| Primary | Change From Baseline to 8 Weeks in 24-Item Hamilton Depression Rating Scale (HAMD-24) Item 7 (Work and Activities) | Item 7 of the HAMD-24 assesses loss of interest or pleasure in work and activities and is an essential symptom in MDD. Scores range from 0 (no difficulty/no loss) to 4 (difficulty/loss). | Number of participants with non-missing data at baseline and post-baseline visit. | Posted | | Least Squares Mean | Standard Error | units on a scale | | baseline, 8 weeks | | | | ID | Title | Description |
|---|
| OG000 | Group A - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG001 | Group A - Placebo | placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). | | OG002 | Group B - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG003 | Group B - Placebo | placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). |
| | Units | Counts |
|---|
| Participants | - OG000214
- OG001102
- OG002220
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000-1.32± 0.07
- OG001-1.07± 0.11
- OG002-1.37± 0.07
- OG003
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | Mixed Models Analysis | Model=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit | 0.051 | Repeated Measures Analysis for Group A change from baseline to 8 week endpoint. | | | | | | 95 | | | | | | No | Superiority or Other | | | | |
|
| Secondary | Change From Baseline to 12 Week and 9 Month Endpoints in the 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score and HAMD-24 Subscales (8 Week Endpoint for Maier Subscale) | 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). Please see baseline demographics for subscale total scores. | Number of participants with non-missing data at baseline and post-baseline visit. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline, 8 weeks, 12 weeks, 9 months | | | | ID | Title | Description |
|---|
| OG000 | Group A - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG001 | Group A - Placebo | placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). | | OG002 | Group B - Duloxetine | |
|
| Secondary | Change From Baseline to 12 Week and 9 Month Endpoints in the HAMD-24 Total Score | | Number of participants with non-missing data at baseline and post-baseline visit. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline, 12 weeks, 9 months | | | | ID | Title | Description |
|---|
| OG000 | Group A - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG001 | Group A - Placebo | placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). | | OG002 | Group B - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG003 | Group B - Placebo | placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). |
|
| Secondary | Change From Baseline to 12 Week and 9 Month Endpoints in the HAMD-24 Item 1:Depressed Mood | Measures depressed mood on a scale of 0 (absent) to 4 (very depressed). | Number of participants with non-missing data at baseline and post-baseline visit. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline, 12 weeks, 9 months | | | | ID | Title | Description |
|---|
| OG000 | Group A - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG001 | Group A - Placebo | placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). | | OG002 | Group B - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG003 | Group B - Placebo | |
|
| Secondary | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 2:Feelings of Guilt | Measures feelings of guilt on a scale of 0 (absent) to 4 (very guilty). | Number of participants with non-missing data at baseline and post-baseline visit. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline, 12 weeks, 9 months | | | | ID | Title | Description |
|---|
| OG000 | Group A - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG001 | Group A - Placebo | placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). | | OG002 | Group B - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG003 | Group B - Placebo | |
|
| Secondary | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 3:Suicide | Measures thoughts of suicide on a scale of 0 (absent) to 4 (attempts suicide). | Number of participants with non-missing data at baseline and post-baseline visit. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline, 12 weeks, 9 Months | | | | ID | Title | Description |
|---|
| OG000 | Group A - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG001 | Group A - Placebo | placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). | | OG002 | Group B - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG003 | Group B - Placebo | |
|
| Secondary | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 4:Insomnia Early | Measures early insomnia on a scale of 0 (no difficulty falling asleep) to 2 (complains of nightly difficulty falling asleep). | Number of participants with non-missing data at baseline and post-baseline visit. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline, 12 weeks, 9 months | | | | ID | Title | Description |
|---|
| OG000 | Group A - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG001 | Group A - Placebo | placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). | | OG002 | Group B - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG003 | Group B - Placebo |
|
| Secondary | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 5:Insomnia Middle | Measures middle insomnia on a scale of 0 (no difficulty) to 2 (waking during the night). | Number of participants with non-missing data at baseline and post-baseline visit. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline, 12 weeks, 9 months | | | | ID | Title | Description |
|---|
| OG000 | Group A - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG001 | Group A - Placebo | placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). | | OG002 | Group B - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG003 | Group B - Placebo |
|
| Secondary | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 6:Insomnia Late | Measures late insomnia on a scale of 0 (no difficulty) to 2 (unable to fall asleep again if gets out of bed). | Number of participants with non-missing data at baseline and post-baseline visit. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline, 12 weeks, 9 months | | | | ID | Title | Description |
