Depressive Disorder, Major, Diabetic Neuropathies
Conditions
Brief summary
The primary objective is to evaluate, separately in diabetic polyneuropathic pain (DPNP) patients with and without co-morbid major depressive disorder (MDD), whether duloxetine given as 60 mg to 120 mg once daily (QD) leads to a clinically relevant improvement as measured by the change in Brief Pain Inventory (BPI) 24 hours average interference score from baseline to after 12 weeks. A clinically relevant improvement will be demonstrated if the confidence interval for the mean change from baseline does not lie above the clinically relevant change of -1.35. If statistically significant results are obtained for the DPNP patients with MDD, then the same evaluation will be performed for the DPNP patients without MDD in another confirmatory analysis. As secondary objectives the study will compare the two groups (MDD+/MDD-) regarding efficacy of duloxetine on BPI severity scales, the distribution of different percentages of pain reduction among the patient population, and the patients and physicians impressions of severity and improvement of pain. The study will also compare treatment outcomes regarding patient-relevant functionality and quality of life (QoL) between the two groups (MDD+/MDD-) by evaluating each single BPI interference item, the Short Form 12 (SF-12) Health Questionnaire and the West Haven Multidimensional Pain Inventory (MPI). As a third group of secondary objectives the efficacy of duloxetine of the psychological symptoms (e.g. depression) of DPNP patients with or without depression will be assessed using the Hamilton depression scale, the Beck Depression Inventory-II and the hospital Anxiety and Depression Scale. Further the effect of duloxetine treatment on fasting blood glucose (FBG) and hemoglobin A1c (HbA1c) will be evaluated. To monitor safety and tolerability, treatment discontinuation rates, treatment emergent adverse events, change in vital signs, laboratory results and suicidal thoughts will be assessed.
Interventions
given to (1) all patients week 2-6; (2) all responders of both arms week 7-12
DRUGDuloxetine 30 mg QD
given to (1) all patients for one week as taper in; (2) all patients for taper down (responder for 2 weeks)
DRUGDuloxetine 90 mg QD
given to non-responders of both arms from day of notice that 120 mg is not tolerated to week 12 as 60 mg+30 mg Duloxetine QD
DRUGDuloxetine 120 mg QD
given to non-responders of both arms from week 7-12 as 2x60 mg Duloxetine QD, if tolerated
Sponsors
Boehringer Ingelheim
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Present with pain due to bilateral peripheral neuropathy (according to International Statistical Classification of Diseases and Related Health Problems 10 (ICD 10). 2. To qualify for the MDD+ cohort, patients need to meet the ICD-10 criteria for MDD. Furthermore, Hamilton rating scale for depression 17 (HAMD-17) scores need to match with the ICD-10 criteria for qualification of the MDD+ or MDD- groups. 3. Male or female outpatients at least 18 years of age. 4. Females with child bearing potential must test negative for a serum pregnancy test at Visit 1. Females of child-bearing potential (not surgically sterilized and between menarche and 1 year post-menopause) must agree to utilize medically acceptable and reliable means of birth control as determined by the investigator during the study and for 1 month following the last dose of the study. Examples of reliable methods include use of oral contraceptives or Depo-Clinovir Contraceptive Injection (sterile medroxyprogesterone acetate suspension, Pharmacia), partner with vasectomy, diaphragms with contraceptive jelly, cervical caps with contraceptive jelly, condoms with contraceptive foam, or intrauterine devices. Women who are pregnant or breast-feeding may not participate in the study. 5. Educational level and degree of understanding such that they can communicate intelligibly with the investigator and study coordinator. 6. Judged to be reliable and agrees to keep all appointments for clinic visits, tests, and procedures required by the protocol.
Exclusion criteria
1. Have already a diagnosis of Depression and are currently treated with an antidepressant medication for depression, when entering the study. 2. Suffer from pain that cannot be clearly differentiated from or conditions that interfere with the assessment of DPNPain. 3. Had a historical exposure to drugs known to cause neuropathy, that could have been responsible for neuropathy. 4. Have previously been treated with duloxetine (for DPNP or MDD) 5. Are judged to be at suicidal risk by the clinical investigator or as defined by a score of 2 or greater on question 9 of the Beck Depression Inventory-II (BDI-II). 6. Had a history of substance abuse or dependence within the past year, excluding nicotine and caffeine.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of Brief Pain Inventory (BPI) Average Interference Score From Baseline to Week 12 | Baseline and 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain During Treatment (BPI) From Baseline to Week 2 | Baseline and 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). |
| Change of Brief Pain Inventory (BPI) Average Interference Score From Baseline to Week 6 | Baseline and 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). |
| Change in BPI Worst Pain During Treatment From Baseline to Week 2 | Baseline and 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). |
| Change in Worst Pain (BPI) From Baseline to Week 6 | Baseline and 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). |
| Change in Worst Pain (BPI) From Baseline to Week 12 | Baseline and 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). |
| Change in Least Pain (BPI) From Baseline to Week 2 | Baseline and 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). |
| Change in Least Pain During Treatment (BPI) From Baseline to Week 6 | Baseline and 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). |
| Change in Least Pain (BPI) From Baseline to Week 12 | Baseline and 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). |
| Change in Average Pain (BPI) From Baseline to Week 2 | Baseline and 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). |
| Change in Average Pain During Treatment (BPI) From Baseline to Week 6 | Baseline and 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). |
| Change in Average Pain (BPI) From Baseline to Week 12 | Baseline and 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). |
| Number of Patients With a Reduction in BPI Average Pain at Week 2 | Baseline and Week 2 | — |
| Number of Patients With a Reduction in BPI Average Pain at Week 6 | Baseline and Week 6 | — |
| Change in Pain (BPI) From Baseline to Week 6 | Baseline and 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). |
| Change in Pain During Treatment (BPI) From Baseline to Week 12 | Baseline and 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). |
| Change in Relief of Pain (BPI) From the Week Before Baseline to the Week Before Week 2 | Baseline and 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). |
| Change in Relief of Pain (BPI) From the Week Before Baseline to the Week Before Week 6 | Baseline and 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). |
| Change in Relief of Pain (BPI) From the Week Before Baseline to the Week Before Week 12 | Baseline and 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). |
| Change in Interference of Pain With General Activity (BPI) From Baseline to Week 2 | Baseline and 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). |
| Change in Interference of Pain With General Activity (BPI) From Baseline to Week 6 | Baseline and 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). |
| Change in Interference of Pain With General Activity (BPI) From Baseline to Week 12 | Baseline and 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). |
| Change in Interference of Pain With Mood (BPI) From Baseline to Week 2 | Baseline and 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). |
| Change in Interference of Pain With Mood (BPI) From Baseline to Week 6 | Baseline and 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). |
| Change in Interference of Pain With Mood (BPI) From Baseline to Week 12 | Baseline and 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). |
| Change in Interference of Pain With Walking Ability (BPI) From Baseline to Week 2 | Baseline and 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). |
| Change in Interference of Pain With Walking Ability (BPI) From Baseline to Week 6 | Baseline and 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). |
| Change in Interference of Pain With Walking Ability (BPI) From Baseline to Week 12 | Baseline and 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). |
| Change in Interference of Pain With Normal Work (BPI) From Baseline to Week 2 | Baseline and 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). |
| Change in Interference of Pain With Normal Work (BPI) From Baseline to Week 6 | Baseline and 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). |
| Change in Interference of Pain With Normal Work (BPI) From Baseline to Week 12 | Baseline and 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). |
| Change in Interference of Pain With Relations to Other People (BPI) From Baseline to Week 2 | Baseline and 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). |
| Change in Interference of Pain With Relations to Other People (BPI) From Baseline to Week 6 | Baseline and 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). |
| Change in Interference of Pain With Relations to Other People (BPI) From Baseline to Week 12 | Baseline and 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). |
| Change in Interference of Pain With Sleep (BPI) From Baseline to Week 2 | Baseline and 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). |
| Change in Interference of Pain With Sleep (BPI) From Baseline to Week 6 | Baseline and 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). |
| Change in Interference of Pain With Sleep (BPI) From Baseline to Week 12 | Baseline and 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). |
| Change in Interference of Pain With Enjoyment of Life (BPI) From Baseline to Week 2 | Baseline and 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). |
| Change in Interference of Pain With Enjoyment of Life (BPI) From Baseline to Week 6 | Baseline and 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). |
| Change in Interference of Pain With Enjoyment of Life (BPI) From Baseline to Week 12 | Baseline and 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). |
| Patient Global Impression - Improvement (PGI-I) at Week 2 | Baseline and 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). |
| Patient Global Impression - Improvement (PGI-I) at Week 6 | Baseline and 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). |
