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A Duloxetine Dosing Strategy Study in Korean Patients With Major Depressive Disorder

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ClinicalTrials.gov Identifier: NCT00960986
Recruitment Status : Completed
First Posted : August 18, 2009
Results First Posted : April 17, 2012
Last Update Posted : December 31, 2014
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Major Depressive Disorder (MDD)
Intervention Drug: Duloxetine hydrochloride
Enrollment 249
Recruitment Details  
Pre-assignment Details Period 1 was a 3- to 30-day screening and washout period; Period 2 (Week 0-1) was a 1-week initial dosing period (randomization to duloxetine 30 mg with food, 30 mg without food, 60 mg with food, or 60 mg without food); Period 3 (Week 1-8) was a 7-week therapy period (treatment switched to duloxetine 60 mg once daily (QD) until study end.
Arm/Group Title Duloxetine 60 mg With Food Duloxetine 60 mg Without Food Duloxetine 30 mg With Food Duloxetine 30 mg Without Food
Hide Arm/Group Description Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks Duloxetine 60 mg capsule po QD without food for 8 weeks Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
Period Title: Period 1 (Screening and Washout)
Started 59 63 63 64
Completed 56 59 59 61
Not Completed 3 4 4 3
Reason Not Completed
Adverse Event             1             2             1             1
Lost to Follow-up             0             0             2             1
Protocol Violation             1             0             0             0
Withdrawal by Subject             1             2             1             1
Period Title: Period 2 (1-week Initial Dosing Period)
Started 56 59 59 61
Completed 56 59 59 61
Not Completed 0 0 0 0
Period Title: Period 3 (7-week Therapy Period)
Started 56 59 59 61
Completed 26 36 39 36
Not Completed 30 23 20 25
Reason Not Completed
Adverse Event             17             15             10             12
Death             0             0             1             0
Lost to Follow-up             0             0             1             0
Protocol Violation             10             4             3             11
Withdrawal by Subject             2             2             4             2
Lack of Efficacy             1             2             1             0
Arm/Group Title Duloxetine 60 mg With Food Duloxetine 60 mg Without Food Duloxetine 30 mg With Food Duloxetine 30 mg Without Food Total
Hide Arm/Group Description Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks Duloxetine 60 mg capsule po QD without food for 8 weeks Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks Total of all reporting groups
Overall Number of Baseline Participants 59 63 63 64 249
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 59 participants 63 participants 63 participants 64 participants 249 participants
44.65
(31.58 to 53.73)
47.90
(38.65 to 58.90)
49.94
(40.04 to 62.24)
44.65
(32.84 to 56.92)
46.81
(34.78 to 59.25)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants 63 participants 63 participants 64 participants 249 participants
Female
43
  72.9%
47
  74.6%
47
  74.6%
40
  62.5%
177
  71.1%
Male
16
  27.1%
16
  25.4%
16
  25.4%
24
  37.5%
72
  28.9%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Korean Number Analyzed 59 participants 63 participants 63 participants 64 participants 249 participants
59 63 63 64 249
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Korea, Republic of Number Analyzed 59 participants 63 participants 63 participants 64 participants 249 participants
59 63 63 64 249
Body Mass Index (BMI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Kilogram per square meter (kg/m^2)
Number Analyzed 59 participants 63 participants 63 participants 64 participants 249 participants
24.56  (4.034) 23.28  (3.133) 23.06  (3.430) 23.84  (3.612) 23.67  (3.584)
[1]
Measure Description: BMI measures the participant's body weight divided by the square of his or her height.
