Trial Outcomes & Findings for A Study for Adult Patients With Fibromyalgia (NCT NCT00965081)
NCT ID: NCT00965081
Last Updated: 2011-11-03
Results Overview
BPI Average Pain score ranges from 0 (no pain) to 10 (pain as bad as you can imagine). Treatment group difference in Least Squares (LS) Means changes from analysis of covariance (ANCOVA) with terms for treatment group, pooled investigators, baseline. Baseline-observation-carried-forward (BOCF) method used to impute endpoint value for those who discontinued initial double-blind therapy (DBT) due to adverse event (AE); last non-missing observation during initial DBT used to impute missing endpoint for all others. Analyses included all participants having non-missing baseline and endpoint.
COMPLETED
PHASE4
308 participants
Baseline, 12 weeks
2011-11-03
Participant Flow
Participants who enter the study with a diagnosis of major depressive disorder (MDD) and who also meet the predefined blinded criteria for worsening of depression during the acute therapy phase will be rescued to daily duloxetine 60 mg for the remainder of the acute therapy phase.
Participant milestones
| Measure |
Duloxetine
Duloxetine 30 milligrams (mg) dose daily (QD) by mouth (po) at the same time each day for 12 weeks
Participants who enter the study with a diagnosis of major depressive disorder (MDD) will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression.
|
Placebo
Placebo (inactive capsules identical in appearance to duloxetine capsules) QD po at the same time each day for 12 weeks
Participants who enter the study with a diagnosis of MDD will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression.
|
|---|---|---|
|
Overall Study
STARTED
|
155
|
153
|
|
Overall Study
COMPLETED
|
121
|
110
|
|
Overall Study
NOT COMPLETED
|
34
|
43
|
Reasons for withdrawal
| Measure |
Duloxetine
Duloxetine 30 milligrams (mg) dose daily (QD) by mouth (po) at the same time each day for 12 weeks
Participants who enter the study with a diagnosis of major depressive disorder (MDD) will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression.
|
Placebo
Placebo (inactive capsules identical in appearance to duloxetine capsules) QD po at the same time each day for 12 weeks
Participants who enter the study with a diagnosis of MDD will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression.
|
|---|---|---|
|
Overall Study
Adverse Event
|
14
|
9
|
|
Overall Study
Lack of Efficacy
|
2
|
5
|
|
Overall Study
Lost to Follow-up
|
4
|
5
|
|
Overall Study
Physician Decision
|
2
|
0
|
|
Overall Study
Protocol Violation
|
2
|
5
|
|
Overall Study
Sponsor Decision
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
4
|
7
|
|
Overall Study
Switched to Rescue Arm
|
5
|
12
|
Baseline Characteristics
A Study for Adult Patients With Fibromyalgia
Baseline characteristics by cohort
| Measure |
Duloxetine
n=155 Participants
Duloxetine 30 milligrams (mg) dose daily (QD) by mouth (po) at the same time each day for 12 weeks
Participants who enter the study with a diagnosis of major depressive disorder (MDD) will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression.
|
Placebo
n=153 Participants
Placebo (inactive capsules identical in appearance to duloxetine capsules) QD po at the same time each day for 12 weeks
Participants who enter the study with a diagnosis of MDD will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression.
