Trial Outcomes & Findings for A Study in the Treatment of Children and Adolescents With Major Depressive Disorder (NCT NCT00849693)
NCT ID: NCT00849693
Last Updated: 2012-04-19
Results Overview
CDRS-R Total score measure the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. A rating of 1 indicates normal functioning. Total scores range from 17 to 113. In general, scores below 20 indicate an absence of depression, scores of 20 to 30 indicate borderline depression, and scores of 40 to 60 indicate moderate depression. Least Square (LS) means are adjusted for baseline, pooled investigator, age category, visit, treatment, treatment\*visit, age category\*visit and baseline\*visit.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
463 participants
Primary outcome timeframe
Baseline, Week 10
Results posted on
2012-04-19
Participant Flow
This study consisted of a 10-week acute treatment phase, and a 6-month extension phase.
Participant milestones
| Measure |
Duloxetine 60 mg / Duloxetine 60-120 mg
Participants were treated with Duloxetine 60 milligram (mg) orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
|
Duloxetine 30 mg/Duloxetine 60-120 mg
Participants were treated with Duloxetine 30 mg orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
|
Fluoxetine 20 mg/Fluoxetine 20-40 mg
Participants were treated with Fluoxetine 20 mg orally, once daily for 10 weeks during acute treatment phase and Fluoxetine 20-40 mg orally, once daily for 6 months during extension phase
|
Placebo/Duloxetine 60-120 mg
Participants were treated with placebo orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
|
|---|---|---|---|---|
|
Acute Treatment Phase
STARTED
|
108
|
116
|
117
|
122
|
|
Acute Treatment Phase
COMPLETED
|
75
|
81
|
84
|
85
|
|
Acute Treatment Phase
NOT COMPLETED
|
33
|
35
|
33
|
37
|
|
Extension Phase
STARTED
|
73
|
80
|
84
|
82
|
|
Extension Phase
COMPLETED
|
43
|
50
|
49
|
44
|
|
Extension Phase
NOT COMPLETED
|
30
|
30
|
35
|
38
|
Reasons for withdrawal
| Measure |
Duloxetine 60 mg / Duloxetine 60-120 mg
Participants were treated with Duloxetine 60 milligram (mg) orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
|
Duloxetine 30 mg/Duloxetine 60-120 mg
Participants were treated with Duloxetine 30 mg orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
|
Fluoxetine 20 mg/Fluoxetine 20-40 mg
Participants were treated with Fluoxetine 20 mg orally, once daily for 10 weeks during acute treatment phase and Fluoxetine 20-40 mg orally, once daily for 6 months during extension phase
|
Placebo/Duloxetine 60-120 mg
Participants were treated with placebo orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
|
|---|---|---|---|---|
|
Acute Treatment Phase
Adverse Event
|
12
|
7
|
6
|
4
|
|
Acute Treatment Phase
Lost to Follow-up
|
5
|
8
|
11
|
9
|
|
Acute Treatment Phase
Protocol Violation
|
1
|
5
|
2
|
6
|
|
Acute Treatment Phase
Withdrawal by Subject
|
5
|
5
|
3
|
8
|
|
Acute Treatment Phase
Parent or caregiver decision
|
7
|
6
|
7
|
7
|
|
Acute Treatment Phase
Physician Decision
|
2
|
1
|
2
|
1
|
|
Acute Treatment Phase
Sponsor decision
|
0
|
0
|
1
|
0
|
|
Acute Treatment Phase
Lack of Efficacy
|
1
|
3
|
1
|
2
|
|
Extension Phase
Adverse Event
|
4
|
6
|
3
|
7
|
|
Extension Phase
Lost to Follow-up
|
7
|
5
|
6
|
6
|
|
Extension Phase
Protocol Violation
|
0
|
3
|
2
|
3
|
|
Extension Phase
Withdrawal by Subject
|
6
|
9
|
10
|
15
|
|
Extension Phase
Parent or caregiver decision
|
9
|
4
|
10
|
5
|
|
Extension Phase
Physician Decision
|
1
|
1
|
2
|
0
|
|
Extension Phase
Sponsor decision
|
1
|
0
|
0
|
1
|
|
Extension Phase
Lack of Efficacy
|
2
|
2
|
2
|
1
|
Baseline Characteristics
A Study in the Treatment of Children and Adolescents With Major Depressive Disorder
Baseline characteristics by cohort
| Measure |
Duloxetine 60 mg / Duloxetine 60-120 mg
n=108 Participants
Participants were treated with Duloxetine 60 milligram (mg) orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
|
Duloxetine 30 mg/Duloxetine 60-120 mg
n=116 Participants
Participants were treated with Duloxetine 30 mg orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
|
Fluoxetine 20 mg/Fluoxetine 20-40 mg
n=117 Participants
Participants were treated with Fluoxetine 20 mg orally, once daily for 10 weeks during acute treatment phase and Fluoxetine 20-40 mg orally, once daily for 6 months during extension phase
|
Placebo/Duloxetine 60-120 mg
n=122 Participants
Participants were treated with placebo orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
|
Total
n=463 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age Continuous
|
12.92 years
STANDARD_DEVIATION 2.925 • n=93 Participants
|
12.86 years
STANDARD_DEVIATION 2.904 • n=4 Participants
|
13.04 years
STANDARD_DEVIATION 3.205 • n=27 Participants
|
13.09 years
STANDARD_DEVIATION 2.895 • n=483 Participants
|
12.98 years
STANDARD_DEVIATION 2.977 • n=36 Participants
|
|
Sex: Female, Male
Female
|
60 Participants
n=93 Participants
|
47 Participants
n=4 Participants
|
61 Participants
n=27 Participants
|
69 Participants
n=483 Participants
|
237 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=93 Participants
|
69 Participants
n=4 Participants
|
56 Participants
n=27 Participants
|
53 Participants
n=483 Participants
|
226 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
15 Participant
n=93 Participants
|
23 Participant
n=4 Participants
|
16 Participant
n=27 Participants
|
19 Participant
n=483 Participants
|
73 Participant
n=36 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participant
n=93 Participants
|
1 Participant
n=4 Participants
|
1 Participant
n=27 Participants
|
1 Participant
n=483 Participants
|
3 Participant
n=36 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
27 Participant
n=93 Participants