| Patient Global Impression - Improvement (PGI-I) at Week 12 | Baseline and 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). |
| Change in Beck Depression Inventory Total Score (BDI-II) From Baseline to Week 2 | Baseline and 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. |
| Change in Beck Depression Inventory Total Score (BDI-II) From Baseline to Week 6 | Baseline and 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. |
| Change in Beck Depression Inventory Total Score (BDI-II) From Baseline to Week 12 | Baseline and 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. |
| Change in Hospital Anxiety and Depression Scale (HADS) Anxiety Total Score From Baseline to Week 2 | Baseline and 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). |
| Change in HADS Anxiety Total Score From Baseline to Week 6 | Baseline and 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). |
| Change in HADS Anxiety Total Score From Baseline to Week 12 | Baseline and 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). |
| Change in HADS Depression Total Score From Baseline to Week 2 | Baseline and 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). |
| Change in HADS Depression Total Score From Baseline to Week 6 | Baseline and 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). |
| Change in HADS Depression Total Score From Baseline to Week 12 | Baseline and 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). |
| Change in Short Form Health Survey (SF-12) - Physical Component Summary From Baseline to Week 6 | Baseline and 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. |
| Change in Short Form Health Survey (SF-12) - Physical Component Summary From Baseline to Week 12 | Baseline and 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. |
| Change in Short Form Health Survey (SF-12) - Mental Component Summary From Baseline to Week 6 | Baseline and 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. |
| Change in Short Form Health Survey (SF-12) - Mental Component Summary From Baseline to Week 12 | Baseline and 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. |
| Change in Multidimensional Pain Inventory (MPI): Interference of Pain (With Subjective Well-being) From Baseline to Week 6 | Baseline and 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). |
| Change in Multidimensional Pain Inventory (MPI): Interference of Pain From Baseline to Week 12 | Baseline and 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). |
| Change in Multidimensional Pain Inventory (MPI): Support From Baseline to Week 6 | Baseline and 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). |
| Change in Multidimensional Pain Inventory (MPI): Support Which the Patient Received From Baseline to Week 12 | Baseline and 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). |
| Change in Multidimensional Pain Inventory (MPI): Pain Severity From Baseline to Week 6 | Baseline and 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). |
| Change in Multidimensional Pain Inventory (MPI): Pain Severity From Baseline to Week 12 | Baseline and 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). |
| Change in Multidimensional Pain Inventory (MPI): Life Control From Baseline to Week 6 | Baseline and 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). |
| Change in Multidimensional Pain Inventory (MPI): Life Control From Baseline to Week 12 | Baseline and 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). |
| Change in Multidimensional Pain Inventory (MPI): Affective Distress From Baseline to Week 6 | Baseline and 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). |
| Change in Multidimensional Pain Inventory (MPI): Affective Distress From Baseline to Week 12 | Baseline and 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). |
| Change in Multidimensional Pain Inventory (MPI): Negative Responses From Baseline to Week 6 | Baseline and 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). |
| Change in Multidimensional Pain Inventory (MPI): Negative Responses From Baseline to Week 12 | Baseline and 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). |
| Change in Multidimensional Pain Inventory (MPI): Solicitous Responses From Baseline to Week 6 | Baseline and 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). |
| Change in Multidimensional Pain Inventory (MPI): Solicitous Responses From Baseline to Week 12 | Baseline and 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). |
| 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 | Baseline and 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). |
| 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 | Baseline and 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). |
| Change in Multidimensional Pain Inventory (MPI): Household Chores From Baseline to Week 6 | Baseline and 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). |
| Change in Multidimensional Pain Inventory (MPI): Household Chores From Baseline to Week 12 | Baseline and 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). |
| Change in Multidimensional Pain Inventory (MPI): Outdoor Work From Baseline to Week 6 | Baseline and 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). |
| Change in Multidimensional Pain Inventory (MPI): Outdoor Work From Baseline to Week 12 | Baseline and 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). |
| Change in Multidimensional Pain Inventory (MPI): Social Activities From Baseline to Week 6 | Baseline and 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). |
| Change in Multidimensional Pain Inventory (MPI): Social Activities From Baseline to Week 12 | Baseline and 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). |
| Change in Multidimensional Pain Inventory (MPI): General Activities From Baseline to Week 6 | Baseline and 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). |
| Change in Multidimensional Pain Inventory (MPI): General Activities From Baseline to Week 12 | Baseline and 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). |
| Change in Clinical Global Impression - Severity Pain From Baseline to Week 2 | Baseline and 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). |
| Change in Clinical Global Impression - Severity Pain From Baseline to Week 6 | Baseline and 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). |
| Change in Clinical Global Impression - Severity Pain From Baseline to Week 12 | Baseline and 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). |
| Change in Hamilton Depression Score From Baseline to Week 2 | Baseline and 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. |
| Change in Hamilton Depression Score From Baseline to Week 6 | Baseline and 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. |
| Number of Patients With a Reduction in BPI Average Pain at Week 12 | Baseline and Week 12 | — |
| Suicidal Thoughts by BDI-II at Week 2 | Week 2 | — |
| Suicidal Thoughts by BDI-II at Week 6 | Week 6 | — |
| Suicidal Thoughts by BDI-II at Week 12 | Week 12 | — |
| Suicidal Thoughts or Behaviours by HAMD-17 at Week 2 | Week 2 | — |
| Suicidal Thoughts or Behaviours by HAMD-17 at Week 6 | Week 6 | — |
| Suicidal Thoughts or Behaviours by HAMD-17 at Week 12 | Week 12 | — |
| Change of Fasting Blood Glucose From Baseline at Week 12 | Baseline and Week 12 | Ancova analysis controlling for baseline and insulin intake |
| Change of Glycosylated Hemoglobin A1c (HbA1c) From Baseline at Week 12 | Baseline and Week 12 | Ancova analysis controlling for baseline and insulin intake |
| Change of Systolic Blood Pressure From Baseline at Week 12 | Baseline and Week 12 | — |
| Change of Diastolic Blood Pressure From Baseline at Week 12 | Baseline and Week 12 | — |
| Change of Pulse Rate From Baseline at Week 12 | Baseline and Week 12 | — |
| Change in Hamilton Depression Score From Baseline to Week 12 | Baseline and 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. |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Without Major Depressive Disorder (MDD-) Patients with diabetic polyneuropathy and no depression | 78 |
| With Major Depressive Disorder (MDD+) Patients with diabetic polyneuropathy and depression | 30 |
| Total | 108 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 17 | 5 |
| Overall Study | Lack of Efficacy | 3 | 0 |
| Overall Study | Lost to Follow-up | 1 | 1 |
| Overall Study | Other reason (not specified) | 1 | 0 |
| Overall Study | Protocol Violation | 1 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 1 |
Baseline characteristics
| Characteristic | Without Major Depressive Disorder (MDD-) | With Major Depressive Disorder (MDD+) | Total |
|---|---|---|---|
| Age, Continuous | 67.5 Years STANDARD_DEVIATION 10.2 | 66.6 Years STANDARD_DEVIATION 9.8 | 67.3 Years STANDARD_DEVIATION 10.1 |
| Sex: Female, Male Female | 36 Participants | 15 Participants | 51 Participants |
| Sex: Female, Male Male | 42 Participants | 15 Participants | 57 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 28 / 78 | 16 / 30 |
| serious Total, serious adverse events | 4 / 78 | 2 / 30 |
Outcome results
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).
Time frame: Baseline and Week 12
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Without Major Depressive Disorder (MDD-) | Change of Brief Pain Inventory (BPI) Average Interference Score From Baseline to Week 12 | -1.7 Scores on a scale | Standard Deviation 1.65 |
| With Major Depressive Disorder (MDD+) | Change of Brief Pain Inventory (BPI) Average Interference Score From Baseline to Week 12 | -2.2 Scores on a scale | Standard Deviation 2 |
| MDD- Non-Responder | Change of Brief Pain Inventory (BPI) Average Interference Score From Baseline to Week 12 | -0.9 Scores on a scale | Standard Deviation 2.5 |
| MDD+ Non-Responder | Change of Brief Pain Inventory (BPI) Average Interference Score From Baseline to Week 12 | -2.6 Scores on a scale | Standard Deviation 3.31 |
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).
Time frame: Baseline and Week 12
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Without Major Depressive Disorder (MDD-) | Change of Brief Pain Inventory (BPI) Average Interference Score From Baseline to Week 12 | -1.4 Scores on a scale | Standard Deviation 1.91 |
| With Major Depressive Disorder (MDD+) | Change of Brief Pain Inventory (BPI) Average Interference Score From Baseline to Week 12 | -2.2 Scores on a scale | Standard Deviation 2.2 |
p-value: <0.000195% CI: [-1.89, -1.1]ANCOVA
p-value: <0.000195% CI: [-2.3, -1.04]ANCOVA
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).
Time frame: Baseline and Week 12
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Without Major Depressive Disorder (MDD-) | Change in Average Pain (BPI) From Baseline to Week 12 | -2.4 Scores on a scale | Standard Deviation 1.88 |
| With Major Depressive Disorder (MDD+) | Change in Average Pain (BPI) From Baseline to Week 12 | -2.2 Scores on a scale | Standard Deviation 2.07 |
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).
