relative of the participant  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 151 participants
no 126
yes 25
Depression in mother or father of participant  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 151 participants
no 149
yes 1
unknown 1
Depression in sibling or child of participant  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 151 participants
no 150
yes 1
Disease stage of the modified Hoen and Yahr staging scale   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 151 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]
Measure Description: 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] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 151 participants
no 119
yes 32
[1]
Measure Description: Any axis 1 disorder except depressive disorder.
Other Axis 1 disorder in parents of participant   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 151 participants
no 149
yes 1
unknown 1
[1]
Measure Description: Any axis 1 disorder except depressive disorder.
Other Axis 1 disorder in second degree relative of participant   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 151 participants
no 127
yes 24
[1]
Measure Description: Any axis 1 disorder except depressive disorder.
Other Axis 1 disorder in sibling or child of participant   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 151 participants
no 150
yes 1
[1]
Measure Description: Any axis 1 disorder except depressive disorder.
Presence of major depressive episode diagnosed with Mini International Neuropsychiatric Interview   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 151 participants
no 2
yes 149
[1]
Measure Description: 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] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 151 participants
28.3  (1.8)
[1]
Measure Description: 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.
1.Primary Outcome
Title Number of Participants Reporting Serious Adverse Events or Other Adverse Events Leading Either to Discontinuation or to Death
Hide Description The results reported are the number of participants who discontinued the study as a result of an adverse event (serious or other) or death.
Time Frame baseline through 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All treated participants.
Arm/Group Title Duloxetine
Hide Arm/Group Description:
Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
Overall Number of Participants Analyzed 151
Measure Type: Number
Unit of Measure: participants
13
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage
Estimated Value 8.6
Confidence Interval (1-Sided) 95%
13.3
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline to 12 Weeks on the Unified Parkinson's Disease Rating Scale (UPDRS) Total Score
Hide Description Rating tool to follow the longitudinal course of Parkinson's Disease. It is composed of Section I: Mentation, Behavior, and Mood; Section II: Activities of Daily Living; Section III: Motor Examination; Section IV: Complications of therapy. These are evaluated by interview. Some sections require that multiple grades be assigned to each extremity. Only Sections II and III were rated in this study. A total of 160 points are possible (52 in Section II and 108 in Section III), where 0 represents no disability and 160 indicates maximal grade of disability.
Time Frame baseline, 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All treated participants were included in the analysis population. Last observation carried forward analysis. Two participants were excluded from calculation of change as they had no post-baseline measure.
Arm/Group Title Duloxetine
Hide Arm/Group Description:
Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
Overall Number of Participants Analyzed 151
Mean (Standard Deviation)
Unit of Measure: units on a scale
baseline; n=151 32.0  (12.6)
change; n=149 -0.3  (6.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine
Comments Tested was the null hypothesis that there would be no change on the total UDPRS score from baseline to 12-week endpoint.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5553
Comments p-value is for total UDPRS score - change. A priori threshold for p-values was 0.05.
Method t-test, 2 sided
Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline to 12 Weeks on the UKU (Udvalg for Kliniske Undersogelser: Committee for Clinical Investigations) Side Effect Rating Scale
Hide Description Clinician-rated scale, providing side effect ratings of psychopharmacological medications. 48 items, each item is rated on a 4-point scale (0=not present; 1=mild; 2=moderate; 3=severe). The test is divided in 6 subscales, total scores for each subscale are calculated based on a weighted secondary scoring system. Subscales: psychic (score range:0-30), neurological (score range:0-24), autonomic (score range:0-33), other (score range:0-75), global assesment by subject (score range:0-3), and global assessment by doctor (score range:0-3). Higher ratings indicate greater impairment.
Time Frame baseline, 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All treated participants were included in the analysis population. Last observation carried forward analysis. One participant was excluded as no data for UKU were available and other participants were excluded as relevant due to absence of either baseline or post-baseline measure.
