A Phase 4 interventional study of duloxetine and fluoxetine in Depression, sponsored by Eli Lilly and Company. Completed at 61 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-06-15.
Sponsored by Eli Lilly and Company · Phase 4, Interventional, and Treatment
The purpose of this study is to compare duloxetine with other antidepressants in the treatment of severe depression.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 750 is above the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.
Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
study drug
Drug: duloxetine
Drug: citalopram
Drug: fluoxetine
Drug: paroxetine
Drug: sertraline
30-120 milligrams (mgs) orally daily for 12 weeks
Also known as: LY248686, Cymbalta
20-80 mgs orally daily for 12 weeks
20-40 mgs orally daily for 12 weeks
20-50 mgs orally daily for 12 weeks
50-200 mgs orally daily for 12 weeks
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Change From Baseline in Pulse Rate at Week-12 Endpoint
Mean change from baseline to endpoint in pulse rate
Time frame: Baseline, 12 Weeks
Change From Baseline in Weight at Week-12 Endpoint
Mean change from baseline to endpoint in weight
Time frame: Baseline, 12 Weeks
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
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
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
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
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).
| Milestone | Duloxetine | Selective Serotonin Reuptake Inhibitor (SSRI) |
|---|---|---|
| Started | 372 | 378 |
| Completed | 272 | 281 |
| Not completed | 100 | 97 |
| Withdrew: Lost to follow-up | 39 | 35 |
| Withdrew: Protocol violation | 23 | 24 |
| Withdrew: Adverse event | 22 | 12 |
| Withdrew: Withdrawal by subject | 13 | 17 |
| Withdrew: Lack of efficacy | 3 | 6 |
| Withdrew: Physician decision | 0 | 2 |
| Withdrew: Sponsor decision | 0 | 1 |
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.
| Probability of remission | Duloxetine | 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] | 0.36 ± 0.03 | 0.32 ± 0.03 |
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.
| units on a scale | Duloxetine | Selective Serotonin Reuptake Inhibitor (SSRI) |
|---|---|---|
| Change From Baseline in QIDS-SR Total Score at 12-Week Endpoint (Mood Measure) | -13.4 ± 0.36 | -12.6 ± 0.35 |
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 remission | Duloxetine | 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] | 0.53 ± 0.03 | 0.44 ± 0.03 |
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 | Duloxetine | 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] | 0.71 ± 0.03 | 0.64 ± 0.03 |
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.
| Probability of response | Duloxetine | 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] | 0.73 ± 0.03 | 0.61 ± 0.03 |
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).
| units on a scale | Duloxetine | Selective Serotonin Reuptake Inhibitor (SSRI) |
|---|---|---|
| Change From Baseline in HAMD-17 Total Score at 12-Week Endpoint (Mood Measure) | -17.03 ± 0.43 | -15.3 ± 0.42 |
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.
| units on a scale | Duloxetine | Selective Serotonin Reuptake Inhibitor (SSRI) |
|---|---|---|
| Change From Baseline in HAMD-17 Anxiety/Somatization Subscale Score at 12-Week Endpoint (Mood Measure) | -4.89 ± 0.16 | -4.24 ± 0.15 |
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).
| units on a scale | Duloxetine | Selective Serotonin Reuptake Inhibitor (SSRI) |
|---|---|---|
| Change From Baseline in HAMD-17 Maier Subscale Score at 12-Week Endpoint (Mood Measure) | -9.01 ± 0.23 | -8.16 ± 0.22 |
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).
| units on a scale | Duloxetine | Selective Serotonin Reuptake Inhibitor (SSRI) |
|---|---|---|
| Change From Baseline in HAMD-17 Bech Subscale Score at 12-Week Endpoint (Mood Measure) | -9.21 ± 0.24 | -8.40 ± 0.24 |
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).
| units on a scale | Duloxetine | Selective Serotonin Reuptake Inhibitor (SSRI) |
|---|---|---|
| Change From Baseline in HAMD-17 Retardation Subscale Score at 12-Week Endpoint (Mood Measure) | -5.99 ± 0.16 | -5.49 ± 0.16 |
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).
| units on a scale | Duloxetine | Selective Serotonin Reuptake Inhibitor (SSRI) |
|---|---|---|
| Change From Baseline in HAMD-17 Sleep Subscale Score at 12-Week Endpoint (Mood Measure) | -2.77 ± 0.12 | -2.58 ± 0.12 |
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.
| units on a scale | Duloxetine | 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) | -2.95 ± 0.21 | -2.39 ± 0.20 |
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.