Previously diagnosed with major depressive disorder (MDD)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 59 participants 63 participants 63 participants 64 participants 249 participants
59 63 63 64 249
Duration since first major depressive disorder (MDD) episode  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 59 participants 63 participants 63 participants 64 participants 249 participants
1.47
(0.52 to 4.29)
2.65
(0.77 to 5.32)
2.52
(0.48 to 9.12)
1.29
(0.52 to 4.40)
1.92
(0.54 to 5.55)
Age at first major depressive disorder (MDD) episode  
Mean (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 59 participants 63 participants 63 participants 64 participants 249 participants
41.21
(29.00 to 51.00)
43.33
(34.67 to 53.00)
43.86
(27.00 to 59.60)
41.58
(29.00 to 54.00)
42.52
(30.00 to 54.00)
Number of previous MDD episodes/exacerbations in the last 24 months  
Median (Inter-Quartile Range)
Unit of measure:  Number of episodes in last 24 months
Number Analyzed 59 participants 63 participants 63 participants 64 participants 249 participants
1.0
(0.0 to 1.0)
1.0
(0.0 to 1.0)
1.0
(0.0 to 1.0)
1.0
(0.0 to 1.0)
1.0
(0.0 to 1.0)
Received previous therapy for current episode  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 59 participants 63 participants 63 participants 64 participants 249 participants
yes 18 25 18 26 87
no 41 38 45 38 162
17-item Hamilton Depression Rating Scale (HAMD-17) Total Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 59 participants 63 participants 63 participants 64 participants 249 participants
21.0  (5.18) 22.3  (5.69) 22.9  (5.45) 20.3  (5.23) 21.6  (5.46)
[1]
Measure Description: The HAMD-17 measured depression severity. Each item was evaluated and scored using either a 5-point scale (for example, absent; mild; moderate; severe; very severe) or a 3-point scale (for example, absent; mild; marked). The total score ranged from 0 (not at all depressed)-52 (severely depressed).
Clinical Global Impression of Severity (CGI-S) Score   [1] 
Mean (Inter-Quartile Range)
Unit of measure:  Units on a scale
Number Analyzed 59 participants 63 participants 63 participants 64 participants 249 participants
4.4
(4.0 to 5.0)
4.5
(4.0 to 5.0)
4.7
(4.0 to 5.0)
4.2
(4.0 to 5.0)
4.4
(4.0 to 5.0)
[1]
Measure Description: The CGI-S Rating Scale was a 7-point scale: 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; or 7=extremely ill.
Association for Methodology and Documentation in Psychiatry (AMDP-5) Item 112 (Nausea) Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 59 participants 63 participants 63 participants 64 participants 249 participants
0.3  (0.72) 0.2  (0.59) 0.2  (0.61) 0.1  (0.38) 0.2  (0.58)
[1]
Measure Description: AMDP-5 Item 112 (nausea) measured nausea severity. The scores ranged from 0-3: 0=Not present; 1=Mild; 2=Moderate; 3=Severe.
1.Primary Outcome
Title Mean Maximum Nausea Severity, Association for Methodology and Documentation in Psychiatry (AMDP-5) Adverse Event (AE) Scale Item 112 (Nausea)
Hide Description AMDP-5 AE scale Item 112 (nausea) measured nausea severity during treatment (Week 0-8). The scores ranged from 0-3: 0=Not present; 1=Mild; 2=Moderate; 3=Severe.
Time Frame 1 week and 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population included all participants who took at least 1 study drug dose analysed according to the drug dose actually taken.
Arm/Group Title Duloxetine 60 mg With Food Duloxetine 60 mg Without Food Duloxetine 30 mg With Food Duloxetine 30 mg Without Food
Hide Arm/Group Description:
Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks
Duloxetine 60 mg capsule po QD without food for 8 weeks
Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks
Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
Overall Number of Participants Analyzed 56 59 59 61
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Week 0-1
1.4
(1.06 to 1.69)
1.2
(0.89 to 1.49)
0.9
(0.62 to 1.11)
0.8
(0.57 to 1.06)
Week 1-8 (n=35; n=43; n=48; n=46)
0.5
(0.25 to 0.67)
0.5
(0.27 to 0.66)
0.7
(0.45 to 0.96)
0.4
(0.19 to 0.59)
2.Secondary Outcome
Title Mean Change From Baseline to 8-Week Endpoint in Association for Methodology and Documentation in Psychiatry (AMDP-5) Adverse Event (AE) Scale Item 112 (Nausea)
Hide Description Scores for AE scale Item 112 (nausea) of AMDP-5 (Week 0-8) ranged from 0-3: 0=Not present; 1=Mild; 2=Moderate; 3=Severe. Least Squares (LS) Means were adjusted for treatment group, site, visit and treatment-by-visit interaction, gender, age, baseline score and baseline score-by-visit interaction, and an unstructured covariate matrix.