|
21 Participant
n=4 Participants
|
21 Participant
n=27 Participants
|
24 Participant
n=483 Participants
|
93 Participant
n=36 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participant
n=93 Participants
|
1 Participant
n=4 Participants
|
0 Participant
n=27 Participants
|
0 Participant
n=483 Participants
|
1 Participant
n=36 Participants
|
|
Race/Ethnicity, Customized
White
|
54 Participant
n=93 Participants
|
61 Participant
n=4 Participants
|
67 Participant
n=27 Participants
|
62 Participant
n=483 Participants
|
244 Participant
n=36 Participants
|
|
Race/Ethnicity, Customized
Multiracial
|
6 Participant
n=93 Participants
|
6 Participant
n=4 Participants
|
9 Participant
n=27 Participants
|
13 Participant
n=483 Participants
|
34 Participant
n=36 Participants
|
|
Race/Ethnicity, Customized
Not Provided
|
6 Participant
n=93 Participants
|
3 Participant
n=4 Participants
|
3 Participant
n=27 Participants
|
3 Participant
n=483 Participants
|
15 Participant
n=36 Participants
|
|
Region of Enrollment
United States
|
87 participants
n=93 Participants
|
86 participants
n=4 Participants
|
93 participants
n=27 Participants
|
98 participants
n=483 Participants
|
364 participants
n=36 Participants
|
|
Region of Enrollment
Mexico
|
16 participants
n=93 Participants
|
25 participants
n=4 Participants
|
16 participants
n=27 Participants
|
17 participants
n=483 Participants
|
74 participants
n=36 Participants
|
|
Region of Enrollment
Canada
|
5 participants
n=93 Participants
|
5 participants
n=4 Participants
|
7 participants
n=27 Participants
|
7 participants
n=483 Participants
|
24 participants
n=36 Participants
|
|
Region of Enrollment
Argentina
|
0 participants
n=93 Participants
|
0 participants
n=4 Participants
|
1 participants
n=27 Participants
|
0 participants
n=483 Participants
|
1 participants
n=36 Participants
|
|
Children's Depression Rating Scale-Revised (CDRS-R) Total Score
|
59.3 units on a scale
STANDARD_DEVIATION 10.87 • n=93 Participants
|
59.8 units on a scale
STANDARD_DEVIATION 11.00 • n=4 Participants
|
57.9 units on a scale
STANDARD_DEVIATION 10.11 • n=27 Participants
|
58.2 units on a scale
STANDARD_DEVIATION 9.35 • n=483 Participants
|
58.8 units on a scale
STANDARD_DEVIATION 10.33 • n=36 Participants
|
|
CDRS-R Subscale Scores
Mood
|
16.6 units on a scale
STANDARD_DEVIATION 3.69 • n=93 Participants
|
16.4 units on a scale
STANDARD_DEVIATION 3.64 • n=4 Participants
|
16.0 units on a scale
STANDARD_DEVIATION 3.52 • n=27 Participants
|
16.0 units on a scale
STANDARD_DEVIATION 3.38 • n=483 Participants
|
16.2 units on a scale
STANDARD_DEVIATION 3.55 • n=36 Participants
|
|
CDRS-R Subscale Scores
Somatic
|
19.6 units on a scale
STANDARD_DEVIATION 4.58 • n=93 Participants
|
19.7 units on a scale
STANDARD_DEVIATION 4.87 • n=4 Participants
|
19.3 units on a scale
STANDARD_DEVIATION 4.60 • n=27 Participants
|
19.5 units on a scale
STANDARD_DEVIATION 4.28 • n=483 Participants
|
19.5 units on a scale
STANDARD_DEVIATION 4.57 • n=36 Participants
|
|
CDRS-R Subscale Scores
Subjective
|
10.1 units on a scale
STANDARD_DEVIATION 3.51 • n=93 Participants
|
10.6 units on a scale
STANDARD_DEVIATION 3.60 • n=4 Participants
|
10.0 units on a scale
STANDARD_DEVIATION 3.35 • n=27 Participants
|
10.0 units on a scale
STANDARD_DEVIATION 2.79 • n=483 Participants
|
10.2 units on a scale
STANDARD_DEVIATION 3.32 • n=36 Participants
|
|
CDRS-R Subscale Scores
Behavior
|
13.0 units on a scale
STANDARD_DEVIATION 3.04 • n=93 Participants
|
13.1 units on a scale
STANDARD_DEVIATION 3.19 • n=4 Participants
|
12.7 units on a scale
STANDARD_DEVIATION 3.12 • n=27 Participants
|
12.6 units on a scale
STANDARD_DEVIATION 3.14 • n=483 Participants
|
12.8 units on a scale
STANDARD_DEVIATION 3.12 • n=36 Participants
|
|
Clinical Global Impressions of Severity (CGI-Severity) score
|
4.6 units on a scale
STANDARD_DEVIATION 0.65 • n=93 Participants
|
4.6 units on a scale
STANDARD_DEVIATION 0.65 • n=4 Participants
|
4.6 units on a scale
STANDARD_DEVIATION 0.59 • n=27 Participants
|
4.5 units on a scale
STANDARD_DEVIATION 0.63 • n=483 Participants
|
4.6 units on a scale
STANDARD_DEVIATION 0.63 • n=36 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 10Population: Participants with both a baseline and at least one post-baseline value.
CDRS-R Total score measure the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. A rating of 1 indicates normal functioning. Total scores range from 17 to 113. In general, scores below 20 indicate an absence of depression, scores of 20 to 30 indicate borderline depression, and scores of 40 to 60 indicate moderate depression. Least Square (LS) means are adjusted for baseline, pooled investigator, age category, visit, treatment, treatment\*visit, age category\*visit and baseline\*visit.
Outcome measures
| Measure |
Duloxetine 60mg
n=105 Participants
Duloxetine 60mg orally, once daily for 10 weeks
|
Placebo
n=117 Participants
Placebo capsules identical in appearance, color, taste, and smell to study drug orally, once daily for 10 weeks
|
Fluoxetine 20 mg/Fluoxetine 20-40 mg
Participants were treated with Fluoxetine 20 mg orally, once daily for 10 weeks during acute treatment phase and Fluoxetine 20-40 mg orally, once daily for 6 months during extension phase
|
Placebo/Duloxetine 60-120 mg
Participants were treated with placebo orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
|
|---|---|---|---|---|
|
Change From Baseline in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at Week 10 Endpoint
|
-23.9 units on a scale
Standard Error 1.30
|
-21.6 units on a scale
Standard Error 1.27
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 10, Week 36Population: Participants with value during treatment phase and at least one post-Week 10 value.