Time frame: Baseline and Week 2
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Without Major Depressive Disorder (MDD-) | Change in Average Pain (BPI) From Baseline to Week 2 | -1.6 Scores on a scale | Standard Deviation 1.87 |
| With Major Depressive Disorder (MDD+) | Change in Average Pain (BPI) From Baseline to Week 2 | -1.1 Scores on a scale | Standard Deviation 1.63 |
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).
Time frame: Baseline and Week 6
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Without Major Depressive Disorder (MDD-) | Change in Average Pain During Treatment (BPI) From Baseline to Week 6 | -2.6 Scores on a scale | Standard Deviation 1.92 |
| With Major Depressive Disorder (MDD+) | Change in Average Pain During Treatment (BPI) From Baseline to Week 6 | -2.6 Scores on a scale | Standard Deviation 2 |
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.
Time frame: Baseline and Week 12
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Without Major Depressive Disorder (MDD-) | Change in Beck Depression Inventory Total Score (BDI-II) From Baseline to Week 12 | -1.6 Scores on a scale | Standard Deviation 6.02 |
| With Major Depressive Disorder (MDD+) | Change in Beck Depression Inventory Total Score (BDI-II) From Baseline to Week 12 | -7.8 Scores on a scale | Standard Deviation 7.25 |
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.
Time frame: Baseline and Week 2
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Without Major Depressive Disorder (MDD-) | Change in Beck Depression Inventory Total Score (BDI-II) From Baseline to Week 2 | -0.9 Scores on a scale | Standard Deviation 3.61 |
| With Major Depressive Disorder (MDD+) | Change in Beck Depression Inventory Total Score (BDI-II) From Baseline to Week 2 | -3.1 Scores on a scale | Standard Deviation 5.79 |
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.
Time frame: Baseline and Week 6
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Without Major Depressive Disorder (MDD-) | Change in Beck Depression Inventory Total Score (BDI-II) From Baseline to Week 6 | -1.8 Scores on a scale | Standard Deviation 5.93 |
| With Major Depressive Disorder (MDD+) | Change in Beck Depression Inventory Total Score (BDI-II) From Baseline to Week 6 | -7.3 Scores on a scale | Standard Deviation 7.05 |
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).
Time frame: Baseline and Week 2
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Without Major Depressive Disorder (MDD-) | Change in BPI Worst Pain During Treatment From Baseline to Week 2 | -2.2 Scores on a scale | Standard Deviation 2.27 |
| With Major Depressive Disorder (MDD+) | Change in BPI Worst Pain During Treatment From Baseline to Week 2 | -1.9 Scores on a scale | Standard Deviation 2.19 |
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).
Time frame: Baseline and Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Without Major Depressive Disorder (MDD-) | Change in Clinical Global Impression - Severity Pain From Baseline to Week 12 | -0.8 Scores of a scale | Standard Deviation 1.08 |
| With Major Depressive Disorder (MDD+) | Change in Clinical Global Impression - Severity Pain From Baseline to Week 12 | -1.0 Scores of a scale | Standard Deviation 0.94 |
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).
Time frame: Baseline and Week 2
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Without Major Depressive Disorder (MDD-) | Change in Clinical Global Impression - Severity Pain From Baseline to Week 2 | -0.5 Scores on a scale | Standard Deviation 0.96 |
| With Major Depressive Disorder (MDD+) | Change in Clinical Global Impression - Severity Pain From Baseline to Week 2 | -0.4 Scores on a scale | Standard Deviation 0.62 |
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).
Time frame: Baseline and Week 6
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Without Major Depressive Disorder (MDD-) | Change in Clinical Global Impression - Severity Pain From Baseline to Week 6 | -0.7 Scores on a scale | Standard Deviation 1.02 |
| With Major Depressive Disorder (MDD+) | Change in Clinical Global Impression - Severity Pain From Baseline to Week 6 | -0.8 Scores on a scale | Standard Deviation 0.78 |
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).
Time frame: Baseline and Week 12
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Without Major Depressive Disorder (MDD-) | Change in HADS Anxiety Total Score From Baseline to Week 12 | -1.0 Scores on a scale | Standard Deviation 3.03 |
| With Major Depressive Disorder (MDD+) | Change in HADS Anxiety Total Score From Baseline to Week 12 | -3.3 Scores on a scale | Standard Deviation 4.08 |
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).
Time frame: Baseline and Week 6
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Without Major Depressive Disorder (MDD-) | Change in HADS Anxiety Total Score From Baseline to Week 6 | -0.8 Scores on a scale | Standard Deviation 2.98 |
| With Major Depressive Disorder (MDD+) | Change in HADS Anxiety Total Score From Baseline to Week 6 | -2.2 Scores on a scale | Standard Deviation 3.03 |
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).
Time frame: Baseline and Week 12
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Without Major Depressive Disorder (MDD-) | Change in HADS Depression Total Score From Baseline to Week 12 | -0.7 Scores on a scale | Standard Deviation 3.07 |
| With Major Depressive Disorder (MDD+) | Change in HADS Depression Total Score From Baseline to Week 12 | -3.7 Scores on a scale | Standard Deviation 3.92 |
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).
Time frame: Baseline and Week 2
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Without Major Depressive Disorder (MDD-) | Change in HADS Depression Total Score From Baseline to Week 2 | -0.5 Scores on a scale | Standard Deviation 1.65 |
| With Major Depressive Disorder (MDD+) | Change in HADS Depression Total Score From Baseline to Week 2 | -1.6 Scores on a scale | Standard Deviation 3.21 |
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).
Time frame: Baseline and Week 6
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Without Major Depressive Disorder (MDD-) | Change in HADS Depression Total Score From Baseline to Week 6 | -0.8 Scores on a scale | Standard Deviation 2.8 |
| With Major Depressive Disorder (MDD+) | Change in HADS Depression Total Score From Baseline to Week 6 | -3.4 Scores on a scale | Standard Deviation 3.78 |
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.
Time frame: Baseline and Week 12
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Without Major Depressive Disorder (MDD-) | Change in Hamilton Depression Score From Baseline to Week 12 | -0.8 Scores on a scale | Standard Deviation 3.3 |
| With Major Depressive Disorder (MDD+) | Change in Hamilton Depression Score From Baseline to Week 12 | -9.7 Scores on a scale | Standard Deviation 5.5 |
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.
Time frame: Baseline and Week 2
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Without Major Depressive Disorder (MDD-) | Change in Hamilton Depression Score From Baseline to Week 2 | -0.2 Scores on a scale | Standard Deviation 2.5 |
| With Major Depressive Disorder (MDD+) | Change in Hamilton Depression Score From Baseline to Week 2 | -4.5 Scores on a scale | Standard Deviation 5.29 |
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.
Time frame: Baseline and Week 6
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Without Major Depressive Disorder (MDD-) | Change in Hamilton Depression Score From Baseline to Week 6 | -1.5 Scores of a scale | Standard Deviation 2.89 |
| With Major Depressive Disorder (MDD+) | Change in Hamilton Depression Score From Baseline to Week 6 | -9.3 Scores of a scale | Standard Deviation 4.99 |
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).
Time frame: Baseline and Week 2
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Without Major Depressive Disorder (MDD-) | Change in Hospital Anxiety and Depression Scale (HADS) Anxiety Total Score From Baseline to Week 2 | -0.7 Scores on a scale | Standard Deviation 2.23 |
| With Major Depressive Disorder (MDD+) | Change in Hospital Anxiety and Depression Scale (HADS) Anxiety Total Score From Baseline to Week 2 | -1.2 Scores on a scale | Standard Deviation 2.94 |
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).
Time frame: Baseline and Week 12
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Without Major Depressive Disorder (MDD-) | Change in Interference of Pain With Enjoyment of Life (BPI) From Baseline to Week 12 | -0.9 Scores on a scale | Standard Deviation 2.93 |
| With Major Depressive Disorder (MDD+) | Change in Interference of Pain With Enjoyment of Life (BPI) From Baseline to Week 12 | -2.1 Scores on a scale | Standard Deviation 2.3 |
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).
Time frame: Baseline and Week 2
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Without Major Depressive Disorder (MDD-) | Change in Interference of Pain With Enjoyment of Life (BPI) From Baseline to Week 2 | -0.7 Scores on a scale | Standard Deviation 2.06 |
| With Major Depressive Disorder (MDD+) | Change in Interference of Pain With Enjoyment of Life (BPI) From Baseline to Week 2 | -0.6 Scores on a scale | Standard Deviation 1.97 |
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).
