| Primary | Change of Brief Pain Inventory (BPI) Average Interference Score From Baseline to Week 12 | The change from baseline reflects the week 12 value minus the baseline value. The BPI average interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes). | All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5 | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Without Major Depressive Disorder (MDD-) | Patients with diabetic polyneuropathy and no depression | | OG001 | With Major Depressive Disorder (MDD+) | Patients with diabetic polyneuropathy and depression |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000-1.4± 1.91
- OG001-2.2± 2.2
|
|
| | 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 |
|---|
| | ANCOVA | with last observation carried forward (LOCF) | < 0.0001 | | LSmean | -1.49 | | | 2-Sided | 95 | -1.89 | -1.10 | | | | No | Superiority or Other | | | | | ANCOVA | | < 0.0001 |
|
| Secondary | Change of Brief Pain Inventory (BPI) Average Interference Score From Baseline to Week 6 | The change from baseline reflects the week 6 value minus the baseline value. The BPI average interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes). | All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5 | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Without Major Depressive Disorder (MDD-) | Patients with diabetic polyneuropathy and no depression | | OG001 | With Major Depressive Disorder (MDD+) | Patients with diabetic polyneuropathy and depression |
| |
| Secondary | Change in BPI Worst Pain During Treatment From Baseline to Week 2 | The change from baseline reflects the week 2 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine). | All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5 | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Week 2 | | | | ID | Title | Description |
|---|
| OG000 | Without Major Depressive Disorder (MDD-) | Patients with diabetic polyneuropathy and no depression | | OG001 | With Major Depressive Disorder (MDD+) | Patients with diabetic polyneuropathy and depression |
| |
| Secondary | Change in Worst Pain (BPI) From Baseline to Week 6 | The change from baseline reflects the week 6 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine). | All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5 | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Without Major Depressive Disorder (MDD-) | Patients with diabetic polyneuropathy and no depression | | OG001 | With Major Depressive Disorder (MDD+) | Patients with diabetic polyneuropathy and depression |
| |
| Secondary | Change in Worst Pain (BPI) From Baseline to Week 12 | The change from baseline reflects the week 12 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine). | All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5 | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Without Major Depressive Disorder (MDD-) | Patients with diabetic polyneuropathy and no depression | | OG001 | With Major Depressive Disorder (MDD+) | Patients with diabetic polyneuropathy and depression |
| |
| Secondary | Change in Least Pain (BPI) From Baseline to Week 2 | The change from baseline reflects the week 2 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine). | All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5 | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Week 2 | | | | ID | Title | Description |
|---|
| OG000 | Without Major Depressive Disorder (MDD-) | Patients with diabetic polyneuropathy and no depression | | OG001 | With Major Depressive Disorder (MDD+) | Patients with diabetic polyneuropathy and depression |
| |
| Secondary | Change in Least Pain During Treatment (BPI) From Baseline to Week 6 | The change from baseline reflects the week 6 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine). | All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5 | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Without Major Depressive Disorder (MDD-) | Patients with diabetic polyneuropathy and no depression | | OG001 | With Major Depressive Disorder (MDD+) | Patients with diabetic polyneuropathy and depression |
| |
| Secondary | Change in Least Pain (BPI) From Baseline to Week 12 | The change from baseline reflects the week 12 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine). | All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5 | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Without Major Depressive Disorder (MDD-) | Patients with diabetic polyneuropathy and no depression | | OG001 | With Major Depressive Disorder (MDD+) | Patients with diabetic polyneuropathy and depression |
| |
| Secondary | Change in Average Pain (BPI) From Baseline to Week 2 | The change from baseline reflects the week 2 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine). | All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5 | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Week 2 | | | | ID | Title | Description |
|---|
| OG000 | Without Major Depressive Disorder (MDD-) | Patients with diabetic polyneuropathy and no depression | | OG001 | With Major Depressive Disorder (MDD+) | Patients with diabetic polyneuropathy and depression |
| |
| Secondary | Change in Average Pain During Treatment (BPI) From Baseline to Week 6 | The change from baseline reflects the week 6 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine). | All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5 | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Without Major Depressive Disorder (MDD-) | Patients with diabetic polyneuropathy and no depression | | OG001 | With Major Depressive Disorder (MDD+) | Patients with diabetic polyneuropathy and depression |
| |
| Secondary | Change in Average Pain (BPI) From Baseline to Week 12 | The change from baseline reflects the week 12 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine). | All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5 | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Without Major Depressive Disorder (MDD-) | Patients with diabetic polyneuropathy and no depression | | OG001 | With Major Depressive Disorder (MDD+) | Patients with diabetic polyneuropathy and depression |
| |
| Secondary | Number of Patients With a Reduction in BPI Average Pain at Week 2 | | All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5 | Posted | | Number | | Participants | | Baseline and Week 2 | | | | ID | Title | Description |
|---|
| OG000 | Without Major Depressive Disorder (MDD-) | Patients with diabetic polyneuropathy and no depression | | OG001 | With Major Depressive Disorder (MDD+) | Patients with diabetic polyneuropathy and depression |
| |
| Secondary | Number of Patients With a Reduction in BPI Average Pain at Week 6 | | All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5 | Posted | | Number | | Participants | | Baseline and Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Without Major Depressive Disorder (MDD-) | Patients with diabetic polyneuropathy and no depression | | OG001 | With Major Depressive Disorder (MDD+) | Patients with diabetic polyneuropathy and depression |