CDRS-R Total score measure the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. A rating of 1 indicates normal functioning. Total scores range from 17 to 113. In general, scores below 20 indicate an absence of depression, scores of 20 to 30 indicate borderline depression, and scores of 40 to 60 indicate moderate depression. LS means are adjusted for baseline, pooled investigator, age category, visit, age category\*visit and baseline\*visit.
Outcome measures
| Measure |
Duloxetine 60mg
n=70 Participants
Duloxetine 60mg orally, once daily for 10 weeks
|
Placebo
n=78 Participants
Placebo capsules identical in appearance, color, taste, and smell to study drug orally, once daily for 10 weeks
|
Fluoxetine 20 mg/Fluoxetine 20-40 mg
n=80 Participants
Participants were treated with Fluoxetine 20 mg orally, once daily for 10 weeks during acute treatment phase and Fluoxetine 20-40 mg orally, once daily for 6 months during extension phase
|
Placebo/Duloxetine 60-120 mg
n=79 Participants
Participants were treated with placebo orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
|
|---|---|---|---|---|
|
Change From Week 10 in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at Week 36 Endpoint
|
-7.8 units on a scale
Standard Error 1.04
|
-7.4 units on a scale
Standard Error 1.23
|
-10.0 units on a scale
Standard Error 1.17
|
-9.0 units on a scale
Standard Error 1.84
|
SECONDARY outcome
Timeframe: Baseline, Week 10Population: Participants with both a baseline and at least one post-baseline value.
CDRS-R Total score measure the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. A rating of 1 indicates normal functioning. Total scores range from 17 to 113. In general, scores below 20 indicate an absence of depression, scores of 20 to 30 indicate borderline depression, and scores of 40 to 60 indicate moderate depression. Least Square (LS) means are adjusted for baseline, pooled investigator, age category, visit, treatment, treatment\*visit, age category\*visit and baseline\*visit.
Outcome measures
| Measure |
Duloxetine 60mg
n=114 Participants
Duloxetine 60mg orally, once daily for 10 weeks
|
Placebo
n=112 Participants
Placebo capsules identical in appearance, color, taste, and smell to study drug orally, once daily for 10 weeks
|
Fluoxetine 20 mg/Fluoxetine 20-40 mg
n=117 Participants
Participants were treated with Fluoxetine 20 mg orally, once daily for 10 weeks during acute treatment phase and Fluoxetine 20-40 mg orally, once daily for 6 months during extension phase
|
Placebo/Duloxetine 60-120 mg
Participants were treated with placebo orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
|
|---|---|---|---|---|
|
Change From Baseline in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at Week 10 Endpoint
|
-24.6 units on a scale
Standard Error 1.29
|
-22.6 units on a scale
Standard Error 1.27
|
-21.6 units on a scale
Standard Error 1.27
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 10Population: Participants with both a baseline and at least one post-baseline values.
CDRS-R Subscale scores include Mood (Sum of items 8, 11, 14, 15), Somatic (Sum of items 4-7, 16, 17), Subjective (Sum of items 9, 10, 12, 13) and Behavior (Sum of items 1-3). Mood and Subjective subscale scores range from 4 to 28; Somatic subscale scores range from 6 to 36; Behavior subscale scores range from 3 to 21. Higher score indicates greater severity of disease. LS means are adjusted for baseline, pooled investigator, age category, visit, treatment, treatment\*visit, age category\*visit and baseline\*visit.
Outcome measures
| Measure |
Duloxetine 60mg
n=105 Participants
Duloxetine 60mg orally, once daily for 10 weeks
|
Placebo
n=114 Participants
Placebo capsules identical in appearance, color, taste, and smell to study drug orally, once daily for 10 weeks
|
Fluoxetine 20 mg/Fluoxetine 20-40 mg
n=112 Participants
Participants were treated with Fluoxetine 20 mg orally, once daily for 10 weeks during acute treatment phase and Fluoxetine 20-40 mg orally, once daily for 6 months during extension phase
|
Placebo/Duloxetine 60-120 mg
n=117 Participants
Participants were treated with placebo orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
|
|---|---|---|---|---|
|
Change From Baseline in Children's Depression Rating Scale-Revised (CDRS-R) Subscale Score at Week 10 Endpoint
Mood
|
-7.1 units on a scale
Standard Error 0.44
|
-7.2 units on a scale
Standard Error 0.44
|
-6.6 units on a scale
Standard Error 0.43
|
-6.4 units on a scale
Standard Error 0.43
|
|
Change From Baseline in Children's Depression Rating Scale-Revised (CDRS-R) Subscale Score at Week 10 Endpoint
Somatic
|
-7.6 units on a scale
Standard Error 0.48
|
-7.9 units on a scale
Standard Error 0.48
|
-7.1 units on a scale
Standard Error 0.47
|
-6.4 units on a scale
Standard Error 0.47
|
|
Change From Baseline in Children's Depression Rating Scale-Revised (CDRS-R) Subscale Score at Week 10 Endpoint
Subjective
|
-3.6 units on a scale
Standard Error 0.26
|
-4.0 units on a scale
Standard Error 0.26
|
-3.5 units on a scale
Standard Error 0.26
|
-3.6 units on a scale
Standard Error 0.26
|
|
Change From Baseline in Children's Depression Rating Scale-Revised (CDRS-R) Subscale Score at Week 10 Endpoint
Behavior
|
-5.8 units on a scale
Standard Error 0.36
|
-5.6 units on a scale
Standard Error 0.36
|
-5.6 units on a scale
Standard Error 0.35
|
-5.4 units on a scale
Standard Error 0.35
|
SECONDARY outcome
Timeframe: Week 10, Week 36Population: Participants with value during treatment phase and at least one post-Week 10 value.
CDRS-R Subscale scores include Mood (Sum of items 8, 11, 14, 15), Somatic (Sum of items 4-7, 16, 17), Subjective (Sum of items 9, 10, 12, 13) and Behavior (Sum of items 1-3). Mood and Subjective subscale scores range from 4 to 28; Somatic subscale scores range from 6 to 36; Behavior subscale scores range from 3 to 21. Higher score indicates greater severity of disease. LS means are adjusted for baseline, pooled investigator, age category, visit, age category\*visit and baseline\*visit.
