Depression
Conditions
Keywords
Severe Depressive Episode
Brief summary
The purpose of this study is to compare duloxetine with other antidepressants in the treatment of severe depression.
Interventions
DRUGduloxetine
30-120 milligrams (mgs) orally daily for 12 weeks
DRUGfluoxetine
20-80 mgs orally daily for 12 weeks
DRUGcitalopram
20-40 mgs orally daily for 12 weeks
DRUGparoxetine
20-50 mgs orally daily for 12 weeks
DRUGsertraline
50-200 mgs orally daily for 12 weeks
Sponsors
Boehringer Ingelheim
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* At least 18 years of age * Have major depression and are currently in a severe depressive episode * Have a degree of understanding such that patient can communicate with the investigator and study staff * All females must test negative for pregnancy * Females of childbearing potential must use reliable method of birth control during the study and for 1 month after taking the last dose of study drug
Exclusion criteria
* Have not responded to duloxetine for depression in the past * Have a history of bipolar disorder, a psychotic disorder (such as schizophrenia), a cognitive disorder (such as moderate or severe dementia), or obsessive-compulsive disorder (OCD) * Are at significant risk for suicide * Have not responded to 2 or more adequate trials of antidepressant medications during the current depressive episode * Have a serious, unstable medical condition * Have a current or recent history of substance abuse or dependence * Have had electroconvulsive therapy (ECT), transcranial magnetic stimulation (rTMS), or vagus nerve stimulation (VNS) in the past year * Have started psychotherapy within 6 weeks prior to study entry * Have a serious medical illness or clinically significant laboratory abnormality that is not stabilized or is anticipated, in the judgment of the investigator, to require hospitalization or use of an excluded medication during the course of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Probability of Remission [16-item Quick Inventory of Depressive Symptomatology (QIDS-SR) Score Less Than or Equal to 5 at 12-Week Endpoint] | 12 weeks | Visitwise probability of participants per treatment meeting remission criteria (QIDS-SR total score \[TS\]\</=5 at week 12 endpoint) were estimated using a pseudolikelihood-based mixed-models repeated measures analysis for a categorical outcome, model included fixed, categorical effects of treatment group (duloxetine vs. SSRIs), visit, treatment group-by-visit & continuous, fixed covariate of baseline QIDS-SR TS, and random effect of participant. Primary analysis contrasted remission probability at week 12 endpoint between treatment groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in HAMD-17 Retardation Subscale Score at 12-Week Endpoint (Mood Measure) | Baseline, 12 Weeks | The HAMD-17 Retardation subscale consists of Items 1, 7, 8, 14 and evaluates dysfunction in mood, work, and sexual activity, as well as overall motor retardation. Total subscale scores range from 0 (normal) to 14 (severe). |
| Change From Baseline in Systolic Blood Pressure at Week-12 Endpoint | Baseline, 12 Weeks | Mean change from baseline to endpoint in systolic blood pressure |
| Change From Baseline in Diastolic Blood Pressure at Week-12 Endpoint | Baseline, 12 Weeks | Mean change from baseline to endpoint in diastolic blood pressure |
| Change From Baseline in Pulse Rate at Week-12 Endpoint | Baseline, 12 Weeks | Mean change from baseline to endpoint in pulse rate |
| Change From Baseline in Weight at Week-12 Endpoint | Baseline, 12 Weeks | Mean change from baseline to endpoint in weight |
| Change From Baseline in QIDS-SR Total Score at 12-Week Endpoint (Mood Measure) | Baseline, 12 weeks | The QIDS-SR is a 16-item, participant-rated short form of the Inventory of Depressive Symptomatology that assesses 9 domains: sad mood, concentration, self-outlook, suicidal ideation, involvement, energy/fatigability, sleep disturbance, appetite/weight increase/decrease and psychomotor agitation/retardation. Scores range from 0 (none) to 27 (very severe). The QIDS-SR total score was used to derive the mean change from baseline to endpoint depression. |
| Probability of Remission [17-item Hamilton Depression Rating Scale (HAMD-17) (Mood Measure) Less Than or Equal to 7 at 12-Week Endpoint] | 12 weeks | Visitwise percentages of participants meeting remission criteria HAMD-17 total score \[TS\] \</=7 at week 12 endpoint) were estimated using a categorical, pseudolike-lihood-based repeated measures approach, & included fixed, categorical effects of treatment group (duloxetine vs. SSRIs), visit, treatment group-by-visit interaction, & continuous, fixed covariate of baseline HAMD-17 TS. Primary analysis will be contrast of remission rates at week 12 endpoint between treatment groups, & represents estimated remission rates for each treatment group had all participants completed 12 weeks of therapy. |
| Probability of Response [QIDS-SR Total Score (Mood Measure) Greater Than Or Equal To 50 Percent Reduction From Baseline To 12 Week Endpoint] | Baseline, 12-Weeks | Visitwise percentages of participants meeting response criteria (50% reduction from baseline QIDS-SR total score at 12-week endpoint) were estimated using a categorical, pseudolikelihood-based repeated measures approach, & included fixed, categorical effects of treatment group, visit, treatment group-by-visit interaction, & continuous, fixed covariate of baseline QIDS-SR. The primary analysis will be the contrast of response rates at week 12 endpoint between treatment groups, and represents estimated response rates for each treatment group had all participants completed 12 weeks of therapy. |
| Probability of Response [HAMD-17 Total Score (Mood Measure) Greater Than Or Equal To 50 Percent Reduction From Baseline To 12 Week Endpoint] | Baseline, 12-Weeks | Visitwise percentages of participants meeting response criteria 50% reduction from baseline in HAMD-17 total score at 12-Week endpoint) were estimated using a categorical, pseudolike-lihood-based repeated measures approach, & included fixed, categorical effects of treatment group, visit, treatment group-by-visit interaction, & continuous, fixed covariate of baseline HAMD-17 TS. Primary analysis will be the contrast of response rates at week 12 endpoint between treatment groups, & represents estimated response rates for each treatment group had all participants completed 12 weeks of therapy. |
| Change From Baseline in HAMD-17 Total Score at 12-Week Endpoint (Mood Measure) | Baseline, 12 Weeks | The HAMD-17 is a rater-administered assessment of depression severity and improvement, with total score ranges from 0 (not at all depressed) to 52 (most severely depressed). |
| Change From Baseline in HAMD-17 Anxiety/Somatization Subscale Score at 12-Week Endpoint (Mood Measure) | Baseline, 12 Weeks | HAMD-17 subscale consists of items 10, 11, 12, 13, 15, and 17 evaluates agitation, and severity of psychic and somatic manifestations of anxiety. Total subscale scores range from 0 (normal) to 18 (severe). Mean change from baseline to endpoint. |