| |
| Secondary | Number of Patients With a Reduction in BPI Average Pain at Week 12 | | All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5 | Posted | | Number | | Participants | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Without Major Depressive Disorder (MDD-) | Patients with diabetic polyneuropathy and no depression | | OG001 | With Major Depressive Disorder (MDD+) | Patients with diabetic polyneuropathy and depression |
| |
| Secondary | Change in Pain During Treatment (BPI) From Baseline to Week 2 | The change from baseline reflects the pain at week 2 minus the pain at baseline. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine). | All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5 | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Week 2 | | | | ID | Title | Description |
|---|
| OG000 | Without Major Depressive Disorder (MDD-) | Patients with diabetic polyneuropathy and no depression | | OG001 | With Major Depressive Disorder (MDD+) | Patients with diabetic polyneuropathy and depression |
| |
| Secondary | Change in Pain (BPI) From Baseline to Week 6 | The change from baseline reflects the pain at week 6 minus the pain at baseline. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine). | All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5 | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Without Major Depressive Disorder (MDD-) | Patients with diabetic polyneuropathy and no depression | | OG001 | With Major Depressive Disorder (MDD+) | Patients with diabetic polyneuropathy and depression |
| |
| Secondary | Change in Pain During Treatment (BPI) From Baseline to Week 12 | The change from baseline reflects the pain at week 12 minus the pain at baseline. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine). | All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5 | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Without Major Depressive Disorder (MDD-) | Patients with diabetic polyneuropathy and no depression | | OG001 | With Major Depressive Disorder (MDD+) | Patients with diabetic polyneuropathy and depression |
| |
| Secondary | Change in Relief of Pain (BPI) From the Week Before Baseline to the Week Before Week 2 | The change from baseline reflects the week 2 value minus the baseline value. The relief of pain ranges from 0% (no relief) to 100% (complete relief). | All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5 | Posted | | Mean | Standard Deviation | scores on a scale | | Baseline and Week 2 | | | | ID | Title | Description |
|---|
| OG000 | Without Major Depressive Disorder (MDD-) | Patients with diabetic polyneuropathy and no depression | | OG001 | With Major Depressive Disorder (MDD+) | Patients with diabetic polyneuropathy and depression |
| |
| Secondary | Change in Relief of Pain (BPI) From the Week Before Baseline to the Week Before Week 6 | The change from baseline reflects the week 6 value minus the baseline value. The relief of pain ranges from 0% (no relief) to 100% (complete relief). | All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5 | Posted | | Mean | Standard Deviation | scores on a scale | | Baseline and Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Without Major Depressive Disorder (MDD-) | Patients with diabetic polyneuropathy and no depression | | OG001 | With Major Depressive Disorder (MDD+) | Patients with diabetic polyneuropathy and depression |
| |
| Secondary | Change in Relief of Pain (BPI) From the Week Before Baseline to the Week Before Week 12 | The change from baseline reflects the week 12 value minus the baseline value. The relief of pain ranges from 0% (no relief) to 100% (complete relief). | All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5 | Posted | | Mean | Standard Deviation | scores on a scale | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Without Major Depressive Disorder (MDD-) | Patients with diabetic polyneuropathy and no depression | | OG001 | With Major Depressive Disorder (MDD+) | Patients with diabetic polyneuropathy and depression |
| |
| Secondary | Change in Interference of Pain With General Activity (BPI) From Baseline to Week 2 | The change from baseline reflects the week 2 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes). | All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5 | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Week 2 | | | | ID | Title | Description |
|---|
| OG000 | Without Major Depressive Disorder (MDD-) | Patients with diabetic polyneuropathy and no depression | | OG001 | With Major Depressive Disorder (MDD+) | Patients with diabetic polyneuropathy and depression |
| |
| Secondary | Change in Interference of Pain With General Activity (BPI) From Baseline to Week 6 | The change from baseline reflects the week 6 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes). | All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5 | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Without Major Depressive Disorder (MDD-) | Patients with diabetic polyneuropathy and no depression | | OG001 | With Major Depressive Disorder (MDD+) | Patients with diabetic polyneuropathy and depression |
| |
| Secondary | Change in Interference of Pain With General Activity (BPI) From Baseline to Week 12 | The change from baseline reflects the week 12 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes). | All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5 | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Without Major Depressive Disorder (MDD-) | Patients with diabetic polyneuropathy and no depression | | OG001 | With Major Depressive Disorder (MDD+) | Patients with diabetic polyneuropathy and depression |
| |
| Secondary | Change in Interference of Pain With Mood (BPI) From Baseline to Week 2 | The change from baseline reflects the week 2 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes). | All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5 | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Week 2 | | | | ID | Title | Description |
|---|
| OG000 | Without Major Depressive Disorder (MDD-) | Patients with diabetic polyneuropathy and no depression | | OG001 | With Major Depressive Disorder (MDD+) | Patients with diabetic polyneuropathy and depression |
| |
| Secondary | Change in Interference of Pain With Mood (BPI) From Baseline to Week 6 | The change from baseline reflects the week 6 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes). | All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5 | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Without Major Depressive Disorder (MDD-) | Patients with diabetic polyneuropathy and no depression | | OG001 | With Major Depressive Disorder (MDD+) | Patients with diabetic polyneuropathy and depression |
| |
| Secondary | Change in Interference of Pain With Mood (BPI) From Baseline to Week 12 | The change from baseline reflects the week 12 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes). | All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5 | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Without Major Depressive Disorder (MDD-) | Patients with diabetic polyneuropathy and no depression | | OG001 | With Major Depressive Disorder (MDD+) | Patients with diabetic polyneuropathy and depression |