Outcome measures
| Measure |
Duloxetine 60mg
n=70 Participants
Duloxetine 60mg orally, once daily for 10 weeks
|
Placebo
n=78 Participants
Placebo capsules identical in appearance, color, taste, and smell to study drug orally, once daily for 10 weeks
|
Fluoxetine 20 mg/Fluoxetine 20-40 mg
n=80 Participants
Participants were treated with Fluoxetine 20 mg orally, once daily for 10 weeks during acute treatment phase and Fluoxetine 20-40 mg orally, once daily for 6 months during extension phase
|
Placebo/Duloxetine 60-120 mg
n=79 Participants
Participants were treated with placebo orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
|
|---|---|---|---|---|
|
Change From Week 10 in Children's Depression Rating Scale-Revised (CDRS-R) Subscale Score at Week 36 Endpoint
Mood
|
-1.9 units on a scale
Standard Error 0.43
|
-1.9 units on a scale
Standard Error 0.42
|
-2.4 units on a scale
Standard Error 0.44
|
-2.3 units on a scale
Standard Error 0.59
|
|
Change From Week 10 in Children's Depression Rating Scale-Revised (CDRS-R) Subscale Score at Week 36 Endpoint
Somatic
|
-2.8 units on a scale
Standard Error 0.41
|
-2.4 units on a scale
Standard Error 0.52
|
-4.0 units on a scale
Standard Error 0.47
|
-3.2 units on a scale
Standard Error 0.66
|
|
Change From Week 10 in Children's Depression Rating Scale-Revised (CDRS-R) Subscale Score at Week 36 Endpoint
Subjective
|
-1.2 units on a scale
Standard Error 0.25
|
-1.3 units on a scale
Standard Error 0.19
|
-1.5 units on a scale
Standard Error 0.21
|
-1.0 units on a scale
Standard Error 0.32
|
|
Change From Week 10 in Children's Depression Rating Scale-Revised (CDRS-R) Subscale Score at Week 36 Endpoint
Behavior
|
-2.1 units on a scale
Standard Error 0.30
|
-1.8 units on a scale
Standard Error 0.32
|
-2.7 units on a scale
Standard Error 0.28
|
-2.4 units on a scale
Standard Error 0.50
|
SECONDARY outcome
Timeframe: Baseline, Week 10Population: Participants with both a baseline and at least one post-baseline value.
CGI-Severity evaluates the severity of illness at the time of assessment. The score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). LS means are adjusted for baseline, pooled investigator, age category, visit, treatment, treatment\*visit, age category\*visit and baseline\*visit.
Outcome measures
| Measure |
Duloxetine 60mg
n=105 Participants
Duloxetine 60mg orally, once daily for 10 weeks
|
Placebo
n=114 Participants
Placebo capsules identical in appearance, color, taste, and smell to study drug orally, once daily for 10 weeks
|
Fluoxetine 20 mg/Fluoxetine 20-40 mg
n=112 Participants
Participants were treated with Fluoxetine 20 mg orally, once daily for 10 weeks during acute treatment phase and Fluoxetine 20-40 mg orally, once daily for 6 months during extension phase
|
Placebo/Duloxetine 60-120 mg
n=117 Participants
Participants were treated with placebo orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
|
|---|---|---|---|---|
|
Change From Baseline in Clinical Global Impressions of Severity (CGI-Severity) Scale at Week 10 Endpoint
|
-1.5 units on a scale
Standard Error 0.12
|
-1.5 units on a scale
Standard Error 0.12
|
-1.4 units on a scale
Standard Error 0.11
|
-1.4 units on a scale
Standard Error 0.11
|
SECONDARY outcome
Timeframe: Week 10, Week 36Population: Participants with value during treatment phase and at least one post-Week 10 value.
CGI-Severity evaluates the severity of illness at the time of assessment. The score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). LS means are adjusted for baseline, pooled investigator, age category, visit, age category\*visit and baseline\*visit.
Outcome measures
| Measure |
Duloxetine 60mg
n=69 Participants
Duloxetine 60mg orally, once daily for 10 weeks
|
Placebo
n=78 Participants
Placebo capsules identical in appearance, color, taste, and smell to study drug orally, once daily for 10 weeks
|
Fluoxetine 20 mg/Fluoxetine 20-40 mg
n=81 Participants
Participants were treated with Fluoxetine 20 mg orally, once daily for 10 weeks during acute treatment phase and Fluoxetine 20-40 mg orally, once daily for 6 months during extension phase
|
Placebo/Duloxetine 60-120 mg
n=79 Participants
Participants were treated with placebo orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
|
|---|---|---|---|---|
|
Change From Week 10 in Clinical Global Impressions of Severity (CGI-Severity) Scale at Week 36 Endpoint
|
-1.1 units on a scale
Standard Error 0.13
|
-0.9 units on a scale
Standard Error 0.16
|
-1.3 units on a scale
Standard Error 0.12
|
-1.0 units on a scale
Standard Error 0.13
|
SECONDARY outcome
Timeframe: Baseline through Week 10Population: Participants with a baseline and at least one post-baseline C-SSRS suicidal ideation or suicidal behavior score and who are at risk for treatment emergent suicidal ideation or behavior.
Columbia Suicide Rating Scale (C-SSRS) captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior: a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation: a "yes" answer to any one of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation. Treatment Emergent Suicidal Ideation is worsening or new occurrence of events during treatment compared to lead-in baseline (Week -1 to 0).
Outcome measures
| Measure |
Duloxetine 60mg
n=105 Participants
Duloxetine 60mg orally, once daily for 10 weeks
|
Placebo
n=115 Participants
Placebo capsules identical in appearance, color, taste, and smell to study drug orally, once daily for 10 weeks
|
Fluoxetine 20 mg/Fluoxetine 20-40 mg
n=112 Participants
Participants were treated with Fluoxetine 20 mg orally, once daily for 10 weeks during acute treatment phase and Fluoxetine 20-40 mg orally, once daily for 6 months during extension phase
|
Placebo/Duloxetine 60-120 mg
n=117 Participants
Participants were treated with placebo orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
|
|---|---|---|---|---|
|
Number of Participants With Suicidal Ideation or Suicidal Behavior Baseline Through Week 10
Treatment Emergent Suicidal Ideation
|
7 participants
|
6 participants
|
9 participants
|
11 participants
|
|
Number of Participants With Suicidal Ideation or Suicidal Behavior Baseline Through Week 10
Suicidal Ideation
|
16 participants
|
11 participants
|
13 participants
|
15 participants
|
|
Number of Participants With Suicidal Ideation or Suicidal Behavior Baseline Through Week 10
Suicidal Behavior
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Week 10 through Week 36Population: Participants with a baseline and at least one post-baseline C-SSRS suicidal ideation or suicidal behavior score and who are at risk for treatment emergent suicidal ideation or behavior.