| Change From Baseline in HAMD-17 Maier Subscale Score at 12-Week Endpoint (Mood Measure) | Baseline, 12 weeks | HAMD-17 Maier Subscale consists of Items 1, 2, 7, 8, 9, 10 and represents the core symptoms of depression. Total subscale scores range from 0 (normal) to 24 (severe). |
| Change From Baseline in HAMD-17 Bech Subscale Score at 12-Week Endpoint (Mood Measure) | Baseline, 12 Weeks | HAMD-17 Bech subscale consists of items 1, 2, 7, 8, 10, and 13 used to evaluate core symptoms of Major Depressive Disorder (MDD). Total subscale scores range from 0 (normal) to 22 (severe). |
| Change From Baseline in HAMD-17 Sleep Subscale Score at 12-Week Endpoint (Mood Measure) | Baseline, 12 Weeks | The HAMD-17 Sleep Subscale consists of Items 4, 5, 6 and evaluates initial, middle, and late insomnia. Total subscale scores range from 0 (no difficulty) to 6 (difficulty). |
| Change From Baseline in Brief Pain Inventory (BPI) Average 24-hour Pain Score, in Particpants With a Baseline BPI Average 24-hour Pain Score of 3 or Greater, at 12-Week Endpoint (Pain Measure) | Baseline, 12 Weeks | The BPI is a self-reported scale measuring pain severity and pain-specific interference on function on a scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine). The BPI average 24-hour pain measure was used to derive the overall mean change from baseline to endpoint, in those participants who had a BPI average 24-hour pain score of 3 or greater at baseline. |
| Change From Baseline in BPI Average 24 Hour Pain Score at 12-Week Endpoint (Pain Measure) | Baseline, 12 weeks | The BPI is a self-reported scale measuring pain severity and pain-specific interference on function, with scores ranging from 0 (does not interfere) to 10 (completely interferes). The BPI average 24-hour pain measure was used to derive the overall mean change from baseline to endpoint. |
| Change From Baseline in Sheehan Disability Scale (SDS) Global Functional Impairment Score at 12-Week Endpoint (Functional Outcome Measure) | Baseline, 12 weeks | The SDS is a participant-rated anchored visual analog scale to assess disability across the three domains of work/school, social life, and family life, with each item scored from 0 (not at all) to 10 (very severely), with a summarization of the 3 items to evaluate global functioning. The Global Functional Impairment Score is a total score score that ranges from 0 (unimpaired) to 30 (highly impaired), and was used to derived the mean change from baseline to endpoint. |
| Change From Baseline in SDS Work/School Item Score at 12-Week Endpoint (Functional Outcome Measure) | Baseline, 12 Weeks | The SDS is completed by the participant and Item 1 is used to assess the effect of the participant's symptoms on their work/school schedule. Scores range from 0 to 10 with higher values indicating greater disruption in the participant's work/school life. |
| Change From Baseline in Sheehan Disability Scale (SDS) Family/Home Item Score at Week-12 Endpoint (Functional Outcome Measure) | Baseline, 12 Weeks | The SDS is completed by the participant and Item 3 is used to assess the effect of the participant's symptoms on their family life/home responsibilities. Scores range from 0 to 10 with higher values indicating greater disruption in the participant's family life/home responsibilities. |
| Change From Baseline in SDS Social Item Score at 12-Week Endpoint (Functional Outcome Measure) | Baseline, 12 Weeks | The SDS is completed by the participant and is used to assess the effect of the participant's symptoms on their work/social/family life. Total scores range from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in World Health Organization Health and Work Performance Questionnaire, Clinical Trials 7-Day Version (HPQ), Absenteeism at 12-Week Endpoint | Baseline, 12 Weeks | Self-administered assessment used to determine a subject's work performance in terms of employment status, absenteeism if employed, productivity while at work, usual occupation, and annual income. Tool assesses the potential impact of change in depressive symptoms on work productivity and its associated employer costs. Defined on a 0-100 scale for the percentage of work days the respondent missed in the past 30 days. Absolute absenteeism: actual hours worked minus expected hours equals number of missed work days. Mean change baseline to endpoint is reported. |
| Change From Baseline in World Health Organization Health and Work Performance Questionnaire, Clinical Trials 7-Day Version (HPQ), Presenteeism Score, at Week-12 Endpoint | Baseline, 12 Weeks | Self-administered assessment used to determine a participant's work performance (employment status, absenteeism if employed, productivity while at work, usual occupation, & annual income). Tool assesses the potential impact of change in depressive symptoms on work productivity & its associated employer costs using a 0-100 scale in which 0 meant doing no work at all on days spent at work and 100 meant performing at the level of a top worker. Absolute presenteeism: difference between score for self and score for average worker in same job. Mean change baseline to endpoint is reported. |
| Change From Baseline in World Health Organization Health and Work Performance Questionnaire, Clinical Trials 7-Day Version (HPQ), Dollars of Income Lost Due to Work Presenteeism (WP)Score, at Week-12 Endpoint | Baseline, 12 Weeks | WP score was calculated by taking midpoint of annual before-tax income reported on HPQ. A multiplier of 1.25 produced estimated direct & indirect (i.e. benefits) income. Annual hours expected to work were calculated from expected daily work hours, multiplied by 236 days. Hourly, indirect income was total direct + indirect income, divided by # of expected annual work hours. Indirect hours lost annually for WP=hours expected to be worked annually times WP percent, times hourly rate=dollars earned, and then subtracted from total direct + indirect income=dollars lost annually due to WP. |
| Change From Baseline in World Health Organization Health and Work Performance Questionnaire, Clinical Trials 7-Day Version (HPQ), Dollars of Income Lost Due to Work Absenteeism Score at Week-12 Endpoint | Baseline, 12 weeks | Self-administered assessment used to determine a participant's work performance in terms of employment status, absenteeism if employed, productivity while at work, usual occupation, and annual income. Tool assesses the potential impact of change in depressive symptoms on work productivity and its associated employer costs. Scale ranges from 0 to 100% of work days in past 30 days. Absenteeism and presenteeism were combined into a measure of total lost work performance by adding absenteeism to the value (\[100-absenteeism\] × \[100-presenteeism\]). Mean change baseline to endpoint. |
Countries
United States
Participant flow
Recruitment details
The United States study started in May 2008 and completed in March 2009. A total of 72 sites participated (65 Psychiatric, 5 Family Practice, and 2 Internal Medicine specialties).