Time frame: Baseline and Week 6
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Without Major Depressive Disorder (MDD-) | Change in Interference of Pain With Enjoyment of Life (BPI) From Baseline to Week 6 | -1.2 Scores on a scale | Standard Deviation 2.52 |
| With Major Depressive Disorder (MDD+) | Change in Interference of Pain With Enjoyment of Life (BPI) From Baseline to Week 6 | -2.2 Scores on a scale | Standard Deviation 2.9 |
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).
Time frame: Baseline and Week 12
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Without Major Depressive Disorder (MDD-) | Change in Interference of Pain With General Activity (BPI) From Baseline to Week 12 | -2.4 Scores on a scale | Standard Deviation 2.53 |
| With Major Depressive Disorder (MDD+) | Change in Interference of Pain With General Activity (BPI) From Baseline to Week 12 | -2.7 Scores on a scale | Standard Deviation 2.76 |
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).
Time frame: Baseline and Week 2
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Without Major Depressive Disorder (MDD-) | Change in Interference of Pain With General Activity (BPI) From Baseline to Week 2 | -1.6 Scores on a scale | Standard Deviation 2.5 |
| With Major Depressive Disorder (MDD+) | Change in Interference of Pain With General Activity (BPI) From Baseline to Week 2 | -1.1 Scores on a scale | Standard Deviation 2.02 |
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).
Time frame: Baseline and Week 6
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Without Major Depressive Disorder (MDD-) | Change in Interference of Pain With General Activity (BPI) From Baseline to Week 6 | -1.8 Scores on a scale | Standard Deviation 2.89 |
| With Major Depressive Disorder (MDD+) | Change in Interference of Pain With General Activity (BPI) From Baseline to Week 6 | -2.5 Scores on a scale | Standard Deviation 3.16 |
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).
Time frame: Baseline and Week 12
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Without Major Depressive Disorder (MDD-) | Change in Interference of Pain With Mood (BPI) From Baseline to Week 12 | -1.2 Scores on a scale | Standard Deviation 2.68 |
| With Major Depressive Disorder (MDD+) | Change in Interference of Pain With Mood (BPI) From Baseline to Week 12 | -3.0 Scores on a scale | Standard Deviation 3.28 |
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).
Time frame: Baseline and Week 2
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Without Major Depressive Disorder (MDD-) | Change in Interference of Pain With Mood (BPI) From Baseline to Week 2 | -1.1 Scores on a scale | Standard Deviation 2.3 |
| With Major Depressive Disorder (MDD+) | Change in Interference of Pain With Mood (BPI) From Baseline to Week 2 | -1.5 Scores on a scale | Standard Deviation 1.73 |
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).
Time frame: Baseline and Week 6
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Without Major Depressive Disorder (MDD-) | Change in Interference of Pain With Mood (BPI) From Baseline to Week 6 | -1.4 Scores on a scale | Standard Deviation 2.4 |
| With Major Depressive Disorder (MDD+) | Change in Interference of Pain With Mood (BPI) From Baseline to Week 6 | -3.1 Scores on a scale | Standard Deviation 3.08 |
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).
Time frame: Baseline and Week 12
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Without Major Depressive Disorder (MDD-) | Change in Interference of Pain With Normal Work (BPI) From Baseline to Week 12 | -1.4 Scores on a scale | Standard Deviation 1.89 |
| With Major Depressive Disorder (MDD+) | Change in Interference of Pain With Normal Work (BPI) From Baseline to Week 12 | -1.8 Scores on a scale | Standard Deviation 2.67 |
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).
Time frame: Baseline and Week 2
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Without Major Depressive Disorder (MDD-) | Change in Interference of Pain With Normal Work (BPI) From Baseline to Week 2 | -0.9 Scores on a scale | Standard Deviation 1.76 |
| With Major Depressive Disorder (MDD+) | Change in Interference of Pain With Normal Work (BPI) From Baseline to Week 2 | -0.1 Scores on a scale | Standard Deviation 2.34 |
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).
Time frame: Baseline and Week 6
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Without Major Depressive Disorder (MDD-) | Change in Interference of Pain With Normal Work (BPI) From Baseline to Week 6 | -1.1 Scores on a scale | Standard Deviation 2.47 |
| With Major Depressive Disorder (MDD+) | Change in Interference of Pain With Normal Work (BPI) From Baseline to Week 6 | -1.3 Scores on a scale | Standard Deviation 2.92 |
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).
Time frame: Baseline and Week 12
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Without Major Depressive Disorder (MDD-) | Change in Interference of Pain With Relations to Other People (BPI) From Baseline to Week 12 | -0.4 Scores on a scale | Standard Deviation 2.42 |
| With Major Depressive Disorder (MDD+) | Change in Interference of Pain With Relations to Other People (BPI) From Baseline to Week 12 | -1.7 Scores on a scale | Standard Deviation 2.71 |
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).
Time frame: Baseline and Week 2
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Without Major Depressive Disorder (MDD-) | Change in Interference of Pain With Relations to Other People (BPI) From Baseline to Week 2 | -0.5 Scores on a scale | Standard Deviation 2.68 |
| With Major Depressive Disorder (MDD+) | Change in Interference of Pain With Relations to Other People (BPI) From Baseline to Week 2 | -0.1 Scores on a scale | Standard Deviation 2.8 |
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).
Time frame: Baseline and Week 6
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Without Major Depressive Disorder (MDD-) | Change in Interference of Pain With Relations to Other People (BPI) From Baseline to Week 6 | -0.6 Scores on a scale | Standard Deviation 2.64 |
| With Major Depressive Disorder (MDD+) | Change in Interference of Pain With Relations to Other People (BPI) From Baseline to Week 6 | -1.7 Scores on a scale | Standard Deviation 2.6 |
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).
Time frame: Baseline and Week 12
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Without Major Depressive Disorder (MDD-) | Change in Interference of Pain With Sleep (BPI) From Baseline to Week 12 | -1.5 Scores on a scale | Standard Deviation 2.53 |
| With Major Depressive Disorder (MDD+) | Change in Interference of Pain With Sleep (BPI) From Baseline to Week 12 | -1.9 Scores on a scale | Standard Deviation 3.05 |
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).
Time frame: Baseline and Week 2
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Without Major Depressive Disorder (MDD-) | Change in Interference of Pain With Sleep (BPI) From Baseline to Week 2 | -0.8 Scores on a scale | Standard Deviation 3.21 |
| With Major Depressive Disorder (MDD+) | Change in Interference of Pain With Sleep (BPI) From Baseline to Week 2 | -1.0 Scores on a scale | Standard Deviation 2.46 |
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).
Time frame: Baseline and Week 6
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Without Major Depressive Disorder (MDD-) | Change in Interference of Pain With Sleep (BPI) From Baseline to Week 6 | -1.1 Scores on a scale | Standard Deviation 3.5 |
| With Major Depressive Disorder (MDD+) | Change in Interference of Pain With Sleep (BPI) From Baseline to Week 6 | -1.5 Scores on a scale | Standard Deviation 3.44 |
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).
Time frame: Baseline and Week 12
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Without Major Depressive Disorder (MDD-) | Change in Interference of Pain With Walking Ability (BPI) From Baseline to Week 12 | -1.9 Scores on a scale | Standard Deviation 2.86 |
| With Major Depressive Disorder (MDD+) | Change in Interference of Pain With Walking Ability (BPI) From Baseline to Week 12 | -2.4 Scores on a scale | Standard Deviation 3.11 |
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).
Time frame: Baseline and Week 2
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Without Major Depressive Disorder (MDD-) | Change in Interference of Pain With Walking Ability (BPI) From Baseline to Week 2 | -0.9 Scores on a scale | Standard Deviation 2.03 |
| With Major Depressive Disorder (MDD+) | Change in Interference of Pain With Walking Ability (BPI) From Baseline to Week 2 | -1.0 Scores on a scale | Standard Deviation 2.19 |
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).
Time frame: Baseline and Week 6
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Without Major Depressive Disorder (MDD-) | Change in Interference of Pain With Walking Ability (BPI) From Baseline to Week 6 | -1.3 Scores on a scale | Standard Deviation 2.55 |
| With Major Depressive Disorder (MDD+) | Change in Interference of Pain With Walking Ability (BPI) From Baseline to Week 6 | -2.1 Scores on a scale | Standard Deviation 3.26 |
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).
Time frame: Baseline and Week 12
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Without Major Depressive Disorder (MDD-) | Change in Least Pain (BPI) From Baseline to Week 12 | -1.5 Scores on a scale | Standard Deviation 2.13 |
| With Major Depressive Disorder (MDD+) | Change in Least Pain (BPI) From Baseline to Week 12 | -1.1 Scores on a scale | Standard Deviation 2.07 |
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).
Time frame: Baseline and Week 2
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Without Major Depressive Disorder (MDD-) | Change in Least Pain (BPI) From Baseline to Week 2 | -1.1 Scores on a scale | Standard Deviation 2.35 |
| With Major Depressive Disorder (MDD+) | Change in Least Pain (BPI) From Baseline to Week 2 | -0.2 Scores on a scale | Standard Deviation 1.7 |
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).