|---|
| OG000 | Group A - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG001 | Group A - Placebo | placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). | | OG002 | Group B - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG003 | Group B - Placebo |
|
| Secondary | Change From Baseline to 9 Month Endpoint in HAMD-24 - Item 7:Work and Activities | Item 7 of the HAMD-24 assesses loss of interest or pleasure in work and activities and is an essential symptom in MDD. Scores range from 0 (no difficulty/no loss) to 4 (difficulty/loss). | Number of participants with non-missing data at baseline and post-baseline visit. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline, 9 months | | | | ID | Title | Description |
|---|
| OG000 | Group A - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG001 | Group A - Placebo | placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). | | OG002 | Group B - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG003 |
|
| Secondary | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 8:Retardation | Measures slowness of thought and speech; impaired ability to concentrate; decreased motor activity on a scale of 0 (normal speech and thought) to 4 (complete stupor). | Number of participants with non-missing data at baseline and post-baseline visit. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline, 12 weeks, 9 months | | | | ID | Title | Description |
|---|
| OG000 | Group A - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG001 | Group A - Placebo | placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). | | OG002 | Group B - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG003 |
|
| Secondary | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 9:Agitation | Measures agitation on a scale of 0 (none) to 4 (hand-wringing, nail-biting) | Number of participants with non-missing data at baseline and post-baseline visit. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline, 12 weeks, 9 months | | | | ID | Title | Description |
|---|
| OG000 | Group A - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG001 | Group A - Placebo | placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). | | OG002 | Group B - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG003 | Group B - Placebo | |
|
| Secondary | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 10:Anxiety (Psychic) | Measures anxiety on a scale of 0 (no difficulty) to 4 (fears expressed) | Number of participants with non-missing data at baseline and post-baseline visit. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline, 12 weeks, 9 months | | | | ID | Title | Description |
|---|
| OG000 | Group A - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG001 | Group A - Placebo | placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). | | OG002 | Group B - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG003 | Group B - Placebo |
|
| Secondary | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 11:Anxiety (Somatic) | Measures physiological concomitants of anxiety on a scale of 0 (absent) to 4 (incapacitating). | Number of participants with non-missing data at baseline and post-baseline visit. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline, 12 weeks, 9 months | | | | ID | Title | Description |
|---|
| OG000 | Group A - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG001 | Group A - Placebo | placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). | | OG002 | Group B - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG003 | Group B - Placebo |
|
| Secondary | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 12:Somatic Symptoms/Gastrointestinal | Measures gastrointestical somatic symptoms on a scale of 0 (none) to 2 (difficulty eating, requires medication for symptoms). | Number of participants with non-missing data at baseline and post-baseline visit. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline, 12 weeks, 9 months | | | | ID | Title | Description |
|---|
| OG000 | Group A - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG001 | Group A - Placebo | placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). | | OG002 | Group B - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG003 |
|
| Secondary | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 13:Somatic Symptoms/General | Measures general somatic symptoms on a scale of 0 (none) to 2 (any clear-cut symptoms). | Number of participants with non-missing data at baseline and post-baseline visit. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline, 12 weeks, 9 months | | | | ID | Title | Description |
|---|
| OG000 | Group A - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG001 | Group A - Placebo | placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). | | OG002 | Group B - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG003 | Group B - Placebo |
|
| Secondary | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 14:Genital Symptoms | Measures genital symptoms (loss of libido, menstrual disturbances) on a scale of 0 (absent) to 2 (severe). | Number of participants with non-missing data at baseline and post-baseline visit. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline, 12 weeks, 9 months | | | | ID | Title | Description |
|---|
| OG000 | Group A - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG001 | Group A - Placebo | placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). | | OG002 | Group B - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG003 | Group B - Placebo |
|
| Secondary | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 15:Hypochondriasis | Measures hypochondriasis on a scale of 0 (not present) to 4 (hypochondriacal delusions). | Number of participants with non-missing data at baseline and post-baseline visit. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline, 12 weeks, 9 months | | | | ID | Title | Description |
|---|
| OG000 | Group A - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG001 | Group A - Placebo | placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). | | OG002 | Group B - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG003 | Group B - Placebo |
|