Participants by arm
| Arm | Count |
|---|---|
| Duloxetine 30-120 milligrams (mgs) orally daily for 12 weeks | 372 |
| Selective Serotonin Reuptake Inhibitor (SSRI) all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks | 378 |
| Total | 750 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 22 | 12 |
| Overall Study | Lack of Efficacy | 3 | 6 |
| Overall Study | Lost to Follow-up | 39 | 35 |
| Overall Study | Physician Decision | 0 | 2 |
| Overall Study | Protocol Violation | 23 | 24 |
| Overall Study | Sponsor decision | 0 | 1 |
| Overall Study | Withdrawal by Subject | 13 | 17 |
Baseline characteristics
| Characteristic | Total | Selective Serotonin Reuptake Inhibitor (SSRI) | Duloxetine |
|---|---|---|---|
| 17-Item Hamilton Depression Rating Scale (HAMD-17) Anxiety/Somatization Subscale Score | 7.43 units on a scale STANDARD_DEVIATION 2.23 | 7.42 units on a scale STANDARD_DEVIATION 2.25 | 7.45 units on a scale STANDARD_DEVIATION 2.22 |
| 17-Item Hamilton Depression Rating Scale (HAMD-17) Bech Subscale Score | 13.05 units on a scale STANDARD_DEVIATION 2.04 | 13.13 units on a scale STANDARD_DEVIATION 1.95 | 12.97 units on a scale STANDARD_DEVIATION 2.13 |
| 17-Item Hamilton Depression Rating Scale (HAMD-17) Maier Subscale Score | 12.47 units on a scale STANDARD_DEVIATION 2.27 | 12.48 units on a scale STANDARD_DEVIATION 2.22 | 12.47 units on a scale STANDARD_DEVIATION 2.33 |
| 17-Item Hamilton Depression Rating Scale (HAMD-17) Retardation Subscale | 8.45 units on a scale STANDARD_DEVIATION 1.55 | 8.53 units on a scale STANDARD_DEVIATION 1.54 | 8.36 units on a scale STANDARD_DEVIATION 1.55 |
| 17-Item Hamilton Depression Rating Scale (HAMD-17) Sleep Subscale Score | 4.75 units on a scale STANDARD_DEVIATION 1.34 | 4.77 units on a scale STANDARD_DEVIATION 1.33 | 4.73 units on a scale STANDARD_DEVIATION 1.35 |
| 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score | 25.03 units on a scale STANDARD_DEVIATION 4.34 | 25.03 units on a scale STANDARD_DEVIATION 4.24 | 25.03 units on a scale STANDARD_DEVIATION 4.44 |
| Age Continuous | 44.1 years STANDARD_DEVIATION 13.02 | 43.8 years STANDARD_DEVIATION 13.05 | 44.3 years STANDARD_DEVIATION 13.01 |
| Brief Pain Inventory (BPI) Average 24-Hour Pain Score | 2.81 units on a scale STANDARD_DEVIATION 2.77 | 2.98 units on a scale STANDARD_DEVIATION 2.79 | 2.64 units on a scale STANDARD_DEVIATION 2.74 |
| History, Age at First Episode | 30.97 years STANDARD_DEVIATION 14.34 | 30.42 years STANDARD_DEVIATION 14.3 | 31.53 years STANDARD_DEVIATION 14.39 |
| History, Met Diagnosis of Major Mood Disorder (MDD) | 750 participants | 378 participants | 372 participants |
| History, Number of Previous MDD Episodes | 5.91 episodes STANDARD_DEVIATION 13.37 | 5.09 episodes STANDARD_DEVIATION 11.08 | 6.74 episodes STANDARD_DEVIATION 15.32 |
| History, Time Since Most Recent MDD Episode | 11.84 months STANDARD_DEVIATION 25.57 | 11.92 months STANDARD_DEVIATION 30.69 | 11.76 months STANDARD_DEVIATION 19.06 |
| Quick Inventory of Depressive Symptomatology (QIDS-SR) Total Score | 21.67 units on a scale STANDARD_DEVIATION 1.701 | 21.70 units on a scale STANDARD_DEVIATION 1.7 | 21.64 units on a scale STANDARD_DEVIATION 1.71 |
| Race/Ethnicity, Customized African Descent | 144 participants | 68 participants | 76 participants |
| Race/Ethnicity, Customized Caucasian | 472 participants | 241 participants | 231 participants |
| Race/Ethnicity, Customized East/Southeast Asian | 9 participants | 7 participants | 2 participants |
| Race/Ethnicity, Customized Hispanic | 111 participants | 52 participants | 59 participants |
| Race/Ethnicity, Customized Missing | 1 participants | 1 participants | 0 participants |
| Race/Ethnicity, Customized Other | 10 participants | 7 participants | 3 participants |
| Race/Ethnicity, Customized Western Asian | 3 participants | 2 participants | 1 participants |
| Region of Enrollment United States | 750 participants | 378 participants | 372 participants |
| Sex: Female, Male Female | 496 Participants | 259 Participants | 237 Participants |
| Sex: Female, Male Male | 254 Participants | 119 Participants | 135 Participants |
| Sheehan Disability Scale (SDS) Global Functional Impairment Score | 22.71 units on a scale STANDARD_DEVIATION 5.79 | 22.72 units on a scale STANDARD_DEVIATION 6.05 | 22.70 units on a scale STANDARD_DEVIATION 5.52 |
| Sheehan Disability Scale (SDS) Item 1: Symptoms Disrupted Work/School | 7.05 units on a scale STANDARD_DEVIATION 2.42 | 7.09 units on a scale STANDARD_DEVIATION 2.45 | 7.00 units on a scale STANDARD_DEVIATION 2.4 |