Arm/Group Title Duloxetine
Hide Arm/Group Description:
Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
Overall Number of Participants Analyzed 151
Mean (Standard Deviation)
Unit of Measure: units on a scale
Psychic subscale, baseline; n=136 6.8  (4.6)
Psychic subscale, change; n=114 -3.5  (4.4)
Neurological subscale, baseline; n=132 4.2  (2.8)
Neurological subscale, change; n=112 -1.2  (1.9)
Autonomic subscale, baseline; n=132 1.9  (2.2)
Autonomic subscale, change; n=113 -0.6  (1.9)
Other subscale, baseline; n=49 0.9  (2.3)
Other subscale, baseline; n=35 0.2  (2.3)
Global assessment by participant, baseline; n=150 0.2  (0.5)
Global assessment by participant, change; n=129 0.1  (0.7)
Global assessment by doctor, baseline; n=150 0.1  (0.5)
Global assessment by doctor, change; n=129 0.1  (0.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine
Comments Tested was the null hypothesis that there would be no change on the total psychic subscale score from baseline to 12-week endpoint.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments p-value is for psychic subscale. A priori threshold for p-values was 0.05.
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Duloxetine
Comments Tested was the null hypothesis that there would be no change on the total neurological subscale score from baseline to 12-week endpoint.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments p-value is for neurological subscale. A priori threshold for p-values was 0.05.
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Duloxetine
Comments Tested was the null hypothesis that there would be no change on the total autonomic subscale score from baseline to 12-week endpoint.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0014
Comments p-value is for autonomic subscale. A priori threshold for p-values was 0.05.
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Duloxetine
Comments Tested was the null hypothesis that there would be no change on the total other subscale score from baseline to 12-week endpoint.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5586
Comments p-value is for other subscale. A priori threshold for p-values was 0.05.
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Duloxetine
Comments Tested was the null hypothesis that there would be no change on the global assessment by paticipant subscale score from baseline to 12-week endpoint.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0848
Comments p-value is for global assessment by paticipant. A priori threshold for p-values was 0.05.
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Duloxetine
Comments Tested was the null hypothesis that there would be no change on the global assessment by doctor subscale score from baseline to 12-week endpoint.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0263
Comments p-value is for global assessment by doctor. A priori threshold for p-values was 0.05.
Method t-test, 2 sided
Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline on the Pittsburgh Sleep Quality Index (PSQI)
Hide Description Self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. 19 individual items generate seven “component” scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The subject self-rates each of these seven areas of sleep. Scoring of answers is based on a 0 to 3 scale, whereby 3 reflects the negative extreme on the Likert Scale. The total score is the sum of the 7 component scores (total score range: 0-21).
Time Frame baseline, 4 weeks, 8 weeks, 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All treated participants with baseline and post-baseline data for >= 1 visit for >= 1 efficacy variable were included in the analyses (Full Analysis Set population). Last observation carried forward analysis. Excluded 2 participants (no baseline measure of PSQI) and 13 participants from calculation of change (absence of any post-baseline measure).
Arm/Group Title Duloxetine
Hide Arm/Group Description:
Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
Overall Number of Participants Analyzed 149
Mean (Standard Deviation)
Unit of Measure: units on a scale
baseline, n=147 8.6  (3.7)
4 weeks change, n=134 -2.8  (3.1)
8 weeks change, n=134 -3.3  (3.5)
12 weeks change, n=134 -3.2  (3.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine
Comments Tested was the null hypothesis that there would be no change on the Pittsburgh Sleep Quality Index from baseline to 4-week endpoint.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments p-value is for 4 weeks change. A priori threshold for p-values was 0.05.
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Duloxetine
Comments Tested was the null hypothesis that there would be no change on the Pittsburgh Sleep Quality Index from baseline to 8-week endpoint.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments p-value is for 8 weeks change. A priori threshold for p-values was 0.05.
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Duloxetine
Comments Tested was the null hypothesis that there would be no change on the Pittsburgh Sleep Quality Index from baseline to 12-week endpoint.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments p-value is for 12 weeks change. A priori threshold for p-values was 0.05.
Method t-test, 2 sided
Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline to 12 Weeks on the 17-item Hamilton Depression Rating Scale (HAMD-17) Total Score
Hide Description The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).
Time Frame baseline, 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All treated participants for whom both baseline data and post-baseline data for at least 1 visit for at least one efficacy variable were available (Full analysis set population) were included in the analyses. Last observation carried forward analysis.
Arm/Group Title Duloxetine
Hide Arm/Group Description:
Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
Overall Number of Participants Analyzed 149
Mean (Standard Deviation)
Unit of Measure: units on a scale
baseline 19.2  (3.5)
change -10.1  (6.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine
Comments Tested was the null hypothesis that there would be no change on the HAMD-17 total score from baseline to 12-week endpoint.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments p-value is for the HAMD-17 total score. A priori threshold for p-values was 0.05.