Columbia Suicide Rating Scale (C-SSRS) captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior: a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation: a "yes" answer to any one of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation. Treatment Emergent Suicidal Ideation is worsening or new occurrence of events during treatment compared to lead-in baseline (Week 7-10).
Outcome measures
| Measure |
Duloxetine 60mg
n=71 Participants
Duloxetine 60mg orally, once daily for 10 weeks
|
Placebo
n=78 Participants
Placebo capsules identical in appearance, color, taste, and smell to study drug orally, once daily for 10 weeks
|
Fluoxetine 20 mg/Fluoxetine 20-40 mg
n=80 Participants
Participants were treated with Fluoxetine 20 mg orally, once daily for 10 weeks during acute treatment phase and Fluoxetine 20-40 mg orally, once daily for 6 months during extension phase
|
Placebo/Duloxetine 60-120 mg
n=79 Participants
Participants were treated with placebo orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
|
|---|---|---|---|---|
|
Number of Participants With Suicidal Ideation or Suicidal Behavior Week 10 Through Week 36
Suicidal Ideation
|
6 participants
|
12 participants
|
8 participants
|
8 participants
|
|
Number of Participants With Suicidal Ideation or Suicidal Behavior Week 10 Through Week 36
Suicidal Behavior
|
2 participants
|
3 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Suicidal Ideation or Suicidal Behavior Week 10 Through Week 36
Treatment Emergent Suicidal Ideation
|
5 participants
|
8 participants
|
7 participants
|
6 participants
|
SECONDARY outcome
Timeframe: Baseline through Week 10Population: Participants with normal ALT value (ALT\<1 x ULN) at last non-missing baseline visit and at least one non-missing post-baseline value.
Total number of participants with any abnormal post-baseline value, based on all values at scheduled and unscheduled visits. Potentially clinically significant hepatic laboratory results at any time are defined as alanine transaminase (ALT) ≥3 x upper limit of normal (ULN), ALT ≥5 x ULN and ALT ≥10 x ULN, as well as ALT ≥3 x ULN and Total Bilirubin ≥2 x ULN.
Outcome measures
| Measure |
Duloxetine 60mg
n=95 Participants
Duloxetine 60mg orally, once daily for 10 weeks
|
Placebo
n=98 Participants
Placebo capsules identical in appearance, color, taste, and smell to study drug orally, once daily for 10 weeks
|
Fluoxetine 20 mg/Fluoxetine 20-40 mg
n=102 Participants
Participants were treated with Fluoxetine 20 mg orally, once daily for 10 weeks during acute treatment phase and Fluoxetine 20-40 mg orally, once daily for 6 months during extension phase
|
Placebo/Duloxetine 60-120 mg
n=100 Participants
Participants were treated with placebo orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
|
|---|---|---|---|---|
|
Number of Participants With Potentially Clinically Significant Hepatic Laboratory Results Any Time Baseline Through Week 10
ALT≥3 x ULN
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Potentially Clinically Significant Hepatic Laboratory Results Any Time Baseline Through Week 10
ALT≥5 x ULN
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Potentially Clinically Significant Hepatic Laboratory Results Any Time Baseline Through Week 10
ALT≥10 x ULN
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Potentially Clinically Significant Hepatic Laboratory Results Any Time Baseline Through Week 10
ALT≥3 x ULN and Total Bilirubin≥2 x ULN
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Week 10 through Week 36Population: Participants with normal ALT value (ALT\<1 x ULN) at last non-missing visit before Week 10 and at least one non-missing post-Week 10 value.
Total number of participants with any abnormal post-baseline value, based on all values at scheduled and unscheduled visits. Potentially clinically significant hepatic laboratory results at any time are defined as ALT ≥3 x ULN, ALT ≥5 x ULN and ALT ≥10 x ULN, as well as ALT≥3 x ULN and Total Bilirubin ≥2 x ULN.
Outcome measures
| Measure |
Duloxetine 60mg
n=69 Participants
Duloxetine 60mg orally, once daily for 10 weeks
|
Placebo
n=69 Participants
Placebo capsules identical in appearance, color, taste, and smell to study drug orally, once daily for 10 weeks
|
Fluoxetine 20 mg/Fluoxetine 20-40 mg
n=77 Participants
Participants were treated with Fluoxetine 20 mg orally, once daily for 10 weeks during acute treatment phase and Fluoxetine 20-40 mg orally, once daily for 6 months during extension phase
|
Placebo/Duloxetine 60-120 mg
n=73 Participants
Participants were treated with placebo orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
|
|---|---|---|---|---|
|
Number of Participants With Potentially Clinically Significant Hepatic Laboratory Results Any Time Week 10 Through Week 36
ALT≥3 x ULN
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Potentially Clinically Significant Hepatic Laboratory Results Any Time Week 10 Through Week 36
ALT≥5 x ULN
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Potentially Clinically Significant Hepatic Laboratory Results Any Time Week 10 Through Week 36
ALT≥10 x ULN
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Potentially Clinically Significant Hepatic Laboratory Results Any Time Week 10 Through Week 36
ALT≥3 x ULN and Total Bilirubin≥2 x ULN
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline through Week 10Population: Participants with normal baseline value and at least one post-baseline value, and who were at risk for the specific PCS criteria.
PCS increase in systolic and diastolic BP was defined as increase of ≥5 millimeter mercury (mm Hg) from baseline (BL) high value to a value above the 95th percentile at post-BL; PCS increase of pulse was defined as \>140 and increase of ≥15 from BL high value for age 7-11 and \>120 and increase of ≥15 from BL high value for age 12-17; PCS decrease of pulse was defined as \<60 and a decrease of ≥25 from BL low value for age 7-11 and \<50 and a decrease of ≥15 from BL low value for age 12-17; PCS decrease of weight was defined as decrease of at least 3.5% from BL low value.