| Sheehan Disability Scale (SDS) Item 2: Symptoms Disrupted Social Life/Leisure Activities | 7.82 units on a scale STANDARD_DEVIATION 2.05 | 7.82 units on a scale STANDARD_DEVIATION 2.13 | 7.81 units on a scale STANDARD_DEVIATION 1.97 |
| Sheehan Disability Scale (SDS) Item 3: Symptoms Disrupted Family Life/Home Responsibilities | 7.67 units on a scale STANDARD_DEVIATION 2.15 | 7.68 units on a scale STANDARD_DEVIATION 2.28 | 7.67 units on a scale STANDARD_DEVIATION 2.02 |
| Weight | 86.42 kilograms (kg) STANDARD_DEVIATION 23.18 | 86.23 kilograms (kg) STANDARD_DEVIATION 23.97 | 86.62 kilograms (kg) STANDARD_DEVIATION 22.37 |
| World Health Organization Health and Work Performance Questionnaire (HPQ), Absolute Absenteeism | 31.00 hours lost per week STANDARD_DEVIATION 66.48 | 33.29 hours lost per week STANDARD_DEVIATION 72.9 | 28.64 hours lost per week STANDARD_DEVIATION 59.28 |
| World Health Organization Health and Work Performance Questionnaire (HPQ), Absolute Presenteeism | 49.74 units on a scale STANDARD_DEVIATION 23.16 | 50.63 units on a scale STANDARD_DEVIATION 23.86 | 48.85 units on a scale STANDARD_DEVIATION 22.47 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 277 / 372 | 112 / 157 | 47 / 57 | 36 / 45 | 86 / 119 |
| serious Total, serious adverse events | 4 / 372 | 2 / 157 | 1 / 57 | 1 / 45 | 2 / 119 |
Outcome results
Primary
Probability of Remission [16-item Quick Inventory of Depressive Symptomatology (QIDS-SR) Score Less Than or Equal to 5 at 12-Week Endpoint]
Visitwise probability of participants per treatment meeting remission criteria (QIDS-SR total score \[TS\]\</=5 at week 12 endpoint) were estimated using a pseudolikelihood-based mixed-models repeated measures analysis for a categorical outcome, model included fixed, categorical effects of treatment group (duloxetine vs. SSRIs), visit, treatment group-by-visit & continuous, fixed covariate of baseline QIDS-SR TS, and random effect of participant. Primary analysis contrasted remission probability at week 12 endpoint between treatment groups.
Time frame: 12 weeks
Population: Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=366, SSRI N=371; and Week 12: Duloxetine N=273, SSRI N=284
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Probability of Remission [16-item Quick Inventory of Depressive Symptomatology (QIDS-SR) Score Less Than or Equal to 5 at 12-Week Endpoint] | 0.36 Probability of remission | Standard Error 0.03 |
| Selective Serotonin Reuptake Inhibitor (SSRI) | Probability of Remission [16-item Quick Inventory of Depressive Symptomatology (QIDS-SR) Score Less Than or Equal to 5 at 12-Week Endpoint] | 0.32 Probability of remission | Standard Error 0.03 |
Comparison: Categorical, pseudo-likelihood-based repeated measures approach (MMRM-CAT). The analysis will contrast the remission rates at 12 week endpoint between treatment groups.p-value: 0.26Mixed Models Analysis
Secondary
Change From Baseline in BPI Average 24 Hour Pain Score at 12-Week Endpoint (Pain Measure)
The BPI is a self-reported scale measuring pain severity and pain-specific interference on function, with scores ranging from 0 (does not interfere) to 10 (completely interferes). The BPI average 24-hour pain measure was used to derive the overall mean change from baseline to endpoint.
Time frame: Baseline, 12 weeks
Population: Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=346, SSRI N=348; and Week 12: Duloxetine N=249, SSRI N=257
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Change From Baseline in BPI Average 24 Hour Pain Score at 12-Week Endpoint (Pain Measure) | -1.83 units on a scale | Standard Error 0.15 |
| Selective Serotonin Reuptake Inhibitor (SSRI) | Change From Baseline in BPI Average 24 Hour Pain Score at 12-Week Endpoint (Pain Measure) | -1.43 units on a scale | Standard Error 0.15 |
Comparison: Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at 12-Week endpoint.p-value: 0.03Mixed Models Analysis
Secondary
Change From Baseline in Brief Pain Inventory (BPI) Average 24-hour Pain Score, in Particpants With a Baseline BPI Average 24-hour Pain Score of 3 or Greater, at 12-Week Endpoint (Pain Measure)
The BPI is a self-reported scale measuring pain severity and pain-specific interference on function on a scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine). The BPI average 24-hour pain measure was used to derive the overall mean change from baseline to endpoint, in those participants who had a BPI average 24-hour pain score of 3 or greater at baseline.