|
Total
n=308 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
50.89 Years
STANDARD_DEVIATION 11.90 • n=5 Participants
|
50.72 Years
STANDARD_DEVIATION 12.45 • n=7 Participants
|
50.80 Years
STANDARD_DEVIATION 12.16 • n=5 Participants
|
|
Sex: Female, Male
Female
|
146 Participants
n=5 Participants
|
147 Participants
n=7 Participants
|
293 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
133 Participants
n=5 Participants
|
136 Participants
n=7 Participants
|
269 Participants
n=5 Participants
|
|
Region of Enrollment
Argentina
|
40 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Region of Enrollment
Israel
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
42 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
|
Region of Enrollment
Puerto Rico
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
56 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
112 Participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
28.91 kilograms/meters squared (kg/m2)
STANDARD_DEVIATION 6.00 • n=5 Participants
|
29.49 kilograms/meters squared (kg/m2)
STANDARD_DEVIATION 6.90 • n=7 Participants
|
29.20 kilograms/meters squared (kg/m2)
STANDARD_DEVIATION 6.46 • n=5 Participants
|
|
Brief Pain Inventory (BPI) Average Pain Score
|
6.50 Units on a scale
STANDARD_DEVIATION 1.47 • n=5 Participants
|
6.37 Units on a scale
STANDARD_DEVIATION 1.67 • n=7 Participants
|
6.44 Units on a scale
STANDARD_DEVIATION 1.57 • n=5 Participants
|
|
Brief Pain Inventory (BPI) Mean Interference Score
|
5.97 Units on a scale
STANDARD_DEVIATION 2.17 • n=5 Participants
|
5.78 Units on a scale
STANDARD_DEVIATION 2.28 • n=7 Participants
|
5.88 Units on a scale
STANDARD_DEVIATION 2.23 • n=5 Participants
|
|
Fibromyalgia Impact Questionnaire (FIQ) Total Score
|
51.11 Units on a scale
STANDARD_DEVIATION 12.17 • n=5 Participants
|
50.44 Units on a scale
STANDARD_DEVIATION 13.71 • n=7 Participants
|
50.78 Units on a scale
STANDARD_DEVIATION 12.94 • n=5 Participants
|
|
Beck Depression Inventory (BDI) Total Score
|
15.00 Units on a scale
STANDARD_DEVIATION 9.64 • n=5 Participants
|
16.84 Units on a scale
STANDARD_DEVIATION 11.47 • n=7 Participants
|
15.92 Units on a scale
STANDARD_DEVIATION 10.61 • n=5 Participants
|
|
Clinical Global Impression of Severity (CGI-S) for Depression Score
|
2.30 Units on a scale
STANDARD_DEVIATION 1.38 • n=5 Participants
|
2.45 Units on a scale
STANDARD_DEVIATION 1.45 • n=7 Participants
|
2.38 Units on a scale
STANDARD_DEVIATION 1.42 • n=5 Participants
|
|
Patient's Global Impressions of Severity (PGI-S) Score
|
3.74 Units on a scale
STANDARD_DEVIATION 1.33 • n=5 Participants
|
3.74 Units on a scale
STANDARD_DEVIATION 1.47 • n=7 Participants
|
3.74 Units on a scale
STANDARD_DEVIATION 1.40 • n=5 Participants
|
|
Beck Anxiety Inventory (BAI) Total Score
|
14.26 Units on a scale
STANDARD_DEVIATION 9.35 • n=5 Participants
|
15.04 Units on a scale
STANDARD_DEVIATION 10.69 • n=7 Participants
|
14.65 Units on a scale
STANDARD_DEVIATION 10.04 • n=5 Participants
|
|
Diagnosis of Major Depressive Disorder (MDD)
Diagnosis of MDD
|
32 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Diagnosis of Major Depressive Disorder (MDD)
No diagnosis of MDD
|
123 Participants
n=5 Participants
|
116 Participants
n=7 Participants
|
239 Participants
n=5 Participants
|
|
Diagnosis of Generalized Anxiety Disorder (GAD)
Diagnosis of GAD
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Diagnosis of Generalized Anxiety Disorder (GAD)
No diagnosis of GAD
|
144 Participants
n=5 Participants
|
145 Participants
n=7 Participants
|
289 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 12 weeksPopulation: Intent-to-treat (ITT) population: all randomized participants. ITT treatment group is group to which participant was randomized regardless of treatment actually received. BOCF method used to impute endpoint value if initial DBT discontinued due to AE. Change from baseline analyses included all those with baseline and ≤1 post-baseline observation.
BPI Average Pain score ranges from 0 (no pain) to 10 (pain as bad as you can imagine). Treatment group difference in Least Squares (LS) Means changes from analysis of covariance (ANCOVA) with terms for treatment group, pooled investigators, baseline. Baseline-observation-carried-forward (BOCF) method used to impute endpoint value for those who discontinued initial double-blind therapy (DBT) due to adverse event (AE); last non-missing observation during initial DBT used to impute missing endpoint for all others. Analyses included all participants having non-missing baseline and endpoint.
