Trial Outcomes & Findings for Study on the Tolerability of Duloxetine in Depressed Patients With Parkinson's Disease (NCT NCT00437125)
NCT ID: NCT00437125
Last Updated: 2010-09-08
Results Overview
The results reported are the number of participants who discontinued the study as a result of an adverse event (serious or other) or death.
COMPLETED
PHASE4
151 participants
baseline through 12 weeks
2010-09-08
Participant Flow
167 participants were screened and 16 participants were screen failures
Participant milestones
| Measure |
Duloxetine
Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
|
|---|---|
|
Overall Study
STARTED
|
151
|
|
Overall Study
COMPLETED
|
119
|
|
Overall Study
NOT COMPLETED
|
32
|
Reasons for withdrawal
| Measure |
Duloxetine
Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
|
|---|---|
|
Overall Study
Adverse Event
|
12
|
|
Overall Study
Death
|
1
|
|
Overall Study
Clinical Relapse
|
1
|
|
Overall Study
Lack of Efficacy
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Withdrawal by Subject
|
13
|
|
Overall Study
Withdrawal by Caregiver
|
2
|
|
Overall Study
Physician Decision
|
1
|
Baseline Characteristics
Study on the Tolerability of Duloxetine in Depressed Patients With Parkinson's Disease
Baseline characteristics by cohort
| Measure |
Duloxetine
n=151 Participants
Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
|
|---|---|
|
Age Continuous
|
63.6 years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
85 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
66 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
151 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
151 participants
n=5 Participants
|
|
Current alcohol consumption by participants
no
|
130 participants
n=5 Participants
|
|
Current alcohol consumption by participants
yes
|
21 participants
n=5 Participants
|
|
Current use of tobacco products by participants
no
|
140 participants
n=5 Participants
|
|
Current use of tobacco products by participants
yes
|
11 participants
n=5 Participants
|
|
Depression in a distant relative of the participant
no
|
120 participants
n=5 Participants
|
|
Depression in a distant relative of the participant
yes
|
1 participants
n=5 Participants
|
|
Depression in a distant relative of the participant
unknown
|
30 participants
n=5 Participants
|
|
Depression in a second degree relative of the participant
no
|
126 participants
n=5 Participants
|
|
Depression in a second degree relative of the participant
yes
|
25 participants
n=5 Participants
|
|
Depression in mother or father of participant
no
|
149 participants
n=5 Participants
|
|
Depression in mother or father of participant
yes
|
1 participants
n=5 Participants
|
|
Depression in mother or father of participant
unknown
|
1 participants
n=5 Participants
|
|
Depression in sibling or child of participant
no
|
150 participants
n=5 Participants
|
|
Depression in sibling or child of participant
yes
|
1 participants
n=5 Participants
|
|
Disease stage of the modified Hoen and Yahr staging scale
unilateral disease
|
23 participants
n=5 Participants
|
|
Disease stage of the modified Hoen and Yahr staging scale
unilateral plus axial involvement
|
16 participants
n=5 Participants
|
|
Disease stage of the modified Hoen and Yahr staging scale
bilateral disease, without impairment of balance
|
63 participants
n=5 Participants
|
|
Disease stage of the modified Hoen and Yahr staging scale
mild bilateral disease
|
40 participants
n=5 Participants
|
|
Disease stage of the modified Hoen and Yahr staging scale
mild to moderate bilateral disease
|
9 participants
n=5 Participants
|
|
Other Axis 1 disorder in distant relative of participant
no
|
119 participants
n=5 Participants
|
|
Other Axis 1 disorder in distant relative of participant
yes
|
32 participants
n=5 Participants
|
|
Other Axis 1 disorder in parents of participant
no
|
149 participants
n=5 Participants
|
|
Other Axis 1 disorder in parents of participant
yes
|
1 participants
n=5 Participants
|
|
Other Axis 1 disorder in parents of participant
unknown
|
1 participants
n=5 Participants
|
|
Other Axis 1 disorder in second degree relative of participant
no
|
127 participants
n=5 Participants
|
|
Other Axis 1 disorder in second degree relative of participant
yes
|
24 participants
n=5 Participants
|
|
Other Axis 1 disorder in sibling or child of participant
no
|
150 participants
n=5 Participants
|
|
Other Axis 1 disorder in sibling or child of participant
yes
|
1 participants
n=5 Participants
|
|
Presence of major depressive episode diagnosed with Mini International Neuropsychiatric Interview
no
|
2 participants
n=5 Participants
|
|
Presence of major depressive episode diagnosed with Mini International Neuropsychiatric Interview
yes
|
149 participants
n=5 Participants
|
|
Mini Mental State Examination (MMSE) Total Score
|
28.3 units on a scale
STANDARD_DEVIATION 1.8 • n=5 Participants
|
PRIMARY outcome
Timeframe: baseline through 12 weeksPopulation: All treated participants.