Time frame: Baseline and Week 6
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Without Major Depressive Disorder (MDD-) | Change in Least Pain During Treatment (BPI) From Baseline to Week 6 | -1.7 Scores on a scale | Standard Deviation 1.92 |
| With Major Depressive Disorder (MDD+) | Change in Least Pain During Treatment (BPI) From Baseline to Week 6 | -1.3 Scores on a scale | Standard Deviation 2.1 |
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).
Time frame: Baseline and Week 12
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Without Major Depressive Disorder (MDD-) | Change in Multidimensional Pain Inventory (MPI): Affective Distress From Baseline to Week 12 | -0.5 Scores on a scale | Standard Deviation 1 |
| With Major Depressive Disorder (MDD+) | Change in Multidimensional Pain Inventory (MPI): Affective Distress From Baseline to Week 12 | -0.8 Scores on a scale | Standard Deviation 1.13 |
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).
Time frame: Baseline and Week 6
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Without Major Depressive Disorder (MDD-) | Change in Multidimensional Pain Inventory (MPI): Affective Distress From Baseline to Week 6 | -0.3 Scores on a scale | Standard Deviation 1.01 |
| With Major Depressive Disorder (MDD+) | Change in Multidimensional Pain Inventory (MPI): Affective Distress From Baseline to Week 6 | -0.5 Scores on a scale | Standard Deviation 1.04 |
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).
Time frame: Baseline and Week 12
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Without Major Depressive Disorder (MDD-) | 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 | -0.2 Scores on a scale | Standard Deviation 1.19 |
| With Major Depressive Disorder (MDD+) | 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 | 0.0 Scores on a scale | Standard Deviation 2.43 |
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).
Time frame: Baseline and Week 6
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Without Major Depressive Disorder (MDD-) | 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 | -0.1 Scores on a scale | Standard Deviation 1.35 |
| With Major Depressive Disorder (MDD+) | 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 | -0.1 Scores on a scale | Standard Deviation 2.25 |
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).
Time frame: Baseline and Week 12
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Without Major Depressive Disorder (MDD-) | Change in Multidimensional Pain Inventory (MPI): General Activities From Baseline to Week 12 | -0.3 Scores on a scale | Standard Deviation 2.73 |
| With Major Depressive Disorder (MDD+) | Change in Multidimensional Pain Inventory (MPI): General Activities From Baseline to Week 12 | 0.3 Scores on a scale | Standard Deviation 0.95 |
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).
Time frame: Baseline and Week 6
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Without Major Depressive Disorder (MDD-) | Change in Multidimensional Pain Inventory (MPI): General Activities From Baseline to Week 6 | -0.2 Scores on a scale | Standard Deviation 1.66 |
| With Major Depressive Disorder (MDD+) | Change in Multidimensional Pain Inventory (MPI): General Activities From Baseline to Week 6 | 0.1 Scores on a scale | Standard Deviation 0.6 |
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).
Time frame: Baseline and Week 12
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Without Major Depressive Disorder (MDD-) | Change in Multidimensional Pain Inventory (MPI): Household Chores From Baseline to Week 12 | 0.1 Scores on a scale | Standard Deviation 1.29 |
| With Major Depressive Disorder (MDD+) | Change in Multidimensional Pain Inventory (MPI): Household Chores From Baseline to Week 12 | -0.1 Scores on a scale | Standard Deviation 0.99 |
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).
Time frame: Baseline and Week 6
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Without Major Depressive Disorder (MDD-) | Change in Multidimensional Pain Inventory (MPI): Household Chores From Baseline to Week 6 | 0.0 Scores on a scale | Standard Deviation 1.24 |
| With Major Depressive Disorder (MDD+) | Change in Multidimensional Pain Inventory (MPI): Household Chores From Baseline to Week 6 | -0.1 Scores on a scale | Standard Deviation 0.79 |
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).
Time frame: Baseline and Week 12
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Without Major Depressive Disorder (MDD-) | Change in Multidimensional Pain Inventory (MPI): Interference of Pain From Baseline to Week 12 | -1.1 Scores on a scale | Standard Deviation 1.13 |
| With Major Depressive Disorder (MDD+) | Change in Multidimensional Pain Inventory (MPI): Interference of Pain From Baseline to Week 12 | -1.0 Scores on a scale | Standard Deviation 1.37 |
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).
Time frame: Baseline and Week 6
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Without Major Depressive Disorder (MDD-) | Change in Multidimensional Pain Inventory (MPI): Interference of Pain (With Subjective Well-being) From Baseline to Week 6 | -1.0 Scores on a scale | Standard Deviation 1.06 |
| With Major Depressive Disorder (MDD+) | Change in Multidimensional Pain Inventory (MPI): Interference of Pain (With Subjective Well-being) From Baseline to Week 6 | -0.9 Scores on a scale | Standard Deviation 1.24 |
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).
Time frame: Baseline and Week 12
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Without Major Depressive Disorder (MDD-) | Change in Multidimensional Pain Inventory (MPI): Life Control From Baseline to Week 12 | 0.4 Scores on a scale | Standard Deviation 1.1 |
| With Major Depressive Disorder (MDD+) | Change in Multidimensional Pain Inventory (MPI): Life Control From Baseline to Week 12 | 0.3 Scores on a scale | Standard Deviation 1.57 |
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).
Time frame: Baseline and Week 6
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Without Major Depressive Disorder (MDD-) | Change in Multidimensional Pain Inventory (MPI): Life Control From Baseline to Week 6 | 0.2 Scores on a scale | Standard Deviation 1.14 |
| With Major Depressive Disorder (MDD+) | Change in Multidimensional Pain Inventory (MPI): Life Control From Baseline to Week 6 | 0.2 Scores on a scale | Standard Deviation 1.16 |
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).
Time frame: Baseline and Week 12
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Without Major Depressive Disorder (MDD-) | Change in Multidimensional Pain Inventory (MPI): Negative Responses From Baseline to Week 12 | 0.1 Scores on a scale | Standard Deviation 0.73 |
| With Major Depressive Disorder (MDD+) | Change in Multidimensional Pain Inventory (MPI): Negative Responses From Baseline to Week 12 | -0.3 Scores on a scale | Standard Deviation 2.03 |
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).
Time frame: Baseline and Week 6
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Without Major Depressive Disorder (MDD-) | Change in Multidimensional Pain Inventory (MPI): Negative Responses From Baseline to Week 6 | -0.1 Scores on a scale | Standard Deviation 0.87 |
| With Major Depressive Disorder (MDD+) | Change in Multidimensional Pain Inventory (MPI): Negative Responses From Baseline to Week 6 | -0.7 Scores on a scale | Standard Deviation 2.16 |
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).
Time frame: Baseline and Week 12
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Without Major Depressive Disorder (MDD-) | Change in Multidimensional Pain Inventory (MPI): Outdoor Work From Baseline to Week 12 | -1.6 Scores on a scale | Standard Deviation 10.24 |
| With Major Depressive Disorder (MDD+) | Change in Multidimensional Pain Inventory (MPI): Outdoor Work From Baseline to Week 12 | 0.6 Scores on a scale | Standard Deviation 2.37 |
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).
Time frame: Baseline and Week 6
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Without Major Depressive Disorder (MDD-) | Change in Multidimensional Pain Inventory (MPI): Outdoor Work From Baseline to Week 6 | -1.2 Scores on a scale | Standard Deviation 6.29 |
| With Major Depressive Disorder (MDD+) | Change in Multidimensional Pain Inventory (MPI): Outdoor Work From Baseline to Week 6 | 0.3 Scores on a scale | Standard Deviation 2.01 |
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).
Time frame: Baseline and Week 12
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Without Major Depressive Disorder (MDD-) | Change in Multidimensional Pain Inventory (MPI): Pain Severity From Baseline to Week 12 | -1.5 Scores on a scale | Standard Deviation 1.39 |
| With Major Depressive Disorder (MDD+) | Change in Multidimensional Pain Inventory (MPI): Pain Severity From Baseline to Week 12 | -1.2 Scores on a scale | Standard Deviation 1.35 |
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).
Time frame: Baseline and Week 6
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Without Major Depressive Disorder (MDD-) | Change in Multidimensional Pain Inventory (MPI): Pain Severity From Baseline to Week 6 | -1.2 Scores on a scale | Standard Deviation 1.34 |
| With Major Depressive Disorder (MDD+) | Change in Multidimensional Pain Inventory (MPI): Pain Severity From Baseline to Week 6 | -1.0 Scores on a scale | Standard Deviation 1.33 |
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).