Outcome measures
| Measure |
Duloxetine
n=153 Participants
Duloxetine 30 milligrams (mg) dose daily (QD) by mouth (po) at the same time each day for 12 weeks
Participants who enter the study with a diagnosis of major depressive disorder (MDD) will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression.
|
Placebo
n=153 Participants
Placebo (inactive capsules identical in appearance to duloxetine capsules) QD po at the same time each day for 12 weeks
Participants who enter the study with a diagnosis of MDD will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression.
|
|---|---|---|
|
Change From Baseline to 12-Week Endpoint in the Brief Pain Inventory (BPI) "24-Hour Average Pain" Item (Question 3) of the BPI-Modified Short Form Score
|
-2.04 Units on a scale
Standard Error 0.20
|
-1.70 Units on a scale
Standard Error 0.20
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: Intention to treat (ITT) population: analyses conducted per initial group assignments. The LOCF method was used to impute the missing endpoint during initial double-blind therapy.
BPI-Modified Short Form mean interference score ranges from 0 (does not interfere) to 10 (completely interferes) for pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Treatment group difference in the Least Squares (LS) Means changes from baseline to endpoint is from an analysis of covariance (ANCOVA) with terms for treatment group, pooled investigators and baseline. Last-observation-carried forward (LOCF) endpoint defined as last available post-baseline value obtained during initial double-blind therapy.
Outcome measures
| Measure |
Duloxetine
n=153 Participants
Duloxetine 30 milligrams (mg) dose daily (QD) by mouth (po) at the same time each day for 12 weeks
Participants who enter the study with a diagnosis of major depressive disorder (MDD) will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression.
|
Placebo
n=153 Participants
Placebo (inactive capsules identical in appearance to duloxetine capsules) QD po at the same time each day for 12 weeks
Participants who enter the study with a diagnosis of MDD will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression.
|
|---|---|---|
|
Change From Baseline to 12-Week Endpoint in the Brief Pain Inventory (BPI) - Modified Short Form
Worst Pain
|
-2.23 Units on a scale
Standard Error 0.23
|
-1.98 Units on a scale
Standard Error 0.23
|
|
Change From Baseline to 12-Week Endpoint in the Brief Pain Inventory (BPI) - Modified Short Form
Least Pain
|
-1.56 Units on a scale
Standard Error 0.20
|
-1.36 Units on a scale
Standard Error 0.20
|
|
Change From Baseline to 12-Week Endpoint in the Brief Pain Inventory (BPI) - Modified Short Form
Pain Right Now
|
-2.25 Units on a scale
Standard Error 0.23
|
-1.90 Units on a scale
Standard Error 0.23
|
|
Change From Baseline to 12-Week Endpoint in the Brief Pain Inventory (BPI) - Modified Short Form
Pain Interference - General Activity
|
-2.19 Units on a scale
Standard Error 0.24
|
-1.91 Units on a scale
Standard Error 0.24
|
|
Change From Baseline to 12-Week Endpoint in the Brief Pain Inventory (BPI) - Modified Short Form
Pain Interference - Mood
|
-2.40 Units on a scale
Standard Error 0.24
|
-1.82 Units on a scale
Standard Error 0.24
|
|
Change From Baseline to 12-Week Endpoint in the Brief Pain Inventory (BPI) - Modified Short Form
Pain Interference - Walking ability
|
-2.31 Units on a scale
Standard Error 0.22
|
-1.74 Units on a scale
Standard Error 0.22
|
|
Change From Baseline to 12-Week Endpoint in the Brief Pain Inventory (BPI) - Modified Short Form
Pain Interference - Normal Work
|
-2.20 Units on a scale
Standard Error 0.24
|
-1.77 Units on a scale
Standard Error 0.24
|
|
Change From Baseline to 12-Week Endpoint in the Brief Pain Inventory (BPI) - Modified Short Form
Pain Interference - Relations with Other People
|
-2.05 Units on a scale
Standard Error 0.23
|
-1.34 Units on a scale
Standard Error 0.23
|
|
Change From Baseline to 12-Week Endpoint in the Brief Pain Inventory (BPI) - Modified Short Form
Pain Interference - Sleep
|
-2.06 Units on a scale
Standard Error 0.25
|
-1.75 Units on a scale
Standard Error 0.25
|
|
Change From Baseline to 12-Week Endpoint in the Brief Pain Inventory (BPI) - Modified Short Form
Pain Interference - Enjoyment of Life
|
-2.48 Units on a scale
Standard Error 0.24
|
-1.93 Units on a scale
Standard Error 0.24
|
|
Change From Baseline to 12-Week Endpoint in the Brief Pain Inventory (BPI) - Modified Short Form
Mean Interference Score
|
-2.28 Units on a scale
Standard Error 0.20
|
-1.78 Units on a scale
Standard Error 0.20
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Intention to treat (ITT) population: analyses conducted per initial group assignments. The last-observation-carried-forward (LOCF) method was used to impute the missing endpoint during initial double-blind therapy.