| Secondary | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 16:Loss of Weight | Measures weight loss since last visit on a scale of 0 (no weight loss) to 2 (definite weight loss caused by present illness). | Number of participants with non-missing data at baseline and post-baseline visit. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline, 12 weeks, 9 months | | | | ID | Title | Description |
|---|
| OG000 | Group A - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG001 | Group A - Placebo | placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). | | OG002 | Group B - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG003 | Group B - Placebo |
|
| Secondary | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 17:Insight | Measures insight on a scale of 0 (acknowledges being depressed and ill) to 2 (denies being ill at all). | Number of participants with non-missing data at baseline and post-baseline visit. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline, 12 weeks, 9 months | | | | ID | Title | Description |
|---|
| OG000 | Group A - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG001 | Group A - Placebo | placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). | | OG002 | Group B - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG003 | Group B - Placebo |
|
| Secondary | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 18A:Diurnal Variation | Measures whether symptoms are worse in morning or evening on a scale of 0 (no variation), 1 (worse in morning), or 2 (worse in evening). | Number of participants with non-missing data at baseline and post-baseline visit. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline, 12 weeks, 9 months | | | | ID | Title | Description |
|---|
| OG000 | Group A - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG001 | Group A - Placebo | placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). | | OG002 | Group B - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG003 | Group B - Placebo |
|
| Secondary | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 18B:Diurnal Variation-Severity | Measures the severity of the diurnal variation on a scale of 0 (none) to 2 (severe). | Number of participants with non-missing data at baseline and post-baseline visit. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline, 12 weeks, 9 months | | | | ID | Title | Description |
|---|
| OG000 | Group A - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG001 | Group A - Placebo | placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). | | OG002 | Group B - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG003 | Group B - Placebo |
|
| Secondary | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 19: Depersonalization and Derealization | Measures feelings of unreality on a scale of 0 (absent) to 4 (incapacitating). | Number of participants with non-missing data at baseline and post-baseline visit. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline, 12 weeks, 9 months | | | | ID | Title | Description |
|---|
| OG000 | Group A - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG001 | Group A - Placebo | placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). | | OG002 | Group B - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG003 | Group B - Placebo |
|
| Secondary | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 20:Paranoid Symptoms | Measures paranoid symptoms on a scale of 0 (none) to 2 (severe). | Number of participants with non-missing data at baseline and post-baseline visit. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline, 12 weeks, 9 months | | | | ID | Title | Description |
|---|
| OG000 | Group A - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG001 | Group A - Placebo | placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). | | OG002 | Group B - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG003 | Group B - Placebo | |
|
| Secondary | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 21:Obsessional and Compulsive Symptoms | Measures obsessional and compulsive symptoms on a scale of 0 (absent) to 2 (severe). | Number of participants with non-missing data at baseline and post-baseline visit. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline, 12 weeks, 9 months | | | | ID | Title | Description |
|---|
| OG000 | Group A - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG001 | Group A - Placebo | placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). | | OG002 | Group B - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG003 | Group B - Placebo |
|
| Secondary | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 22B:Helplessness | Measures feelings of helplessness on a scale of 0 (absent) to 4 (severe). | Number of participants with non-missing data at baseline and post-baseline visit. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline, 12 weeks, 9 months | | | | ID | Title | Description |
|---|
| OG000 | Group A - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG001 | Group A - Placebo | placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). | | OG002 | Group B - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG003 | Group B - Placebo | |
|
| Secondary | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 23B:Hopelessness | Measures feelings of hopelessness on a scale of 0 (absent) to 4 (expresses feelings of discouragement, despair, and/or pessimism about the future which cannot be dispelled). | Number of participants with non-missing data at baseline and post-baseline visit. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline, 12 weeks, 9 months | | | | ID | Title | Description |
|---|
| OG000 | Group A - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG001 | Group A - Placebo | placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). | | OG002 | Group B - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG003 |
|
| Secondary | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 24B:Worthlessness | Measures feelings of worthlessness on a scale of 0 (absent) to 4 (severe). | Number of participants with non-missing data at baseline and post-baseline visit. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline, 12 weeks, 9 months | | | | ID | Title | Description |
|---|