Method t-test, 2 sided
Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline to 12 Weeks on the Clinical Global Impression-Severity Scale
Hide Description Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).
Time Frame baseline, 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All treated participants for whom both baseline data and post-baseline data for at least 1 visit for at least one efficacy variable were available (Full analysis set population) were included in the analyses. Last observation carried forward analysis.
Arm/Group Title Duloxetine
Hide Arm/Group Description:
Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
Overall Number of Participants Analyzed 149
Mean (Standard Deviation)
Unit of Measure: units on a scale
baseline 4.0  (0.7)
change -1.5  (1.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine
Comments Tested was the null hypothesis that there would be no change on the Clinical Global Impression-Severity scale score from baseline to end of week 12 of treatment.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments p-value is for Clinical Global Impression-Severity scale - change. A priori threshold for p-values was 0.05.
Method t-test, 2 sided
Comments [Not Specified]
7.Secondary Outcome
Title Patient's Global Impression-Improvement at Week 12
Hide Description A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. Scoring: 1=very much better; 2=much better; 3=low better; 4=no change; 5=low worse; 6=much worse; 7=very much worse.
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All treated participants for whom both baseline data and post-baseline data for at least 1 visit for at least one efficacy variable were available (Full analysis set population) were included in the analyses.
Arm/Group Title Duloxetine
Hide Arm/Group Description:
Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
Overall Number of Participants Analyzed 149
Measure Type: Number
Unit of Measure: participants
score=1 5
score=2 63
score=3 38
score=4 10
score=5 3
score=6 0
score=7 0
8.Secondary Outcome
Title Change From Baseline to 12 Weeks in Beck Depression Inventory (BDI) Total Score
Hide Description A 21-item, patient-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a four-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.
Time Frame baseline, 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All treated participants for whom both baseline data and post-baseline data for at least 1 visit for at least one efficacy variable were available (Full analysis set population) were included in the analyses. Last observation carried forward analysis. 27 participants had no post baseline measure.
Arm/Group Title Duloxetine
Hide Arm/Group Description:
Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
Overall Number of Participants Analyzed 149
Mean (Standard Deviation)
Unit of Measure: units on a scale
baseline, n=149 21.6  (6.1)
change, n=122 -12.0  (7.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine
Comments Tested was the null hypothesis that there would be no difference between baseline and post-baseline in BDI scores
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments p-value is for BDI score - change. A priori threshold for p-values was 0.05.
Method t-test, 2 sided
Comments [Not Specified]
9.Secondary Outcome
Title Change From Baseline to 12 Weeks in Visual Analog Scale (VAS)
Hide Description VAS for pain consists of 6 questions that assess overall pain, headache, back pain, shoulder pain, pain interference with daily activities, and pain while awake. Participant rates pain on a 100 millimeter (mm) line between two anchors (0= no pain and 100=very severe pain). Here, the line was only 93 mm long due to an error on the clinical research form and scores were adjusted to 0 to 93.
Time Frame baseline, 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All treated participants for whom both baseline data and post-baseline data for at least 1 visit for at least 1 efficacy variable were available (Full analysis set population) were included in the analyses. Last observation carried forward analysis. Excluded were 2 participants with only post-baseline data and 1 participant with only baseline data.
Arm/Group Title Duloxetine
Hide Arm/Group Description:
Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
Overall Number of Participants Analyzed 149
Mean (Standard Deviation)
Unit of Measure: units on a scale
Overall pain, baseline; n=147 30.5  (24.1)
Overall pain, change; n=146 -5.1  (20.1)
Headaches, baseline; n=147 15.9  (20.3)
Headaches, change; n=146 -5.4  (17.1)
Back ache, baseline; n=147 34.9  (27.2)
Back ache, change; n=146 -10.2  (20.8)
Shoulder pain, baseline; n=147 26.7  (27.1)
Shoulder pain, change; n=146 -10.3  (22.1)
Interference, baseline; n=147 30.4  (26.8)
Interference, change; n=146 -8.2  (22.3)
Pain while awake, baseline; n=147 31.7  (25.9)
Pain while awake, change; n=146 -9.9  (21.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine
Comments Tested was the null hypothesis that there would be no change from baseline to 12 weeks in VAS overall pain scores.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0027
Comments p-value is for VAS overall pain score - change. A priori threshold for p-values was 0.05.