The PGI-I scale is a patient-rated instrument that measures perceived improvement in symptoms. It is a 7-point scale: score of 1 is "very much better," 4 is "no change," and 7 is "very much worse." Treatment group difference in Least Squares (LS) Means at endpoint is from an analysis of covariance (ANCOVA); model included terms for treatment group, pooled investigators and baseline PGI-Severity (PGI-S).
Outcome measures
| Measure |
Duloxetine
n=153 Participants
Duloxetine 30 milligrams (mg) dose daily (QD) by mouth (po) at the same time each day for 12 weeks
Participants who enter the study with a diagnosis of major depressive disorder (MDD) will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression.
|
Placebo
n=153 Participants
Placebo (inactive capsules identical in appearance to duloxetine capsules) QD po at the same time each day for 12 weeks
Participants who enter the study with a diagnosis of MDD will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression.
|
|---|---|---|
|
Patient Global Impression - Improvement (PGI-I) at Endpoint
|
2.97 Units on a scale
Standard Error 0.12
|
3.35 Units on a scale
Standard Error 0.12
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Intention to treat (ITT) population: analyses conducted per initial group assignments. The last-observation-carried-forward (LOCF) method was used to impute the missing endpoint during initial double-blind therapy.
The CGI-I measures clinician's perception of patient improvement at time of assessment compared with start of treatment. Scores range from 1 (very much improved) to 7 (very much worse). The treatment group difference in Least Squares (LS) Means at endpoint is from an analysis of covariance (ANCOVA). The model included terms for treatment group, pooled investigators and baseline CGI-Severity (CGI-S).
Outcome measures
| Measure |
Duloxetine
n=152 Participants
Duloxetine 30 milligrams (mg) dose daily (QD) by mouth (po) at the same time each day for 12 weeks
Participants who enter the study with a diagnosis of major depressive disorder (MDD) will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression.
|
Placebo
n=153 Participants
Placebo (inactive capsules identical in appearance to duloxetine capsules) QD po at the same time each day for 12 weeks
Participants who enter the study with a diagnosis of MDD will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression.
|
|---|---|---|
|
Clinical Global Impression of Improvement (CGI-I) for Depression at Endpoint
|
3.34 Units on a scale
Standard Error 0.09
|
3.51 Units on a scale
Standard Error 0.09
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: Intention to treat (ITT) population: analyses conducted per initial group assignments. The last-observation-carried-forward (LOCF) method was used to impute the missing endpoint during initial double-blind therapy.
The BDI-II is a 21-item, patient-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a 4-point scale for each item ranging from 0 to 3 (0 = not present; 3 = present in the extreme). The treatment group difference in the Least Squares (LS) Means change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included terms for treatment group, pooled investigators and baseline.
Outcome measures
| Measure |
Duloxetine
n=140 Participants
Duloxetine 30 milligrams (mg) dose daily (QD) by mouth (po) at the same time each day for 12 weeks
Participants who enter the study with a diagnosis of major depressive disorder (MDD) will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression.
|
Placebo
n=134 Participants
Placebo (inactive capsules identical in appearance to duloxetine capsules) QD po at the same time each day for 12 weeks
Participants who enter the study with a diagnosis of MDD will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression.
|
|---|---|---|
|
Change From Baseline to 12-Week Endpoint Beck Depression Inventory-II (BDI-II)
|
-5.47 Units on a scale
Standard Error 0.60
|
-3.91 Units on a scale
Standard Error 0.61
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: Intention to treat (ITT) population: analyses conducted per randomly assigned groups. Baseline-observation-carried-forward (BOCF) method used to impute endpoint value for those who discontinued initial double-blind therapy(DB) due to adverse event; last non-missing observation during initial DB used to impute the missing endpoint for all others.
FIQ is a 20-item self-administered questionnaire that measures fibromyalgia (FM) patient status, progress, and outcomes over the past week. The total score ranges from 0 to 80 with higher scores reflecting a more negative impact of FM. The treatment group difference in the Least Squares (LS) Means change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included terms for treatment group, pooled investigators and baseline.