| |
| Secondary | Change in Interference of Pain With Walking Ability (BPI) From Baseline to Week 2 | The change from baseline reflects the week 2 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes). | All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5 | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Week 2 | | | | ID | Title | Description |
|---|
| OG000 | Without Major Depressive Disorder (MDD-) | Patients with diabetic polyneuropathy and no depression | | OG001 | With Major Depressive Disorder (MDD+) | Patients with diabetic polyneuropathy and depression |
| |
| Secondary | Change in Interference of Pain With Walking Ability (BPI) From Baseline to Week 6 | The change from baseline reflects the week 6 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes). | All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5 | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Without Major Depressive Disorder (MDD-) | Patients with diabetic polyneuropathy and no depression | | OG001 | With Major Depressive Disorder (MDD+) | Patients with diabetic polyneuropathy and depression |
| |
| Secondary | Change in Interference of Pain With Walking Ability (BPI) From Baseline to Week 12 | The change from baseline reflects the week 12 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes). | All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5 | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Without Major Depressive Disorder (MDD-) | Patients with diabetic polyneuropathy and no depression | | OG001 | With Major Depressive Disorder (MDD+) | Patients with diabetic polyneuropathy and depression |
| |
| Secondary | Change in Interference of Pain With Normal Work (BPI) From Baseline to Week 2 | The change from baseline reflects the week 2 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes). | All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5 | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Week 2 | | | | ID | Title | Description |
|---|
| OG000 | Without Major Depressive Disorder (MDD-) | Patients with diabetic polyneuropathy and no depression | | OG001 | With Major Depressive Disorder (MDD+) | Patients with diabetic polyneuropathy and depression |
| |
| Secondary | Change in Interference of Pain With Normal Work (BPI) From Baseline to Week 6 | The change from baseline reflects the week 6 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes). | All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5 | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Without Major Depressive Disorder (MDD-) | Patients with diabetic polyneuropathy and no depression | | OG001 | With Major Depressive Disorder (MDD+) | Patients with diabetic polyneuropathy and depression |
| |
| Secondary | Change in Interference of Pain With Normal Work (BPI) From Baseline to Week 12 | The change from baseline reflects the week 12 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes). | All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5 | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Without Major Depressive Disorder (MDD-) | Patients with diabetic polyneuropathy and no depression | | OG001 | With Major Depressive Disorder (MDD+) | Patients with diabetic polyneuropathy and depression |
| |
| Secondary | Change in Interference of Pain With Relations to Other People (BPI) From Baseline to Week 2 | The change from baseline reflects the week 2 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes). | All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5 | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Week 2 | | | | ID | Title | Description |
|---|
| OG000 | Without Major Depressive Disorder (MDD-) | Patients with diabetic polyneuropathy and no depression | | OG001 | With Major Depressive Disorder (MDD+) | Patients with diabetic polyneuropathy and depression |
| |
| Secondary | Change in Interference of Pain With Relations to Other People (BPI) From Baseline to Week 6 | The change from baseline reflects the week 6 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes). | All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5 | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Without Major Depressive Disorder (MDD-) | Patients with diabetic polyneuropathy and no depression | | OG001 | With Major Depressive Disorder (MDD+) | Patients with diabetic polyneuropathy and depression |
| |
| Secondary | Change in Interference of Pain With Relations to Other People (BPI) From Baseline to Week 12 | The change from baseline reflects the week 12 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes). | All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5 | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Without Major Depressive Disorder (MDD-) | Patients with diabetic polyneuropathy and no depression | | OG001 | With Major Depressive Disorder (MDD+) | Patients with diabetic polyneuropathy and depression |
| |
| Secondary | Change in Interference of Pain With Sleep (BPI) From Baseline to Week 2 | The change from baseline reflects the week 2 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes). | All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5 | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Week 2 | | | | ID | Title | Description |
|---|
| OG000 | Without Major Depressive Disorder (MDD-) | Patients with diabetic polyneuropathy and no depression | | OG001 | With Major Depressive Disorder (MDD+) | Patients with diabetic polyneuropathy and depression |
| |
| Secondary | Change in Interference of Pain With Sleep (BPI) From Baseline to Week 6 | The change from baseline reflects the week 6 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes). | All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5 | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Without Major Depressive Disorder (MDD-) | Patients with diabetic polyneuropathy and no depression | | OG001 | With Major Depressive Disorder (MDD+) | Patients with diabetic polyneuropathy and depression |
| |
| Secondary | Change in Interference of Pain With Sleep (BPI) From Baseline to Week 12 | The change from baseline reflects the week 12 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes). | All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5 | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Without Major Depressive Disorder (MDD-) | Patients with diabetic polyneuropathy and no depression | | OG001 | With Major Depressive Disorder (MDD+) | Patients with diabetic polyneuropathy and depression |
| |
| Secondary | Change in Interference of Pain With Enjoyment of Life (BPI) From Baseline to Week 2 | The change from baseline reflects the week 2 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes). | All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5 | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Week 2 | | | | ID | Title | Description |
