Trial Outcomes & Findings for Switching to Duloxetine in Patients With Depression (NCT NCT00696774)
NCT ID: NCT00696774
Last Updated: 2010-09-08
Results Overview
BPI-SF interference score asks about the degree to which pain interferes with mood, walking and other physical activity, work, social activity, relations with others, and sleep. BPI-SF interference score ranges from 0 (no interference) to 10 (interferes completely). Response is defined as a \>=50% reduction in the Maier subscale score from baseline. The Maier subscale (Items 1,2,7,8,9,10) represents "core" symptoms of depression. Total subscale scores range from 0 (normal) to 24 (severe). Factors used for adjustment for least squares means are listed in 'Other relevant information' section.
COMPLETED
PHASE4
242 participants
Baseline, 4 weeks
2010-09-08
Participant Flow
270 participants began the study. 26 were screen failures (17 did not meet entry criteria, 7 decided to withdraw, and 2 withdrew based on the physician's decision). 2 participants discontinued before enrollment (1 was lost to follow-up and 1 decided to withdraw).
Participant milestones
| Measure |
Responders
60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III).
|
Non-Responders
60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-Responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III).
|
Unclassified
Participants who received 60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II) with unknown response status.
|
|---|---|---|---|
|
Period II
STARTED
|
115
|
91
|
36
|
|
Period II
COMPLETED
|
115
|
91
|
0
|
|
Period II
NOT COMPLETED
|
0
|
0
|
36
|
|
Period III
STARTED
|
113
|
88
|
0
|
|
Period III
COMPLETED
|
106
|
81
|
0
|
|
Period III
NOT COMPLETED
|
7
|
7
|
0
|
Reasons for withdrawal
| Measure |
Responders
60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III).
|
Non-Responders
60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-Responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III).
|
Unclassified
Participants who received 60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II) with unknown response status.
|
|---|---|---|---|
|
Period II
Adverse Event
|
0
|
0
|
15
|
|
Period II
Lost to Follow-up
|
0
|
0
|
4
|
|
Period II
Protocol Violation
|
0
|
0
|
11
|
|
Period II
Withdrawal by Subject
|
0
|
0
|
4
|
|
Period II
Sponsor Decision
|
0
|
0
|
0
|
|
Period II
Lack of Efficacy
|
0
|
0
|
2
|
|
Period III
Adverse Event
|
1
|
1
|
0
|
|
Period III
Lost to Follow-up
|
2
|
1
|
0
|
|
Period III
Protocol Violation
|
1
|
1
|
0
|
|
Period III
Withdrawal by Subject
|
1
|
2
|
0
|
|
Period III
Sponsor Decision
|
2
|
0
|
0
|
|
Period III
Lack of Efficacy
|
0
|
2
|
0
|
Baseline Characteristics
Switching to Duloxetine in Patients With Depression
Baseline characteristics by cohort
| Measure |
Duloxetine Responders
n=115 Participants
60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III).
|
Duloxetine Non-Responders
n=91 Participants
60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III).
|
Unclassified
n=36 Participants
Participants who received 60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II) with unknown response status.