Time frame: Baseline and Week 12
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Without Major Depressive Disorder (MDD-) | Change in Multidimensional Pain Inventory (MPI): Social Activities From Baseline to Week 12 | 0.1 Scores on a scale | Standard Deviation 0.64 |
| With Major Depressive Disorder (MDD+) | Change in Multidimensional Pain Inventory (MPI): Social Activities From Baseline to Week 12 | 0.3 Scores on a scale | Standard Deviation 1.11 |
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).
Time frame: Baseline and Week 6
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Without Major Depressive Disorder (MDD-) | Change in Multidimensional Pain Inventory (MPI): Social Activities From Baseline to Week 6 | 0.1 Scores on a scale | Standard Deviation 0.8 |
| With Major Depressive Disorder (MDD+) | Change in Multidimensional Pain Inventory (MPI): Social Activities From Baseline to Week 6 | 0.1 Scores on a scale | Standard Deviation 0.7 |
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).
Time frame: Baseline and Week 12
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Without Major Depressive Disorder (MDD-) | Change in Multidimensional Pain Inventory (MPI): Solicitous Responses From Baseline to Week 12 | -0.2 Scores on a scale | Standard Deviation 1.1 |
| With Major Depressive Disorder (MDD+) | Change in Multidimensional Pain Inventory (MPI): Solicitous Responses From Baseline to Week 12 | 0.2 Scores on a scale | Standard Deviation 2.3 |
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).
Time frame: Baseline and Week 6
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Without Major Depressive Disorder (MDD-) | Change in Multidimensional Pain Inventory (MPI): Solicitous Responses From Baseline to Week 6 | -0.2 Scores on a scale | Standard Deviation 1.12 |
| With Major Depressive Disorder (MDD+) | Change in Multidimensional Pain Inventory (MPI): Solicitous Responses From Baseline to Week 6 | -0.2 Scores on a scale | Standard Deviation 2.08 |
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).
Time frame: Baseline and Week 6
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Without Major Depressive Disorder (MDD-) | Change in Multidimensional Pain Inventory (MPI): Support From Baseline to Week 6 | -0.4 Scores on a scale | Standard Deviation 1.28 |
| With Major Depressive Disorder (MDD+) | Change in Multidimensional Pain Inventory (MPI): Support From Baseline to Week 6 | 0.5 Scores on a scale | Standard Deviation 1.59 |
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).
Time frame: Baseline and Week 12
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Without Major Depressive Disorder (MDD-) | Change in Multidimensional Pain Inventory (MPI): Support Which the Patient Received From Baseline to Week 12 | -0.2 Scores on a scale | Standard Deviation 1.54 |
| With Major Depressive Disorder (MDD+) | Change in Multidimensional Pain Inventory (MPI): Support Which the Patient Received From Baseline to Week 12 | 0.4 Scores on a scale | Standard Deviation 1.9 |
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).
Time frame: Baseline and Week 6
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Without Major Depressive Disorder (MDD-) | Change in Pain (BPI) From Baseline to Week 6 | -2.0 Scores on a scale | Standard Deviation 2.27 |
| With Major Depressive Disorder (MDD+) | Change in Pain (BPI) From Baseline to Week 6 | -1.7 Scores on a scale | Standard Deviation 3.01 |
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).
Time frame: Baseline and Week 12
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Without Major Depressive Disorder (MDD-) | Change in Pain During Treatment (BPI) From Baseline to Week 12 | -1.7 Scores on a scale | Standard Deviation 2.6 |
| With Major Depressive Disorder (MDD+) | Change in Pain During Treatment (BPI) From Baseline to Week 12 | -1.5 Scores on a scale | Standard Deviation 2.21 |
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).
Time frame: Baseline and Week 2
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Without Major Depressive Disorder (MDD-) | Change in Pain During Treatment (BPI) From Baseline to Week 2 | -1.4 Scores on a scale | Standard Deviation 2.34 |
| With Major Depressive Disorder (MDD+) | Change in Pain During Treatment (BPI) From Baseline to Week 2 | -1.0 Scores on a scale | Standard Deviation 2.06 |
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).
Time frame: Baseline and Week 12
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Without Major Depressive Disorder (MDD-) | Change in Relief of Pain (BPI) From the Week Before Baseline to the Week Before Week 12 | 30.2 scores on a scale | Standard Deviation 35.85 |
| With Major Depressive Disorder (MDD+) | Change in Relief of Pain (BPI) From the Week Before Baseline to the Week Before Week 12 | 22.9 scores on a scale | Standard Deviation 33.55 |
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).
Time frame: Baseline and Week 2
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Without Major Depressive Disorder (MDD-) | Change in Relief of Pain (BPI) From the Week Before Baseline to the Week Before Week 2 | 21.5 scores on a scale | Standard Deviation 33.87 |
| With Major Depressive Disorder (MDD+) | Change in Relief of Pain (BPI) From the Week Before Baseline to the Week Before Week 2 | 18.0 scores on a scale | Standard Deviation 35 |
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).
Time frame: Baseline and Week 6
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Without Major Depressive Disorder (MDD-) | Change in Relief of Pain (BPI) From the Week Before Baseline to the Week Before Week 6 | 23.5 scores on a scale | Standard Deviation 37.3 |
| With Major Depressive Disorder (MDD+) | Change in Relief of Pain (BPI) From the Week Before Baseline to the Week Before Week 6 | 31.7 scores on a scale | Standard Deviation 45.49 |
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.
Time frame: Baseline and Week 12
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Without Major Depressive Disorder (MDD-) | Change in Short Form Health Survey (SF-12) - Mental Component Summary From Baseline to Week 12 | 0.7 Scores on a scale | Standard Deviation 10.19 |
| With Major Depressive Disorder (MDD+) | Change in Short Form Health Survey (SF-12) - Mental Component Summary From Baseline to Week 12 | 6.0 Scores on a scale | Standard Deviation 13.07 |
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.
Time frame: Baseline and Week 6
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Without Major Depressive Disorder (MDD-) | Change in Short Form Health Survey (SF-12) - Mental Component Summary From Baseline to Week 6 | -0.9 Scores on a scale | Standard Deviation 8.19 |
| With Major Depressive Disorder (MDD+) | Change in Short Form Health Survey (SF-12) - Mental Component Summary From Baseline to Week 6 | 5.0 Scores on a scale | Standard Deviation 11.11 |
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.
Time frame: Baseline and Week 12
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Without Major Depressive Disorder (MDD-) | Change in Short Form Health Survey (SF-12) - Physical Component Summary From Baseline to Week 12 | 3.5 Scores on a scale | Standard Deviation 9.64 |
| With Major Depressive Disorder (MDD+) | Change in Short Form Health Survey (SF-12) - Physical Component Summary From Baseline to Week 12 | 2.4 Scores on a scale | Standard Deviation 11.51 |
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.
Time frame: Baseline and Week 6
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Without Major Depressive Disorder (MDD-) | Change in Short Form Health Survey (SF-12) - Physical Component Summary From Baseline to Week 6 | 4.0 Scores on a scale | Standard Deviation 8.37 |
| With Major Depressive Disorder (MDD+) | Change in Short Form Health Survey (SF-12) - Physical Component Summary From Baseline to Week 6 | -0.0 Scores on a scale | Standard Deviation 11.74 |
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).
Time frame: Baseline and Week 12
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Without Major Depressive Disorder (MDD-) | Change in Worst Pain (BPI) From Baseline to Week 12 | -2.8 Scores on a scale | Standard Deviation 2.55 |
| With Major Depressive Disorder (MDD+) | Change in Worst Pain (BPI) From Baseline to Week 12 | -3.2 Scores on a scale | Standard Deviation 3.41 |
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).
Time frame: Baseline and Week 6
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Without Major Depressive Disorder (MDD-) | Change in Worst Pain (BPI) From Baseline to Week 6 | -2.6 Scores on a scale | Standard Deviation 2.36 |
| With Major Depressive Disorder (MDD+) | Change in Worst Pain (BPI) From Baseline to Week 6 | -3.3 Scores on a scale | Standard Deviation 2.56 |
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).