The results reported are the number of participants who discontinued the study as a result of an adverse event (serious or other) or death.
Outcome measures
| Measure |
Duloxetine
n=151 Participants
Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
|
|---|---|
|
Number of Participants Reporting Serious Adverse Events or Other Adverse Events Leading Either to Discontinuation or to Death
|
13 participants
|
SECONDARY outcome
Timeframe: baseline, 12 weeksPopulation: All treated participants were included in the analysis population. Last observation carried forward analysis. Two participants were excluded from calculation of change as they had no post-baseline measure.
Rating tool to follow the longitudinal course of Parkinson's Disease. It is composed of Section I: Mentation, Behavior, and Mood; Section II: Activities of Daily Living; Section III: Motor Examination; Section IV: Complications of therapy. These are evaluated by interview. Some sections require that multiple grades be assigned to each extremity. Only Sections II and III were rated in this study. A total of 160 points are possible (52 in Section II and 108 in Section III), where 0 represents no disability and 160 indicates maximal grade of disability.
Outcome measures
| Measure |
Duloxetine
n=151 Participants
Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
|
|---|---|
|
Change From Baseline to 12 Weeks on the Unified Parkinson's Disease Rating Scale (UPDRS) Total Score
baseline; n=151
|
32.0 units on a scale
Standard Deviation 12.6
|
|
Change From Baseline to 12 Weeks on the Unified Parkinson's Disease Rating Scale (UPDRS) Total Score
change; n=149
|
-0.3 units on a scale
Standard Deviation 6.1
|
SECONDARY outcome
Timeframe: baseline, 12 weeksPopulation: All treated participants were included in the analysis population. Last observation carried forward analysis. One participant was excluded as no data for UKU were available and other participants were excluded as relevant due to absence of either baseline or post-baseline measure.
Clinician-rated scale, providing side effect ratings of psychopharmacological medications. 48 items, each item is rated on a 4-point scale (0=not present; 1=mild; 2=moderate; 3=severe). The test is divided in 6 subscales, total scores for each subscale are calculated based on a weighted secondary scoring system. Subscales: psychic (score range:0-30), neurological (score range:0-24), autonomic (score range:0-33), other (score range:0-75), global assesment by subject (score range:0-3), and global assessment by doctor (score range:0-3). Higher ratings indicate greater impairment.