|
Total
n=242 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
43.5 years
STANDARD_DEVIATION 12.9 • n=5 Participants
|
45.6 years
STANDARD_DEVIATION 12.5 • n=7 Participants
|
47.4 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
44.9 years
STANDARD_DEVIATION 12.5 • n=4 Participants
|
|
Sex: Female, Male
Female
|
88 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
182 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
67 participants
n=5 Participants
|
66 participants
n=7 Participants
|
17 participants
n=5 Participants
|
150 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
East Asian
|
43 participants
n=5 Participants
|
23 participants
n=7 Participants
|
12 participants
n=5 Participants
|
78 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
African
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
3 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
7 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
West Asian
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
4 participants
n=4 Participants
|
|
Region of Enrollment
Korea, Republic of
|
18 participants
n=5 Participants
|
11 participants
n=7 Participants
|
9 participants
n=5 Participants
|
38 participants
n=4 Participants
|
|
Region of Enrollment
Brazil
|
9 participants
n=5 Participants
|
11 participants
n=7 Participants
|
13 participants
n=5 Participants
|
33 participants
n=4 Participants
|
|
Region of Enrollment
China
|
25 participants
n=5 Participants
|
13 participants
n=7 Participants
|
3 participants
n=5 Participants
|
41 participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
63 participants
n=5 Participants
|
56 participants
n=7 Participants
|
11 participants
n=5 Participants
|
130 participants
n=4 Participants
|
|
Had Major Depressive Disorder (MDD) Hospitalizations in the Past 24 Months
Yes
|
8 participants
n=5 Participants
|
5 participants
n=7 Participants
|
2 participants
n=5 Participants
|
15 participants
n=4 Participants
|
|
Had Major Depressive Disorder (MDD) Hospitalizations in the Past 24 Months
No
|
107 participants
n=5 Participants
|
86 participants
n=7 Participants
|
34 participants
n=5 Participants
|
227 participants
n=4 Participants
|
|
Had Previous MDD in the Past 24 Months
Yes
|
79 participants
n=5 Participants
|
54 participants
n=7 Participants
|
24 participants
n=5 Participants
|
157 participants
n=4 Participants
|
|
Had Previous MDD in the Past 24 Months
No
|
36 participants
n=5 Participants
|
37 participants
n=7 Participants
|
12 participants
n=5 Participants
|
85 participants
n=4 Participants
|
|
Had at Least One Historical Illness
Yes
|
44 participants
n=5 Participants
|
32 participants
n=7 Participants
|
15 participants
n=5 Participants
|
91 participants
n=4 Participants
|
|
Had at Least One Historical Illness
No
|
71 participants
n=5 Participants
|
59 participants
n=7 Participants
|
21 participants
n=5 Participants
|
151 participants
n=4 Participants
|
|
Previous Treatment
SSRI
|
83 participants
n=5 Participants
|
69 participants
n=7 Participants
|
25 participants
n=5 Participants
|
177 participants
n=4 Participants
|
|
Previous Treatment
SNRI
|
31 participants
n=5 Participants
|
21 participants
n=7 Participants
|
9 participants
n=5 Participants
|
61 participants
n=4 Participants
|
|
Previous Treatment
Missing or Unknown
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
4 participants
n=4 Participants
|
|
17-Item Hamilton Depression Rating Scale (HAMD-17) Anxiety/Somatization Score
|
7.7 units on a scale
STANDARD_DEVIATION 2.1 • n=5 Participants
|
8.0 units on a scale
STANDARD_DEVIATION 2.0 • n=7 Participants
|
7.4 units on a scale
STANDARD_DEVIATION 1.7 • n=5 Participants
|
7.8 units on a scale
STANDARD_DEVIATION 2.0 • n=4 Participants
|
|
17-Item Hamilton Depression Rating Scale (HAMD-17) Core Score
|
8.1 units on a scale