| OG000 | Group A - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG001 | Group A - Placebo | placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). | | OG002 | Group B - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG003 | Group B - Placebo |
|
| Secondary | Change From Baseline to 12 Week Endpoint in 30-Item Brief Profile of Mood States (BPOMS) Scale and Subscales (Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment). | The 30-item BPOMS measures mood states and has 6 factors: tension-anxiety, depression-dejection, anxiety-hostility, fatigue, confusion, and vigor. Item scores: 0 (not at all) to 4 (extremely). Each factor scores range from 0 to 20. The Total score is sum of all factor scores minus the factor score for vigor (Total=Ten+Dep+Ang+Fat+Con-Vig). | Number of participants with non-missing data at baseline and post-baseline visit. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline, 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | Group A - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG001 | Group A - Placebo | placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). | | OG002 | Group B - Duloxetine | |
|
| Secondary | Change From Baseline to 9 Month Endpoint in 30-Item Brief Profile of Mood States (BPOMS) Scale and Subscales (Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment) | The 30-item BPOMS measures mood states and has 6 factors: tension-anxiety, depression-dejection, anxiety-hostility, fatigue, confusion, and vigor. Item scores: 0 (not at all) to 4 (extremely). Each factor scores range from 0 to 20. The Total score is sum of all factor scores minus the factor score for vigor (Total=Ten+Dep+Ang+Fat+Con-Vig). | Number of participants with non-missing data at baseline and post-baseline visit. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline, 9 months | | | | ID | Title | Description |
|---|
| OG000 | Group A - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG001 | Group A - Placebo | placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). | | OG002 | Group B - Duloxetine | |
|
| Secondary | Change From Baseline to 12 Week Endpoint in Sheehan Disability Scale (SDS) Total Score and Subscores | The SDS is completed by the patient and is used to assess the effect of the patient's symptoms on their work/social/family life. Individual item scores range from 0 to 10. Total scores range from 0 to 30 with higher values indicating greater disruption in the patient's work/social/family life. | Number of participants with non-missing data at baseline and post-baseline visit. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline, 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | Group A - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG001 | Group A - Placebo | placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). | | OG002 | Group B - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months |
|
| Secondary | Change From Baseline to 9 Month Endpoint in Sheehan Disability Scale (SDS) Total Score and Subscores | The SDS is completed by the patient and is used to assess the effect of the patient's symptoms on their work/social/family life. Individual item scores range from 0 to 10. Total scores range from 0 to 30 with higher values indicating greater disruption in the patient's work/social/family life. | Number of participants with non-missing data at baseline and post-baseline visit. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline, 9 months | | | | ID | Title | Description |
|---|
| OG000 | Group A - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG001 | Group A - Placebo | placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). | | OG002 | Group B - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months |
|
| Secondary | Path Analysis of BPOMS Total Score to Overall Improvement in HAMD-24 Item 7 | Relative contribution of improvement on the mood states, defined by BPOMS total score (calculated from subscales) to overall improvement in work and activities, HAMD-24 item 7 using path analysis. | | Posted | | Number | | coefficient | | Over 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | Group A - Ordinary Coefficient | Mathematical estimate of the relationship between the dependent variable and the independent variable from linear regression in the Duloxetine 60 mg group. | | OG001 | Group A - Standardized Coefficient | Mathematical estimate of the relationship between the dependent variable and the independent variable from linear regression expressed in units of standard deviation in the Duloxetine 60 mg group. | | OG002 | Group B - Ordinary Coefficient | Mathematical estimate of the relationship between the dependent variable and the independent variable from linear regression in the Duloxetine 60 mg group. | | OG003 | Group B - Standardized Coefficient | |
|
| Secondary | Path Analysis of BPOMS Total Score to Overall Improvement in HAMD-24 Item 7 - Percent of Total Effect | For Group A, at least one effect was in the opposite direction, percent of total effect was not calculated. | | Posted | | Number | | percent of total effect | | over 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | Group B - Percent of Total Effect | The percentage of the total treatment effect explained by the direct and indirect effects of treatment in the duloxetine 60 mg group. |
| | |
| Secondary | Path Analysis of BPOMS Total Score to Overall Improvement in Sheehan Disability Scale (SDS) Total Score | Relative contribution of improvement on the mood states, defined by BPOMS total score (determined from subscales) to overall improvement in SDS total score using path analysis. | | Posted | | Number | | coefficient | | over 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | Group A - Ordinary Coefficient | Mathematical estimate of the relationship between the dependent variable and the independent variable from linear regression in the Duloxetine 60 mg group. | | OG001 | Group A - Standardized Coefficient | Mathematical estimate of the relationship between the dependent variable and the independent variable from linear regression expressed in units of standard deviation in the Duloxetine 60 mg group. | | OG002 | Group B - Ordinary Coefficient | Mathematical estimate of the relationship between the dependent variable and the independent variable from linear regression in the Duloxetine 60 mg group. | | OG003 | Group B - Standardized Coefficient | |