|---|
| OG000 | Without Major Depressive Disorder (MDD-) | Patients with diabetic polyneuropathy and no depression | | OG001 | With Major Depressive Disorder (MDD+) | Patients with diabetic polyneuropathy and depression |
| |
| Secondary | Change in Interference of Pain With Enjoyment of Life (BPI) From Baseline to Week 6 | The change from baseline reflects the week 6 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes). | All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5 | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Without Major Depressive Disorder (MDD-) | Patients with diabetic polyneuropathy and no depression | | OG001 | With Major Depressive Disorder (MDD+) | Patients with diabetic polyneuropathy and depression |
| |
| Secondary | Change in Interference of Pain With Enjoyment of Life (BPI) From Baseline to Week 12 | The change from baseline reflects the week 12 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes). | All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5 | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Without Major Depressive Disorder (MDD-) | Patients with diabetic polyneuropathy and no depression | | OG001 | With Major Depressive Disorder (MDD+) | Patients with diabetic polyneuropathy and depression |
| |
| Secondary | Patient Global Impression - Improvement (PGI-I) at Week 2 | The investigator judged the improvement of the patient's global impression during treatment. The score ranges from 1 (very much better) to 7 (very much worse). | All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5 | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Week 2 | | | | ID | Title | Description |
|---|
| OG000 | Without Major Depressive Disorder (MDD-) | Patients with diabetic polyneuropathy and no depression | | OG001 | With Major Depressive Disorder (MDD+) | Patients with diabetic polyneuropathy and depression |
| |
| Secondary | Patient Global Impression - Improvement (PGI-I) at Week 6 | The investigator judged the improvement of the patient's global impression during treatment. The score ranges from 1 (very much better) to 7 (very much worse). | All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5 | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Without Major Depressive Disorder (MDD-) | Patients with diabetic polyneuropathy and no depression | | OG001 | With Major Depressive Disorder (MDD+) | Patients with diabetic polyneuropathy and depression |
| |
| Secondary | Patient Global Impression - Improvement (PGI-I) at Week 12 | The investigator judged the improvement of the patient's global impression during treatment. The score ranges from 1 (very much better) to 7 (very much worse). | All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5 | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Without Major Depressive Disorder (MDD-) | Patients with diabetic polyneuropathy and no depression | | OG001 | With Major Depressive Disorder (MDD+) | Patients with diabetic polyneuropathy and depression |
| |
| Secondary | Change in Beck Depression Inventory Total Score (BDI-II) From Baseline to Week 2 | The change from baseline reflects the week 2 value minus the baseline value. The BDI-II total score ranges from 0 to 63, with a higher score indicating a higher level of depression. | All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5 | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Week 2 | | | | ID | Title | Description |
|---|
| OG000 | Without Major Depressive Disorder (MDD-) | Patients with diabetic polyneuropathy and no depression | | OG001 | With Major Depressive Disorder (MDD+) | Patients with diabetic polyneuropathy and depression |
| |
| Secondary | Change in Beck Depression Inventory Total Score (BDI-II) From Baseline to Week 6 | The change from baseline reflects the week 6 value minus the baseline value. The BDI-II total score ranges from 0 to 63, with a higher score indicating a higher level of depression. | All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5 | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Without Major Depressive Disorder (MDD-) | Patients with diabetic polyneuropathy and no depression | | OG001 | With Major Depressive Disorder (MDD+) | Patients with diabetic polyneuropathy and depression |
| |
| Secondary | Change in Beck Depression Inventory Total Score (BDI-II) From Baseline to Week 12 | The change from baseline reflects the week 12 value minus the baseline value. The BDI-II total score ranges from 0 to 63, with a higher score indicating a higher level of depression. | All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5 | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Without Major Depressive Disorder (MDD-) | Patients with diabetic polyneuropathy and no depression | | OG001 | With Major Depressive Disorder (MDD+) | Patients with diabetic polyneuropathy and depression |
| |
| Secondary | Change in Hospital Anxiety and Depression Scale (HADS) Anxiety Total Score From Baseline to Week 2 | The change from baseline reflects the week 2 value minus the baseline value. The HADS anxiety total score ranges from 0 (no anxiety) to 21 (extreme anxiety). | All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5 | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Week 2 | | | | ID | Title | Description |
|---|
| OG000 | Without Major Depressive Disorder (MDD-) | Patients with diabetic polyneuropathy and no depression | | OG001 | With Major Depressive Disorder (MDD+) | Patients with diabetic polyneuropathy and depression |
| |
| Secondary | Change in HADS Anxiety Total Score From Baseline to Week 6 | The change from baseline reflects the week 6 value minus the baseline value. The HADS anxiety total score ranges from 0 (no anxiety) to 21 (extreme anxiety). | All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5 | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Without Major Depressive Disorder (MDD-) | Patients with diabetic polyneuropathy and no depression | | OG001 | With Major Depressive Disorder (MDD+) | Patients with diabetic polyneuropathy and depression |
| |
| Secondary | Change in HADS Anxiety Total Score From Baseline to Week 12 | The change from baseline reflects the week 12 value minus the baseline value. The HADS anxiety total score ranges from 0 (no anxiety) to 21 (extreme anxiety). | All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5 | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Without Major Depressive Disorder (MDD-) | Patients with diabetic polyneuropathy and no depression | | OG001 | With Major Depressive Disorder (MDD+) | Patients with diabetic polyneuropathy and depression |
| |
| Secondary | Change in HADS Depression Total Score From Baseline to Week 2 | The change from baseline reflects the week 2 value minus the baseline value. The HADS depression total score ranges from 0 (no depression) to 21 (extreme depression). | All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5 | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Week 2 | | | | ID | Title | Description |