STANDARD_DEVIATION 2.6 • n=5 Participants
|
9.0 units on a scale
STANDARD_DEVIATION 2.6 • n=7 Participants
|
7.9 units on a scale
STANDARD_DEVIATION 2.8 • n=5 Participants
|
8.4 units on a scale
STANDARD_DEVIATION 2.7 • n=4 Participants
|
|
17-Item Hamilton Depression Rating Scale (HAMD-17) Maier Score
|
10.7 units on a scale
STANDARD_DEVIATION 2.6 • n=5 Participants
|
11.7 units on a scale
STANDARD_DEVIATION 2.6 • n=7 Participants
|
10.0 units on a scale
STANDARD_DEVIATION 2.7 • n=5 Participants
|
11.0 units on a scale
STANDARD_DEVIATION 2.7 • n=4 Participants
|
|
17-Item Hamilton Depression Rating Scale (HAMD-17) Retardation Score
|
7.1 units on a scale
STANDARD_DEVIATION 2.1 • n=5 Participants
|
8.2 units on a scale
STANDARD_DEVIATION 1.9 • n=7 Participants
|
7.2 units on a scale
STANDARD_DEVIATION 2.4 • n=5 Participants
|
7.5 units on a scale
STANDARD_DEVIATION 2.1 • n=4 Participants
|
|
17-Item Hamilton Depression Rating Scale (HAMD-17) Sleep Score
|
3.1 units on a scale
STANDARD_DEVIATION 1.6 • n=5 Participants
|
3.4 units on a scale
STANDARD_DEVIATION 1.4 • n=7 Participants
|
3.2 units on a scale
STANDARD_DEVIATION 1.7 • n=5 Participants
|
3.2 units on a scale
STANDARD_DEVIATION 1.5 • n=4 Participants
|
|
17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score
|
21.3 units on a scale
STANDARD_DEVIATION 4.5 • n=5 Participants
|
23.3 units on a scale
STANDARD_DEVIATION 4.5 • n=7 Participants
|
20.7 units on a scale
STANDARD_DEVIATION 4.5 • n=5 Participants
|
21.9 units on a scale
STANDARD_DEVIATION 4.6 • n=4 Participants
|
|
Age of First Episode of MDD
|
35.2 years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
33.5 years
STANDARD_DEVIATION 13.6 • n=7 Participants
|
36.9 years
STANDARD_DEVIATION 12.8 • n=5 Participants
|
34.8 years
STANDARD_DEVIATION 12.6 • n=4 Participants
|
|
Brief Pain Inventory - Short Form (BPI-SF) Average Pain Score
|
4.7 Units on a scale
STANDARD_DEVIATION 1.9 • n=5 Participants
|
5.0 Units on a scale
STANDARD_DEVIATION 2.0 • n=7 Participants
|
4.4 Units on a scale
STANDARD_DEVIATION 2.2 • n=5 Participants
|
4.8 Units on a scale
STANDARD_DEVIATION 2.0 • n=4 Participants
|
|
Brief Pain Inventory - Short Form Interference Score
|
5.2 Units on a scale
STANDARD_DEVIATION 1.6 • n=5 Participants
|
5.9 Units on a scale
STANDARD_DEVIATION 1.8 • n=7 Participants
|
5.2 Units on a scale
STANDARD_DEVIATION 1.9 • n=5 Participants
|
5.5 Units on a scale
STANDARD_DEVIATION 1.8 • n=4 Participants
|
|
Changes in Sexual Function Questionnaire (CSFQ)
|
35.3 Units on a scale
STANDARD_DEVIATION 10.3 • n=5 Participants
|
35.4 Units on a scale
STANDARD_DEVIATION 9.8 • n=7 Participants
|
33.8 Units on a scale
STANDARD_DEVIATION 9.4 • n=5 Participants
|
35.1 Units on a scale
STANDARD_DEVIATION 10.0 • n=4 Participants
|
|
Clinical Global Impressions - Severity (CGI-Severity) Score
|
4.2 Units on a scale
STANDARD_DEVIATION 0.6 • n=5 Participants
|
4.4 Units on a scale
STANDARD_DEVIATION 0.6 • n=7 Participants
|
4.3 Units on a scale
STANDARD_DEVIATION 0.7 • n=5 Participants
|
4.3 Units on a scale
STANDARD_DEVIATION 0.6 • n=4 Participants
|
|
Duration of the Current Episode
|
249.4 days
STANDARD_DEVIATION 378.3 • n=5 Participants
|
264.5 days
STANDARD_DEVIATION 318.1 • n=7 Participants
|
194.1 days
STANDARD_DEVIATION 182.6 • n=5 Participants
|
247.3 days
STANDARD_DEVIATION 333.3 • n=4 Participants
|
|
Hamilton Anxiety Rating Scale (HAMA) Total Score
|
17.9 Units on a scale
STANDARD_DEVIATION 6.8 • n=5 Participants
|
21.4 Units on a scale
STANDARD_DEVIATION 6.8 • n=7 Participants
|
17.9 Units on a scale
STANDARD_DEVIATION 7.6 • n=5 Participants
|
19.2 Units on a scale
STANDARD_DEVIATION 7.1 • n=4 Participants
|
|
Number of MDD Hospitalizations in the Past 24 Months
|
1.0 hospitalizations
STANDARD_DEVIATION 0.0 • n=5 Participants
|
1.0 hospitalizations
STANDARD_DEVIATION 0.0 • n=7 Participants