Time frame: Baseline, 12 Weeks
Population: Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=211, SSRI N=233; and Week 12: Duloxetine N=156, N=166
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Change From Baseline in Brief Pain Inventory (BPI) Average 24-hour Pain Score, in Particpants With a Baseline BPI Average 24-hour Pain Score of 3 or Greater, at 12-Week Endpoint (Pain Measure) | -2.95 units on a scale | Standard Error 0.21 |
| Selective Serotonin Reuptake Inhibitor (SSRI) | Change From Baseline in Brief Pain Inventory (BPI) Average 24-hour Pain Score, in Particpants With a Baseline BPI Average 24-hour Pain Score of 3 or Greater, at 12-Week Endpoint (Pain Measure) | -2.39 units on a scale | Standard Error 0.2 |
Comparison: Only those patients who had at least moderate pain at baseline (defined as baseline BPI Average 24-Hour Pain Score greater than or equal to 3). Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at 12-Week endpoint.p-value: 0.03Mixed Models Analysis
Secondary
Change From Baseline in Diastolic Blood Pressure at Week-12 Endpoint
Mean change from baseline to endpoint in diastolic blood pressure
Time frame: Baseline, 12 Weeks
Population: Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=367, SSRI N=371: and Week 12: Duloxetine N=274, SSRI N=285
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Change From Baseline in Diastolic Blood Pressure at Week-12 Endpoint | -0.14 mmHg | Standard Error 0.48 |
| Selective Serotonin Reuptake Inhibitor (SSRI) | Change From Baseline in Diastolic Blood Pressure at Week-12 Endpoint | 0.45 mmHg | Standard Error 0.46 |
Comparison: Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at endpoint.p-value: 0.32Mixed Models Analysis
Secondary
Change From Baseline in HAMD-17 Anxiety/Somatization Subscale Score at 12-Week Endpoint (Mood Measure)
HAMD-17 subscale consists of items 10, 11, 12, 13, 15, and 17 evaluates agitation, and severity of psychic and somatic manifestations of anxiety. Total subscale scores range from 0 (normal) to 18 (severe). Mean change from baseline to endpoint.
Time frame: Baseline, 12 Weeks
Population: Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=367, SSRI N=371; and Week 12: Duloxetine N=274, SSRI N=284
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Change From Baseline in HAMD-17 Anxiety/Somatization Subscale Score at 12-Week Endpoint (Mood Measure) | -4.89 units on a scale | Standard Error 0.16 |
| Selective Serotonin Reuptake Inhibitor (SSRI) | Change From Baseline in HAMD-17 Anxiety/Somatization Subscale Score at 12-Week Endpoint (Mood Measure) | -4.24 units on a scale | Standard Error 0.15 |
Comparison: Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at 12-Week endpoint.p-value: 0.001Mixed Models Analysis
Secondary
Change From Baseline in HAMD-17 Bech Subscale Score at 12-Week Endpoint (Mood Measure)
HAMD-17 Bech subscale consists of items 1, 2, 7, 8, 10, and 13 used to evaluate core symptoms of Major Depressive Disorder (MDD). Total subscale scores range from 0 (normal) to 22 (severe).
Time frame: Baseline, 12 Weeks
Population: Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=367, SSRI N=371; and Week 12: Duloxetine N=274; SSRI N=284
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Change From Baseline in HAMD-17 Bech Subscale Score at 12-Week Endpoint (Mood Measure) | -9.21 units on a scale | Standard Error 0.24 |
| Selective Serotonin Reuptake Inhibitor (SSRI) | Change From Baseline in HAMD-17 Bech Subscale Score at 12-Week Endpoint (Mood Measure) | -8.40 units on a scale | Standard Error 0.24 |
Comparison: Repeated Measures Analysis.Treatment comparisons will include the contrast between treatment groups at 12-Week endpoint.p-value: 0.01Mixed Models Analysis
Secondary
Change From Baseline in HAMD-17 Maier Subscale Score at 12-Week Endpoint (Mood Measure)
HAMD-17 Maier Subscale consists of Items 1, 2, 7, 8, 9, 10 and represents the core symptoms of depression. Total subscale scores range from 0 (normal) to 24 (severe).
Time frame: Baseline, 12 weeks
Population: Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=367, SSRI N=371; and Week 12: Duloxetine N=274, SSRI N=284
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Change From Baseline in HAMD-17 Maier Subscale Score at 12-Week Endpoint (Mood Measure) | -9.01 units on a scale | Standard Error 0.23 |
| Selective Serotonin Reuptake Inhibitor (SSRI) | Change From Baseline in HAMD-17 Maier Subscale Score at 12-Week Endpoint (Mood Measure) | -8.16 units on a scale | Standard Error 0.22 |
Comparison: Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at 12-Week endpoint.p-value: 0.003Mixed Models Analysis
Secondary
Change From Baseline in HAMD-17 Retardation Subscale Score at 12-Week Endpoint (Mood Measure)
The HAMD-17 Retardation subscale consists of Items 1, 7, 8, 14 and evaluates dysfunction in mood, work, and sexual activity, as well as overall motor retardation. Total subscale scores range from 0 (normal) to 14 (severe).
Time frame: Baseline, 12 Weeks
Population: Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=366, SSRI N=371; and Week 12: Duloxetine N=273, SSRI N=284
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Change From Baseline in HAMD-17 Retardation Subscale Score at 12-Week Endpoint (Mood Measure) | -5.99 units on a scale | Standard Error 0.16 |
| Selective Serotonin Reuptake Inhibitor (SSRI) | Change From Baseline in HAMD-17 Retardation Subscale Score at 12-Week Endpoint (Mood Measure) | -5.49 units on a scale | Standard Error 0.16 |
Comparison: Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at 12-Week endpoint.p-value: 0.02Mixed Models Analysis
Secondary
Change From Baseline in HAMD-17 Sleep Subscale Score at 12-Week Endpoint (Mood Measure)
The HAMD-17 Sleep Subscale consists of Items 4, 5, 6 and evaluates initial, middle, and late insomnia. Total subscale scores range from 0 (no difficulty) to 6 (difficulty).
Time frame: Baseline, 12 Weeks
Population: Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=367, SSRI N=371; and Week 12: Duloxetine N=274, SSRI N=285
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Change From Baseline in HAMD-17 Sleep Subscale Score at 12-Week Endpoint (Mood Measure) | -2.77 units on a scale | Standard Error 0.12 |
| Selective Serotonin Reuptake Inhibitor (SSRI) | Change From Baseline in HAMD-17 Sleep Subscale Score at 12-Week Endpoint (Mood Measure) | -2.58 units on a scale | Standard Error 0.12 |
Comparison: Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at 12-Week endpoint.p-value: 0.2Mixed Models Analysis
Secondary
Change From Baseline in HAMD-17 Total Score at 12-Week Endpoint (Mood Measure)
The HAMD-17 is a rater-administered assessment of depression severity and improvement, with total score ranges from 0 (not at all depressed) to 52 (most severely depressed).
