Trial Outcomes & Findings for A Study of Duloxetine in Major Depressive Disorder (MDD) and Associated Painful Symptoms (NCT NCT01000805)
NCT ID: NCT01000805
Last Updated: 2012-01-13
Results Overview
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). The overall change is based on the estimated main treatment effect. The Least Squares (LS) Mean Value was adjusted for treatment, investigator, visit, baseline, treatment\*visit interaction, and baseline\*visit interaction.
COMPLETED
PHASE4
528 participants
Day 1 through 8 weeks
2012-01-13
Participant Flow
Participant milestones
| Measure |
Duloxetine
Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week followed by 60 mg QD, po for 7 weeks.
|
Placebo
Participants received placebo QD, po for 8 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
262
|
266
|
|
Overall Study
COMPLETED
|
192
|
204
|
|
Overall Study
NOT COMPLETED
|
70
|
62
|
Reasons for withdrawal
| Measure |
Duloxetine
Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week followed by 60 mg QD, po for 7 weeks.
|
Placebo
Participants received placebo QD, po for 8 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
21
|
9
|
|
Overall Study
Lack of Efficacy
|
5
|
16
|
|
Overall Study
Lost to Follow-up
|
16
|
21
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Protocol Violation
|
12
|
8
|
|
Overall Study
Withdrawal by Subject
|
16
|
6
|
|
Overall Study
Sponsor Decision
|
0
|
1
|
Baseline Characteristics
A Study of Duloxetine in Major Depressive Disorder (MDD) and Associated Painful Symptoms
Baseline characteristics by cohort
| Measure |
Duloxetine
n=262 Participants
Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week followed by 60 mg QD, po for 7 weeks.
|
Placebo
n=266 Participants
Participants received placebo QD, po for 8 weeks.
|
Total
n=528 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
46.15 years
STANDARD_DEVIATION 13.27 • n=5 Participants
|
45.73 years
STANDARD_DEVIATION 12.85 • n=7 Participants
|
45.94 years
STANDARD_DEVIATION 13.05 • n=5 Participants
|
|
Sex: Female, Male
Female
|
180 Participants
n=5 Participants
|
184 Participants
n=7 Participants
|
364 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
82 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
164 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
68 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
131 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
194 Participants
n=5 Participants
|
203 Participants
n=7 Participants
|
397 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
31 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
222 Participants
n=5 Participants
|
213 Participants
n=7 Participants
|
435 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
18 participants
n=5 Participants
|
16 participants
n=7 Participants
|
34 participants
n=5 Participants
|
|
Region of Enrollment
France
|
29 participants
n=5 Participants
|
33 participants
n=7 Participants
|
62 participants
n=5 Participants
|
|
Region of Enrollment
Puerto Rico
|
37 participants
n=5 Participants
|
35 participants
n=7 Participants
|
72 participants
n=5 Participants
|
|
Region of Enrollment
Romania
|
11 participants
n=5 Participants
|
15 participants
n=7 Participants
|
26 participants
n=5 Participants
|
|
Region of Enrollment
Sweden
|
22 participants
n=5 Participants
|
22 participants
n=7 Participants
|
44 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
145 participants
n=5 Participants
|
145 participants
n=7 Participants
|
290 participants
n=5 Participants
|
|
Brief Pain Inventory Severity: Worst Pain Score (BPI-S: Worst Pain)
|
6.93 units on a scale
STANDARD_DEVIATION 1.65 • n=5 Participants
|
6.86 units on a scale
STANDARD_DEVIATION 1.70 • n=7 Participants
|
6.89 units on a scale
STANDARD_DEVIATION 1.67 • n=5 Participants
|
|
Brief Pain Inventory Severity: Least Pain Score (BPI-S: Least Pain)
|
4.27 units on a scale