|
1.0 hospitalizations
STANDARD_DEVIATION 0.0 • n=5 Participants
|
1.0 hospitalizations
STANDARD_DEVIATION 0.0 • n=4 Participants
|
|
Number of Previous MDD Episodes in the Past 24 Months
|
1.6 MDD episodes
STANDARD_DEVIATION 0.8 • n=5 Participants
|
1.5 MDD episodes
STANDARD_DEVIATION 0.7 • n=7 Participants
|
1.8 MDD episodes
STANDARD_DEVIATION 1.5 • n=5 Participants
|
1.6 MDD episodes
STANDARD_DEVIATION 0.9 • n=4 Participants
|
|
Sheehan Disability Scale (SDS)
|
5.4 Units on a scale
STANDARD_DEVIATION 2.9 • n=5 Participants
|
6.3 Units on a scale
STANDARD_DEVIATION 3.0 • n=7 Participants
|
5.5 Units on a scale
STANDARD_DEVIATION 3.0 • n=5 Participants
|
5.7 Units on a scale
STANDARD_DEVIATION 3.0 • n=4 Participants
|
|
Treatment Satisfaction Questionnaire for Medication (TSQM)
|
44.2 Units on a scale
STANDARD_DEVIATION 17.6 • n=5 Participants
|
41.6 Units on a scale
STANDARD_DEVIATION 18.2 • n=7 Participants
|
47.2 Units on a scale
STANDARD_DEVIATION 20.8 • n=5 Participants
|
43.7 Units on a scale
STANDARD_DEVIATION 18.3 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, 4 weeksPopulation: Efficacy Population: Participants who had at least one post-baseline observation were included in the efficacy analysis. The group "Unclassified" was excluded from statistical testing.
BPI-SF interference score asks about the degree to which pain interferes with mood, walking and other physical activity, work, social activity, relations with others, and sleep. BPI-SF interference score ranges from 0 (no interference) to 10 (interferes completely). Response is defined as a \>=50% reduction in the Maier subscale score from baseline. The Maier subscale (Items 1,2,7,8,9,10) represents "core" symptoms of depression. Total subscale scores range from 0 (normal) to 24 (severe). Factors used for adjustment for least squares means are listed in 'Other relevant information' section.
Outcome measures
| Measure |
Duloxetine Responders
n=108 Participants
60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III).
|
Duloxetine Non-Responders
n=85 Participants
60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III).
|
|---|---|---|
|
Change From Baseline in Brief Pain Inventory-Modified Short Form (BPI-SF) Interference Score Between Responder and Non-Responder Participants at 4 Weeks
|
-2.35 Units on a scale
Interval -2.83 to -1.87
|
-1.69 Units on a scale
Interval -2.18 to 1.21
|
SECONDARY outcome
Timeframe: Baseline, 4 weeks, 8 weeksPopulation: Efficacy Population: Participants who had at least one post-baseline observation were included in the efficacy analysis. The group "Unclassified" was excluded from statistical testing.
The Maier subscale (Items 1,2,7,8,9,10) represents the "core" symptoms of depression. Total subscale scores range from 0 (normal) to 24 (severe). Response is defined as a \>=50% reduction in the Maier subscale score from baseline.
Outcome measures
| Measure |
Duloxetine Responders
n=193 Participants
60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III).
|
Duloxetine Non-Responders
60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III).
|
|---|---|---|
|
Percentage of Participants Meeting Criteria for Response on the 17-Item Hamilton Depression Rating Scale (HAMD-17) Maier Subscale at 4 and 8 Weeks
Week 4 (n=193)
|
56.0 Percentage of participants
Interval 48.7 to 63.1
|
—
|
|
Percentage of Participants Meeting Criteria for Response on the 17-Item Hamilton Depression Rating Scale (HAMD-17) Maier Subscale at 4 and 8 Weeks
Week 8 (n=179)
|
73.7 Percentage of participants
Interval 66.7 to 80.0
|
—
|
SECONDARY outcome
Timeframe: Baseline, 8 weeksPopulation: Efficacy Population: Participants who had at least one post-baseline observation were included in the efficacy analysis. The group "Unclassified" was excluded from statistical testing.