Outcome measures
| Measure |
Duloxetine
n=153 Participants
Duloxetine 30 milligrams (mg) dose daily (QD) by mouth (po) at the same time each day for 12 weeks
Participants who enter the study with a diagnosis of major depressive disorder (MDD) will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression.
|
Placebo
n=153 Participants
Placebo (inactive capsules identical in appearance to duloxetine capsules) QD po at the same time each day for 12 weeks
Participants who enter the study with a diagnosis of MDD will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression.
|
|---|---|---|
|
Change From Baseline to 12-Week Endpoint Fibromyalgia Impact Questionnaire (FIQ)
|
-14.62 Units on a scale
Standard Error 1.38
|
-9.75 Units on a scale
Standard Error 1.38
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: Intention to treat (ITT) population: analyses conducted per initial group assignments. The last-observation-carried-forward (LOCF) method used to impute the missing endpoint during initial double-blind therapy.
The BAI is a 21-item patient-completed questionnaire designed to assess the characteristics of anxiety. Each item is rated on a 4-point scale (0=not present; 3=present in the extreme). The total score ranges from 0 to 63; the higher the score, the more severe the anxiety symptoms. The treatment group difference in the Least Squares (LS) Means at endpoint is from an analysis of covariance (ANCOVA). The model included terms for treatment group, pooled investigators and baseline.
Outcome measures
| Measure |
Duloxetine
n=138 Participants
Duloxetine 30 milligrams (mg) dose daily (QD) by mouth (po) at the same time each day for 12 weeks
Participants who enter the study with a diagnosis of major depressive disorder (MDD) will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression.
|
Placebo
n=132 Participants
Placebo (inactive capsules identical in appearance to duloxetine capsules) QD po at the same time each day for 12 weeks
Participants who enter the study with a diagnosis of MDD will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression.
|
|---|---|---|
|
Change From Baseline to 12-Week Endpoint Beck Anxiety Inventory (BAI)
|
-3.76 Units on a scale
Standard Error 0.67
|
-3.31 Units on a scale
Standard Error 0.68
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: Intention to treat (ITT) population: analyses conducted per initial group assignments. The last-observation-carried-forward (LOCF) method used to impute the missing endpoint.
SF-36 has 36 items with 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional, general health; each scored on 0 to 100 scale. Higher scores indicate better status. Mental component summary (MCS) and physical component summary (PCS) based on 8 SF-36 domains. Scales scored using norm-based methods; mean is 50 and standard deviation is 10 in U.S. population. Treatment group difference in Least Squares (LS) Means at endpoint from analysis of covariance. Terms for treatment group, pooled investigators, baseline in model.
Outcome measures
| Measure |
Duloxetine
n=153 Participants
Duloxetine 30 milligrams (mg) dose daily (QD) by mouth (po) at the same time each day for 12 weeks
Participants who enter the study with a diagnosis of major depressive disorder (MDD) will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression.
|
Placebo
n=153 Participants
Placebo (inactive capsules identical in appearance to duloxetine capsules) QD po at the same time each day for 12 weeks
Participants who enter the study with a diagnosis of MDD will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression.