|
| Secondary | Path Analysis of BPOMS Total Score to Overall Improvement in SDS Total Score - Percent of Total Effect | For Group A, at least one effect was in the opposite direction, percent of total effect was not calculated. | | Posted | | Number | | percent of total effect | | Over 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | Group B - Percent of Total Effect | The percentage of the total treatment effect explained by the direct and indirect effects of treatment in the duloxetine 60 mg group. |
| | |
| Secondary | Change From Baseline to 12 Week and 9 Month Endpoints in 16-Item Quick Inventory of Depressive Symptomatology Self Report (QIDS16SR) Total Score | A 16-item patient-rated measure of depressive symptomatology. The total score ranges from 0 to 27 with higher scores indicative of greater severity. | Number of participants with non-missing data at baseline and post-baseline visit. | Posted | | Least Squares Mean | Standard Deviation | units on a scale | | Baseline, 12 weeks, 9 months | | | | ID | Title | Description |
|---|
| OG000 | Group A - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG001 | Group A - Placebo | placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). | | OG002 | Group B - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | |
|
| Secondary | Probability of Remission at 12 Week Endpoint and Sustained Remission at 9 Month Endpoint | Probability of remission as measured by the HAMD17 Total Score ≤ 7 and by the QIDS16SR Total Score ≤ 5. The visitwise percentages of patients meeting criteria in the Acute Therapy Phase for remission (visitwise binary outcome, yes/no) will be analyzed using a categorical, pseudo-likelihood-based repeated measures approach. This analysis will include the fixed, categorical effects of treatment, investigator, visit, and treatment-by-visit interaction, as well as the continuous, fixed covariate of baseline score. | Number of participants with non-missing data at baseline and post-baseline visit. | Posted | | Least Squares Mean | Standard Error | probability of remission | | 12 weeks, 9 months | | | | ID | Title | Description |
|---|
| OG000 | Group A - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG001 | Group A - Placebo | placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). | | OG002 | Group B - Duloxetine |
|
| Secondary | Probability of Response at 12 Week Endpoint | Probability of response as measured by ≥ 50% Improvement in the HAMD17 Total Score and ≥ 50% Improvement in the QIDS16SR Total Score. The visitwise percentages of patients meeting criteria in the Acute Therapy Phase for response (visitwise binary outcome, yes/no) will be analyzed using a categorical, pseudo-likelihood-based repeated measures approach. This analysis will include the fixed, categorical effects of treatment, investigator, visit, and treatment-by-visit interaction, as well as the continuous, fixed covariate of baseline score. | Number of participants with non-missing data at baseline and post-baseline visit. | Posted | | Least Squares Mean | Standard Error | probability of response | | 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | Group A - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG001 | Group A - Placebo | placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). | | OG002 | Group B - Duloxetine | |
|
| Secondary | Change From Baseline to 12 Week and 9 Month Endpoints in Pain Numerical Rating Scale (NRS) | Item 1=Average musculoskeletal pain severity over the last week as measured by an 11-point Likert scale. Scores range from 0 (no pain) to 10 (worst possible pain). Item 7=How much they have been bothered by pain over the last week. Scores range from 0 (not bothered at all)to 10 (extremely bothered). | Number of participants with non-missing data at baseline and post-baseline visit. | Posted | | Least Squares Mean | Standard Deviation | units on a scale | | Baseline, 12 weeks, 9 months | | | | ID | Title | Description |
|---|
| OG000 | Group A - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG001 | Group A - Placebo | placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). | | OG002 | Group B - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months |
|
| Secondary | Change From Baseline to 12 Week and 9 Month Endpoint in the Clinical Global Impression-Severity Scale (CGI-S) | Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients. | Number of participants with non-missing data at baseline and post-baseline visit. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline, 12 weeks, 9 months | | | | ID | Title | Description |
|---|
| OG000 | Group A - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG001 | Group A - Placebo | placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). | | OG002 | Group B - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG003 |
|
| Secondary | Change From Baseline to 12 Week and 9 Month Endpoints in the Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (MGH-CPFQ) | A 7-item patitent-rated questionnaire pertaining to a patient's cognitive and physical well-being. It assesses motivation, wakefulness, energy, focus, recall, word-finding difficulty, and mental acuity. Each of the 7 questions is scored on a 6-point scale ranging fom 1 (greater than normal) to 6 (totally absent). Total score ranges from 7 to 42. | Number of participants with non-missing data at baseline and post-baseline visit. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline, 12 weeks, 9 months | | | | ID | Title | Description |
|---|
| OG000 | Group A - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG001 | Group A - Placebo | placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). | | OG002 | Group B - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months |
|