The HAMD-17 total score 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). Factors used for adjustment for least squares means are listed in 'Other relevant information' section.
Outcome measures
| Measure |
Duloxetine Responders
n=108 Participants
60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III).
|
Duloxetine Non-Responders
n=85 Participants
60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III).
|
|---|---|---|
|
Change From Baseline HAMD-17 Total Score at 8 Weeks
|
-15.64 Units on a scale
Interval -16.86 to -14.41
|
-9.79 Units on a scale
Interval -11.1 to -8.47
|
SECONDARY outcome
Timeframe: Baseline, 8 weeksPopulation: Efficacy Population: Participants who had at least one post-baseline observation were included in the efficacy analysis. The group "Unclassified" was excluded from statistical testing.
The Core subscale (Items 1,2,3,7,8) evaluates "core" symptoms of depression. Total subscale scores range from 0 (normal) to 20 (severe). Factors used for adjustment for least squares means are listed in 'Other relevant information' section.
Outcome measures
| Measure |
Duloxetine Responders
n=108 Participants
60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III).
|
Duloxetine Non-Responders
n=85 Participants
60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III).
|
|---|---|---|
|
Change From Baseline HAMD-17 Core Subscale at 8 Weeks
|
-6.87 Units on a scale
Interval -7.41 to -6.33
|
-4.40 Units on a scale
Interval -4.99 to -3.81
|
SECONDARY outcome
Timeframe: Baseline, 8 weeksPopulation: Efficacy Population: Participants who had at least one post-baseline observation were included in the efficacy analysis. The group "Unclassified" was excluded from statistical testing.
The Maier subscale (Items 1,2,7,8,9,10) represents the "core" symptoms of depression. Total subscale scores range from 0 (normal) to 24 (severe). Factors used for adjustment for least squares means are listed in 'Other relevant information' section.
Outcome measures
| Measure |
Duloxetine Responders
n=108 Participants
60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III).
|
Duloxetine Non-Responders
n=85 Participants
60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III).
|
|---|---|---|
|
Change From Baseline HAMD-17 Maier Subscale at 8 Weeks
|
-8.58 Units on a scale
Interval -9.25 to -7.9
|
-5.29 Units on a scale
Interval -6.01 to -4.56
|
SECONDARY outcome
Timeframe: Baseline, 8 weeksPopulation: Efficacy Population: Participants who had at least one post-baseline observation were included in the efficacy analysis. The group "Unclassified" was excluded from statistical testing.
The Anxiety/Somatization Subscale (Items 10-13, 15, 17) evaluates severity of psychic and somatic manifistations of anxiety as well as agitation. Total subscale scores range from 0 (normal) to 18 (severe). Factors used for adjustment for least squares means are listed in 'Other relevant information' section.
Outcome measures
| Measure |
Duloxetine Responders
n=108 Participants
60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III).
|
Duloxetine Non-Responders
n=85 Participants
60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III).
|
|---|---|---|
|
Change From Baseline HAMD-17 Anxiety/Somatization Subscale at 8 Weeks
|
-5.29 Units on a scale
Interval -5.84 to -4.73
|
-3.07 Units on a scale
Interval -3.68 to -2.47
|
SECONDARY outcome
Timeframe: Baseline, 8 weeksPopulation: Efficacy Population: Participants who had at least one post-baseline observation were included in the efficacy analysis. The group "Unclassified" was excluded from statistical testing.
The Retardation Subscale (Items 1,7,8,14) evaluates dysfunction in mood, work, and sexual activity, as well as overall motor retardation. Total subscale scores range from 0 (normal) to 14 (severe). Factors used for adjustment for least squares means are listed in 'Other relevant information' section.