Time Frame Baseline, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population included all participants who took at least 1 study drug dose analysed according to the drug dose actually taken. N = number of subjects with a baseline and post-baseline result at the Week 8 visit.
Arm/Group Title Duloxetine 60 mg With Food Duloxetine 60 mg Without Food Duloxetine 30 mg With Food Duloxetine 30 mg Without Food
Hide Arm/Group Description:
Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks
Duloxetine 60 mg capsule po QD without food for 8 weeks
Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks
Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
Overall Number of Participants Analyzed 28 37 39 37
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.02  (0.08) -0.02  (0.07) -0.01  (0.07) -1.12  (0.07)
3.Secondary Outcome
Title Mean Change From Baseline to 1-Week and 8-Week Endpoints in Association for Methodology and Documentation in Psychiatry (AMDP-5) Measure: Gastric Events Score
Hide Description Gastric events scores (average of Item 112 [nausea] + Item 113 [vomiting]) of AMDP-5 (Week 0-8) ranged from 0-3: 0=Not present; 1=Mild; 2=Moderate; 3=Severe. Least Squares (LS) Means were adjusted for treatment group, site, visit and treatment-by-visit interaction, gender, age, baseline score and baseline score-by-visit interaction, and an unstructured covariate matrix.
Time Frame Baseline, 1 week and 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population included all participants who took at least 1 study drug dose analysed according to the drug dose actually taken.
Arm/Group Title Duloxetine 60 mg With Food Duloxetine 60 mg Without Food Duloxetine 30 mg With Food Duloxetine 30 mg Without Food
Hide Arm/Group Description:
Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks
Duloxetine 60 mg capsule po QD without food for 8 weeks
Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks
Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
Overall Number of Participants Analyzed 56 59 59 61
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
1-week change 0.73  (0.10) 0.72  (0.10) 0.35  (0.10) 0.37  (0.10)
8-week change (n=28; n=37; n=39; n=37) -0.04  (0.04) -0.04  (0.04) -0.04  (0.04) -0.09  (0.04)
4.Secondary Outcome
Title Mean Change From Baseline to 1-Week and 8-Week Endpoints in Association for Methodology and Documentation in Psychiatry (AMDP-5) Measure: Common Adverse Events (AEs) Score
Hide Description AMDP-5 common AEs score was used to create a composite measure of AEs from previous duloxetine studies (incidence >5% and 2X placebo rate). The common AEs total score was the sum of the following 8 AMDP-5 items: 1) Mean of Item 112 (nausea) + 113 (vomiting); 2) Item 111 (dry mouth); 3) Item 115 (constipation); 4) Mean of Items 101-104 (insomnia); Item 122 (increased perspiration); 8) Item 106 (decreased appetite). Score was based on a 5-point scale: 1=absent, 2=mild, 3=moderate, 4=severe, 5=extremely severe; Higher score=worse severity.
Time Frame Baseline, 1 week, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population included all participants who took at least 1 study drug dose analysed according to the drug dose actually taken.
Arm/Group Title Duloxetine 60 mg With Food Duloxetine 60 mg Without Food Duloxetine 30 mg With Food Duloxetine 30 mg Without Food
Hide Arm/Group Description:
Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks
Duloxetine 60 mg capsule po QD without food for 8 weeks
Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks
Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
Overall Number of Participants Analyzed 56 59 59 61
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
1-week change 1.25  (0.44) 1.28  (0.42) -0.00  (0.43) -0.37  (0.41)
8-week change (n=28; n=37; n=39; n=37) -3.54  (0.47) -2.99  (0.42) -2.33  (0.41) -3.23  (0.41)
5.Secondary Outcome
Title Mean Change From Baseline to 1-Week and 8-Week Endpoints in 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score
Hide Description The HAMD-17 total score ranged from 0 (not at all depressed)-52 (severely depressed). Least squares (LS) Means were adjusted for treatment group, site, visit and treatment-by-visit interaction, gender, age, baseline score and baseline score-by-visit interaction, and an unstructured covariance matrix.