STANDARD_DEVIATION 2.17 • n=5 Participants
|
4.11 units on a scale
STANDARD_DEVIATION 2.22 • n=7 Participants
|
4.19 units on a scale
STANDARD_DEVIATION 2.19 • n=5 Participants
|
|
Brief Pain Inventory Severity: Average Pain Score (BPI-S: Average Pain)
|
5.68 units on a scale
STANDARD_DEVIATION 1.69 • n=5 Participants
|
5.58 units on a scale
STANDARD_DEVIATION 1.67 • n=7 Participants
|
5.63 units on a scale
STANDARD_DEVIATION 1.68 • n=5 Participants
|
|
Brief Pain Inventory Severity: Pain Right Now Score (BPI-S: Pain Right Now)
|
5.29 units on a scale
STANDARD_DEVIATION 2.37 • n=5 Participants
|
5.34 units on a scale
STANDARD_DEVIATION 2.10 • n=7 Participants
|
5.32 units on a scale
STANDARD_DEVIATION 2.24 • n=5 Participants
|
|
Brief Pain Inventory - Interference (BPI-I)
|
5.65 units on a scale
STANDARD_DEVIATION 2.20 • n=5 Participants
|
5.67 units on a scale
STANDARD_DEVIATION 2.11 • n=7 Participants
|
5.66 units on a scale
STANDARD_DEVIATION 2.16 • n=5 Participants
|
|
Clinical Global Impressions of Severity Scale (CGI-S)
|
4.58 units on a scale
STANDARD_DEVIATION 0.63 • n=5 Participants
|
4.58 units on a scale
STANDARD_DEVIATION 0.63 • n=7 Participants
|
4.58 units on a scale
STANDARD_DEVIATION 0.63 • n=5 Participants
|
|
Montgomery Asberg Depression Rating Scale (MADRS) Total Score
|
29.91 units on a scale
STANDARD_DEVIATION 4.92 • n=5 Participants
|
30.39 units on a scale
STANDARD_DEVIATION 5.25 • n=7 Participants
|
30.15 units on a scale
STANDARD_DEVIATION 5.09 • n=5 Participants
|
|
Sheehan Disability Scale-Item 1 (SDS-Item 1), N=196,200,396
|
6.24 units on a scale
STANDARD_DEVIATION 2.30 • n=5 Participants
|
6.23 units on a scale
STANDARD_DEVIATION 2.15 • n=7 Participants
|
6.23 units on a scale
STANDARD_DEVIATION 2.22 • n=5 Participants
|
|
Sheehan Disability Scale-Item 2 (SDS-Item 2), N=262,265,527
|
6.43 units on a scale
STANDARD_DEVIATION 2.27 • n=5 Participants
|
6.50 units on a scale
STANDARD_DEVIATION 2.15 • n=7 Participants
|
6.46 units on a scale
STANDARD_DEVIATION 2.21 • n=5 Participants
|
|
Sheehan Disability Scale-Item 3 (SDS-Item 3), N=262,265,527
|
6.42 units on a scale
STANDARD_DEVIATION 2.21 • n=5 Participants
|
6.45 units on a scale
STANDARD_DEVIATION 2.06 • n=7 Participants
|
6.44 units on a scale
STANDARD_DEVIATION 2.13 • n=5 Participants
|
|
Sheehan Disability Scale -Total Score (SDS Total), N=262,265,527
|
19.16 units on a scale
STANDARD_DEVIATION 6.00 • n=5 Participants
|
19.38 units on a scale
STANDARD_DEVIATION 5.84 • n=7 Participants
|
19.27 units on a scale
STANDARD_DEVIATION 5.92 • n=5 Participants
|
|
Number of Previous Major Depressive Disorder (MDD) Episodes
|
3.52 number of previous episodes
STANDARD_DEVIATION 3.98 • n=5 Participants
|
3.67 number of previous episodes
STANDARD_DEVIATION 4.88 • n=7 Participants
|
3.60 number of previous episodes
STANDARD_DEVIATION 4.45 • n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 through 8 weeksPopulation: All randomized participants with a baseline and at least 1 post-baseline result.
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). The overall change is based on the estimated main treatment effect. The Least Squares (LS) Mean Value was adjusted for treatment, investigator, visit, baseline, treatment\*visit interaction, and baseline\*visit interaction.
Outcome measures
| Measure |
Duloxetine
n=251 Participants
Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week followed by 60 mg QD, po for 7 weeks.
|
Placebo
n=261 Participants
Participants received placebo QD, po for 8 weeks.
|
|---|---|---|
|
Change From Baseline in the Brief Pain Inventory-Short Form (BPI-SF) Average Pain Score During the 8-week Treatment Period
|
-1.93 units on a scale
Standard Error 0.11
|
-1.31 units on a scale
Standard Error 0.10
|
PRIMARY outcome
Timeframe: Baseline, 8 weeksPopulation: All randomized participants with a baseline and at least 1 post-baseline result.