Outcome measures
| Measure |
Duloxetine
n=151 Participants
Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
|
|---|---|
|
Change From Baseline to 12 Weeks on the UKU (Udvalg for Kliniske Undersogelser: Committee for Clinical Investigations) Side Effect Rating Scale
Psychic subscale, baseline; n=136
|
6.8 units on a scale
Standard Deviation 4.6
|
|
Change From Baseline to 12 Weeks on the UKU (Udvalg for Kliniske Undersogelser: Committee for Clinical Investigations) Side Effect Rating Scale
Psychic subscale, change; n=114
|
-3.5 units on a scale
Standard Deviation 4.4
|
|
Change From Baseline to 12 Weeks on the UKU (Udvalg for Kliniske Undersogelser: Committee for Clinical Investigations) Side Effect Rating Scale
Global assessment by participant, change; n=129
|
0.1 units on a scale
Standard Deviation 0.7
|
|
Change From Baseline to 12 Weeks on the UKU (Udvalg for Kliniske Undersogelser: Committee for Clinical Investigations) Side Effect Rating Scale
Neurological subscale, baseline; n=132
|
4.2 units on a scale
Standard Deviation 2.8
|
|
Change From Baseline to 12 Weeks on the UKU (Udvalg for Kliniske Undersogelser: Committee for Clinical Investigations) Side Effect Rating Scale
Neurological subscale, change; n=112
|
-1.2 units on a scale
Standard Deviation 1.9
|
|
Change From Baseline to 12 Weeks on the UKU (Udvalg for Kliniske Undersogelser: Committee for Clinical Investigations) Side Effect Rating Scale
Autonomic subscale, baseline; n=132
|
1.9 units on a scale
Standard Deviation 2.2
|
|
Change From Baseline to 12 Weeks on the UKU (Udvalg for Kliniske Undersogelser: Committee for Clinical Investigations) Side Effect Rating Scale
Autonomic subscale, change; n=113
|
-0.6 units on a scale
Standard Deviation 1.9
|
|
Change From Baseline to 12 Weeks on the UKU (Udvalg for Kliniske Undersogelser: Committee for Clinical Investigations) Side Effect Rating Scale
Other subscale, baseline; n=49
|
0.9 units on a scale
Standard Deviation 2.3
|
|
Change From Baseline to 12 Weeks on the UKU (Udvalg for Kliniske Undersogelser: Committee for Clinical Investigations) Side Effect Rating Scale
Other subscale, baseline; n=35
|
0.2 units on a scale
Standard Deviation 2.3
|
|
Change From Baseline to 12 Weeks on the UKU (Udvalg for Kliniske Undersogelser: Committee for Clinical Investigations) Side Effect Rating Scale
Global assessment by participant, baseline; n=150
|
0.2 units on a scale
Standard Deviation 0.5
|
|
Change From Baseline to 12 Weeks on the UKU (Udvalg for Kliniske Undersogelser: Committee for Clinical Investigations) Side Effect Rating Scale
Global assessment by doctor, baseline; n=150
|
0.1 units on a scale
Standard Deviation 0.5
|
|
Change From Baseline to 12 Weeks on the UKU (Udvalg for Kliniske Undersogelser: Committee for Clinical Investigations) Side Effect Rating Scale
Global assessment by doctor, change; n=129
|
0.1 units on a scale
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: baseline, 4 weeks, 8 weeks, 12 weeksPopulation: All treated participants with baseline and post-baseline data for \>= 1 visit for \>= 1 efficacy variable were included in the analyses (Full Analysis Set population). Last observation carried forward analysis. Excluded 2 participants (no baseline measure of PSQI) and 13 participants from calculation of change (absence of any post-baseline measure).
Self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. 19 individual items generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The subject self-rates each of these seven areas of sleep. Scoring of answers is based on a 0 to 3 scale, whereby 3 reflects the negative extreme on the Likert Scale. The total score is the sum of the 7 component scores (total score range: 0-21).
Outcome measures
| Measure |
Duloxetine
n=149 Participants
Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
|
|---|---|
|
Change From Baseline on the Pittsburgh Sleep Quality Index (PSQI)
baseline, n=147
|
8.6 units on a scale
Standard Deviation 3.7
|
|
Change From Baseline on the Pittsburgh Sleep Quality Index (PSQI)
4 weeks change, n=134
|
-2.8 units on a scale
Standard Deviation 3.1
|
|
Change From Baseline on the Pittsburgh Sleep Quality Index (PSQI)
8 weeks change, n=134
|
-3.3 units on a scale
Standard Deviation 3.5
|
|
Change From Baseline on the Pittsburgh Sleep Quality Index (PSQI)
12 weeks change, n=134
|
-3.2 units on a scale
Standard Deviation 3.5
|
SECONDARY outcome
Timeframe: baseline, 12 weeksPopulation: All treated participants for whom both baseline data and post-baseline data for at least 1 visit for at least one efficacy variable were available (Full analysis set population) were included in the analyses. Last observation carried forward analysis.
The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).