Time Frame Baseline, 1 week, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy population included the number of participants with baseline and at least 1 post-baseline value analysed under the intent-to-treat (ITT) principle according to the drug dose they were assigned.
Arm/Group Title Duloxetine 60 mg With Food Duloxetine 60 mg Without Food Duloxetine 30 mg With Food Duloxetine 30 mg Without Food
Hide Arm/Group Description:
Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks
Duloxetine 60 mg capsule po QD without food for 8 weeks
Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks
Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
Overall Number of Participants Analyzed 56 59 59 61
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
1-week change -2.83  (0.57) -2.85  (0.55) -3.84  (0.56) -4.34  (0.54)
8-week change (n=28; n=37; n=39; n=37) -15.39  (1.01) -13.45  (0.90) -13.60  (0.88) -13.07  (0.89)
6.Secondary Outcome
Title Mean Change From Baseline to 1-Week and 8-Week Endpoints in 17-Item Hamilton Depression Rating Scale (HAMD-17) Maier Subscale
Hide Description The HAMD-17 Maier subscale (Items 1, 2, 7, 8, 9, 10 of HAMD-17 questionnaire) represented the "core" symptoms of depression. Total subscale scores ranged from 0 (normal)-24 (severe). Least Squares (LS) Means were adjusted for treatment group, site, visit and treatment-by-visit interaction, gender, age, baseline score and baseline score-by-visit interaction, and an unstructured covariate matrix.
Time Frame Baseline, 1 week, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy population included the number of participants with baseline and at least 1 post-baseline value analysed under the intent-to-treat (ITT) principle according to the drug dose they were assigned.
Arm/Group Title Duloxetine 60 mg With Food Duloxetine 60 mg Without Food Duloxetine 30 mg With Food Duloxetine 30 mg Without Food
Hide Arm/Group Description:
Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks
Duloxetine 60 mg capsule po QD without food for 8 weeks
Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks
Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
Overall Number of Participants Analyzed 56 59 59 61
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
1-week change -2.06  (0.33) -1.90  (0.32) -2.15  (0.32) -2.64  (0.31)
8-week change (n=28; n=37; n=39; n=37) -8.01  (0.50) -7.12  (0.45) -7.55  (0.44) -7.30  (0.44)
7.Secondary Outcome
Title Mean Change From Baseline to 1-Week and 8-Week Endpoints in 17-Item Hamilton Depression Rating Scale (HAMD-17) Core Mood Subscale
Hide Description The HAMD-17 Core Mood subscale (Items 1, 2, 3, 7, 8 of HAMD-17 questionnaire) represented the core symptoms of depression. Total subscale scores ranged from 0 (normal)-20 (severe). Least Squares (LS) Means were adjusted for treatment group, site, visit and treatment-by-visit interaction, gender, age, baseline score and baseline score-by-visit interaction, and an unstructured covariate matrix.
Time Frame Baseline, 1 week, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy population included the number of participants with baseline and at least 1 post-baseline value analysed under the intent-to-treat (ITT) principle according to the drug dose they were assigned.
Arm/Group Title Duloxetine 60 mg With Food Duloxetine 60 mg Without Food Duloxetine 30 mg With Food Duloxetine 30 mg Without Food
Hide Arm/Group Description:
Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks
Duloxetine 60 mg capsule po QD without food for 8 weeks
Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks
Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
Overall Number of Participants Analyzed 56 59 59 61
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
1-week change -1.43  (0.27) -1.18  (0.26) -1.52  (0.26) -1.76  (0.25)
8-week change (n=28; n=37; n=39; n=37) -6.18  (0.40) -5.39  (0.36) -5.85  (0.35) -5.67  (0.35)
8.Secondary Outcome
Title Mean Change From Baseline to 1-Week and 8-Week Endpoints in 17-Item Hamilton Depression Rating Scale (HAMD-17) Anxiety/Somatization Subscale
Hide Description The HAMD-17 Anxiety/Somatization subscale (Items 10, 11, 12, 13, 15, 17 of HAMD-17 questionnaire) evaluated the severity of psychic and somatic manifestations of anxiety and agitation. Total subscale scores ranged from 0 (normal)-18 (severe). Least Squares (LS) Means were adjusted for treatment group, site, visit and treatment-by-visit interaction, gender, age, baseline score and baseline score-by-visit interaction, and an unstructured covariate matrix.