Outcome measures
| Measure |
Duloxetine 60mg
n=108 Participants
Duloxetine 60mg orally, once daily for 10 weeks
|
Placebo
n=116 Participants
Placebo capsules identical in appearance, color, taste, and smell to study drug orally, once daily for 10 weeks
|
Fluoxetine 20 mg/Fluoxetine 20-40 mg
n=117 Participants
Participants were treated with Fluoxetine 20 mg orally, once daily for 10 weeks during acute treatment phase and Fluoxetine 20-40 mg orally, once daily for 6 months during extension phase
|
Placebo/Duloxetine 60-120 mg
n=122 Participants
Participants were treated with placebo orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
|
|---|---|---|---|---|
|
Percentage of Participants With Potentially Clinically Significant (PCS) Changes in Systolic Blood Pressure (BP), Diastolic BP, Pulse, and Weight Any Time Baseline Through Week 10
Diastolic BP Increase (N=93, 100, 99, 110)
|
11.8 percentage of participants
|
7.0 percentage of participants
|
10.1 percentage of participants
|
4.5 percentage of participants
|
|
Percentage of Participants With Potentially Clinically Significant (PCS) Changes in Systolic Blood Pressure (BP), Diastolic BP, Pulse, and Weight Any Time Baseline Through Week 10
Systolic BP Increase (N=88, 95, 93, 98)
|
9.1 percentage of participants
|
12.6 percentage of participants
|
12.9 percentage of participants
|
10.2 percentage of participants
|
|
Percentage of Participants With Potentially Clinically Significant (PCS) Changes in Systolic Blood Pressure (BP), Diastolic BP, Pulse, and Weight Any Time Baseline Through Week 10
Pulse Decrease (N=100, 108, 108, 112)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Potentially Clinically Significant (PCS) Changes in Systolic Blood Pressure (BP), Diastolic BP, Pulse, and Weight Any Time Baseline Through Week 10
Pulse Increase (N=105, 114, 112, 117)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Potentially Clinically Significant (PCS) Changes in Systolic Blood Pressure (BP), Diastolic BP, Pulse, and Weight Any Time Baseline Through Week 10
Weight Decrease (N=105, 114, 112, 117)
|
13.3 percentage of participants
|
8.8 percentage of participants
|
11.6 percentage of participants
|
5.1 percentage of participants
|
SECONDARY outcome
Timeframe: Week 10 through Week 36Population: Participates with normal value before week 10 and at least one non-missing post-Week 10 value, and who are at risk for the specific PCS criteria.
PCS increase in systolic and diastolic BP was defined as increase of ≥5 mm Hg from baseline (BL) high value to a value above the 95th percentile at post-BL; PCS increase of pulse was defined as \>140 and increase of ≥15 from BL high value for age 7-11 and \>120 and increase of ≥15 from BL high value for age 12-17; PCS decrease of pulse was defined as \<60 and a decrease of ≥25 from BL low value for age 7-11 and \<50 and a decrease of ≥15 from BL low value for age 12-17; PCS decrease of weight was defined as decrease of at least 3.5% from BL low value.
Outcome measures
| Measure |
Duloxetine 60mg
n=73 Participants
Duloxetine 60mg orally, once daily for 10 weeks
|
Placebo
n=80 Participants
Placebo capsules identical in appearance, color, taste, and smell to study drug orally, once daily for 10 weeks
|
Fluoxetine 20 mg/Fluoxetine 20-40 mg
n=84 Participants
Participants were treated with Fluoxetine 20 mg orally, once daily for 10 weeks during acute treatment phase and Fluoxetine 20-40 mg orally, once daily for 6 months during extension phase
|
Placebo/Duloxetine 60-120 mg
n=82 Participants
Participants were treated with placebo orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
|
|---|---|---|---|---|
|
Percentage of Participants With Potentially Clinically Significant (PCS) Changes in Systolic Blood Pressure (BP), Diastolic BP, Pulse, and Weight Any Time Week 10 Through Week 36
Diastolic BP Increase (N=55, 65, 64, 69)
|
14.5 percentage of participants
|
4.6 percentage of participants
|
20.3 percentage of participants
|
11.6 percentage of participants
|
|
Percentage of Participants With Potentially Clinically Significant (PCS) Changes in Systolic Blood Pressure (BP), Diastolic BP, Pulse, and Weight Any Time Week 10 Through Week 36
Systolic BP Increase (N=53, 62, 57, 57)
|
9.4 percentage of participants
|
6.5 percentage of participants
|
7.0 percentage of participants
|
10.5 percentage of participants
|
|
Percentage of Participants With Potentially Clinically Significant (PCS) Changes in Systolic Blood Pressure (BP), Diastolic BP, Pulse, and Weight Any Time Week 10 Through Week 36
Pulse Decrease (N=68, 75, 76, 73)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Potentially Clinically Significant (PCS) Changes in Systolic Blood Pressure (BP), Diastolic BP, Pulse, and Weight Any Time Week 10 Through Week 36
Pulse Increase (N=71, 78, 81, 79)
|
1.4 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
1.3 percentage of participants
|
|
Percentage of Participants With Potentially Clinically Significant (PCS) Changes in Systolic Blood Pressure (BP), Diastolic BP, Pulse, and Weight Any Time Week 10 Through Week 36
Weight Decrease (N=71, 78, 81, 79)
|
2.8 percentage of participants
|
9.0 percentage of participants
|
3.7 percentage of participants
|
13.9 percentage of participants
|
Adverse Events
Duloxetine 60 mg - Acute
Serious events: 4 serious events
Other events: 76 other events
Deaths: 0 deaths
Duloxetine 30 mg - Acute
Serious events: 2 serious events
Other events: 66 other events
Deaths: 0 deaths
Fluoxetine 20 mg - Acute
Serious events: 6 serious events
Other events: 69 other events
Deaths: 0 deaths
Placebo - Acute
Serious events: 2 serious events
Other events: 71 other events
Deaths: 0 deaths
Duloxetine 60 mg - Extension
Serious events: 3 serious events
Other events: 49 other events
Deaths: 0 deaths
Duloxetine 30 mg - Extension
Serious events: 2 serious events
Other events: 46 other events
Deaths: 0 deaths
Fluoxetine 20 mg - Extension
Serious events: 1 serious events
Other events: 45 other events
Deaths: 0 deaths
Placebo/Duloxetine - Extension
Serious events: 4 serious events
Other events: 52 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Duloxetine 60 mg - Acute
n=108 participants at risk
Duloxetine 60 mg, orally, once daily for 10 weeks
|
Duloxetine 30 mg - Acute
n=116 participants at risk
Duloxetine 30 mg, orally, once daily for 10 weeks
|
Fluoxetine 20 mg - Acute
n=117 participants at risk
Fluoxetine 20 mg, orally, once daily for 10 weeks
|
Placebo - Acute
n=122 participants at risk
Placebo capsules identical in appearance, color, taste, and smell to study drug, orally, once daily for 10 weeks
|
Duloxetine 60 mg - Extension
n=73 participants at risk
Duloxetine 60-120 mg , orally, once daily for 6 months
|
Duloxetine 30 mg - Extension
n=81 participants at risk
Duloxetine 60-120 mg , orally, once daily for 6 months
One participant who had completed the acute treatment phase and didn't go into the extension phase, was accidentally dispensed the drug at the last visit of the acute treatment phase. Based on intent-to-treat principal, this participant was included in the extension phase analyses for adverse events (AEs; resulting in one more participant being analyzed for AEs than the number of participants who started the extension phase \[see Participant Flow section\]).