The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). The Least Squares (LS) Mean Value was adjusted for treatment, investigator, visit, baseline, treatment\*visit interaction, and baseline\*visit interaction.
Outcome measures
| Measure |
Duloxetine
n=251 Participants
Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week followed by 60 mg QD, po for 7 weeks.
|
Placebo
n=262 Participants
Participants received placebo QD, po for 8 weeks.
|
|---|---|---|
|
Change From Baseline in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score at Week 8
|
-16.77 units on a scale
Standard Error 0.67
|
-12.73 units on a scale
Standard Error 0.64
|
SECONDARY outcome
Timeframe: Baseline, 8 weeksPopulation: All randomized participants with a baseline and at least 1 post-baseline result.
SDS is completed by participant; used to assess effect of the participant's symptoms on their work/social/family life. Total scores range from 0 to 30; higher values indicate greater disruption in the participant's work/social/family life. Each item score ranges from 0 to 10 with higher values indicating greater disruption in the participant's work/school life (item 1), social life/leisure activities (item 2), or family life/home responsibilities (item 3). The LS Mean Value was adjusted for treatment, investigator, visit, baseline, treatment\*visit interaction, and baseline\*visit interaction.
Outcome measures
| Measure |
Duloxetine
n=250 Participants
Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week followed by 60 mg QD, po for 7 weeks.
|
Placebo
n=260 Participants
Participants received placebo QD, po for 8 weeks.
|
|---|---|---|
|
Change From Baseline in the Sheehan Disability Scale (SDS) Total and Item Scores at Week 8
Disrupt Work/School Work (N=182, 196)
|
-2.82 units on a scale
Standard Error 0.22
|
-2.36 units on a scale
Standard Error 0.20
|
|
Change From Baseline in the Sheehan Disability Scale (SDS) Total and Item Scores at Week 8
Disrupt Social Life/Leisure Activities
|
-3.04 units on a scale
Standard Error 0.19
|
-2.31 units on a scale
Standard Error 0.18
|
|
Change From Baseline in the Sheehan Disability Scale (SDS) Total and Item Scores at Week 8
Disrupt Family/Home Responsibilities
|
-3.02 units on a scale
Standard Error 0.19
|
-2.49 units on a scale
Standard Error 0.18
|
|
Change From Baseline in the Sheehan Disability Scale (SDS) Total and Item Scores at Week 8
SDS Total Score
|
-8.88 units on a scale
Standard Error 0.54
|
-7.13 units on a scale
Standard Error 0.52
|
SECONDARY outcome
Timeframe: Baseline, up to 8 weeksPopulation: All randomized participants with a post-baseline result, Last Observation Carried Forward (LOCF).
The Montgomery Asberg Depression Rating Scale (MADRS) is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Remission is defined as achieving a MADRS total score ≤12.
Outcome measures
| Measure |
Duloxetine
n=251 Participants
Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week followed by 60 mg QD, po for 7 weeks.
|
Placebo
n=262 Participants
Participants received placebo QD, po for 8 weeks.
|
|---|---|---|
|
Change From Baseline in the Percentage of Participants Achieving Remission up to Week 8
|
47.0 percentage of participants
|
32.8 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 8 weeksPopulation: All randomized participants with a baseline and at least 1 post-baseline value.
The Montgomery Asberg Depression Rating Scale (MADRS) is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale from 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Remission is defined as achieving a MADRS total score ≤12 at the last 2 nonmissing consecutive visits (for example, visit 3 \[week 1\] and visit 4 \[week 2\], or visit 4 \[week 2\] and visit 5 \[week 4\], or visit 5 \[week 4\] and visit 6 \[week 8\]).
Outcome measures
| Measure |
Duloxetine
n=251 Participants
Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week followed by 60 mg QD, po for 7 weeks.
|
Placebo
n=262 Participants
Participants received placebo QD, po for 8 weeks.
|
|---|---|---|
|
Percentage of Participants Achieving Remission up to Week 8
|
29.5 percentage of participants
|
18.7 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, 4 weeksPopulation: All randomized participants with a baseline and at least 1 post-baseline result.