Time Frame Baseline, 1 week, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy population included the number of participants with baseline and at least 1 post-baseline value analysed under the intent-to-treat (ITT) principle according to the drug dose they were assigned.
Arm/Group Title Duloxetine 60 mg With Food Duloxetine 60 mg Without Food Duloxetine 30 mg With Food Duloxetine 30 mg Without Food
Hide Arm/Group Description:
Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks
Duloxetine 60 mg capsule po QD without food for 8 weeks
Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks
Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
Overall Number of Participants Analyzed 56 59 59 61
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
1-week change -0.75  (0.25) -1.15  (0.24) -1.36  (0.24) -1.41  (0.23)
8-week change (n=28; n=37; n=39; n=37) -4.93  (0.41) -4.50  (0.36) -4.57  (0.35) -4.26  (0.35)
9.Secondary Outcome
Title Mean Change From Baseline to 1-Week and 8-Week Endpoints in 17-Item Hamilton Depression Rating Scale (HAMD-17) Retardation/Somatization Subscale
Hide Description The HAMD-17 Retardation/Somatization subscale (Items 1, 7, 8, 14 of HAMD-17 questionnaire) evaluated dysfunction in mood, work, sexual activity, and overall motor retardation. Total subscale scores ranged from 0 (normal)-14 (severe). Least Squares (LS) Means were adjusted for treatment group, site, visit and treatment-by-visit interaction, gender, age, baseline score and baseline score-by-visit interaction, and an unstructured covariate matrix.
Time Frame Baseline, 1 week, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy population included the number of participants with baseline and at least 1 post-baseline value analysed under the intent-to-treat (ITT) principle according to the drug dose they were assigned.
Arm/Group Title Duloxetine 60 mg With Food Duloxetine 60 mg Without Food Duloxetine 30 mg With Food Duloxetine 30 mg Without Food
Hide Arm/Group Description:
Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks
Duloxetine 60 mg capsule po QD without food for 8 weeks
Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks
Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
Overall Number of Participants Analyzed 56 59 59 61
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
1-week change -0.83  (0.22) -0.87  (0.21) -1.02  (0.22) -1.20  (0.21)
8-week change (n=28; n=37; n=39; n=37) -4.92  (0.35) -4.37  (0.31) -4.63  (0.31) -4.55  (0.31)
10.Secondary Outcome
Title Mean Change From Baseline to 1-Week and 8-Week Endpoints in 17-Item Hamilton Depression Rating Scale (HAMD-17) Sleep Subscale
Hide Description The HAMD-17 Sleep subscale (Items 4, 5, 6 of HAMD-17 questionnaire) evaluated initial, middle, and late insomnia. Total subscale scores ranged from 0 (no difficulty)-6 (difficulty). Least Squares (LS) Means were adjusted for treatment group, site, visit and treatment-by-visit interaction, gender, age, baseline score and baseline score-by-visit interaction, and an unstructured covariate matrix.
Time Frame Baseline, 1 week, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy population included the number of participants with baseline and at least 1 post-baseline value analysed under the intent-to-treat (ITT) principle according to the drug dose they were assigned.
Arm/Group Title Duloxetine 60 mg With Food Duloxetine 60 mg Without Food Duloxetine 30 mg With Food Duloxetine 30 mg Without Food
Hide Arm/Group Description:
Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks
Duloxetine 60 mg capsule po QD without food for 8 weeks
Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks
Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
Overall Number of Participants Analyzed 56 59 59 61
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
1-week change -0.72  (0.21) -0.64  (0.21) -0.66  (0.21) -1.01  (0.20)
8-week change (n=28; n=37; n=39; n=37) -2.77  (0.27) -2.32  (0.24) -2.09  (0.23) -2.10  (0.23)
11.Secondary Outcome
Title Mean Change From Baseline to 1-Week and 8-Week Endpoints in Clinical Global Impressions of Severity (CGI-S)
Hide Description The CGI-S Rating Scale was a 7-point scale: 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; or 7=extremely ill. Least squares (LS) Means were adjusted for treatment group, site, visit and treatment-by-visit interaction, gender, age, baseline score and baseline score-by-visit interaction, and an unstructured covariance matrix.