Outcome measures
| Measure |
Duloxetine
n=149 Participants
Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
|
|---|---|
|
Change From Baseline to 12 Weeks on the 17-item Hamilton Depression Rating Scale (HAMD-17) Total Score
baseline
|
19.2 units on a scale
Standard Deviation 3.5
|
|
Change From Baseline to 12 Weeks on the 17-item Hamilton Depression Rating Scale (HAMD-17) Total Score
change
|
-10.1 units on a scale
Standard Deviation 6.5
|
SECONDARY outcome
Timeframe: baseline, 12 weeksPopulation: All treated participants for whom both baseline data and post-baseline data for at least 1 visit for at least one efficacy variable were available (Full analysis set population) were included in the analyses. Last observation carried forward analysis.
Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).
Outcome measures
| Measure |
Duloxetine
n=149 Participants
Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
|
|---|---|
|
Change From Baseline to 12 Weeks on the Clinical Global Impression-Severity Scale
baseline
|
4.0 units on a scale
Standard Deviation 0.7
|
|
Change From Baseline to 12 Weeks on the Clinical Global Impression-Severity Scale
change
|
-1.5 units on a scale
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: All treated participants for whom both baseline data and post-baseline data for at least 1 visit for at least one efficacy variable were available (Full analysis set population) were included in the analyses.
A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. Scoring: 1=very much better; 2=much better; 3=low better; 4=no change; 5=low worse; 6=much worse; 7=very much worse.
Outcome measures
| Measure |
Duloxetine
n=149 Participants
Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
|
|---|---|
|
Patient's Global Impression-Improvement at Week 12
score=1
|
5 participants
|
|
Patient's Global Impression-Improvement at Week 12
score=2
|
63 participants
|
|
Patient's Global Impression-Improvement at Week 12
score=3
|
38 participants
|
|
Patient's Global Impression-Improvement at Week 12
score=4
|
10 participants
|
|
Patient's Global Impression-Improvement at Week 12
score=5
|
3 participants
|
|
Patient's Global Impression-Improvement at Week 12
score=6
|
0 participants
|
|
Patient's Global Impression-Improvement at Week 12
score=7
|
0 participants
|
SECONDARY outcome
Timeframe: baseline, 12 weeksPopulation: All treated participants for whom both baseline data and post-baseline data for at least 1 visit for at least one efficacy variable were available (Full analysis set population) were included in the analyses. Last observation carried forward analysis. 27 participants had no post baseline measure.
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 four-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.
Outcome measures
| Measure |
Duloxetine
n=149 Participants
Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
|
|---|---|
|
Change From Baseline to 12 Weeks in Beck Depression Inventory (BDI) Total Score
baseline, n=149
|
21.6 units on a scale
Standard Deviation 6.1
|
|
Change From Baseline to 12 Weeks in Beck Depression Inventory (BDI) Total Score
change, n=122
|
-12.0 units on a scale
Standard Deviation 7.8
|
SECONDARY outcome
Timeframe: baseline, 12 weeksPopulation: All treated participants for whom both baseline data and post-baseline data for at least 1 visit for at least 1 efficacy variable were available (Full analysis set population) were included in the analyses. Last observation carried forward analysis. Excluded were 2 participants with only post-baseline data and 1 participant with only baseline data.
VAS for pain consists of 6 questions that assess overall pain, headache, back pain, shoulder pain, pain interference with daily activities, and pain while awake. Participant rates pain on a 100 millimeter (mm) line between two anchors (0= no pain and 100=very severe pain). Here, the line was only 93 mm long due to an error on the clinical research form and scores were adjusted to 0 to 93.