The MADRS is a rating scale for severity of depressive mood and symptoms. The MADRS has a 10-item checklist. Items are rated on a scale from 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). The Least Squares (LS) Mean Value was adjusted for treatment, investigator, visit, baseline, treatment\*visit interaction, and baseline\*visit interaction.
Outcome measures
| Measure |
Duloxetine
n=251 Participants
Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week followed by 60 mg QD, po for 7 weeks.
|
Placebo
n=262 Participants
Participants received placebo QD, po for 8 weeks.
|
|---|---|---|
|
Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score at Week 4
|
-14.15 units on a scale
Standard Error 0.58
|
-10.49 units on a scale
Standard Error 0.55
|
SECONDARY outcome
Timeframe: Baseline, 2 weeksPopulation: All randomized participants with a baseline and at least 1 post-baseline result.
The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range from 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). The Least Squares (LS) Mean Value was adjusted for treatment, investigator, visit, baseline, treatment\*visit interaction, and baseline\*visit interaction.
Outcome measures
| Measure |
Duloxetine
n=251 Participants
Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week followed by 60 mg QD, po for 7 weeks.
|
Placebo
n=262 Participants
Participants received placebo QD, po for 8 weeks.
|
|---|---|---|
|
Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score at Week 2
|
-9.90 units on a scale
Standard Error 0.49
|
-7.71 units on a scale
Standard Error 0.47
|
SECONDARY outcome
Timeframe: Baseline, 8 weeksPopulation: All randomized participants with a baseline and at least 1 post-baseline result.
Measures pain severity and interference on function. Severity scores: 0 (no pain) to 10 (severe pain) on each question. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference=average of nonmissing scores of individual interference items. LS Mean Value adjusted for treatment, investigator, visit, baseline, treatment\*visit interaction, and baseline\*visit interaction.
Outcome measures
| Measure |
Duloxetine
n=251 Participants
Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week followed by 60 mg QD, po for 7 weeks.
|
Placebo
n=261 Participants
Participants received placebo QD, po for 8 weeks.
|
|---|---|---|
|
Change From Baseline in the Brief Pain Inventory Severity and Interference Scores (BPI-S/BPI-I) at Week 8
BPI Severity for Worst Pain
|
-2.25 units on a scale
Standard Error 0.13
|
-1.60 units on a scale
Standard Error 0.12
|
|
Change From Baseline in the Brief Pain Inventory Severity and Interference Scores (BPI-S/BPI-I) at Week 8
BPI Severity for Least Pain
|
-1.48 units on a scale
Standard Error 0.11
|
-0.86 units on a scale
Standard Error 0.10
|
|
Change From Baseline in the Brief Pain Inventory Severity and Interference Scores (BPI-S/BPI-I) at Week 8
BPI Severity for Average Pain
|
-1.93 units on a scale
Standard Error 0.11
|
-1.31 units on a scale
Standard Error 0.10
|
|
Change From Baseline in the Brief Pain Inventory Severity and Interference Scores (BPI-S/BPI-I) at Week 8
BPI Severity for Pain Right Now
|
-2.00 units on a scale
Standard Error 0.12
|
-1.27 units on a scale
Standard Error 0.12
|
|
Change From Baseline in the Brief Pain Inventory Severity and Interference Scores (BPI-S/BPI-I) at Week 8
BPI Pain Interference with General Activity
|
-2.01 units on a scale
Standard Error 0.13
|
-1.33 units on a scale
Standard Error 0.13
|
|
Change From Baseline in the Brief Pain Inventory Severity and Interference Scores (BPI-S/BPI-I) at Week 8
BPI Pain Interference with Mood
|
-2.49 units on a scale
Standard Error 0.14
|
-1.76 units on a scale
Standard Error 0.13
|
|
Change From Baseline in the Brief Pain Inventory Severity and Interference Scores (BPI-S/BPI-I) at Week 8
BPI Pain Interference with Walking Ability
|
-1.52 units on a scale
Standard Error 0.13
|
-1.06 units on a scale
Standard Error 0.12
|
|
Change From Baseline in the Brief Pain Inventory Severity and Interference Scores (BPI-S/BPI-I) at Week 8