|
|---|---|---|
|
Change From Baseline to 12-Week Endpoint 36-Item Short-Form Health Survey (SF-36)
Physical Component (n=140, n=134)
|
4.75 Units on a scale
Standard Error 0.72
|
3.91 Units on a scale
Standard Error 0.73
|
|
Change From Baseline to 12-Week Endpoint 36-Item Short-Form Health Survey (SF-36)
Bodily Pain Transformed (n=141, n=135)
|
17.06 Units on a scale
Standard Error 1.87
|
14.01 Units on a scale
Standard Error 1.89
|
|
Change From Baseline to 12-Week Endpoint 36-Item Short-Form Health Survey (SF-36)
General Health Transformed (n=140, n=134)
|
7.88 Units on a scale
Standard Error 1.47
|
6.12 Units on a scale
Standard Error 1.50
|
|
Change From Baseline to 12-Week Endpoint 36-Item Short-Form Health Survey (SF-36)
Mental Health Transformed (n=141, n=135)
|
9.36 Units on a scale
Standard Error 1.56
|
5.55 Units on a scale
Standard Error 1.59
|
|
Change From Baseline to 12-Week Endpoint 36-Item Short-Form Health Survey (SF-36)
Physical Functioning (n=141, n=135)
|
9.53 Units on a scale
Standard Error 1.74
|
6.34 Units on a scale
Standard Error 1.76
|
|
Change From Baseline to 12-Week Endpoint 36-Item Short-Form Health Survey (SF-36)
Role-Emotional (n=141, n=135)
|
18.88 Units on a scale
Standard Error 3.45
|
10.69 Units on a scale
Standard Error 3.50
|
|
Change From Baseline to 12-Week Endpoint 36-Item Short-Form Health Survey (SF-36)
Role-Physical (n=141, n=135)
|
18.55 Units on a scale
Standard Error 3.48
|
13.13 Units on a scale
Standard Error 3.52
|
|
Change From Baseline to 12-Week Endpoint 36-Item Short-Form Health Survey (SF-36)
Social Functioning (n=141, n=135)
|
14.05 Units on a scale
Standard Error 1.93
|
6.75 Units on a scale
Standard Error 1.95
|
|
Change From Baseline to 12-Week Endpoint 36-Item Short-Form Health Survey (SF-36)
Vitality (n=141, n=135)
|
11.87 Units on a scale
Standard Error 1.73
|
7.59 Units on a scale
Standard Error 1.74
|
|
Change From Baseline to 12-Week Endpoint 36-Item Short-Form Health Survey (SF-36)
Mental Component (n=140, n=134)
|
5.56 Units on a scale
Standard Error 0.85
|
2.87 Units on a scale
Standard Error 0.87
|
SECONDARY outcome
Timeframe: Baseline through 12 weeksPopulation: Only participants having at least 1 post-baseline C-SSRS assessment were included in this analysis.
The C-SSRS is a scale capturing occurrence, severity, and frequency of suicide-related thoughts and behaviors. The number of participants with suicidal behaviors and ideations are provided. Suicidal behavior: a "yes" answer to any of 5 suicidal behavior questions which include: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation: a "yes" answer to any 1 of 5 suicidal ideation questions which include wish to be dead and 4 different categories of active suicidal ideation.
Outcome measures
| Measure |
Duloxetine
n=152 Participants
Duloxetine 30 milligrams (mg) dose daily (QD) by mouth (po) at the same time each day for 12 weeks
Participants who enter the study with a diagnosis of major depressive disorder (MDD) will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression.
|
Placebo
n=153 Participants
Placebo (inactive capsules identical in appearance to duloxetine capsules) QD po at the same time each day for 12 weeks
Participants who enter the study with a diagnosis of MDD will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression.
|
|---|---|---|
|
Number of Participants With Suicidal Behaviors and Ideations Collected by Columbia -Suicide Severity Rating Scale (C-SSRS)
Non-specific active suicidal thoughts
|
1 Participants
|
0 Participants
|
|
Number of Participants With Suicidal Behaviors and Ideations Collected by Columbia -Suicide Severity Rating Scale (C-SSRS)
Wish to be dead
|
3 Participants
|
3 Participants
|
|
Number of Participants With Suicidal Behaviors and Ideations Collected by Columbia -Suicide Severity Rating Scale (C-SSRS)
Active suicidal ideation with no intent to act
|
1 Participants
|
0 Participants
|
|
Number of Participants With Suicidal Behaviors and Ideations Collected by Columbia -Suicide Severity Rating Scale (C-SSRS)
Active suicidal ideation, some intent, no plan
|
0 Participants
|
0 Participants
|
|
Number of Participants With Suicidal Behaviors and Ideations Collected by Columbia -Suicide Severity Rating Scale (C-SSRS)
Active suicidal ideation with specific plan/intent
|
0 Participants
|
0 Participants
|
|
Number of Participants With Suicidal Behaviors and Ideations Collected by Columbia -Suicide Severity Rating Scale (C-SSRS)
Suicidal behavior - Preparatory acts or behavior
|
0 Participants
|
0 Participants
|
|
Number of Participants With Suicidal Behaviors and Ideations Collected by Columbia -Suicide Severity Rating Scale (C-SSRS)
Suicidal behavior - Aborted attempt
|
0 Participants
|
0 Participants
|
|
Number of Participants With Suicidal Behaviors and Ideations Collected by Columbia -Suicide Severity Rating Scale (C-SSRS)
Suicidal behavior - Interrupted attempt
|
0 Participants
|
0 Participants
|
Adverse Events
Placebo
Duloxetine 30 mg
Duloxetine 60 mg
Serious adverse events
| Measure |
Placebo
n=153 participants at risk
Placebo (inactive capsules identical in appearance to duloxetine capsules) daily by mouth at the same time each day for 12 weeks.