Outcome measures
| Measure |
Duloxetine Responders
n=108 Participants
60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III).
|
Duloxetine Non-Responders
n=85 Participants
60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III).
|
|---|---|---|
|
Change From Baseline HAMD-17 Retardation/Somatization Subscale at 8 Weeks
|
-5.51 Units on a scale
Interval -5.98 to -5.05
|
-3.63 Units on a scale
Interval -4.14 to -3.13
|
SECONDARY outcome
Timeframe: Baseline, 8 weeksPopulation: Efficacy Population: Participants who had at least one post-baseline observation were included in the efficacy analysis. The group "Unclassified" was excluded from statistical testing.
The Sleep Subscale (Items 4,5,6) evaluates initial, middle, and late insomnia. Total subscale scores range from 0 (no difficulty) to 6 (difficulty). Factors used for adjustment for least squares means are listed in 'Other relevant information' section.
Outcome measures
| Measure |
Duloxetine Responders
n=108 Participants
60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III).
|
Duloxetine Non-Responders
n=85 Participants
60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III).
|
|---|---|---|
|
Change From Baseline HAMD-17 Sleep Subscale at 8 Weeks
|
-2.27 Units on a scale
Interval -2.59 to -1.96
|
-1.31 Units on a scale
Interval -1.64 to -0.97
|
SECONDARY outcome
Timeframe: Baseline, 8 weeksPopulation: Efficacy Population: Participants who had at least one post-baseline observation were included in the efficacy analysis. The group "Unclassified" was excluded from statistical testing.
The HAMA scale measures anxiety symptoms accompanying major depressive disorder (MDD). Each item of the 14-item HAMA was scored from 0 (not present) to 4 (very severe), with a resulting maximum total score of 56. Factors used for adjustment for least squares means are listed in 'Other relevant information' section.
Outcome measures
| Measure |
Duloxetine Responders
n=108 Participants
60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III).
|
Duloxetine Non-Responders
n=85 Participants
60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III).
|
|---|---|---|
|
Change From Baseline in the Hamilton Anxiety Rating Scale (HAMA) at 8 Weeks
|
-12.97 Units on a scale
Interval -14.37 to -11.56
|
-8.55 Units on a scale
Interval -10.04 to -7.06
|
SECONDARY outcome
Timeframe: Baseline, 8 weeksPopulation: Efficacy Population: Participants who had at least one post-baseline observation were included in the efficacy analysis. The group "Unclassified" was excluded from statistical testing.
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). Factors used for adjustment for least squares means are listed in 'Other relevant information' section.
Outcome measures
| Measure |
Duloxetine Responders
n=108 Participants
60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III).
|
Duloxetine Non-Responders
n=85 Participants
60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III).
|
|---|---|---|
|
Change From Baseline in the Clinical Global Impression - Severity (CGI-Severity) Scale at 8 Weeks
|
-2.52 Units on a scale
Interval -2.75 to -2.3
|
-1.40 Units on a scale
Interval -1.65 to -1.14
|
SECONDARY outcome
Timeframe: Baseline, 8 weeksPopulation: Efficacy Population: Participants who had at least one post-baseline observation were included in the efficacy analysis. The group "Unclassified" was excluded from statistical testing.
A self-reported scale that measures the severity of pain based on the average pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Factors used for adjustment for least squares means are listed in 'Other relevant information' section.
Outcome measures
| Measure |
Duloxetine Responders
n=108 Participants
60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III).
|
Duloxetine Non-Responders
n=85 Participants
60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III).
|
|---|---|---|
|
Change From Baseline in the Brief Pain Inventory - Modified Short Form (BPI-SF) Average Pain Score at 8 Weeks
|
-2.56 Units on a scale
Interval -3.13 to -1.99
|
-2.14 Units on a scale
Interval -2.75 to -1.53
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Efficacy Population: Participants who had at least one post-baseline observation were included in the efficacy analysis. The group "Unclassified" was excluded from statistical testing.
A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). Factors used for adjustment for least squares means are listed in 'Other relevant information' section.