|---|
| OG000 | Without Major Depressive Disorder (MDD-) | Patients with diabetic polyneuropathy and no depression | | OG001 | With Major Depressive Disorder (MDD+) | Patients with diabetic polyneuropathy and depression |
| |
| Secondary | Change in HADS Depression Total Score From Baseline to Week 6 | The change from baseline reflects the week 6 value minus the baseline value. The HADS depression total score ranges from 0 (no depression) to 21 (extreme depression). | All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5 | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Without Major Depressive Disorder (MDD-) | Patients with diabetic polyneuropathy and no depression | | OG001 | With Major Depressive Disorder (MDD+) | Patients with diabetic polyneuropathy and depression |
| |
| Secondary | Change in HADS Depression Total Score From Baseline to Week 12 | The change from baseline reflects the week 12 value minus the baseline value. The HADS depression total score ranges from 0 (no depression) to 21 (extreme depression). | All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5 | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Without Major Depressive Disorder (MDD-) | Patients with diabetic polyneuropathy and no depression | | OG001 | With Major Depressive Disorder (MDD+) | Patients with diabetic polyneuropathy and depression |
| |
| Secondary | Change in Short Form Health Survey (SF-12) - Physical Component Summary From Baseline to Week 6 | The change from baseline reflects the week 6 value minus the baseline value. A lower score corresponds to a lower level of physical health. Values can range from 0 to 100. | All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5 | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Without Major Depressive Disorder (MDD-) | Patients with diabetic polyneuropathy and no depression | | OG001 | With Major Depressive Disorder (MDD+) | Patients with diabetic polyneuropathy and depression |
| |
| Secondary | Change in Short Form Health Survey (SF-12) - Physical Component Summary From Baseline to Week 12 | The change from baseline reflects the week 12 value minus the baseline value. A lower score corresponds to a lower level of physical health. Values can range from 0 to 100. | All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5 | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Without Major Depressive Disorder (MDD-) | Patients with diabetic polyneuropathy and no depression | | OG001 | With Major Depressive Disorder (MDD+) | Patients with diabetic polyneuropathy and depression |
| |
| Secondary | Change in Short Form Health Survey (SF-12) - Mental Component Summary From Baseline to Week 6 | The change from baseline reflects the week 6 value minus the baseline value. A lower score corresponds to a lower level of mental health. Values can range from 0 to 100. | All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5 | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Without Major Depressive Disorder (MDD-) | Patients with diabetic polyneuropathy and no depression | | OG001 | With Major Depressive Disorder (MDD+) | Patients with diabetic polyneuropathy and depression |
| |
| Secondary | Change in Short Form Health Survey (SF-12) - Mental Component Summary From Baseline to Week 12 | The change from baseline reflects the week 12 value minus the baseline value. A lower score corresponds to a lower level of mental health. Values can range from 0 to 100. | All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5 | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Without Major Depressive Disorder (MDD-) | Patients with diabetic polyneuropathy and no depression | | OG001 | With Major Depressive Disorder (MDD+) | Patients with diabetic polyneuropathy and depression |
| |
| Secondary | Change in Multidimensional Pain Inventory (MPI): Interference of Pain (With Subjective Well-being) From Baseline to Week 6 | Pain-related life interference (with family and marital functioning, work, social activities). The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (no interference) to 6 (extreme interference). | All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5 | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Without Major Depressive Disorder (MDD-) | Patients with diabetic polyneuropathy and no depression | | OG001 | With Major Depressive Disorder (MDD+) | Patients with diabetic polyneuropathy and depression |
| |
| Secondary | Change in Multidimensional Pain Inventory (MPI): Interference of Pain From Baseline to Week 12 | Pain-related life interference (with family and marital functioning, work, social activities). The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (no interference) to 6 (extreme interference). | All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5 | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Without Major Depressive Disorder (MDD-) | Patients with diabetic polyneuropathy and no depression | | OG001 | With Major Depressive Disorder (MDD+) | Patients with diabetic polyneuropathy and depression |
| |
| Secondary | Change in Multidimensional Pain Inventory (MPI): Support From Baseline to Week 6 | Appraisal of support received from spouse, family and significant others. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (no support) to 6 (very much support). | All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5 | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Without Major Depressive Disorder (MDD-) | Patients with diabetic polyneuropathy and no depression | | OG001 | With Major Depressive Disorder (MDD+) | Patients with diabetic polyneuropathy and depression |
| |
| Secondary | Change in Multidimensional Pain Inventory (MPI): Support Which the Patient Received From Baseline to Week 12 | Appraisal of support received from spouse, family and significant others. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (no support) to 6 (very much support). | All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5 | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Without Major Depressive Disorder (MDD-) | Patients with diabetic polyneuropathy and no depression | | OG001 | With Major Depressive Disorder (MDD+) | Patients with diabetic polyneuropathy and depression |
| |
| Secondary | Change in Multidimensional Pain Inventory (MPI): Pain Severity From Baseline to Week 6 | The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (not at all strong) to 6 (very strong). | All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5 | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Without Major Depressive Disorder (MDD-) | Patients with diabetic polyneuropathy and no depression | | OG001 | With Major Depressive Disorder (MDD+) | Patients with diabetic polyneuropathy and depression |
| |