BPI Pain Interference with Normal Work
|
-2.02 units on a scale
Standard Error 0.13
|
-1.46 units on a scale
Standard Error 0.13
|
|
Change From Baseline in the Brief Pain Inventory Severity and Interference Scores (BPI-S/BPI-I) at Week 8
BPI Pain Interference with Relations With Others
|
-2.01 units on a scale
Standard Error 0.13
|
-1.31 units on a scale
Standard Error 0.13
|
|
Change From Baseline in the Brief Pain Inventory Severity and Interference Scores (BPI-S/BPI-I) at Week 8
BPI Pain Interference with Sleep
|
-1.94 units on a scale
Standard Error 0.14
|
-1.56 units on a scale
Standard Error 0.14
|
|
Change From Baseline in the Brief Pain Inventory Severity and Interference Scores (BPI-S/BPI-I) at Week 8
BPI Pain Interference with Enjoyment of Life
|
-2.44 units on a scale
Standard Error 0.14
|
-1.77 units on a scale
Standard Error 0.13
|
|
Change From Baseline in the Brief Pain Inventory Severity and Interference Scores (BPI-S/BPI-I) at Week 8
BPI Mean Pain Interference Score
|
-2.03 units on a scale
Standard Error 0.12
|
-1.46 units on a scale
Standard Error 0.12
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: All randomized participants with a baseline and at least 1 post-baseline result.
A scale that measures the participant'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). The Least Squares (LS) Mean Value was adjusted for treatment, investigator, visit, and treatment\*visit interaction.
Outcome measures
| Measure |
Duloxetine
n=195 Participants
Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week followed by 60 mg QD, po for 7 weeks.
|
Placebo
n=211 Participants
Participants received placebo QD, po for 8 weeks.
|
|---|---|---|
|
Patient's Global Impressions of Improvement Scale (PGI-I) at Week 8
|
2.56 units on a scale
Standard Error 0.08
|
3.04 units on a scale
Standard Error 0.08
|
SECONDARY outcome
Timeframe: Baseline through 8 weeksPopulation: All randomized participants with at least 1 post-baseline C-SSRS result.
The C-SSRS captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of participants with suicidal behaviors, ideations, and acts are provided. Suicidal behavior: a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, and completed suicide. Suicidal ideation: a "yes" answer to any 1 of 5 suicidal ideation questions, which includes wish to be dead, and 4 different categories of active suicidal ideation. Suicidal acts: a "yes" answer to actual attempt or completed suicide.
Outcome measures
| Measure |
Duloxetine
n=251 Participants
Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week followed by 60 mg QD, po for 7 weeks.
|
Placebo
n=262 Participants
Participants received placebo QD, po for 8 weeks.
|
|---|---|---|
|
Number of Participants With Suicidal Behaviors, Ideations, and Acts Based on the Columbia Suicide Severity Rating Scale (C-SSRS) During the Double-blind Treatment Phase
Suicidal Ideation
|
26 participants
|
41 participants
|
|
Number of Participants With Suicidal Behaviors, Ideations, and Acts Based on the Columbia Suicide Severity Rating Scale (C-SSRS) During the Double-blind Treatment Phase
Suicidal Behavior
|
1 participants
|
0 participants
|
|
Number of Participants With Suicidal Behaviors, Ideations, and Acts Based on the Columbia Suicide Severity Rating Scale (C-SSRS) During the Double-blind Treatment Phase
Suicidal Acts
|
2 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline, up to week 8Population: Primary analysis: All randomized participants with a baseline and at least 1 post-baseline result. Secondary analysis: Intention-to-treat population (ITT) with nonmissing baseline value and at least 1 nonmissing post-baseline value, LOCF.
The change from baseline in pulse rate at week 8 is the primary analysis. For the primary analysis of pulse rate, the Least Squares (LS) Mean Value was adjusted for treatment, investigator, baseline, treatment\*visit interaction, and baseline\*visit interaction. The change from baseline in pulse rate up to week 8 is the secondary analysis. The LS Mean Value was adjusted for treatment, investigator, and baseline.