Outcome measures
| Measure |
Duloxetine Responders
n=108 Participants
60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III).
|
Duloxetine Non-Responders
n=85 Participants
60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III).
|
|---|---|---|
|
Change From Baseline in Patient Global Impression - Improvement (PGI-I) Scale Score at 8 Weeks
|
2.12 Units on a scale
Interval 1.85 to 2.38
|
2.61 Units on a scale
Interval 2.33 to 2.9
|
SECONDARY outcome
Timeframe: Baseline, 4 Weeks, 8 weeksPopulation: Efficacy Population: Participants who had at least one post-baseline observation were included in the efficacy analysis. The group "Unclassified" was excluded from statistical testing.
A 14-item patient-rated scale assesses medication-related changes in sexual activity/functioning. Items rated from 1 (never, low enjoyment/pleasure) to 5 (every day, great enjoyment/pleasure). CSFQ measures 5 dimensions of sexual behavior: pleasure; desire/frequency; desire/interest; arousal; orgasm. Lower total scores are associated with diminished sexual functioning. Total scores \<=47 (men) and \<=41 (women) indicate global sexual dysfunction, with all phases of sexual response cycle affected. Factors used for adjustment for least squares means are in 'Other relevant information' section.
Outcome measures
| Measure |
Duloxetine Responders
n=108 Participants
60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III).
|
Duloxetine Non-Responders
n=85 Participants
60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III).
|
|---|---|---|
|
Change From Baseline in the Sexual Functioning Questionnaire Clinical Version (CSFQ) at 4 and 8 Weeks
Week 4
|
0.03 Units on a scale
Interval -1.84 to 1.9
|
-0.78 Units on a scale
Interval -2.76 to 1.21
|
|
Change From Baseline in the Sexual Functioning Questionnaire Clinical Version (CSFQ) at 4 and 8 Weeks
Week 8
|
1.08 Units on a scale
Interval -0.9 to 3.05
|
-0.29 Units on a scale
Interval -2.42 to 1.84
|
SECONDARY outcome
Timeframe: Baseline, 4 weeks, 8 weeksPopulation: Efficacy Population: Participants who had at least one post-baseline observation were included in the efficacy analysis. The group "Unclassified" was excluded from statistical testing.
The TSQM is a participant-reported measure that best describes how the study medication makes them feel since the last study visit, assessing perceived effectiveness, severity of side effects, and convenience. Convenience, Effectiveness, Side-Effects, and Global Satisfaction scale scores range from 0 (extremely dissatisfied) to 100 (extremely satisfied). Factors used for adjustment for least squares means are listed in 'Other relevant information' section.
Outcome measures
| Measure |
Duloxetine Responders
n=108 Participants
60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III).
|
Duloxetine Non-Responders
n=85 Participants
60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III).
|
|---|---|---|
|
Change From Baseline in the Treatment Satisfaction Questionnaire for Medication (TSQM) at 4 and 8 Weeks
Week 4
|
17.64 Units on a scale
Interval 12.88 to 22.39
|
2.59 Units on a scale
Interval -2.16 to 7.34
|
|
Change From Baseline in the Treatment Satisfaction Questionnaire for Medication (TSQM) at 4 and 8 Weeks
Week 8
|
18.67 Units on a scale
Interval 13.37 to 23.97
|
8.19 Units on a scale
Interval 2.65 to 13.73
|
SECONDARY outcome
Timeframe: Baseline, 4 weeks, 8 weeksPopulation: Efficacy Population: Participants who had at least one post-baseline observation were included in the efficacy analysis. The group "Unclassified" was excluded from statistical testing.
The SDS is completed by the patient and is used to assess the effect of the patient's symptoms on their work/social/family life. Total scores range from 0 to 30 with higher values indicating greater disruption in the patient's work/social/family life. Factors used for adjustment for least squares means are listed in 'Other relevant information' section.