|
Duloxetine 30 mg
n=155 participants at risk
Duloxetine 30 mg dose daily by mouth at the same time each day for 12 weeks
|
Duloxetine 60 mg
n=17 participants at risk
Participants who enter the study with a diagnosis of major depressive disorder (MDD) and who also meet the predefined blinded criteria for worsening of depression during the acute therapy phase will be rescued to daily duloxetine 60 mg for the remainder of the acute therapy phase.
|
|---|---|---|---|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.65%
1/153 • Number of events 1
|
0.00%
0/155
|
0.00%
0/17
|
Other adverse events
| Measure |
Placebo
n=153 participants at risk
Placebo (inactive capsules identical in appearance to duloxetine capsules) daily by mouth at the same time each day for 12 weeks.
|
Duloxetine 30 mg
n=155 participants at risk
Duloxetine 30 mg dose daily by mouth at the same time each day for 12 weeks
|
Duloxetine 60 mg
n=17 participants at risk
Participants who enter the study with a diagnosis of major depressive disorder (MDD) and who also meet the predefined blinded criteria for worsening of depression during the acute therapy phase will be rescued to daily duloxetine 60 mg for the remainder of the acute therapy phase.
|
|---|---|---|---|
|
Cardiac disorders
Palpitations
|
0.65%
1/153 • Number of events 1
|
1.9%
3/155 • Number of events 3
|
0.00%
0/17
|
|
Ear and labyrinth disorders
Vertigo
|
1.3%
2/153 • Number of events 2
|
0.65%
1/155 • Number of events 1
|
0.00%
0/17
|
|
Eye disorders
Vision blurred
|
0.65%
1/153 • Number of events 1
|
2.6%
4/155 • Number of events 4
|
0.00%
0/17
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/153
|
1.3%
2/155 • Number of events 3
|
0.00%
0/17
|
|
Gastrointestinal disorders
Abdominal pain
|
2.6%
4/153 • Number of events 5
|
0.65%
1/155 • Number of events 1
|
0.00%
0/17
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.65%
1/153 • Number of events 1
|
3.9%
6/155 • Number of events 6
|
0.00%
0/17
|
|
Gastrointestinal disorders
Constipation
|
1.3%
2/153 • Number of events 2
|
3.2%
5/155 • Number of events 5
|
0.00%
0/17
|
|
Gastrointestinal disorders
Diarrhoea
|
4.6%
7/153 • Number of events 8
|
4.5%
7/155 • Number of events 7
|
5.9%
1/17 • Number of events 1
|
|
Gastrointestinal disorders
Dry mouth
|
2.0%
3/153 • Number of events 3
|
8.4%
13/155 • Number of events 13
|
0.00%
0/17
|
|
Gastrointestinal disorders
Gastritis
|
1.3%
2/153 • Number of events 2
|
1.3%
2/155 • Number of events 2
|
0.00%
0/17
|
|
Gastrointestinal disorders
Nausea
|
3.9%
6/153 • Number of events 7
|
21.3%
33/155 • Number of events 33
|
0.00%
0/17
|
|
Gastrointestinal disorders
Vomiting
|
1.3%
2/153 • Number of events 2
|
0.65%
1/155 • Number of events 1
|
0.00%
0/17
|
|
General disorders
Asthenia
|
0.65%
1/153 • Number of events 1
|
1.9%
3/155 • Number of events 3
|
0.00%
0/17
|
|
General disorders
Chills
|
0.00%
0/153
|
1.3%
2/155 • Number of events 2
|
0.00%
0/17
|
|
General disorders
Fatigue
|
1.3%
2/153 • Number of events 2
|
2.6%
4/155 • Number of events 4
|
0.00%
0/17
|
|
General disorders
Feeling jittery
|
0.65%
1/153 • Number of events 1
|
1.9%
3/155 • Number of events 3
|
0.00%
0/17
|
|
Infections and infestations
Cystitis
|
0.00%
0/153
|
0.65%
1/155 • Number of events 1
|
5.9%
1/17 • Number of events 1
|
|
Infections and infestations
Influenza
|
2.0%
3/153 • Number of events 3
|
1.9%
3/155 • Number of events 4
|
0.00%
0/17
|
|
Infections and infestations
Nasopharyngitis
|
4.6%
7/153 • Number of events 7
|
2.6%
4/155 • Number of events 4
|
0.00%
0/17
|
|
Infections and infestations