Outcome measures
| Measure |
Duloxetine
n=149 Participants
Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
|
|---|---|
|
Change From Baseline to 12 Weeks in Visual Analog Scale (VAS)
Shoulder pain, baseline; n=147
|
26.7 units on a scale
Standard Deviation 27.1
|
|
Change From Baseline to 12 Weeks in Visual Analog Scale (VAS)
Overall pain, baseline; n=147
|
30.5 units on a scale
Standard Deviation 24.1
|
|
Change From Baseline to 12 Weeks in Visual Analog Scale (VAS)
Overall pain, change; n=146
|
-5.1 units on a scale
Standard Deviation 20.1
|
|
Change From Baseline to 12 Weeks in Visual Analog Scale (VAS)
Headaches, baseline; n=147
|
15.9 units on a scale
Standard Deviation 20.3
|
|
Change From Baseline to 12 Weeks in Visual Analog Scale (VAS)
Headaches, change; n=146
|
-5.4 units on a scale
Standard Deviation 17.1
|
|
Change From Baseline to 12 Weeks in Visual Analog Scale (VAS)
Back ache, baseline; n=147
|
34.9 units on a scale
Standard Deviation 27.2
|
|
Change From Baseline to 12 Weeks in Visual Analog Scale (VAS)
Back ache, change; n=146
|
-10.2 units on a scale
Standard Deviation 20.8
|
|
Change From Baseline to 12 Weeks in Visual Analog Scale (VAS)
Shoulder pain, change; n=146
|
-10.3 units on a scale
Standard Deviation 22.1
|
|
Change From Baseline to 12 Weeks in Visual Analog Scale (VAS)
Interference, baseline; n=147
|
30.4 units on a scale
Standard Deviation 26.8
|
|
Change From Baseline to 12 Weeks in Visual Analog Scale (VAS)
Interference, change; n=146
|
-8.2 units on a scale
Standard Deviation 22.3
|
|
Change From Baseline to 12 Weeks in Visual Analog Scale (VAS)
Pain while awake, baseline; n=147
|
31.7 units on a scale
Standard Deviation 25.9
|
|
Change From Baseline to 12 Weeks in Visual Analog Scale (VAS)
Pain while awake, change; n=146
|
-9.9 units on a scale
Standard Deviation 21.8
|
SECONDARY outcome
Timeframe: baseline, 12 weeksPopulation: All treated participants with both baseline data and post-baseline data for at least 1 visit for at least 1 efficacy variable were available (Full analysis set population) were included in the analyses. Last observation carried forward analysis. Excluded were 2 participants with no baseline measure and 29 participants with no post baseline measure.
The PDQ-39 has 39 items. Higher scores reflect lower quality of life. The PDQ-39 has eight subscales: mobility (10 items), activities of daily living (six items), emotional wellbeing (six items), stigma (four items), social support (three items), cognition (four items), communication (three items), and bodily discomfort (three items). Items in each subscale, as well in the total scale, can be summarized into an index and transformed linearly to a 0-100 scale.
Outcome measures
| Measure |
Duloxetine
n=149 Participants
Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
|
|---|---|
|
Change From Baseline to 12 Weeks in Parkinson Disease Questionnaire - 39 Item Version (PDQ-39) Total Score
baseline; n=147
|
32.9 units on a scale
Standard Deviation 12.5
|
|
Change From Baseline to 12 Weeks in Parkinson Disease Questionnaire - 39 Item Version (PDQ-39) Total Score
change; n=118
|
-7.7 units on a scale
Standard Deviation 9.9
|
SECONDARY outcome
Timeframe: baseline through 12 weeksPopulation: All treated participants were included in the analysis population. 5 participants for standing measurement and 6 participants for supine measurements were excluded from calculation of change as they had either no baseline or no post-baseline measure.
For each participant, changes across individual visits were averaged to obtain 1 measurement per participant.
Outcome measures
| Measure |
Duloxetine
n=151 Participants
Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
|
|---|---|
|
Average Change From Baseline to 12 Weeks in Blood Pressure
systolic blood pressure, standing; n=146
|
-0.17 millimeter mercury
95% Confidence Interval 8.03 • Interval -1.49 to 1.14
|
|
Average Change From Baseline to 12 Weeks in Blood Pressure
diastolic blood pressure, standing; n=146
|
0.12 millimeter mercury
95% Confidence Interval 6.16 • Interval -0.89 to 1.13
|
|
Average Change From Baseline to 12 Weeks in Blood Pressure
systolic blood pressure, supine; n=145
|
-0.30 millimeter mercury
95% Confidence Interval 8.71 • Interval -1.73 to 1.13
|
|
Average Change From Baseline to 12 Weeks in Blood Pressure
diastolic blood pressure, supine; n=145
|
-0.45 millimeter mercury
95% Confidence Interval 6.29 • Interval -1.48 to 0.58
|
SECONDARY outcome
Timeframe: baseline through 12 weeksPopulation: All treated participants were included in the analysis population. 6 participants were excluded from calculation of change as they had either no baseline or post-baseline measure.