| Secondary | Change in Multidimensional Pain Inventory (MPI): Pain Severity From Baseline to Week 12 | The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (no control) to 6 (extreme control). | All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5 | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Without Major Depressive Disorder (MDD-) | Patients with diabetic polyneuropathy and no depression | | OG001 | With Major Depressive Disorder (MDD+) | Patients with diabetic polyneuropathy and depression |
| |
| Secondary | Change in Multidimensional Pain Inventory (MPI): Life Control From Baseline to Week 6 | Perceived life control and ability to solve problems and feelings of personal mastery and competence. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (no control) to 6 (extreme control). | All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5 | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Without Major Depressive Disorder (MDD-) | Patients with diabetic polyneuropathy and no depression | | OG001 | With Major Depressive Disorder (MDD+) | Patients with diabetic polyneuropathy and depression |
| |
| Secondary | Change in Multidimensional Pain Inventory (MPI): Life Control From Baseline to Week 12 | Perceived life control and ability to solve problems and feelings of personal mastery and competence. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (no control) to 6 (extreme control). | All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5 | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Without Major Depressive Disorder (MDD-) | Patients with diabetic polyneuropathy and no depression | | OG001 | With Major Depressive Disorder (MDD+) | Patients with diabetic polyneuropathy and depression |
| |
| Secondary | Change in Multidimensional Pain Inventory (MPI): Affective Distress From Baseline to Week 6 | Affective distress, including ratings of depressed mood, irritability, and tension. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (no distress) to 6 (extreme distress). | All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5 | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Without Major Depressive Disorder (MDD-) | Patients with diabetic polyneuropathy and no depression | | OG001 | With Major Depressive Disorder (MDD+) | Patients with diabetic polyneuropathy and depression |
| |
| Secondary | Change in Multidimensional Pain Inventory (MPI): Affective Distress From Baseline to Week 12 | Affective distress, including ratings of depressed mood, irritability, and tension. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (no distress) to 6 (extreme distress). | All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5 | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Without Major Depressive Disorder (MDD-) | Patients with diabetic polyneuropathy and no depression | | OG001 | With Major Depressive Disorder (MDD+) | Patients with diabetic polyneuropathy and depression |
| |
| Secondary | Change in Multidimensional Pain Inventory (MPI): Negative Responses From Baseline to Week 6 | Degree to which significant others display negative responses to the patient's pain behaviors and complaints. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently). | All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5 | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Without Major Depressive Disorder (MDD-) | Patients with diabetic polyneuropathy and no depression | | OG001 | With Major Depressive Disorder (MDD+) | Patients with diabetic polyneuropathy and depression |
| |
| Secondary | Change in Multidimensional Pain Inventory (MPI): Negative Responses From Baseline to Week 12 | Degree to which significant others display negative responses to the patient's pain behaviors and complaints. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently). | All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5 | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Without Major Depressive Disorder (MDD-) | Patients with diabetic polyneuropathy and no depression | | OG001 | With Major Depressive Disorder (MDD+) | Patients with diabetic polyneuropathy and depression |
| |
| Secondary | Change in Multidimensional Pain Inventory (MPI): Solicitous Responses From Baseline to Week 6 | Degree to which significant others display solicitous responses to the patient's pain behaviors and complaints. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently). | All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5 | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Without Major Depressive Disorder (MDD-) | Patients with diabetic polyneuropathy and no depression | | OG001 | With Major Depressive Disorder (MDD+) | Patients with diabetic polyneuropathy and depression |
| |
| Secondary | Change in Multidimensional Pain Inventory (MPI): Solicitous Responses From Baseline to Week 12 | Degree to which significant others display solicitous responses to the patient's pain behaviors and complaints. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently). | All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5 | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Without Major Depressive Disorder (MDD-) | Patients with diabetic polyneuropathy and no depression | | OG001 | With Major Depressive Disorder (MDD+) | Patients with diabetic polyneuropathy and depression |
| |
| Secondary | Change in Multidimensional Pain Inventory (MPI): Degree to Which Significant Others Display Distracting Responses to the Patient's Pain Behaviors and Complaints From Baseline to Week 6 | Degree to which significant others display distracting responses to the patient's pain behaviors and complaints. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently). | All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5 | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Without Major Depressive Disorder (MDD-) | Patients with diabetic polyneuropathy and no depression | | OG001 | With Major Depressive Disorder (MDD+) | Patients with diabetic polyneuropathy and depression |
| |
| Secondary | Change in Multidimensional Pain Inventory (MPI): Degree to Which Significant Others Display Distracting Responses to the Patient's Pain Behaviors and Complaints From Baseline to Week 12 | Degree to which significant others display distracting responses to the patient's pain behaviors and complaints. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently). | All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5 | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Without Major Depressive Disorder (MDD-) | Patients with diabetic polyneuropathy and no depression | | OG001 | With Major Depressive Disorder (MDD+) | Patients with diabetic polyneuropathy and depression |
| |
| Secondary | Change in Multidimensional Pain Inventory (MPI): Household Chores From Baseline to Week 6 | Frequency with which the patient engages in household chores. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently). | All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5 | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Without Major Depressive Disorder (MDD-) | Patients with diabetic polyneuropathy and no depression | | OG001 | With Major Depressive Disorder (MDD+) | Patients with diabetic polyneuropathy and depression |