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Duloxetine
Comments Tested was the null hypothesis that there would be no change from baseline to 12 weeks in VAS headaches scores.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments p-value is for VAS Headaches score - change. A priori threshold for p-values was 0.05.
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Duloxetine
Comments Tested was the null hypothesis that there would be no change from baseline to 12 weeks in VAS back ache scores.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments p-value is for VAS back ache score - change. A priori threshold for p-values was 0.05.
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Duloxetine
Comments Tested was the null hypothesis that there would be no change from baseline to 12 weeks in VAS shoulder pain score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments p-value is for VAS shoulder pain score - change. A priori threshold for p-values was 0.05.
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Duloxetine
Comments Tested was the null hypothesis that there would be no change from baseline to 12 weeks in VAS interference score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments p-value is for VAS interference score - change. A priori threshold for p-values was 0.05.
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Duloxetine
Comments Tested was the null hypothesis that there would be no change from baseline to 12 weeks in VAS pain while awake score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments p-value is for VAS pain while awake score - change. A priori threshold for p-values was 0.05.
Method t-test, 2 sided
Comments [Not Specified]
10.Secondary Outcome
Title Change From Baseline to 12 Weeks in Parkinson Disease Questionnaire - 39 Item Version (PDQ-39) Total Score
Hide Description The PDQ-39 has 39 items. Higher scores reflect lower quality of life. The PDQ-39 has eight subscales: mobility (10 items), activities of daily living (six items), emotional wellbeing (six items), stigma (four items), social support (three items), cognition (four items), communication (three items), and bodily discomfort (three items). Items in each subscale, as well in the total scale, can be summarized into an index and transformed linearly to a 0-100 scale.
Time Frame baseline, 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All treated participants with both baseline data and post-baseline data for at least 1 visit for at least 1 efficacy variable were available (Full analysis set population) were included in the analyses. Last observation carried forward analysis. Excluded were 2 participants with no baseline measure and 29 participants with no post baseline measure.
Arm/Group Title Duloxetine
Hide Arm/Group Description:
Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
Overall Number of Participants Analyzed 149
Mean (Standard Deviation)
Unit of Measure: units on a scale
baseline; n=147 32.9  (12.5)
change; n=118 -7.7  (9.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine
Comments Tested was the null hypothesis that there would be no change from baseline to 12 weeks in PDQ-39 total score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments p-value is for PDQ-39 total score - change. A priori threshold for p-values was 0.05.
Method t-test, 2 sided
Comments [Not Specified]
11.Secondary Outcome
Title Average Change From Baseline to 12 Weeks in Blood Pressure
Hide Description For each participant, changes across individual visits were averaged to obtain 1 measurement per participant.
Time Frame baseline through 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All treated participants were included in the analysis population. 5 participants for standing measurement and 6 participants for supine measurements were excluded from calculation of change as they had either no baseline or no post-baseline measure.
Arm/Group Title Duloxetine
Hide Arm/Group Description:
Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
Overall Number of Participants Analyzed 151
Mean (95% Confidence Interval)
Unit of Measure: millimeter mercury
systolic blood pressure, standing; n=146
-0.17
(-1.49 to 1.14)
diastolic blood pressure, standing; n=146
0.12
(-0.89 to 1.13)
systolic blood pressure, supine; n=145
-0.30
(-1.73 to 1.13)
diastolic blood pressure, supine; n=145
-0.45
(-1.48 to 0.58)
12.Secondary Outcome
Title Average Change From Baseline to 12 Weeks in Heart Rate
Hide Description For each participant, changes across individual visits were averaged to obtain 1 measurement per participant.
Time Frame baseline through 12 weeks
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Hide Analysis Population Description
All treated participants were included in the analysis population. 6 participants were excluded from calculation of change as they had either no baseline or post-baseline measure.
Arm/Group Title Duloxetine
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Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
Overall Number of Participants Analyzed 151
Mean (95% Confidence Interval)
Unit of Measure: beats per minute
standing, n=145
1.61
(0.71 to 2.51)
supine, n=145
1.16
(0.35 to 1.97)
13.Secondary Outcome
Title Number of Participants With Abnormal Electrocardiograms (ECG) During the 12 Week Study
Hide Description Included were participants with normal ECG at baseline who developed abnormal ECGs during the study.