Outcome measures
| Measure |
Duloxetine Responders
n=108 Participants
60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III).
|
Duloxetine Non-Responders
n=85 Participants
60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III).
|
|---|---|---|
|
Change From Baseline in the Sheehan Disability Scale (SDS) at 4 and 8 Weeks
Week 4
|
-8.38 Units on a scale
Interval -10.26 to -6.5
|
-2.49 Units on a scale
Interval -4.42 to -0.57
|
|
Change From Baseline in the Sheehan Disability Scale (SDS) at 4 and 8 Weeks
Week 8
|
-9.95 Units on a scale
Interval -11.91 to -7.99
|
-5.36 Units on a scale
Interval -7.4 to -3.32
|
Adverse Events
Duloxetine Responders
Duloxetine Non-Responders
Unclassified
Serious adverse events
| Measure |
Duloxetine Responders
n=115 participants at risk
60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III).
|
Duloxetine Non-Responders
n=91 participants at risk
60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-Responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III).
|
Unclassified
n=35 participants at risk
Participants who received 60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II) with unknown response status.
|
|---|---|---|---|
|
Psychiatric disorders
Depression
|
0.00%
0/115
|
1.1%
1/91 • Number of events 1
|
0.00%
0/35
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/115
|
1.1%
1/91 • Number of events 1
|
0.00%
0/35
|
Other adverse events
| Measure |
Duloxetine Responders
n=115 participants at risk
60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III).
|
Duloxetine Non-Responders
n=91 participants at risk
60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-Responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III).
|
Unclassified
n=35 participants at risk
Participants who received 60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II) with unknown response status.
|
|---|---|---|---|
|
Eye disorders
Vision blurred
|
0.00%
0/115
|
5.5%
5/91 • Number of events 5
|
0.00%
0/35
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.87%
1/115 • Number of events 1
|
2.2%
2/91 • Number of events 2
|
5.7%
2/35 • Number of events 2
|
|
Gastrointestinal disorders
Constipation
|
11.3%
13/115 • Number of events 13
|
9.9%
9/91 • Number of events 9
|
2.9%
1/35 • Number of events 1
|
|
Gastrointestinal disorders
Dry mouth
|
10.4%
12/115 • Number of events 12
|
15.4%
14/91 • Number of events 14
|
0.00%
0/35
|
|
Gastrointestinal disorders
Nausea
|
17.4%
20/115 • Number of events 20
|
16.5%
15/91 • Number of events 15
|
20.0%
7/35 • Number of events 7
|
|
General disorders
Asthenia
|
0.87%
1/115 • Number of events 1
|
2.2%
2/91 • Number of events 2
|
5.7%
2/35 • Number of events 2
|
|
General disorders
Fatigue
|
2.6%
3/115 • Number of events 3
|
7.7%
7/91 • Number of events 7
|
8.6%
3/35 • Number of events 3
|
|
Infections and infestations
Nasopharyngitis
|
2.6%
3/115 • Number of events 3
|
5.5%
5/91 • Number of events 5
|
2.9%
1/35 • Number of events 1
|
|
Metabolism and nutrition disorders
Anorexia
|
5.2%
6/115 • Number of events 6
|
3.3%
3/91 • Number of events 3
|
0.00%
0/35
|
|
Metabolism and nutrition disorders
Decreased appetite
|
4.3%
5/115 • Number of events 5
|
4.4%
4/91 • Number of events 4
|
5.7%
2/35 • Number of events 2
|
|
Nervous system disorders
Dizziness
|
13.0%
15/115 • Number of events 15
|
11.0%
10/91 • Number of events 10
|
14.3%
5/35 • Number of events 5
|
|
Nervous system disorders
Headache
|
13.0%
15/115 • Number of events 15
|
16.5%
15/91 • Number of events 15
|
5.7%
2/35 • Number of events 2
|
|
Nervous system disorders
Somnolence
|
7.0%
8/115 • Number of events 8
|
7.7%
7/91 • Number of events 7
|
8.6%
3/35 • Number of events 3
|
|
Psychiatric disorders
Anxiety
|
2.6%
3/115 • Number of events 3
|
6.6%
6/91 • Number of events 6
|
0.00%
0/35
|
|
Psychiatric disorders
Insomnia
|
8.7%
10/115 • Number of events 10
|
11.0%
10/91 • Number of events 10
|
2.9%
1/35 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.87%
1/115 • Number of events 1
|
4.4%
4/91 • Number of events 4
|
5.7%
2/35 • Number of events 2
|
|
Vascular disorders
Hot flush
|
2.6%
3/115 • Number of events 3
|
5.5%
5/91 • Number of events 5
|
0.00%
0/35
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60