Time frame: Baseline, 12 Weeks
Population: Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=365, SSRI N=371; and; and Week 12: Duloxetine N=272, SSRI N=283
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Change From Baseline in HAMD-17 Total Score at 12-Week Endpoint (Mood Measure) | -17.03 units on a scale | Standard Error 0.43 |
| Selective Serotonin Reuptake Inhibitor (SSRI) | Change From Baseline in HAMD-17 Total Score at 12-Week Endpoint (Mood Measure) | -15.3 units on a scale | Standard Error 0.42 |
Comparison: Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at 12-Week endpoint.p-value: 0.002Mixed Models Analysis
Secondary
Change From Baseline in Pulse Rate at Week-12 Endpoint
Mean change from baseline to endpoint in pulse rate
Time frame: Baseline, 12 Weeks
Population: Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=367, SSRI N=371; and Week 12: Duloxetine N=274, SSRI N=285
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Change From Baseline in Pulse Rate at Week-12 Endpoint | 2.74 beats per minute (bpm) | Standard Error 0.58 |
| Selective Serotonin Reuptake Inhibitor (SSRI) | Change From Baseline in Pulse Rate at Week-12 Endpoint | 0.47 beats per minute (bpm) | Standard Error 0.57 |
Comparison: Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at endpoint.p-value: 0.002Mixed Models Analysis
Secondary
Change From Baseline in QIDS-SR Total Score at 12-Week Endpoint (Mood Measure)
The QIDS-SR is a 16-item, participant-rated short form of the Inventory of Depressive Symptomatology that assesses 9 domains: sad mood, concentration, self-outlook, suicidal ideation, involvement, energy/fatigability, sleep disturbance, appetite/weight increase/decrease and psychomotor agitation/retardation. Scores range from 0 (none) to 27 (very severe). The QIDS-SR total score was used to derive the mean change from baseline to endpoint depression.
Time frame: Baseline, 12 weeks
Population: Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=366, SSRI N=371; and Week 12: Duloxetine N=273, SSRI N=284
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Change From Baseline in QIDS-SR Total Score at 12-Week Endpoint (Mood Measure) | -13.4 units on a scale | Standard Error 0.36 |
| Selective Serotonin Reuptake Inhibitor (SSRI) | Change From Baseline in QIDS-SR Total Score at 12-Week Endpoint (Mood Measure) | -12.6 units on a scale | Standard Error 0.35 |
Comparison: Repeated Measures Analysis.Treatment comparisons will include the contrast between treatment groups at 12-week endpoint.p-value: 0.07Mixed Models Analysis
Secondary
Change From Baseline in SDS Social Item Score at 12-Week Endpoint (Functional Outcome Measure)
The SDS is completed by the participant and is used to assess the effect of the participant's symptoms on their work/social/family life. Total scores range from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life.
Time frame: Baseline, 12 Weeks
Population: Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=362, SSRI N=370; and Week 12: Duloxetine N=270, SSRI N=283
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Change From Baseline in SDS Social Item Score at 12-Week Endpoint (Functional Outcome Measure) | -4.69 units on a scale | Standard Error 0.18 |
| Selective Serotonin Reuptake Inhibitor (SSRI) | Change From Baseline in SDS Social Item Score at 12-Week Endpoint (Functional Outcome Measure) | -4.04 units on a scale | Standard Error 0.18 |
Comparison: Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at endpoint.p-value: 0.01Mixed Models Analysis
Secondary
Change From Baseline in SDS Work/School Item Score at 12-Week Endpoint (Functional Outcome Measure)
The SDS is completed by the participant and Item 1 is used to assess the effect of the participant's symptoms on their work/school schedule. Scores range from 0 to 10 with higher values indicating greater disruption in the participant's work/school life.
Time frame: Baseline, 12 Weeks
Population: Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=260,SSRI N=267; and Week 12: Duloxetine N=182, SSRI N=192
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Change From Baseline in SDS Work/School Item Score at 12-Week Endpoint (Functional Outcome Measure) | -4.52 units on a scale | Standard Error 0.22 |
| Selective Serotonin Reuptake Inhibitor (SSRI) | Change From Baseline in SDS Work/School Item Score at 12-Week Endpoint (Functional Outcome Measure) | -3.85 units on a scale | Standard Error 0.21 |
Comparison: Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at endpoint.p-value: 0.01Mixed Models Analysis
Secondary
Change From Baseline in Sheehan Disability Scale (SDS) Family/Home Item Score at Week-12 Endpoint (Functional Outcome Measure)
The SDS is completed by the participant and Item 3 is used to assess the effect of the participant's symptoms on their family life/home responsibilities. Scores range from 0 to 10 with higher values indicating greater disruption in the participant's family life/home responsibilities.
Time frame: Baseline, 12 Weeks
Population: Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=363, SSRI N=370; and Week 12: Duloxetine N=271, SSRI N=283
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Change From Baseline in Sheehan Disability Scale (SDS) Family/Home Item Score at Week-12 Endpoint (Functional Outcome Measure) | -4.51 units on a scale | Standard Error 0.19 |
| Selective Serotonin Reuptake Inhibitor (SSRI) | Change From Baseline in Sheehan Disability Scale (SDS) Family/Home Item Score at Week-12 Endpoint (Functional Outcome Measure) | -3.94 units on a scale | Standard Error 0.18 |
Comparison: Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at endpoint.p-value: 0.02Mixed Models Analysis
Secondary
Change From Baseline in Sheehan Disability Scale (SDS) Global Functional Impairment Score at 12-Week Endpoint (Functional Outcome Measure)
The SDS is a participant-rated anchored visual analog scale to assess disability across the three domains of work/school, social life, and family life, with each item scored from 0 (not at all) to 10 (very severely), with a summarization of the 3 items to evaluate global functioning. The Global Functional Impairment Score is a total score score that ranges from 0 (unimpaired) to 30 (highly impaired), and was used to derived the mean change from baseline to endpoint.