| |
| Secondary | Change in Multidimensional Pain Inventory (MPI): Household Chores From Baseline to Week 12 | Frequency with which the patient engages in household chores. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently). | All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5 | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Without Major Depressive Disorder (MDD-) | Patients with diabetic polyneuropathy and no depression | | OG001 | With Major Depressive Disorder (MDD+) | Patients with diabetic polyneuropathy and depression |
| |
| Secondary | Change in Multidimensional Pain Inventory (MPI): Outdoor Work From Baseline to Week 6 | Frequency with which the patient engages in outdoor work. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently). | All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5 | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Without Major Depressive Disorder (MDD-) | Patients with diabetic polyneuropathy and no depression | | OG001 | With Major Depressive Disorder (MDD+) | Patients with diabetic polyneuropathy and depression |
| |
| Secondary | Change in Multidimensional Pain Inventory (MPI): Outdoor Work From Baseline to Week 12 | Frequency with which the patient engages in outdoor work. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently). | All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5 | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Without Major Depressive Disorder (MDD-) | Patients with diabetic polyneuropathy and no depression | | OG001 | With Major Depressive Disorder (MDD+) | Patients with diabetic polyneuropathy and depression |
| |
| Secondary | Change in Multidimensional Pain Inventory (MPI): Social Activities From Baseline to Week 6 | Frequency with which the patient engages in social activities. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently). | All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5 | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Without Major Depressive Disorder (MDD-) | Patients with diabetic polyneuropathy and no depression | | OG001 | With Major Depressive Disorder (MDD+) | Patients with diabetic polyneuropathy and depression |
| |
| Secondary | Change in Multidimensional Pain Inventory (MPI): Social Activities From Baseline to Week 12 | Frequency with which the patient engages in social activities. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently). | All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5 | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Without Major Depressive Disorder (MDD-) | Patients with diabetic polyneuropathy and no depression | | OG001 | With Major Depressive Disorder (MDD+) | Patients with diabetic polyneuropathy and depression |
| |
| Secondary | Change in Multidimensional Pain Inventory (MPI): General Activities From Baseline to Week 6 | Frequency with which the patient engages in general activities. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently). | All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5 | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Without Major Depressive Disorder (MDD-) | Patients with diabetic polyneuropathy and no depression | | OG001 | With Major Depressive Disorder (MDD+) | Patients with diabetic polyneuropathy and depression |
| |
| Secondary | Change in Multidimensional Pain Inventory (MPI): General Activities From Baseline to Week 12 | Frequency with which the patient engages in general activities. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently). | All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5 | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Without Major Depressive Disorder (MDD-) | Patients with diabetic polyneuropathy and no depression | | OG001 | With Major Depressive Disorder (MDD+) | Patients with diabetic polyneuropathy and depression |
| |
| Secondary | Change in Clinical Global Impression - Severity Pain From Baseline to Week 2 | The change from baseline reflects the week 2 value minus the baseline value. The score of the Clinical global impression ranges from 1 (not ill at all) to 7 (extremely ill). | All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5 | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Week 2 | | | | ID | Title | Description |
|---|
| OG000 | Without Major Depressive Disorder (MDD-) | Patients with diabetic polyneuropathy and no depression | | OG001 | With Major Depressive Disorder (MDD+) | Patients with diabetic polyneuropathy and depression |
| |
| Secondary | Change in Clinical Global Impression - Severity Pain From Baseline to Week 6 | The change from baseline reflects the week 6 value minus the baseline value. The score of the Clinical global impression ranges from 1 (not ill at all) to 7 (extremely ill). | All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5 | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Without Major Depressive Disorder (MDD-) | Patients with diabetic polyneuropathy and no depression | | OG001 | With Major Depressive Disorder (MDD+) | Patients with diabetic polyneuropathy and depression |
| |
| Secondary | Change in Clinical Global Impression - Severity Pain From Baseline to Week 12 | The change from baseline reflects the week 12 value minus the baseline value. The score of the Clinical global impression ranges from 1 (not ill at all) to 7 (extremely ill). | | Posted | | Mean | Standard Deviation | Scores of a scale | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Without Major Depressive Disorder (MDD-) | Patients with diabetic polyneuropathy and no depression | | OG001 | With Major Depressive Disorder (MDD+) | Patients with diabetic polyneuropathy and depression |
| |
| Secondary | Change in Hamilton Depression Score From Baseline to Week 2 | The change from baseline reflects the week 2 value minus the baseline value. A lower score corresponds to a lower level of depression. The score ranges from 0 to 52. | All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5 | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Week 2 | | | | ID | Title | Description |
|---|
| OG000 | Without Major Depressive Disorder (MDD-) | Patients with diabetic polyneuropathy and no depression | | OG001 | With Major Depressive Disorder (MDD+) | Patients with diabetic polyneuropathy and depression |
| |
| Secondary | Change in Hamilton Depression Score From Baseline to Week 6 | The change from baseline reflects the week 6 value minus the baseline value. A lower score corresponds to a lower level of depression. The score ranges from 0 to 52. | All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5 | Posted | | Mean | Standard Deviation | Scores of a scale | | Baseline and Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Without Major Depressive Disorder (MDD-) | Patients with diabetic polyneuropathy and no depression | | OG001 | With Major Depressive Disorder (MDD+) | Patients with diabetic polyneuropathy and depression |
| |