Time Frame Baseline, 1 week, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy population included the number of participants with baseline and at least 1 post-baseline value analysed under the intent-to-treat (ITT) principle according to the drug dose they were assigned.
Arm/Group Title Duloxetine 60 mg With Food Duloxetine 60 mg Without Food Duloxetine 30 mg With Food Duloxetine 30 mg Without Food
Hide Arm/Group Description:
Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks
Duloxetine 60 mg capsule po QD without food for 8 weeks
Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks
Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
Overall Number of Participants Analyzed 56 59 59 61
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
1-week change -0.36  (0.09) -0.36  (0.09) -0.44  (0.09) -0.63  (0.09)
8-week change (n=28; n=37; n=39; n=37) -2.43  (0.17) -2.13  (0.15) -2.23  (0.15) -2.27  (0.15)
12.Secondary Outcome
Title Patient Global Impression of Improvement (PGI-I) at 1 Week and 8 Weeks
Hide Description The PGI-I Rating Scale was a 7-point scale: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; or 7=very much worse. Least squares (LS) Means were adjusted for treatment group, site, visit and treatment-by-visit interaction, gender, age, baseline score and baseline score-by-visit interaction and an unstructured covariance matrix.
Time Frame 1 week, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy population included the number of participants with baseline and at least 1 post-baseline value analysed under the intent-to-treat (ITT) principle according to the drug dose they were assigned.
Arm/Group Title Duloxetine 60 mg With Food Duloxetine 60 mg Without Food Duloxetine 30 mg With Food Duloxetine 30 mg Without Food
Hide Arm/Group Description:
Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks
Duloxetine 60 mg capsule po QD without food for 8 weeks
Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks
Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
Overall Number of Participants Analyzed 56 59 59 61
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
1-week change 3.72  (0.13) 3.77  (0.13) 3.52  (0.13) 3.47  (0.12)
8-week change (n=28; n=37; n=39; n=37) 2.31  (0.19) 2.40  (0.17) 2.36  (0.16) 2.40  (0.16)
13.Secondary Outcome
Title Time to Onset of Nausea
Hide Description Events of nausea were taken from the adverse event (AE) data. Participants were censored based on the following rules: 1=study discontinuation date if the participant discontinues the study; 2=study lost to follow-up date if the participant drops out of the study.
Time Frame Baseline to onset of nausea (Baseline up to 8 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population included all participants who took at least 1 study drug dose analysed according to the drug dose actually taken.
Arm/Group Title Duloxetine 60 mg With Food Duloxetine 60 mg Without Food Duloxetine 30 mg With Food Duloxetine 30 mg Without Food
Hide Arm/Group Description:
Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks
Duloxetine 60 mg capsule po QD without food for 8 weeks
Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks
Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
Overall Number of Participants Analyzed 40 38 38 37
Median (95% Confidence Interval)
Unit of Measure: days
2.0
(1.0 to 9.0)
1.0 [1] 
(1.0 to NA)
7.0
(2.0 to 56.0)
6.0 [1] 
(1.0 to NA)
[1]
The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.
14.Secondary Outcome
Title Time to Resolve Nausea
Hide Description Events of nausea were taken from the adverse event (AE) data. Participants were censored based on the following rules: 1=study discontinuation date if the participant discontinues the study; 2=study lost to follow-up date if the participant drops out of the study.
Time Frame Nausea onset up to nausea resolve (Baseline up to 8 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population included all participants who took at least 1 study drug dose analysed according to the drug dose actually taken.