Pharyngitis
|
3.3%
5/153 • Number of events 5
|
1.3%
2/155 • Number of events 2
|
0.00%
0/17
|
|
Infections and infestations
Sinusitis
|
2.0%
3/153 • Number of events 3
|
1.3%
2/155 • Number of events 2
|
0.00%
0/17
|
|
Infections and infestations
Upper respiratory tract infection
|
1.3%
2/153 • Number of events 2
|
1.9%
3/155 • Number of events 3
|
0.00%
0/17
|
|
Infections and infestations
Urinary tract infection
|
3.3%
5/153 • Number of events 5
|
1.3%
2/155 • Number of events 2
|
5.9%
1/17 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fall
|
1.3%
2/153 • Number of events 2
|
0.00%
0/155
|
0.00%
0/17
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.3%
2/153 • Number of events 2
|
4.5%
7/155 • Number of events 7
|
0.00%
0/17
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
2.0%
3/153 • Number of events 3
|
0.00%
0/155
|
0.00%
0/17
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/153
|
1.3%
2/155 • Number of events 2
|
0.00%
0/17
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.0%
3/153 • Number of events 3
|
0.65%
1/155 • Number of events 1
|
0.00%
0/17
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
1.3%
2/153 • Number of events 2
|
0.65%
1/155 • Number of events 1
|
0.00%
0/17
|
|
Nervous system disorders
Dizziness
|
3.9%
6/153 • Number of events 6
|
7.1%
11/155 • Number of events 12
|
0.00%
0/17
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/153
|
1.3%
2/155 • Number of events 2
|
0.00%
0/17
|
|
Nervous system disorders
Headache
|
9.8%
15/153 • Number of events 17
|
13.5%
21/155 • Number of events 21
|
5.9%
1/17 • Number of events 1
|
|
Nervous system disorders
Migraine
|
1.3%
2/153 • Number of events 3
|
1.9%
3/155 • Number of events 3
|
0.00%
0/17
|
|
Nervous system disorders
Paraesthesia
|
1.3%
2/153 • Number of events 2
|
2.6%
4/155 • Number of events 4
|
0.00%
0/17
|
|
Nervous system disorders
Sedation
|
0.65%
1/153 • Number of events 2
|
1.3%
2/155 • Number of events 2
|
0.00%
0/17
|
|
Nervous system disorders
Somnolence
|
2.6%
4/153 • Number of events 4
|
5.8%
9/155 • Number of events 9
|
5.9%
1/17 • Number of events 1
|
|
Nervous system disorders
Tremor
|
0.00%
0/153
|
1.3%
2/155 • Number of events 2
|
0.00%
0/17
|
|
Psychiatric disorders
Anxiety
|
2.0%
3/153 • Number of events 4
|
1.3%
2/155 • Number of events 2
|
0.00%
0/17
|
|
Psychiatric disorders
Depression
|
2.0%
3/153 • Number of events 3
|
0.65%
1/155 • Number of events 1
|
0.00%
0/17
|
|
Psychiatric disorders
Insomnia
|
2.0%
3/153 • Number of events 3
|
5.2%
8/155 • Number of events 8
|
0.00%
0/17
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/153
|
1.3%
2/155 • Number of events 2
|
0.00%
0/17
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.3%
2/153 • Number of events 2
|
0.65%
1/155 • Number of events 1
|
5.9%
1/17 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.0%
3/153 • Number of events 3
|
1.9%
3/155 • Number of events 3
|
0.00%
0/17
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/153
|
2.6%
4/155 • Number of events 4
|
0.00%
0/17
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.65%
1/153 • Number of events 2
|
1.9%
3/155 • Number of events 3
|
0.00%
0/17
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/153
|
0.65%
1/155 • Number of events 1
|
5.9%
1/17 • Number of events 1
|
|
Vascular disorders
Hot flush
|
0.00%
0/153
|
1.3%
2/155 • Number of events 2
|
0.00%
0/17
|
|
Vascular disorders
Hypertension
|
0.00%
0/153
|
1.3%
2/155 • Number of events 2
|
0.00%
0/17
|
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: LTE60