Outcome measures
| Measure |
Duloxetine
n=250 Participants
Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week followed by 60 mg QD, po for 7 weeks.
|
Placebo
n=262 Participants
Participants received placebo QD, po for 8 weeks.
|
|---|---|---|
|
Change From Baseline in Pulse Rate up to Week 8
Change from Baseline in Pulse Rate at Week 8
|
1.58 beats per minute (bpm)
Standard Error 0.59
|
-1.34 beats per minute (bpm)
Standard Error 0.57
|
|
Change From Baseline in Pulse Rate up to Week 8
Change from Baseline in Pulse Rate up to Week 8
|
1.71 beats per minute (bpm)
Standard Error 0.54
|
-0.70 beats per minute (bpm)
Standard Error 0.53
|
SECONDARY outcome
Timeframe: Baseline, up to week 8Population: Primary analysis: All randomized participants with a baseline and at least 1 post-baseline result. Secondary analysis: Intention-to-treat population (ITT) with nonmissing baseline value and at least 1 nonmissing post-baseline value, Last Observation Carried Forward (LOCF).
The change from baseline in SBP and DBP at week 8 is the primary analysis. For the primary analysis of SBP and DBP, the Least Squares (LS) Mean Value was adjusted for treatment, investigator, baseline, treatment\*visit interaction, and baseline\*visit interaction. The change from baseline in SBP and DBP up to week 8 is the secondary analysis. The LS Mean Value was adjusted for treatment, investigator, and baseline.
Outcome measures
| Measure |
Duloxetine
n=250 Participants
Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week followed by 60 mg QD, po for 7 weeks.
|
Placebo
n=262 Participants
Participants received placebo QD, po for 8 weeks.
|
|---|---|---|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Up to Week 8
Change from Baseline in SBP at Week 8
|
1.38 mm Hg
Standard Error 0.80
|
-0.52 mm Hg
Standard Error 0.77
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Up to Week 8
Change from Baseline in DBP at Week 8
|
0.52 mm Hg
Standard Error 0.53
|
0.05 mm Hg
Standard Error 0.51
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Up to Week 8
Change from Baseline in SBP up to Week 8
|
1.41 mm Hg
Standard Error 0.74
|
-0.12 mm Hg
Standard Error 0.72
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Up to Week 8
Change from Baseline in DBP up to Week 8
|
0.31 mm Hg
Standard Error 0.49
|
0.01 mm Hg
Standard Error 0.48
|
SECONDARY outcome
Timeframe: Baseline, up to week 8Population: Primary analysis: All randomized participants with a baseline and at least 1 post-baseline result. Secondary analysis: All randomized participants with a baseline and at least 1 nonmissing post-baseline result, Last Observation Carried Forward (LOCF).
The change from baseline in weight at week 8 is the primary analysis. For the primary analysis of weight, the Least Squares (LS) Mean Value was adjusted for treatment, investigator, baseline, treatment\*visit interaction, and baseline\*visit interaction. The change from baseline in weight up to week 8 is the secondary analysis. The LS Mean Value was adjusted for treatment, investigator, and baseline.
Outcome measures
| Measure |
Duloxetine
n=251 Participants
Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week followed by 60 mg QD, po for 7 weeks.
|
Placebo
n=262 Participants
Participants received placebo QD, po for 8 weeks.
|
|---|---|---|
|
Change From Baseline in Weight up to Week 8
Change from Baseline in Weight at Week 8
|
-0.77 kilograms (kg)
Standard Error 0.15
|
0.19 kilograms (kg)
Standard Error 0.15
|
|
Change From Baseline in Weight up to Week 8
Change from Baseline in Weight up to Week 8
|
-0.74 kilograms (kg)
Standard Error 0.14
|
0.14 kilograms (kg)
Standard Error 0.13
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline through 8 weeksPopulation: All randomized participants with a normal baseline (respective to the specified direction) and at least 1 post-baseline result.
Laboratory assessment of ALT/SGPT during the double-blind treatment phase. Normal ALT/SGPT ranges for males are 6.00 units per liter (U/L) (low) to 43.00 U/L (high). Normal ALT/SGPT ranges for females are 6.00 U/L (low) to 34.00 U/L (high).