Arm/Group Title Duloxetine 60 mg With Food Duloxetine 60 mg Without Food Duloxetine 30 mg With Food Duloxetine 30 mg Without Food
Hide Arm/Group Description:
Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks
Duloxetine 60 mg capsule po QD without food for 8 weeks
Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks
Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
Overall Number of Participants Analyzed 33 25 27 30
Median (95% Confidence Interval)
Unit of Measure: days
6.0
(4.0 to 9.0)
8.0
(5.0 to 15.0)
15.0
(9.0 to 22.0)
6.0
(4.0 to 7.0)
15.Secondary Outcome
Title Percentage of Participants Achieving Response
Hide Description Response was defined as ≥50% decrease from baseline on the 17-item Hamilton Depression Rating Scale (HAMD-17) total score. HAMD-17 total scores ranged from 0 (not at all depressed)-52 (severely depressed).
Time Frame Baseline up to 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy population included the number of participants with baseline and at least 1 post-baseline value analysed under the intent-to-treat (ITT) principle according to the drug dose they were assigned.
Arm/Group Title Duloxetine 60 mg With Food Duloxetine 60 mg Without Food Duloxetine 30 mg With Food Duloxetine 30 mg Without Food
Hide Arm/Group Description:
Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks
Duloxetine 60 mg capsule po QD without food for 8 weeks
Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks
Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
Overall Number of Participants Analyzed 56 59 59 61
Measure Type: Number
Unit of Measure: percentage of participants
51.8 49.2 47.5 47.5
16.Secondary Outcome
Title Percentage of Patients Achieving Remission
Hide Description Remission was defined as 17-item Hamilton Depression Rating Scale (HAMD-17) total score ≤7. HAMD-17 total scores ranged from 0 (not at all depressed)-52 (severely depressed).
Time Frame Baseline up to 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy population included the number of participants with baseline and at least 1 post-baseline value analysed under the intent-to-treat (ITT) principle according to the drug dose they were assigned.
Arm/Group Title Duloxetine 60 mg With Food Duloxetine 60 mg Without Food Duloxetine 30 mg With Food Duloxetine 30 mg Without Food
Hide Arm/Group Description:
Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks
Duloxetine 60 mg capsule po QD without food for 8 weeks
Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks
Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
Overall Number of Participants Analyzed 56 59 59 61
Measure Type: Number
Unit of Measure: percentage of participants
42.9 37.3 35.6 32.8
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Duloxetine 30 mg With Food Duloxetine 60 mg With Food Duloxetine 30 mg Without Food Duloxetine 60 mg Without Food
Hide Arm/Group Description Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks Duloxetine 60 mg capsule po QD without food for 8 weeks
All-Cause Mortality
Duloxetine 30 mg With Food Duloxetine 60 mg With Food Duloxetine 30 mg Without Food Duloxetine 60 mg Without Food
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Duloxetine 30 mg With Food Duloxetine 60 mg With Food Duloxetine 30 mg Without Food Duloxetine 60 mg Without Food
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/63 (1.59%)      1/59 (1.69%)      2/64 (3.13%)      0/63 (0.00%)    
Gastrointestinal disorders         
Diarrhoea  1  0/63 (0.00%)  0 1/59 (1.69%)  1 0/64 (0.00%)  0 0/63 (0.00%)  0