|
Fluoxetine 20 mg - Extension
n=84 participants at risk
Fluoxetine 20-40 mg, orally, once daily for 6 months
|
Placebo/Duloxetine - Extension
n=82 participants at risk
Duloxetine 60-120 mg , orally, once daily for 6 months
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.93%
1/108 • Number of events 1
|
0.00%
0/116
|
0.00%
0/117
|
0.00%
0/122
|
1.4%
1/73 • Number of events 1
|
0.00%
0/81
|
0.00%
0/84
|
0.00%
0/82
|
|
Infections and infestations
Tuberculosis of peripheral lymph nodes
|
0.00%
0/108
|
0.00%
0/116
|
0.85%
1/117 • Number of events 1
|
0.00%
0/122
|
0.00%
0/73
|
0.00%
0/81
|
0.00%
0/84
|
0.00%
0/82
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
1.9%
2/108 • Number of events 2
|
0.00%
0/116
|
0.85%
1/117 • Number of events 1
|
0.00%
0/122
|
0.00%
0/73
|
0.00%
0/81
|
0.00%
0/84
|
1.2%
1/82 • Number of events 1
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/108
|
0.00%
0/116
|
0.00%
0/117
|
0.00%
0/122
|
0.00%
0/73
|
0.00%
0/81
|
0.00%
0/84
|
1.2%
1/82 • Number of events 1
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/108
|
0.00%
0/116
|
0.00%
0/117
|
0.00%
0/122
|
1.4%
1/73 • Number of events 1
|
0.00%
0/81
|
0.00%
0/84
|
0.00%
0/82
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/108
|
0.00%
0/116
|
0.00%
0/117
|
0.00%
0/122
|
0.00%
0/73
|
0.00%
0/81
|
0.00%
0/84
|
1.2%
1/82 • Number of events 1
|
|
Nervous system disorders
Somnolence
|
0.00%
0/108
|
0.00%
0/116
|
0.85%
1/117 • Number of events 1
|
0.00%
0/122
|
0.00%
0/73
|
0.00%
0/81
|
1.2%
1/84 • Number of events 1
|
0.00%
0/82
|
|
Psychiatric disorders
Abnormal behaviour
|
0.00%
0/108
|
0.00%
0/116
|
0.85%
1/117 • Number of events 1
|
0.00%
0/122
|
0.00%
0/73
|
0.00%
0/81
|
0.00%
0/84
|
0.00%
0/82
|
|
Psychiatric disorders
Aggression
|
0.00%
0/108
|
0.00%
0/116
|
1.7%
2/117 • Number of events 2
|
0.00%
0/122
|
0.00%
0/73
|
0.00%
0/81
|
0.00%
0/84
|
0.00%
0/82
|
|
Psychiatric disorders
Depression
|
0.00%
0/108
|
0.00%
0/116
|
0.00%
0/117
|
0.00%
0/122
|
0.00%
0/73
|
1.2%
1/81 • Number of events 1
|
0.00%
0/84
|
0.00%
0/82
|
|
Psychiatric disorders
Depressive symptom
|
0.00%
0/108
|
0.86%
1/116 • Number of events 1
|
0.00%
0/117
|
0.00%
0/122
|
0.00%
0/73
|
0.00%
0/81
|
0.00%
0/84
|
0.00%
0/82
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/108
|
0.86%
1/116 • Number of events 1
|
0.00%
0/117
|
0.00%
0/122
|
0.00%
0/73
|
0.00%
0/81
|
0.00%
0/84
|
0.00%
0/82
|
|
Psychiatric disorders
Homicidal ideation
|
0.00%
0/108
|
0.00%
0/116
|
0.00%
0/117
|
0.82%
1/122 • Number of events 1
|
0.00%
0/73
|
0.00%
0/81
|
0.00%
0/84
|
0.00%
0/82
|
|
Psychiatric disorders
Self injurious behaviour
|
0.00%
0/108
|
0.86%
1/116 • Number of events 1
|
0.00%
0/117
|
0.82%
1/122 • Number of events 1
|
0.00%
0/73
|
0.00%
0/81
|
0.00%
0/84
|
0.00%
0/82
|
|
Psychiatric disorders
Suicidal ideation
|
0.93%
1/108 • Number of events 1
|
0.00%
0/116
|
1.7%
2/117 • Number of events 2
|
0.00%
0/122
|
0.00%
0/73
|
0.00%
0/81
|
0.00%
0/84
|
0.00%
0/82
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/108
|
0.00%
0/116
|
0.00%
0/117
|
0.82%
1/122 • Number of events 1
|
1.4%
1/73 • Number of events 1
|
2.5%
2/81 • Number of events 2
|
0.00%
0/84
|
1.2%
1/82 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson syndrome
|
0.00%
0/108
|
0.00%
0/116
|
0.00%
0/117
|
0.00%
0/122
|
1.4%
1/73 • Number of events 1
|
0.00%
0/81
|
0.00%
0/84
|
0.00%
0/82
|
Other adverse events
| Measure |
Duloxetine 60 mg - Acute
n=108 participants at risk
Duloxetine 60 mg, orally, once daily for 10 weeks
|
Duloxetine 30 mg - Acute
n=116 participants at risk
Duloxetine 30 mg, orally, once daily for 10 weeks
|
Fluoxetine 20 mg - Acute
n=117 participants at risk
Fluoxetine 20 mg, orally, once daily for 10 weeks
|
Placebo - Acute
n=122 participants at risk
Placebo capsules identical in appearance, color, taste, and smell to study drug, orally, once daily for 10 weeks
|
Duloxetine 60 mg - Extension
n=73 participants at risk
Duloxetine 60-120 mg , orally, once daily for 6 months
|
Duloxetine 30 mg - Extension
n=81 participants at risk
Duloxetine 60-120 mg , orally, once daily for 6 months
One participant who had completed the acute treatment phase and didn't go into the extension phase, was accidentally dispensed the drug at the last visit of the acute treatment phase. Based on intent-to-treat principal, this participant was included in the extension phase analyses for adverse events (AEs; resulting in one more participant being analyzed for AEs than the number of participants who started the extension phase \[see Participant Flow section\]).