Time Frame baseline through 12 weeks
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Hide Analysis Population Description
All treated participants were included in the analysis population. 54 participants were excluded from calculation of change as they had abnormal ECG at baseline, no baseline measure, or no post-baseline measure.
Arm/Group Title Duloxetine
Hide Arm/Group Description:
Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
Overall Number of Participants Analyzed 151
Measure Type: Number
Unit of Measure: participants
3
14.Secondary Outcome
Title Laboratory Analytes
Hide Description Laboratory analytes were collected to assess adverse events which are listed in the reported adverse events section.
Time Frame baseline through 12 weeks
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Hide Analysis Population Description
All enrolled participants for whom both baseline data and post-baseline data were available were included in the analyses.
Arm/Group Title Duloxetine
Hide Arm/Group Description:
Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
15.Secondary Outcome
Title Number of Participants Who Responded to Treatment by 12 Weeks
Hide Description Response was defined as a >= 50% reduction in 17-item Hamilton Depression rating scale (HAMD) scores. The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).
Time Frame 12 weeks
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Hide Analysis Population Description
All treated participants for whom both baseline data and post-baseline data for at least 1 visit for at least one efficacy variable were available (Full analysis set population) were included in the analyses. Last observation carried forward analysis.
Arm/Group Title Duloxetine
Hide Arm/Group Description:
Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
Overall Number of Participants Analyzed 149
Measure Type: Number
Unit of Measure: participants
90
16.Secondary Outcome
Title Number of Participants Who Reached Remission by 12 Weeks
Hide Description Remission was defined as reaching a 17-item Hamilton Depression Rating Scale (HAMD) total score <=7. The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All treated participants for whom both baseline data and post-baseline data for at least 1 visit for at least one efficacy variable were available (Full analysis set population) were included in the analyses. Last observation carried forward analysis.
Arm/Group Title Duloxetine
Hide Arm/Group Description:
Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
Overall Number of Participants Analyzed 149
Measure Type: Number
Unit of Measure: participants
68
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Duloxetine
Hide Arm/Group Description Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
All-Cause Mortality
Duloxetine
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Duloxetine
Affected / at Risk (%) # Events
Total   3/151 (1.99%)    
Cardiac disorders   
Atrial fibrillation  1  1/151 (0.66%)  1
Infections and infestations   
Pneumonia  1  1/151 (0.66%)  1
Sepsis  1 [1]  1/151 (0.66%)  1
Musculoskeletal and connective tissue disorders   
Myopathy  1  1/151 (0.66%)  1
Nervous system disorders   
Cerebral haemorrhage  1 [2]  1/151 (0.66%)  1
Renal and urinary disorders   
Renal failure acute  1  1/151 (0.66%)  1
Urinary retention  1  1/151 (0.66%)  1
Respiratory, thoracic and mediastinal disorders   
Pulmonary embolism  1  1/151 (0.66%)  1
Skin and subcutaneous tissue disorders   
Decubitus ulcer  1  1/151 (0.66%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
[1]
This event resulted in death.
[2]
This event resulted in death after completing the 12 week study period but within 30 days after completing the study.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Duloxetine
Affected / at Risk (%) # Events
Total   39/151 (25.83%)    
Ear and labyrinth disorders   
Vertigo  1  2/151 (1.32%)  2
Gastrointestinal disorders   
Aptyalism  1  3/151 (1.99%)  3
Constipation  1  5/151 (3.31%)  5
Diarrhoea  1  2/151 (1.32%)  2
Nausea  1  6/151 (3.97%)  6
General disorders   
Asthenia  1  3/151 (1.99%)  3
Metabolism and nutrition disorders   
Hypercholesterolaemia  1  3/151 (1.99%)  3
Nervous system disorders   
Headache  1  3/151 (1.99%)  3
Somnolence  1  3/151 (1.99%)  3
Tremor  1  2/151 (1.32%)  2
Psychiatric disorders   
Agitation  1  2/151 (1.32%)  2
Anxiety  1  2/151 (1.32%)  2
Psychotic disorder  1  2/151 (1.32%)  2
Skin and subcutaneous tissue disorders   
Hyperhidrosis  1  2/151 (1.32%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
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.
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