Time frame: Baseline, 12 weeks
Population: Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=362, SSRI N=370; and Week 12: Duloxetine N=270, SSRI N=283
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Change From Baseline in Sheehan Disability Scale (SDS) Global Functional Impairment Score at 12-Week Endpoint (Functional Outcome Measure) | -13.56 units on a scale | Standard Error 0.53 |
| Selective Serotonin Reuptake Inhibitor (SSRI) | Change From Baseline in Sheehan Disability Scale (SDS) Global Functional Impairment Score at 12-Week Endpoint (Functional Outcome Measure) | -11.53 units on a scale | Standard Error 0.52 |
Comparison: Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at 12-Week endpoint.p-value: 0.002Mixed Models Analysis
Secondary
Change From Baseline in Systolic Blood Pressure at Week-12 Endpoint
Mean change from baseline to endpoint in systolic blood pressure
Time frame: Baseline, 12 Weeks
Population: Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=367, SSRI N=371; and Week 12: Duloxetine N=274, SSRI N=285
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Change From Baseline in Systolic Blood Pressure at Week-12 Endpoint | 0.58 millimeters of mmercury (mmHg) | Standard Error 0.69 |
| Selective Serotonin Reuptake Inhibitor (SSRI) | Change From Baseline in Systolic Blood Pressure at Week-12 Endpoint | 0.55 millimeters of mmercury (mmHg) | Standard Error 0.68 |
Comparison: Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at endpoint.p-value: 0.97Mixed Models Analysis
Secondary
Change From Baseline in Weight at Week-12 Endpoint
Mean change from baseline to endpoint in weight
Time frame: Baseline, 12 Weeks
Population: Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=366, SSRI N=370; and Week 12: Duloxetine N=273, SSRI N=284
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Change From Baseline in Weight at Week-12 Endpoint | -0.32 kilograms (kg) | Standard Error 0.18 |
| Selective Serotonin Reuptake Inhibitor (SSRI) | Change From Baseline in Weight at Week-12 Endpoint | -0.17 kilograms (kg) | Standard Error 0.18 |
Comparison: Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at endpoint.p-value: 0.53Mixed Models Analysis
Secondary
Probability of Remission [17-item Hamilton Depression Rating Scale (HAMD-17) (Mood Measure) Less Than or Equal to 7 at 12-Week Endpoint]
Visitwise percentages of participants meeting remission criteria HAMD-17 total score \[TS\] \</=7 at week 12 endpoint) were estimated using a categorical, pseudolike-lihood-based repeated measures approach, & included fixed, categorical effects of treatment group (duloxetine vs. SSRIs), visit, treatment group-by-visit interaction, & continuous, fixed covariate of baseline HAMD-17 TS. Primary analysis will be contrast of remission rates at week 12 endpoint between treatment groups, & represents estimated remission rates for each treatment group had all participants completed 12 weeks of therapy.
Time frame: 12 weeks
Population: Intent to treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=365, SSRI N=371 and Week 12: Duloxetine N=272, SSRI N=283
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Probability of Remission [17-item Hamilton Depression Rating Scale (HAMD-17) (Mood Measure) Less Than or Equal to 7 at 12-Week Endpoint] | 0.53 Probability of remission | Standard Error 0.03 |
| Selective Serotonin Reuptake Inhibitor (SSRI) | Probability of Remission [17-item Hamilton Depression Rating Scale (HAMD-17) (Mood Measure) Less Than or Equal to 7 at 12-Week Endpoint] | 0.44 Probability of remission | Standard Error 0.03 |
Comparison: Categorical, pseudo-likelihood-based repeated measures approach (MMRM-CAT). Repeated Measures Analysis. The analysis will contrast the remission remission rates at 12-week endpoint.p-value: 0.03Mixed Models Analysis
Secondary
Probability of Response [HAMD-17 Total Score (Mood Measure) Greater Than Or Equal To 50 Percent Reduction From Baseline To 12 Week Endpoint]
Visitwise percentages of participants meeting response criteria 50% reduction from baseline in HAMD-17 total score at 12-Week endpoint) were estimated using a categorical, pseudolike-lihood-based repeated measures approach, & included fixed, categorical effects of treatment group, visit, treatment group-by-visit interaction, & continuous, fixed covariate of baseline HAMD-17 TS. Primary analysis will be the contrast of response rates at week 12 endpoint between treatment groups, & represents estimated response rates for each treatment group had all participants completed 12 weeks of therapy.
Time frame: Baseline, 12-Weeks
Population: Intent to treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=365, SSRI N=371; and Week 12: Duloxetine N=272, SSRI N=283
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Probability of Response [HAMD-17 Total Score (Mood Measure) Greater Than Or Equal To 50 Percent Reduction From Baseline To 12 Week Endpoint] | 0.73 Probability of response | Standard Error 0.03 |
| Selective Serotonin Reuptake Inhibitor (SSRI) | Probability of Response [HAMD-17 Total Score (Mood Measure) Greater Than Or Equal To 50 Percent Reduction From Baseline To 12 Week Endpoint] | 0.61 Probability of response | Standard Error 0.03 |
Comparison: Categorical, pseudo-likelihood-based repeated measures approach (MMRM-CAT). The analysis will contrast the response rates at 12-week endpoint.p-value: 0.001Mixed Models Analysis
Secondary
Probability of Response [QIDS-SR Total Score (Mood Measure) Greater Than Or Equal To 50 Percent Reduction From Baseline To 12 Week Endpoint]
Visitwise percentages of participants meeting response criteria (50% reduction from baseline QIDS-SR total score at 12-week endpoint) were estimated using a categorical, pseudolikelihood-based repeated measures approach, & included fixed, categorical effects of treatment group, visit, treatment group-by-visit interaction, & continuous, fixed covariate of baseline QIDS-SR. The primary analysis will be the contrast of response rates at week 12 endpoint between treatment groups, and represents estimated response rates for each treatment group had all participants completed 12 weeks of therapy.