| Secondary | Change in Hamilton Depression Score From Baseline to Week 12 | The change from baseline reflects the week 12 value minus the baseline value. A lower score corresponds to a lower level of depression. The score ranges from 0 to 52. | All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5 | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Without Major Depressive Disorder (MDD-) | Patients with diabetic polyneuropathy and no depression | | OG001 | With Major Depressive Disorder (MDD+) | Patients with diabetic polyneuropathy and depression |
| |
| Secondary | Suicidal Thoughts by BDI-II at Week 2 | | All patients receiving at least one dose of study medication and having data at week 2. | Posted | | Number | | Participants | | Week 2 | | | | ID | Title | Description |
|---|
| OG000 | Without Major Depressive Disorder (MDD-) | Patients with diabetic polyneuropathy and no depression | | OG001 | With Major Depressive Disorder (MDD+) | Patients with diabetic polyneuropathy and depression |
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| Secondary | Suicidal Thoughts by BDI-II at Week 6 | | All patients receiving at least one dose of study medication and having data at week 6. | Posted | | Number | | Participants | | Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Without Major Depressive Disorder (MDD-) | Patients with diabetic polyneuropathy and no depression | | OG001 | With Major Depressive Disorder (MDD+) | Patients with diabetic polyneuropathy and depression |
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| Secondary | Suicidal Thoughts by BDI-II at Week 12 | | All patients receiving at least one dose of study medication and having data at week 12. | Posted | | Number | | Participants | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Without Major Depressive Disorder (MDD-) | Patients with diabetic polyneuropathy and no depression | | OG001 | With Major Depressive Disorder (MDD+) | Patients with diabetic polyneuropathy and depression |
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| Secondary | Suicidal Thoughts or Behaviours by HAMD-17 at Week 2 | | All patients receiving at least one dose of study medication and having data at week 2. | Posted | | Number | | Participants | | Week 2 | | | | ID | Title | Description |
|---|
| OG000 | Without Major Depressive Disorder (MDD-) | Patients with diabetic polyneuropathy and no depression | | OG001 | With Major Depressive Disorder (MDD+) | Patients with diabetic polyneuropathy and depression |
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| Secondary | Suicidal Thoughts or Behaviours by HAMD-17 at Week 6 | | All patients receiving at least one dose of study medication and having data at week 6. | Posted | | Number | | Participants | | Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Without Major Depressive Disorder (MDD-) | Patients with diabetic polyneuropathy and no depression | | OG001 | With Major Depressive Disorder (MDD+) | Patients with diabetic polyneuropathy and depression |
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| Secondary | Suicidal Thoughts or Behaviours by HAMD-17 at Week 12 | | All patients receiving at least one dose of study medication and having data at week 12. | Posted | | Number | | Participants | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Without Major Depressive Disorder (MDD-) | Patients with diabetic polyneuropathy and no depression | | OG001 | With Major Depressive Disorder (MDD+) | Patients with diabetic polyneuropathy and depression |
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| Secondary | Change of Fasting Blood Glucose From Baseline at Week 12 | Ancova analysis controlling for baseline and insulin intake | All patients receiving at least one dose of study medication and having data of fasting blood glucose at baseline and at week 12. | Posted | | Least Squares Mean | 95% Confidence Interval | mg/dL | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Without Major Depressive Disorder (MDD-) | Patients with diabetic polyneuropathy and no depression | | OG001 | With Major Depressive Disorder (MDD+) | Patients with diabetic polyneuropathy and depression |
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| Secondary | Change of Glycosylated Hemoglobin A1c (HbA1c) From Baseline at Week 12 | Ancova analysis controlling for baseline and insulin intake | All patients receiving at least one dose of study medication and having data of HbA1c at baseline and at week 12. | Posted | | Least Squares Mean | 95% Confidence Interval | percent | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Without Major Depressive Disorder (MDD-) | Patients with diabetic polyneuropathy and no depression | | OG001 | With Major Depressive Disorder (MDD+) | Patients with diabetic polyneuropathy and depression |
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| Secondary | Change of Systolic Blood Pressure From Baseline at Week 12 | | All patients receiving at least one dose of study medication. | Posted | | Mean | Standard Deviation | mmHg | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Without Major Depressive Disorder (MDD-) | Patients with diabetic polyneuropathy and no depression | | OG001 | With Major Depressive Disorder (MDD+) | Patients with diabetic polyneuropathy and depression |
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| Secondary | Change of Diastolic Blood Pressure From Baseline at Week 12 | | All patients receiving at least one dose of study medication. | Posted | | Mean | Standard Deviation | mmHg | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Without Major Depressive Disorder (MDD-) | Patients with diabetic polyneuropathy and no depression | | OG001 | With Major Depressive Disorder (MDD+) | Patients with diabetic polyneuropathy and depression |
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| Secondary | Change of Pulse Rate From Baseline at Week 12 | | All patients receiving at least one dose of study medication. | Posted | | Mean | Standard Deviation | beats per minute (bpm) | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Without Major Depressive Disorder (MDD-) | Patients with diabetic polyneuropathy and no depression | | OG001 | With Major Depressive Disorder (MDD+) | Patients with diabetic polyneuropathy and depression |
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| Primary | Change of Brief Pain Inventory (BPI) Average Interference Score From Baseline to Week 12 | The change from baseline reflects the week 12 value minus the baseline value. The BPI average interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes). | All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5 | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | MDD- Responder | MDD-, treatment responder. 60mg Duloxetine (DLX) for 12 weeks | | OG001 | MDD+ Responder | MDD+, treatment responder. 60mg Duloxetine (DLX) for 12 weeks | | OG002 | MDD- Non-Responder | MDD-, not treatment responder. 60mg, after week 5 120mg DLX | | OG003 | MDD+ Non-Responder | MDD+, not treatment responder. 60mg, after week 5 120mg DLX |
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