|
Fluoxetine 20 mg - Extension
n=84 participants at risk
Fluoxetine 20-40 mg, orally, once daily for 6 months
|
Placebo/Duloxetine - Extension
n=82 participants at risk
Duloxetine 60-120 mg , orally, once daily for 6 months
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
2.8%
3/108 • Number of events 3
|
1.7%
2/116 • Number of events 2
|
0.00%
0/117
|
0.00%
0/122
|
5.5%
4/73 • Number of events 4
|
1.2%
1/81 • Number of events 1
|
1.2%
1/84 • Number of events 1
|
0.00%
0/82
|
|
Gastrointestinal disorders
Abdominal pain upper
|
12.0%
13/108 • Number of events 14
|
8.6%
10/116 • Number of events 10
|
8.5%
10/117 • Number of events 10
|
7.4%
9/122 • Number of events 12
|
8.2%
6/73 • Number of events 8
|
7.4%
6/81 • Number of events 7
|
8.3%
7/84 • Number of events 7
|
4.9%
4/82 • Number of events 4
|
|
Gastrointestinal disorders
Diarrhoea
|
3.7%
4/108 • Number of events 4
|
7.8%
9/116 • Number of events 9
|
2.6%
3/117 • Number of events 3
|
1.6%
2/122 • Number of events 3
|
1.4%
1/73 • Number of events 1
|
6.2%
5/81 • Number of events 7
|
6.0%
5/84 • Number of events 5
|
2.4%
2/82 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
16.7%
18/108 • Number of events 20
|
18.1%
21/116 • Number of events 22
|
9.4%
11/117 • Number of events 12
|
9.0%
11/122 • Number of events 11
|
8.2%
6/73 • Number of events 7
|
16.0%
13/81 • Number of events 14
|
3.6%
3/84 • Number of events 5
|
9.8%
8/82 • Number of events 10
|
|
Gastrointestinal disorders
Vomiting
|
4.6%
5/108 • Number of events 6
|
6.0%
7/116 • Number of events 8
|
1.7%
2/117 • Number of events 2
|
2.5%
3/122 • Number of events 3
|
5.5%
4/73 • Number of events 4
|
12.3%
10/81 • Number of events 13
|
9.5%
8/84 • Number of events 8
|
9.8%
8/82 • Number of events 9
|
|
General disorders
Fatigue
|
4.6%
5/108 • Number of events 5
|
5.2%
6/116 • Number of events 7
|
3.4%
4/117 • Number of events 4
|
3.3%
4/122 • Number of events 4
|
4.1%
3/73 • Number of events 3
|
2.5%
2/81 • Number of events 2
|
2.4%
2/84 • Number of events 2
|
7.3%
6/82 • Number of events 7
|
|
General disorders
Pyrexia
|
0.93%
1/108 • Number of events 1
|
2.6%
3/116 • Number of events 4
|
0.00%
0/117
|
3.3%
4/122 • Number of events 4
|
4.1%
3/73 • Number of events 3
|
3.7%
3/81 • Number of events 4
|
1.2%
1/84 • Number of events 1
|
9.8%
8/82 • Number of events 8
|
|
Infections and infestations
Nasopharyngitis
|
2.8%
3/108 • Number of events 3
|
3.4%
4/116 • Number of events 4
|
6.0%
7/117 • Number of events 8
|
2.5%
3/122 • Number of events 3
|
4.1%
3/73 • Number of events 3
|
7.4%
6/81 • Number of events 7
|
8.3%
7/84 • Number of events 8
|
3.7%
3/82 • Number of events 3
|
|
Infections and infestations
Upper respiratory tract infection
|
0.93%
1/108 • Number of events 1
|
5.2%
6/116 • Number of events 7
|
2.6%
3/117 • Number of events 3
|
4.9%
6/122 • Number of events 6
|
6.8%
5/73 • Number of events 7
|
4.9%
4/81 • Number of events 6
|
2.4%
2/84 • Number of events 2
|
2.4%
2/82 • Number of events 3
|
|
Injury, poisoning and procedural complications
Incorrect dose administered
|
0.93%
1/108 • Number of events 1
|
0.86%
1/116 • Number of events 1
|
2.6%
3/117 • Number of events 3
|
0.00%
0/122
|
6.8%
5/73 • Number of events 5
|
3.7%
3/81 • Number of events 3
|
4.8%
4/84 • Number of events 4
|
1.2%
1/82 • Number of events 1
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.6%
6/108 • Number of events 6
|
8.6%
10/116 • Number of events 10
|
5.1%
6/117 • Number of events 6
|
3.3%
4/122 • Number of events 4
|
0.00%
0/73
|
3.7%
3/81 • Number of events 3
|
1.2%
1/84 • Number of events 1
|
4.9%
4/82 • Number of events 4
|
|
Nervous system disorders
Dizziness
|
8.3%
9/108 • Number of events 9
|
8.6%
10/116 • Number of events 11
|
4.3%
5/117 • Number of events 5
|
6.6%
8/122 • Number of events 8
|
2.7%
2/73 • Number of events 2
|
7.4%
6/81 • Number of events 6
|
2.4%
2/84 • Number of events 2
|
8.5%
7/82 • Number of events 7
|
|
Nervous system disorders
Headache
|
17.6%
19/108 • Number of events 22
|
17.2%
20/116 • Number of events 27
|
18.8%
22/117 • Number of events 26
|
13.1%
16/122 • Number of events 19
|
8.2%
6/73 • Number of events 8
|
4.9%
4/81 • Number of events 4
|
11.9%
10/84 • Number of events 14
|
13.4%
11/82 • Number of events 13
|
|
Nervous system disorders
Somnolence
|
10.2%
11/108 • Number of events 11
|
2.6%
3/116 • Number of events 3
|
3.4%
4/117 • Number of events 4
|
4.9%
6/122 • Number of events 6
|
1.4%
1/73 • Number of events 1
|
0.00%
0/81
|
0.00%
0/84
|
2.4%
2/82 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.9%
2/108 • Number of events 2
|
3.4%
4/116 • Number of events 4
|
1.7%
2/117 • Number of events 2
|
2.5%
3/122 • Number of events 3
|
2.7%
2/73 • Number of events 2
|
1.2%
1/81 • Number of events 1
|
6.0%
5/84 • Number of events 5
|
3.7%
3/82 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.8%
3/108 • Number of events 3
|
1.7%
2/116 • Number of events 2
|
5.1%
6/117 • Number of events 6
|
2.5%
3/122 • Number of events 3
|
4.1%
3/73 • Number of events 4
|
1.2%
1/81 • Number of events 1
|
0.00%
0/84
|
2.4%
2/82 • Number of events 2
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60