Outcome measures
| Measure |
Duloxetine
n=182 Participants
Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week followed by 60 mg QD, po for 7 weeks.
|
Placebo
n=193 Participants
Participants received placebo QD, po for 8 weeks.
|
|---|---|---|
|
Number of Participants With Abnormal Laboratory Values During the Double-blind Treatment Phase - High Alanine Amino Transferase/Serum Glutamate Pyruvate Transaminase (ALT/SGPT)
|
14 participants
|
5 participants
|
Adverse Events
Duloxetine
Placebo
Serious adverse events
| Measure |
Duloxetine
n=262 participants at risk
Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week followed by 60 mg QD, po for 7 weeks.
|
Placebo
n=266 participants at risk
Participants received placebo QD, po for 8 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Inguinal hernia
|
0.38%
1/262 • Number of events 1
|
0.00%
0/266
|
|
Infections and infestations
Clostridial infection
|
0.38%
1/262 • Number of events 1
|
0.00%
0/266
|
|
Infections and infestations
Diverticulitis
|
0.38%
1/262 • Number of events 1
|
0.00%
0/266
|
|
Infections and infestations
Respiratory tract infection
|
0.38%
1/262 • Number of events 1
|
0.00%
0/266
|
|
Injury, poisoning and procedural complications
Therapeutic agent toxicity
|
0.00%
0/262
|
0.38%
1/266 • Number of events 1
|
|
Nervous system disorders
Syncope
|
0.38%
1/262 • Number of events 1
|
0.00%
0/266
|
|
Psychiatric disorders
Suicide attempt
|
0.38%
1/262 • Number of events 1
|
0.00%
0/266
|
Other adverse events
| Measure |
Duloxetine
n=262 participants at risk
Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week followed by 60 mg QD, po for 7 weeks.
|
Placebo
n=266 participants at risk
Participants received placebo QD, po for 8 weeks.
|
|---|---|---|
|
Eye disorders
Vision blurred
|
2.7%
7/262 • Number of events 7
|
0.00%
0/266
|
|
Gastrointestinal disorders
Abdominal discomfort
|
2.7%
7/262 • Number of events 8
|
0.00%
0/266
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/262
|
2.3%
6/266 • Number of events 6
|
|
Gastrointestinal disorders
Constipation
|
6.5%
17/262 • Number of events 18
|
3.0%
8/266 • Number of events 8
|
|
Gastrointestinal disorders
Diarrhoea
|
5.7%
15/262 • Number of events 17
|
6.0%
16/266 • Number of events 16
|
|
Gastrointestinal disorders
Dry mouth
|
8.4%
22/262 • Number of events 24
|
5.3%
14/266 • Number of events 14
|
|
Gastrointestinal disorders
Dyspepsia
|
3.1%
8/262 • Number of events 8
|
0.75%
2/266 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
19.5%
51/262 • Number of events 55
|
9.0%
24/266 • Number of events 25
|
|
Gastrointestinal disorders
Vomiting
|
2.7%
7/262 • Number of events 7
|
0.00%
0/266
|
|
General disorders
Fatigue
|
4.2%
11/262 • Number of events 12
|
2.6%
7/266 • Number of events 7
|
|
General disorders
Irritability
|
0.76%
2/262 • Number of events 2
|
2.3%
6/266 • Number of events 6
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.0%
13/262 • Number of events 14
|
1.9%
5/266 • Number of events 5
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.38%
1/262 • Number of events 1
|
2.3%
6/266 • Number of events 6
|
|
Nervous system disorders
Dizziness
|
5.0%
13/262 • Number of events 13
|
3.8%
10/266 • Number of events 10
|
|
Nervous system disorders
Headache
|
11.5%
30/262 • Number of events 35
|
8.3%
22/266 • Number of events 28
|
|
Nervous system disorders
Somnolence
|
9.2%
24/262 • Number of events 25
|
3.0%
8/266 • Number of events 8
|
|
Psychiatric disorders
Anxiety
|
3.1%
8/262 • Number of events 8
|
1.9%
5/266 • Number of events 5
|
|
Psychiatric disorders
Insomnia
|
4.2%
11/262 • Number of events 11
|
3.4%
9/266 • Number of events 9
|
|
Respiratory, thoracic and mediastinal disorders
Yawning
|
3.4%
9/262 • Number of events 10
|
0.38%
1/266 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
5.3%
14/262 • Number of events 15
|
1.5%
4/266 • Number of events 4
|
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