| Secondary | Change From Baseline to 12 Week and 9 Month Endpoints in the Social Adaptation Self-evaluation Scale (SASS) Total Score | A 21-item self-rated scale that evaluates patient social motivation and behavior in depression. Each of the 21 items is scored from 0 (minimal social adjustment) to 3 (maximal social adjustment). Total score ranges from 0 to 60. | Number of participants with non-missing data at baseline and post-baseline visit. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline, 12 weeks, 9 months | | | | ID | Title | Description |
|---|
| OG000 | Group A - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG001 | Group A - Placebo | placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). | | OG002 | Group B - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months |
|
| Secondary | Change From Baseline to 12 Week and 9 Month Endpoints in Blood Pressure | Sitting systolic and diastolic blood pressure. | Number of participants with non-missing data at baseline and post-baseline visit. | Posted | | Least Squares Mean | Standard Error | mm Hg | | Baseline, 12 weeks, 9 months | | | | ID | Title | Description |
|---|
| OG000 | Group A - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG001 | Group A - Placebo | placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). | | OG002 | Group B - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG003 | Group B - Placebo | |
|
| Secondary | Change From Baseline to 12 Week and 9 Month Endpoints in Pulse Rate | | Number of participants with non-missing data at baseline and post-baseline visit. | Posted | | Least Squares Mean | Standard Error | beats per minute | | Baseline, 12 weeks, 9 months | | | | ID | Title | Description |
|---|
| OG000 | Group A - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG001 | Group A - Placebo | placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). | | OG002 | Group B - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG003 | Group B - Placebo | placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). |
|
| Secondary | Change From Baseline to 12 Week and 9 Month Endpoints in Weight | | Number of participants with non-missing data at baseline and post-baseline visit. | Posted | | Least Squares Mean | Standard Error | kilograms | | Baseline, 12 weeks, 9 months | | | | ID | Title | Description |
|---|
| OG000 | Group A - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG001 | Group A - Placebo | placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). | | OG002 | Group B - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG003 | Group B - Placebo | placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). |
|
| Secondary | Abnormal Vital Signs at Anytime Over 12 Weeks | | Number of participants wtih a normal baseline and at least one post-baseline measurement. | Posted | | Number | | participants | | over 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | Group A - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG001 | Group A - Placebo | placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). | | OG002 | Group B - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG003 | Group B - Placebo | placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). |
|
| Secondary | Abnormal Vital Signs at Anytime Over 9 Months | | Number of participants with a normal baseline and at least oone post-baseline measurement. | Posted | | Number | | participants | | over 9 months | | | | ID | Title | Description |
|---|
| OG000 | Group A - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG001 | Group A - Placebo | placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). | | OG002 | Group B - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG003 | Group B - Placebo | placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). |
|
| Secondary | Abnormal Vital Signs at 12 Week Endpoint | | Number of participants with a normal baseline and at least one post-baseline measurement. | Posted | | Number | | participants | | 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | Group A - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG001 | Group A - Placebo | placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). | | OG002 | Group B - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG003 | Group B - Placebo | placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). |
|
| Secondary | Abnormal Vital Signs at 9 Month Endpoint | | Number of participants with a normal baseline and at least one post-baseline measurement. | Posted | | Number | | participants | | 9 months | | | | ID | Title | Description |
|---|
| OG000 | Group A - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG001 | Group A - Placebo | placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). | | OG002 | Group B - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG003 | Group B - Placebo | placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). |
|
| Secondary | Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Bilirubin, Creatinine, Uric Acid | | Number of participants with non-missing data at baseline and at least one post-baseline visit. | Posted | | Least Squares Mean | Standard Deviation | micromole per Liter | | Baseline, 12 weeks, 9 months | | | | ID | Title | Description |
|---|
| OG000 | Group A - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG001 | Group A - Placebo | placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). | | OG002 | Group B - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG003 | Group B - Placebo | placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). |
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| Secondary | Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Hematocrit | | Number of participants with non-missing data at baseline and at least one post-baseline visit. | Posted | | Least Squares Mean | Standard Deviation | Proportion of 1.0 | | Baseline, 12 weeks, 9 months | | | | ID | Title | Description |
|---|
| OG000 | Group A - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG001 | Group A - Placebo | placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). | | OG002 | Group B - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG003 | Group B - Placebo | placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). |
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| Secondary | Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Mean Cell Volume (MCV) | | Number of participants with non-missing data at baseline and at least one post-baseline visit. | Posted | | Least Squares Mean | Standard Deviation | femtoliter | | Baseline, 12 weeks, 9 months | | | | ID | Title | Description |