Time frame: Baseline, 12-Weeks
Population: Intent to treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=366, SSRI N=371; and Week 12: Duloxetine N=273, SSRI N=284
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Probability of Response [QIDS-SR Total Score (Mood Measure) Greater Than Or Equal To 50 Percent Reduction From Baseline To 12 Week Endpoint] | 0.71 Probability of response | Standard Error 0.03 |
| Selective Serotonin Reuptake Inhibitor (SSRI) | Probability of Response [QIDS-SR Total Score (Mood Measure) Greater Than Or Equal To 50 Percent Reduction From Baseline To 12 Week Endpoint] | 0.64 Probability of response | Standard Error 0.03 |
Comparison: Categorical, pseudo-likelihood-based repeated measures approach (MMRM-CAT). The analysis will contrast the response rates at 12-week endpoint.p-value: 0.09Mixed Models Analysis
Other Pre-specified
Change From Baseline in World Health Organization Health and Work Performance Questionnaire, Clinical Trials 7-Day Version (HPQ), Absenteeism at 12-Week Endpoint
Self-administered assessment used to determine a subject's work performance in terms of employment status, absenteeism if employed, productivity while at work, usual occupation, and annual income. Tool assesses the potential impact of change in depressive symptoms on work productivity and its associated employer costs. Defined on a 0-100 scale for the percentage of work days the respondent missed in the past 30 days. Absolute absenteeism: actual hours worked minus expected hours equals number of missed work days. Mean change baseline to endpoint is reported.
Time frame: Baseline, 12 Weeks
Population: Intent to Treat. Last Observation Carried Forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Change From Baseline in World Health Organization Health and Work Performance Questionnaire, Clinical Trials 7-Day Version (HPQ), Absenteeism at 12-Week Endpoint | -9.56 hours lost per week | Standard Error 5.14 |
| Selective Serotonin Reuptake Inhibitor (SSRI) | Change From Baseline in World Health Organization Health and Work Performance Questionnaire, Clinical Trials 7-Day Version (HPQ), Absenteeism at 12-Week Endpoint | 0.41 hours lost per week | Standard Error 5.05 |
Comparison: Transformed absolute scorep-value: 0.12ANCOVA
Other Pre-specified
Change From Baseline in World Health Organization Health and Work Performance Questionnaire, Clinical Trials 7-Day Version (HPQ), Dollars of Income Lost Due to Work Absenteeism Score at Week-12 Endpoint
Self-administered assessment used to determine a participant's work performance in terms of employment status, absenteeism if employed, productivity while at work, usual occupation, and annual income. Tool assesses the potential impact of change in depressive symptoms on work productivity and its associated employer costs. Scale ranges from 0 to 100% of work days in past 30 days. Absenteeism and presenteeism were combined into a measure of total lost work performance by adding absenteeism to the value (\[100-absenteeism\] × \[100-presenteeism\]). Mean change baseline to endpoint.
Time frame: Baseline, 12 weeks
Population: Intent to Treat. Last Observation Carried Forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Change From Baseline in World Health Organization Health and Work Performance Questionnaire, Clinical Trials 7-Day Version (HPQ), Dollars of Income Lost Due to Work Absenteeism Score at Week-12 Endpoint | -3978.98 dollars | Standard Error 1708.92 |
| Selective Serotonin Reuptake Inhibitor (SSRI) | Change From Baseline in World Health Organization Health and Work Performance Questionnaire, Clinical Trials 7-Day Version (HPQ), Dollars of Income Lost Due to Work Absenteeism Score at Week-12 Endpoint | -1932.46 dollars | Standard Error 1689.85 |
p-value: 0.34ANCOVA
Other Pre-specified
Change From Baseline in World Health Organization Health and Work Performance Questionnaire, Clinical Trials 7-Day Version (HPQ), Dollars of Income Lost Due to Work Presenteeism (WP)Score, at Week-12 Endpoint
WP score was calculated by taking midpoint of annual before-tax income reported on HPQ. A multiplier of 1.25 produced estimated direct & indirect (i.e. benefits) income. Annual hours expected to work were calculated from expected daily work hours, multiplied by 236 days. Hourly, indirect income was total direct + indirect income, divided by # of expected annual work hours. Indirect hours lost annually for WP=hours expected to be worked annually times WP percent, times hourly rate=dollars earned, and then subtracted from total direct + indirect income=dollars lost annually due to WP.
Time frame: Baseline, 12 Weeks
Population: Intent to Treat. Last Observation Carried Forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Change From Baseline in World Health Organization Health and Work Performance Questionnaire, Clinical Trials 7-Day Version (HPQ), Dollars of Income Lost Due to Work Presenteeism (WP)Score, at Week-12 Endpoint | 7250.93 dollars | Standard Error 954.77 |
| Selective Serotonin Reuptake Inhibitor (SSRI) | Change From Baseline in World Health Organization Health and Work Performance Questionnaire, Clinical Trials 7-Day Version (HPQ), Dollars of Income Lost Due to Work Presenteeism (WP)Score, at Week-12 Endpoint | 5074.09 dollars | Standard Error 957.77 |
p-value: 0.07ANCOVA
Other Pre-specified
Change From Baseline in World Health Organization Health and Work Performance Questionnaire, Clinical Trials 7-Day Version (HPQ), Presenteeism Score, at Week-12 Endpoint
Self-administered assessment used to determine a participant's work performance (employment status, absenteeism if employed, productivity while at work, usual occupation, & annual income). Tool assesses the potential impact of change in depressive symptoms on work productivity & its associated employer costs using a 0-100 scale in which 0 meant doing no work at all on days spent at work and 100 meant performing at the level of a top worker. Absolute presenteeism: difference between score for self and score for average worker in same job. Mean change baseline to endpoint is reported.
Time frame: Baseline, 12 Weeks
Population: Intent to Treat. Last Observation Carried Forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Change From Baseline in World Health Organization Health and Work Performance Questionnaire, Clinical Trials 7-Day Version (HPQ), Presenteeism Score, at Week-12 Endpoint | 24.56 units on a scale | Standard Error 2.14 |
| Selective Serotonin Reuptake Inhibitor (SSRI) | Change From Baseline in World Health Organization Health and Work Performance Questionnaire, Clinical Trials 7-Day Version (HPQ), Presenteeism Score, at Week-12 Endpoint | 20.73 units on a scale | Standard Error 2.11 |
Comparison: Transformed Absolute Scorep-value: 0.16ANCOVA