For each participant, changes across individual visits were averaged to obtain 1 measurement per participant.
Outcome measures
| Measure |
Duloxetine
n=151 Participants
Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
|
|---|---|
|
Average Change From Baseline to 12 Weeks in Heart Rate
standing, n=145
|
1.61 beats per minute
95% Confidence Interval 7.7 • Interval 0.71 to 2.51
|
|
Average Change From Baseline to 12 Weeks in Heart Rate
supine, n=145
|
1.16 beats per minute
95% Confidence Interval 7.9 • Interval 0.35 to 1.97
|
SECONDARY outcome
Timeframe: baseline through 12 weeksPopulation: All treated participants were included in the analysis population. 54 participants were excluded from calculation of change as they had abnormal ECG at baseline, no baseline measure, or no post-baseline measure.
Included were participants with normal ECG at baseline who developed abnormal ECGs during the study.
Outcome measures
| Measure |
Duloxetine
n=151 Participants
Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
|
|---|---|
|
Number of Participants With Abnormal Electrocardiograms (ECG) During the 12 Week Study
|
3 participants
|
SECONDARY outcome
Timeframe: baseline through 12 weeksPopulation: All enrolled participants for whom both baseline data and post-baseline data were available were included in the analyses.
Laboratory analytes were collected to assess adverse events which are listed in the reported adverse events section.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksPopulation: All treated participants for whom both baseline data and post-baseline data for at least 1 visit for at least one efficacy variable were available (Full analysis set population) were included in the analyses. Last observation carried forward analysis.
Response was defined as a \>= 50% reduction in 17-item Hamilton Depression rating scale (HAMD) scores. The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).
Outcome measures
| Measure |
Duloxetine
n=149 Participants
Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
|
|---|---|
|
Number of Participants Who Responded to Treatment by 12 Weeks
|
90 participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: All treated participants for whom both baseline data and post-baseline data for at least 1 visit for at least one efficacy variable were available (Full analysis set population) were included in the analyses. Last observation carried forward analysis.
Remission was defined as reaching a 17-item Hamilton Depression Rating Scale (HAMD) total score \<=7. The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).
Outcome measures
| Measure |
Duloxetine
n=149 Participants
Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
|
|---|---|
|
Number of Participants Who Reached Remission by 12 Weeks
|
68 participants
|
Adverse Events
Duloxetine
Serious adverse events
| Measure |
Duloxetine
n=151 participants at risk
Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
|
|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.66%
1/151 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
0.66%
1/151 • Number of events 1
|
|
Infections and infestations
Sepsis
|
0.66%
1/151 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.66%
1/151 • Number of events 1
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.66%
1/151 • Number of events 1
|
|
Renal and urinary disorders
Renal failure acute
|
0.66%
1/151 • Number of events 1
|
|
Renal and urinary disorders
Urinary retention
|
0.66%
1/151 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.66%
1/151 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.66%
1/151 • Number of events 1
|
Other adverse events
| Measure |
Duloxetine
n=151 participants at risk
Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
|
|---|---|
|
Ear and labyrinth disorders
Vertigo
|
1.3%
2/151 • Number of events 2
|
|
Gastrointestinal disorders
Aptyalism
|
2.0%
3/151 • Number of events 3
|
|
Gastrointestinal disorders
Constipation
|
3.3%
5/151 • Number of events 5
|
|
Gastrointestinal disorders
Diarrhoea
|
1.3%
2/151 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
4.0%
6/151 • Number of events 6
|
|
General disorders
Asthenia
|
2.0%
3/151 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
2.0%
3/151 • Number of events 3
|
|
Nervous system disorders
Headache
|
2.0%
3/151 • Number of events 3
|
|
Nervous system disorders
Somnolence
|
2.0%
3/151 • Number of events 3
|
|
Nervous system disorders
Tremor
|
1.3%
2/151 • Number of events 2
|
|
Psychiatric disorders
Agitation
|
1.3%
2/151 • Number of events 2
|
|
Psychiatric disorders
Anxiety
|
1.3%
2/151 • Number of events 2
|
|
Psychiatric disorders
Psychotic disorder
|
1.3%
2/151 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
1.3%
2/151 • Number of events 2
|
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