| units on a scale | Duloxetine | Selective Serotonin Reuptake Inhibitor (SSRI) |
|---|---|---|
| Change From Baseline in BPI Average 24 Hour Pain Score at 12-Week Endpoint (Pain Measure) | -1.83 ± 0.15 | -1.43 ± 0.15 |
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.
| units on a scale | Duloxetine | Selective Serotonin Reuptake Inhibitor (SSRI) |
|---|---|---|
| Change From Baseline in Sheehan Disability Scale (SDS) Global Functional Impairment Score at 12-Week Endpoint (Functional Outcome Measure) | -13.56 ± 0.53 | -11.53 ± 0.52 |
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.
| units on a scale | Duloxetine | Selective Serotonin Reuptake Inhibitor (SSRI) |
|---|---|---|
| Change From Baseline in SDS Work/School Item Score at 12-Week Endpoint (Functional Outcome Measure) | -4.52 ± 0.22 | -3.85 ± 0.21 |
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.
| dollars | Duloxetine | 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 | 7250.93 ± 954.77 | 5074.09 ± 957.77 |
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.
| dollars | Duloxetine | 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 | -3978.98 ± 1708.92 | -1932.46 ± 1689.85 |
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.
| units on a scale | Duloxetine | Selective Serotonin Reuptake Inhibitor (SSRI) |
|---|---|---|
| Change From Baseline in Sheehan Disability Scale (SDS) Family/Home Item Score at Week-12 Endpoint (Functional Outcome Measure) | -4.51 ± 0.19 | -3.94 ± 0.18 |
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.
| units on a scale | Duloxetine | Selective Serotonin Reuptake Inhibitor (SSRI) |
|---|---|---|
| Change From Baseline in SDS Social Item Score at 12-Week Endpoint (Functional Outcome Measure) | -4.69 ± 0.18 | -4.04 ± 0.18 |
Mean change from baseline to endpoint in systolic blood pressure
| millimeters of mmercury (mmHg) | Duloxetine | Selective Serotonin Reuptake Inhibitor (SSRI) |
|---|---|---|
| Change From Baseline in Systolic Blood Pressure at Week-12 Endpoint | 0.58 ± 0.69 | 0.55 ± 0.68 |
Mean change from baseline to endpoint in diastolic blood pressure
| mmHg | Duloxetine | Selective Serotonin Reuptake Inhibitor (SSRI) |
|---|---|---|
| Change From Baseline in Diastolic Blood Pressure at Week-12 Endpoint | -0.14 ± 0.48 | 0.45 ± 0.46 |
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.
| hours lost per week | Duloxetine | 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 | -9.56 ± 5.14 | 0.41 ± 5.05 |
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.
| units on a scale | Duloxetine | 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 | 24.56 ± 2.14 | 20.73 ± 2.11 |
Mean change from baseline to endpoint in pulse rate
| beats per minute (bpm) | Duloxetine | Selective Serotonin Reuptake Inhibitor (SSRI) |
|---|---|---|
| Change From Baseline in Pulse Rate at Week-12 Endpoint | 2.74 ± 0.58 | 0.47 ± 0.57 |
Mean change from baseline to endpoint in weight
| kilograms (kg) | Duloxetine | Selective Serotonin Reuptake Inhibitor (SSRI) |
|---|---|---|
| Change From Baseline in Weight at Week-12 Endpoint | -0.32 ± 0.18 | -0.17 ± 0.18 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Duloxetine | — | 4/372 (1.1%) | 277/372 (74.5%) |
| Citalopram | — | 2/157 (1.3%) | 112/157 (71.3%) |
| Fluoxetine | — | 1/57 (1.8%) | 47/57 (82.5%) |
| Paroxetine | — | 1/45 (2.2%) | 36/45 (80%) |
| Sertraline | — | 2/119 (1.7%) | 86/119 (72.3%) |
| Event | Duloxetine | Citalopram | Fluoxetine | Paroxetine | Sertraline |
|---|---|---|---|---|---|
| HyponatraemiaMetabolism and nutrition disorders | 0/372 | 0/157 | 0/57 | 1/45 | 0/119 |