Time frame: Baseline and Week 6
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Without Major Depressive Disorder (MDD-) | Change of Brief Pain Inventory (BPI) Average Interference Score From Baseline to Week 6 | -1.2 Scores on a scale | Standard Deviation 1.88 |
| With Major Depressive Disorder (MDD+) | Change of Brief Pain Inventory (BPI) Average Interference Score From Baseline to Week 6 | -2.0 Scores on a scale | Standard Deviation 1.96 |
Secondary
Change of Diastolic Blood Pressure From Baseline at Week 12
Time frame: Baseline and Week 12
Population: All patients receiving at least one dose of study medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Without Major Depressive Disorder (MDD-) | Change of Diastolic Blood Pressure From Baseline at Week 12 | 2.2 mmHg | Standard Deviation 10.03 |
| With Major Depressive Disorder (MDD+) | Change of Diastolic Blood Pressure From Baseline at Week 12 | -0.6 mmHg | Standard Deviation 8.86 |
Secondary
Change of Fasting Blood Glucose From Baseline at Week 12
Ancova analysis controlling for baseline and insulin intake
Time frame: Baseline and Week 12
Population: All patients receiving at least one dose of study medication and having data of fasting blood glucose at baseline and at week 12.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Without Major Depressive Disorder (MDD-) | Change of Fasting Blood Glucose From Baseline at Week 12 | 14.9 mg/dL |
| With Major Depressive Disorder (MDD+) | Change of Fasting Blood Glucose From Baseline at Week 12 | 13.0 mg/dL |
Secondary
Change of Glycosylated Hemoglobin A1c (HbA1c) From Baseline at Week 12
Ancova analysis controlling for baseline and insulin intake
Time frame: Baseline and Week 12
Population: All patients receiving at least one dose of study medication and having data of HbA1c at baseline and at week 12.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Without Major Depressive Disorder (MDD-) | Change of Glycosylated Hemoglobin A1c (HbA1c) From Baseline at Week 12 | 0.1 percent |
| With Major Depressive Disorder (MDD+) | Change of Glycosylated Hemoglobin A1c (HbA1c) From Baseline at Week 12 | 0.1 percent |
Secondary
Change of Pulse Rate From Baseline at Week 12
Time frame: Baseline and Week 12
Population: All patients receiving at least one dose of study medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Without Major Depressive Disorder (MDD-) | Change of Pulse Rate From Baseline at Week 12 | 2.4 beats per minute (bpm) | Standard Deviation 9.53 |
| With Major Depressive Disorder (MDD+) | Change of Pulse Rate From Baseline at Week 12 | 2.9 beats per minute (bpm) | Standard Deviation 9.4 |
Secondary
Change of Systolic Blood Pressure From Baseline at Week 12
Time frame: Baseline and Week 12
Population: All patients receiving at least one dose of study medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Without Major Depressive Disorder (MDD-) | Change of Systolic Blood Pressure From Baseline at Week 12 | -0.4 mmHg | Standard Deviation 16.04 |
| With Major Depressive Disorder (MDD+) | Change of Systolic Blood Pressure From Baseline at Week 12 | -2.8 mmHg | Standard Deviation 17.4 |
Secondary
Number of Patients With a Reduction in BPI Average Pain at Week 12
Time frame: Baseline and Week 12
Population: 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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Without Major Depressive Disorder (MDD-) | Number of Patients With a Reduction in BPI Average Pain at Week 12 | >=30% | 42 Participants |
| Without Major Depressive Disorder (MDD-) | Number of Patients With a Reduction in BPI Average Pain at Week 12 | >=50% | 30 Participants |
| Without Major Depressive Disorder (MDD-) | Number of Patients With a Reduction in BPI Average Pain at Week 12 | Missing | 6 Participants |
| With Major Depressive Disorder (MDD+) | Number of Patients With a Reduction in BPI Average Pain at Week 12 | >=30% | 17 Participants |
| With Major Depressive Disorder (MDD+) | Number of Patients With a Reduction in BPI Average Pain at Week 12 | >=50% | 11 Participants |
| With Major Depressive Disorder (MDD+) | Number of Patients With a Reduction in BPI Average Pain at Week 12 | Missing | 4 Participants |
Secondary
Number of Patients With a Reduction in BPI Average Pain at Week 2
Time frame: Baseline and Week 2
Population: 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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Without Major Depressive Disorder (MDD-) | Number of Patients With a Reduction in BPI Average Pain at Week 2 | >=30% | 29 Participants |
| Without Major Depressive Disorder (MDD-) | Number of Patients With a Reduction in BPI Average Pain at Week 2 | >=50% | 19 Participants |
| Without Major Depressive Disorder (MDD-) | Number of Patients With a Reduction in BPI Average Pain at Week 2 | Missing | 5 Participants |
| With Major Depressive Disorder (MDD+) | Number of Patients With a Reduction in BPI Average Pain at Week 2 | >=30% | 9 Participants |
| With Major Depressive Disorder (MDD+) | Number of Patients With a Reduction in BPI Average Pain at Week 2 | >=50% | 3 Participants |
| With Major Depressive Disorder (MDD+) | Number of Patients With a Reduction in BPI Average Pain at Week 2 | Missing | 2 Participants |
Secondary
Number of Patients With a Reduction in BPI Average Pain at Week 6
Time frame: Baseline and Week 6
Population: 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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Without Major Depressive Disorder (MDD-) | Number of Patients With a Reduction in BPI Average Pain at Week 6 | >=30% | 42 Participants |
| Without Major Depressive Disorder (MDD-) | Number of Patients With a Reduction in BPI Average Pain at Week 6 | >=50% | 30 Participants |
| Without Major Depressive Disorder (MDD-) | Number of Patients With a Reduction in BPI Average Pain at Week 6 | Missing | 14 Participants |
| With Major Depressive Disorder (MDD+) | Number of Patients With a Reduction in BPI Average Pain at Week 6 | >=30% | 17 Participants |
| With Major Depressive Disorder (MDD+) | Number of Patients With a Reduction in BPI Average Pain at Week 6 | >=50% | 12 Participants |
| With Major Depressive Disorder (MDD+) | Number of Patients With a Reduction in BPI Average Pain at Week 6 | Missing | 6 Participants |
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).
Time frame: Baseline and Week 12
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Without Major Depressive Disorder (MDD-) | Patient Global Impression - Improvement (PGI-I) at Week 12 | 2.5 Scores on a scale | Standard Deviation 1.35 |
| With Major Depressive Disorder (MDD+) | Patient Global Impression - Improvement (PGI-I) at Week 12 | 2.7 Scores on a scale | Standard Deviation 1.29 |
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).
Time frame: Baseline and Week 2
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Without Major Depressive Disorder (MDD-) | Patient Global Impression - Improvement (PGI-I) at Week 2 | 3.0 Scores on a scale | Standard Deviation 1.01 |
| With Major Depressive Disorder (MDD+) | Patient Global Impression - Improvement (PGI-I) at Week 2 | 3.2 Scores on a scale | Standard Deviation 0.82 |
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).
Time frame: Baseline and Week 6
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Without Major Depressive Disorder (MDD-) | Patient Global Impression - Improvement (PGI-I) at Week 6 | 2.5 Scores on a scale | Standard Deviation 0.87 |
| With Major Depressive Disorder (MDD+) | Patient Global Impression - Improvement (PGI-I) at Week 6 | 2.5 Scores on a scale | Standard Deviation 1.04 |
Secondary
Suicidal Thoughts by BDI-II at Week 12
Time frame: Week 12
Population: All patients receiving at least one dose of study medication and having data at week 12.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Without Major Depressive Disorder (MDD-) | Suicidal Thoughts by BDI-II at Week 12 | Thoughts of killing myself | 0 Participants |
| Without Major Depressive Disorder (MDD-) | Suicidal Thoughts by BDI-II at Week 12 | Kill myself if chance | 0 Participants |
| Without Major Depressive Disorder (MDD-) | Suicidal Thoughts by BDI-II at Week 12 | Like to kill myself | 0 Participants |
| Without Major Depressive Disorder (MDD-) | Suicidal Thoughts by BDI-II at Week 12 | Missing | 2 Participants |
| Without Major Depressive Disorder (MDD-) | Suicidal Thoughts by BDI-II at Week 12 | No thoughts of killing myself | 63 Participants |
| With Major Depressive Disorder (MDD+) | Suicidal Thoughts by BDI-II at Week 12 | Missing | 0 Participants |
| With Major Depressive Disorder (MDD+) | Suicidal Thoughts by BDI-II at Week 12 | No thoughts of killing myself | 24 Participants |
| With Major Depressive Disorder (MDD+) | Suicidal Thoughts by BDI-II at Week 12 | Thoughts of killing myself | 2 Participants |