|---|
| OG000 | Group A - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG001 | Group A - Placebo | placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). | | OG002 | Group B - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG003 | Group B - Placebo | placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). |
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| Secondary | Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Chloride, Urea Nitrogen, Cholesterol, Sodium | | Number of participants with non-missing data at baseline and at least one post-baseline visit. | Posted | | Least Squares Mean | Standard Deviation | millimole per Liter | | Baseline, 12 weeks, 9 months | | | | ID | Title | Description |
|---|
| OG000 | Group A - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG001 | Group A - Placebo | placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). | | OG002 | Group B - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG003 | Group B - Placebo | placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). |
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| Secondary | Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Platelet Count | | Number of participants with non-missing data at baseline and at least post-baseline visit. | Posted | | Least Squares Mean | Standard Deviation | Billions per Liter | | Baseline, 12 weeks, 9 months | | | | ID | Title | Description |
|---|
| OG000 | Group A - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG001 | Group A - Placebo | placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). | | OG002 | Group B - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG003 | Group B - Placebo | placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). |
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| Secondary | Statistically Significant Changes in Baseline to 9 Month Endpoint Laboratory Values - Alkaline Phosphatase | | Number of participants with non-missing data at baseline and at least one post baseline visit. | Posted | | Least Squares Mean | Standard Deviation | Units per Liter | | baseline, 9 months | | | | ID | Title | Description |
|---|
| OG000 | Group A - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG001 | Group A - Placebo | placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). | | OG002 | Group B - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG003 | Group B - Placebo | placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). |
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| Secondary | Statistically Significant Changes in Baseline to 9 Month Endpoint Laboratory Values - Hemoglobin | | Number of participants with non-missing data at baseline and at least one post-baseline visit. | Posted | | Least Squares Mean | Standard Deviation | millimoles per Liter (iron) | | Baseline, 9 months | | | | ID | Title | Description |
|---|
| OG000 | Group A - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG001 | Group A - Placebo | placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). | | OG002 | Group B - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG003 | Group B - Placebo | placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). |
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| Secondary | Statistically Significant Abnormal Laboratory Values at Anytime/12 Week Endpoint | The number of participants with statistically significant abnormal lab values at anytime and at 12 week endpoint were the same. | Number of participants with a normal baseline and at least one post-baseline measurement. | Posted | | Number | | participants | | over 3 months | | | | ID | Title | Description |
|---|
| OG000 | Group A - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG001 | Group A - Placebo | placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). | | OG002 | Group B - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG003 | Group B - Placebo |
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| Secondary | Statistically Significant Abnormal Laboratory Values at Anytime During 9 Months | | Number of participants with a normal baseline at at least one post-baseline measurement. | Posted | | Number | | participants | | over 9 months | | | | ID | Title | Description |
|---|
| OG000 | Group A - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG001 | Group A - Placebo | placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). | | OG002 | Group B - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG003 | Group B - Placebo | placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). |
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| Secondary | Statistically Significant Abnormal Laboratory Values at 9 Month Endpoint | | Number of participants with a normal baseline and at least one post-baseline measurement. | Posted | | Number | | participants | | 9 months | | | | ID | Title | Description |
|---|
| OG000 | Group A - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG001 | Group A - Placebo | placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). | | OG002 | Group B - Duloxetine | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | | OG003 | Group B - Placebo | placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). |
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| Secondary | Summary of Adverse Events Leading to Discontinuation | | Number of randomized participants in each treatment group. | Posted | | Number | | participants | | over 9 months | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine (Not Escalated) | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which participants remained on duloxetine 60 mg QD, PO for 6 months. | | OG001 | Duloxetine (Escalated) | duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which participants were increased to duloxetine 120 mg QD, PO for 6 months | | OG002 | Placebo (Not Rescued) | placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). | | OG003 | Placebo (Rescued) | placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). |
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