| Cerebrovascular accidentNervous system disorders | 0/372 | 0/157 | 1/57 | 0/45 | 0/119 |
| Cervical vertebral fractureInjury, poisoning and procedural complications | 0/372 | 0/157 | 0/57 | 0/45 | 1/119 |
| Post-traumatic stress disorderPsychiatric disorders | 0/372 | 0/157 | 0/57 | 0/45 | 1/119 |
| PneumoniaInfections and infestations | 0/372 | 1/157 | 0/57 | 0/45 | 0/119 |
| Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders | 0/372 | 1/157 | 0/57 | 0/45 | 0/119 |
| Tibia fractureInjury, poisoning and procedural complications | 1/372 | 0/157 | 0/57 | 0/45 | 0/119 |
| Temporal lobe epilepsyNervous system disorders | 1/372 | 0/157 | 0/57 | 0/45 | 0/119 |
| Suicidal ideationPsychiatric disorders | 1/372 | 0/157 | 0/57 | 0/45 | 0/119 |
| NephrolithiasisRenal and urinary disorders | 1/372 | 0/157 | 0/57 | 0/45 | 0/119 |
| Event | Duloxetine | Citalopram | Fluoxetine | Paroxetine | Sertraline |
|---|---|---|---|---|---|
| Dry mouthGastrointestinal disorders | 66/372 | 16/157 | 11/57 | 4/45 | 13/119 |
| NauseaGastrointestinal disorders | 63/372 | 17/157 | 8/57 | 8/45 | 15/119 |
| FatigueGeneral disorders | 27/372 | 10/157 | 2/57 | 8/45 | 3/119 |
| DiarrhoeaGastrointestinal disorders | 36/372 | 17/157 | 10/57 | 3/45 | 18/119 |
| HeadacheNervous system disorders | 55/372 | 16/157 | 8/57 | 6/45 | 16/119 |
| InsomniaPsychiatric disorders | 25/372 | 3/157 | 8/57 | 3/45 | 4/119 |
| DizzinessNervous system disorders | 23/372 | 4/157 | 1/57 | 5/45 | 7/119 |
| NasopharyngitisInfections and infestations | 11/372 | 5/157 | 1/57 | 4/45 | 5/119 |
| ConstipationGastrointestinal disorders | 33/372 | 8/157 | 1/57 | 2/45 | 3/119 |
| SomnolenceNervous system disorders | 27/372 | 11/157 | 2/57 | 3/45 | 3/119 |
| Age Continuous(years) | Duloxetine | Selective Serotonin Reuptake Inhibitor (SSRI) | Total |
|---|---|---|---|
| Mean | 44.3 ± 13.01 | 43.8 ± 13.05 | 44.1 ± 13.02 |
| Sex: Female, Male(Participants) | Duloxetine | Selective Serotonin Reuptake Inhibitor (SSRI) | Total |
|---|---|---|---|
| Female | 237 | 259 | 496 |
| Male | 135 | 119 | 254 |
| Race/Ethnicity, Customized(participants) | Duloxetine | Selective Serotonin Reuptake Inhibitor (SSRI) | Total |
|---|---|---|---|
| African Descent | 76 | 68 | 144 |
| Caucasian | 231 | 241 | 472 |
| East/Southeast Asian | 2 | 7 | 9 |
| Hispanic | 59 | 52 | 111 |
| Western Asian | 1 | 2 | 3 |
| Other | 3 | 7 | 10 |
| Missing | 0 | 1 | 1 |
| Region of Enrollment(participants) | Duloxetine | Selective Serotonin Reuptake Inhibitor (SSRI) | Total |
|---|---|---|---|
| United States | 372 | 378 | 750 |
| History, Met Diagnosis of Major Mood Disorder (MDD)(participants) | Duloxetine | Selective Serotonin Reuptake Inhibitor (SSRI) | Total |
|---|---|---|---|
| Number | 372 | 378 | 750 |
| 17-Item Hamilton Depression Rating Scale (HAMD-17) Anxiety/Somatization Subscale Score(units on a scale) | Duloxetine | Selective Serotonin Reuptake Inhibitor (SSRI) | Total |
|---|---|---|---|
| Mean | 7.45 ± 2.22 | 7.42 ± 2.25 | 7.43 ± 2.23 |
| 17-Item Hamilton Depression Rating Scale (HAMD-17) Bech Subscale Score(units on a scale) | Duloxetine | Selective Serotonin Reuptake Inhibitor (SSRI) | Total |
|---|---|---|---|
| Mean | 12.97 ± 2.13 | 13.13 ± 1.95 | 13.05 ± 2.04 |
| 17-Item Hamilton Depression Rating Scale (HAMD-17) Maier Subscale Score(units on a scale) | Duloxetine | Selective Serotonin Reuptake Inhibitor (SSRI) | Total |
|---|---|---|---|
| Mean | 12.47 ± 2.33 | 12.48 ± 2.22 | 12.47 ± 2.27 |
15 further baseline measures are reported on the registry.
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