Infections and infestations         
Pelvic inflammatory disease  1  0/63 (0.00%)  0 1/59 (1.69%)  1 0/64 (0.00%)  0 0/63 (0.00%)  0
Injury, poisoning and procedural complications         
Muscle injury  1  0/63 (0.00%)  0 0/59 (0.00%)  0 1/64 (1.56%)  1 0/63 (0.00%)  0
Road traffic accident  1  0/63 (0.00%)  0 0/59 (0.00%)  0 1/64 (1.56%)  1 0/63 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Lipoma  1  0/63 (0.00%)  0 0/59 (0.00%)  0 1/64 (1.56%)  1 0/63 (0.00%)  0
Psychiatric disorders         
Completed suicide  1  1/63 (1.59%)  1 0/59 (0.00%)  0 0/64 (0.00%)  0 0/63 (0.00%)  0
Reproductive system and breast disorders         
Ovarian cyst  1  0/63 (0.00%)  0 1/59 (1.69%)  1 0/64 (0.00%)  0 0/63 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Duloxetine 30 mg With Food Duloxetine 60 mg With Food Duloxetine 30 mg Without Food Duloxetine 60 mg Without Food
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   52/63 (82.54%)      55/59 (93.22%)      57/64 (89.06%)      58/63 (92.06%)    
Cardiac disorders         
Palpitations  1  0/63 (0.00%)  0 4/59 (6.78%)  4 2/64 (3.13%)  2 3/63 (4.76%)  3
Eye disorders         
Vision blurred  1  5/63 (7.94%)  5 1/59 (1.69%)  1 0/64 (0.00%)  0 2/63 (3.17%)  2
Gastrointestinal disorders         
Abdominal discomfort  1  3/63 (4.76%)  3 6/59 (10.17%)  6 7/64 (10.94%)  7 4/63 (6.35%)  5
Constipation  1  12/63 (19.05%)  12 9/59 (15.25%)  10 9/64 (14.06%)  10 10/63 (15.87%)  11
Diarrhoea  1  4/63 (6.35%)  4 3/59 (5.08%)  3 4/64 (6.25%)  5 3/63 (4.76%)  4
Dry mouth  1  10/63 (15.87%)  10 10/59 (16.95%)  11 10/64 (15.63%)  10 12/63 (19.05%)  12
Dyspepsia  1  4/63 (6.35%)  5 4/59 (6.78%)  5 4/64 (6.25%)  4 2/63 (3.17%)  3
Nausea  1  39/63 (61.90%)  42 41/59 (69.49%)  49 38/64 (59.38%)  43 39/63 (61.90%)  43
Vomiting  1  2/63 (3.17%)  2 8/59 (13.56%)  8 8/64 (12.50%)  9 10/63 (15.87%)  10
General disorders         
Asthenia  1  4/63 (6.35%)  4 1/59 (1.69%)  1 5/64 (7.81%)  5 5/63 (7.94%)  6
Metabolism and nutrition disorders         
Decreased appetite  1  11/63 (17.46%)  12 11/59 (18.64%)  11 13/64 (20.31%)  13 11/63 (17.46%)  11
Nervous system disorders         
Dizziness  1  11/63 (17.46%)  11 8/59 (13.56%)  8 10/64 (15.63%)  10 7/63 (11.11%)  7
Headache  1  11/63 (17.46%)  11 10/59 (16.95%)  10 14/64 (21.88%)  16 8/63 (12.70%)  8
Sedation  1  5/63 (7.94%)  5 6/59 (10.17%)  6 5/64 (7.81%)  5 6/63 (9.52%)  6
Somnolence  1  0/63 (0.00%)  0 4/59 (6.78%)  4 5/64 (7.81%)  5 9/63 (14.29%)  10
Tremor  1  1/63 (1.59%)  1 4/59 (6.78%)  4 2/64 (3.13%)  2 2/63 (3.17%)  2
Psychiatric disorders         
Anxiety  1  6/63 (9.52%)  7 4/59 (6.78%)  4 3/64 (4.69%)  3 6/63 (9.52%)  6
Insomnia  1  8/63 (12.70%)  8 8/59 (13.56%)  9 6/64 (9.38%)  6 5/63 (7.94%)  6
Skin and subcutaneous tissue disorders         
Hyperhidrosis  1  5/63 (7.94%)  5 5/59 (8.47%)  5 1/64 (1.56%)  1 5/63 (7.94%)  5
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.1
Large number of protocol violations; bias due to unblinded, open-label design (participants were predisposed to expect an outcome of nausea as the primary endpoint); use of emetogenic medications; incorrect reporting and intake of food and drug.
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: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00960986     History of Changes
Other Study ID Numbers: 9884
F1J-MC-HMFL ( Other Identifier: Eli Lilly and Company )
First Submitted: August 17, 2009
First Posted: August 18, 2009
Results First Submitted: January 17, 2012
Results First Posted: April 17, 2012
Last Update Posted: December 31, 2014