| With Major Depressive Disorder (MDD+) | Suicidal Thoughts by BDI-II at Week 12 | Like to kill myself | 0 Participants |
| With Major Depressive Disorder (MDD+) | Suicidal Thoughts by BDI-II at Week 12 | Kill myself if chance | 0 Participants |
Secondary
Suicidal Thoughts by BDI-II at Week 2
Time frame: Week 2
Population: All patients receiving at least one dose of study medication and having data at week 2.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Without Major Depressive Disorder (MDD-) | Suicidal Thoughts by BDI-II at Week 2 | Missing | 0 Participants |
| Without Major Depressive Disorder (MDD-) | Suicidal Thoughts by BDI-II at Week 2 | Like to kill myself | 0 Participants |
| Without Major Depressive Disorder (MDD-) | Suicidal Thoughts by BDI-II at Week 2 | Thoughts of killing myself | 3 Participants |
| Without Major Depressive Disorder (MDD-) | Suicidal Thoughts by BDI-II at Week 2 | Kill myself if chance | 0 Participants |
| Without Major Depressive Disorder (MDD-) | Suicidal Thoughts by BDI-II at Week 2 | No thoughts of killing myself | 67 Participants |
| With Major Depressive Disorder (MDD+) | Suicidal Thoughts by BDI-II at Week 2 | Kill myself if chance | 0 Participants |
| With Major Depressive Disorder (MDD+) | Suicidal Thoughts by BDI-II at Week 2 | Missing | 0 Participants |
| With Major Depressive Disorder (MDD+) | Suicidal Thoughts by BDI-II at Week 2 | No thoughts of killing myself | 27 Participants |
| With Major Depressive Disorder (MDD+) | Suicidal Thoughts by BDI-II at Week 2 | Thoughts of killing myself | 1 Participants |
| With Major Depressive Disorder (MDD+) | Suicidal Thoughts by BDI-II at Week 2 | Like to kill myself | 0 Participants |
Secondary
Suicidal Thoughts by BDI-II at Week 6
Time frame: Week 6
Population: All patients receiving at least one dose of study medication and having data at week 6.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Without Major Depressive Disorder (MDD-) | Suicidal Thoughts by BDI-II at Week 6 | Thoughts of killing myself | 2 Participants |
| Without Major Depressive Disorder (MDD-) | Suicidal Thoughts by BDI-II at Week 6 | Kill myself if chance | 0 Participants |
| Without Major Depressive Disorder (MDD-) | Suicidal Thoughts by BDI-II at Week 6 | Like to kill myself | 0 Participants |
| Without Major Depressive Disorder (MDD-) | Suicidal Thoughts by BDI-II at Week 6 | Missing | 0 Participants |
| Without Major Depressive Disorder (MDD-) | Suicidal Thoughts by BDI-II at Week 6 | No thoughts of killing myself | 57 Participants |
| With Major Depressive Disorder (MDD+) | Suicidal Thoughts by BDI-II at Week 6 | Missing | 1 Participants |
| With Major Depressive Disorder (MDD+) | Suicidal Thoughts by BDI-II at Week 6 | No thoughts of killing myself | 22 Participants |
| With Major Depressive Disorder (MDD+) | Suicidal Thoughts by BDI-II at Week 6 | Thoughts of killing myself | 1 Participants |
| With Major Depressive Disorder (MDD+) | Suicidal Thoughts by BDI-II at Week 6 | Like to kill myself | 0 Participants |
| With Major Depressive Disorder (MDD+) | Suicidal Thoughts by BDI-II at Week 6 | Kill myself if chance | 0 Participants |
Secondary
Suicidal Thoughts or Behaviours by HAMD-17 at Week 12
Time frame: Week 12
Population: All patients receiving at least one dose of study medication and having data at week 12.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Without Major Depressive Disorder (MDD-) | Suicidal Thoughts or Behaviours by HAMD-17 at Week 12 | Feels life is not worth living | 0 Participants |
| Without Major Depressive Disorder (MDD-) | Suicidal Thoughts or Behaviours by HAMD-17 at Week 12 | Suicidal ideas or gestures | 0 Participants |
| Without Major Depressive Disorder (MDD-) | Suicidal Thoughts or Behaviours by HAMD-17 at Week 12 | Absent | 66 Participants |
| Without Major Depressive Disorder (MDD-) | Suicidal Thoughts or Behaviours by HAMD-17 at Week 12 | Attempts at suicide | 0 Participants |
| Without Major Depressive Disorder (MDD-) | Suicidal Thoughts or Behaviours by HAMD-17 at Week 12 | Thoughts of possible death to self | 0 Participants |
| Without Major Depressive Disorder (MDD-) | Suicidal Thoughts or Behaviours by HAMD-17 at Week 12 | Missing | 0 Participants |
| With Major Depressive Disorder (MDD+) | Suicidal Thoughts or Behaviours by HAMD-17 at Week 12 | Missing | 0 Participants |
| With Major Depressive Disorder (MDD+) | Suicidal Thoughts or Behaviours by HAMD-17 at Week 12 | Absent | 26 Participants |
| With Major Depressive Disorder (MDD+) | Suicidal Thoughts or Behaviours by HAMD-17 at Week 12 | Feels life is not worth living | 1 Participants |
| With Major Depressive Disorder (MDD+) | Suicidal Thoughts or Behaviours by HAMD-17 at Week 12 | Thoughts of possible death to self | 0 Participants |
| With Major Depressive Disorder (MDD+) | Suicidal Thoughts or Behaviours by HAMD-17 at Week 12 | Suicidal ideas or gestures | 0 Participants |
| With Major Depressive Disorder (MDD+) | Suicidal Thoughts or Behaviours by HAMD-17 at Week 12 | Attempts at suicide | 0 Participants |
Secondary
Suicidal Thoughts or Behaviours by HAMD-17 at Week 2
Time frame: Week 2
Population: All patients receiving at least one dose of study medication and having data at week 2.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Without Major Depressive Disorder (MDD-) | Suicidal Thoughts or Behaviours by HAMD-17 at Week 2 | Absent | 68 Participants |
| Without Major Depressive Disorder (MDD-) | Suicidal Thoughts or Behaviours by HAMD-17 at Week 2 | Feels life is not worth living | 0 Participants |
| Without Major Depressive Disorder (MDD-) | Suicidal Thoughts or Behaviours by HAMD-17 at Week 2 | Thoughts of possible death to self | 0 Participants |
| Without Major Depressive Disorder (MDD-) | Suicidal Thoughts or Behaviours by HAMD-17 at Week 2 | Suicidal ideas or gestures | 0 Participants |
| Without Major Depressive Disorder (MDD-) | Suicidal Thoughts or Behaviours by HAMD-17 at Week 2 | Attempts at suicide | 0 Participants |
| Without Major Depressive Disorder (MDD-) | Suicidal Thoughts or Behaviours by HAMD-17 at Week 2 | Missing | 0 Participants |
| With Major Depressive Disorder (MDD+) | Suicidal Thoughts or Behaviours by HAMD-17 at Week 2 | Attempts at suicide | 0 Participants |
| With Major Depressive Disorder (MDD+) | Suicidal Thoughts or Behaviours by HAMD-17 at Week 2 | Absent | 26 Participants |
| With Major Depressive Disorder (MDD+) | Suicidal Thoughts or Behaviours by HAMD-17 at Week 2 | Suicidal ideas or gestures | 0 Participants |
| With Major Depressive Disorder (MDD+) | Suicidal Thoughts or Behaviours by HAMD-17 at Week 2 | Feels life is not worth living | 2 Participants |
| With Major Depressive Disorder (MDD+) | Suicidal Thoughts or Behaviours by HAMD-17 at Week 2 | Missing | 0 Participants |
| With Major Depressive Disorder (MDD+) | Suicidal Thoughts or Behaviours by HAMD-17 at Week 2 | Thoughts of possible death to self | 0 Participants |
Secondary
Suicidal Thoughts or Behaviours by HAMD-17 at Week 6
Time frame: Week 6
Population: All patients receiving at least one dose of study medication and having data at week 6.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Without Major Depressive Disorder (MDD-) | Suicidal Thoughts or Behaviours by HAMD-17 at Week 6 | Absent | 60 Participants |
| Without Major Depressive Disorder (MDD-) | Suicidal Thoughts or Behaviours by HAMD-17 at Week 6 | Feels life is not worth living | 0 Participants |
| Without Major Depressive Disorder (MDD-) | Suicidal Thoughts or Behaviours by HAMD-17 at Week 6 | Thoughts of possible death to self | 0 Participants |
| Without Major Depressive Disorder (MDD-) | Suicidal Thoughts or Behaviours by HAMD-17 at Week 6 | Suicidal ideas or gestures | 0 Participants |
| Without Major Depressive Disorder (MDD-) | Suicidal Thoughts or Behaviours by HAMD-17 at Week 6 | Attempts at suicide | 0 Participants |
| Without Major Depressive Disorder (MDD-) | Suicidal Thoughts or Behaviours by HAMD-17 at Week 6 | Missing | 0 Participants |
| With Major Depressive Disorder (MDD+) | Suicidal Thoughts or Behaviours by HAMD-17 at Week 6 | Attempts at suicide | 0 Participants |
| With Major Depressive Disorder (MDD+) | Suicidal Thoughts or Behaviours by HAMD-17 at Week 6 | Absent | 22 Participants |
| With Major Depressive Disorder (MDD+) | Suicidal Thoughts or Behaviours by HAMD-17 at Week 6 | Suicidal ideas or gestures | 0 Participants |
| With Major Depressive Disorder (MDD+) | Suicidal Thoughts or Behaviours by HAMD-17 at Week 6 | Feels life is not worth living | 2 Participants |
| With Major Depressive Disorder (MDD+) | Suicidal Thoughts or Behaviours by HAMD-17 at Week 6 | Missing | 0 Participants |
| With Major Depressive Disorder (MDD+) | Suicidal Thoughts or Behaviours by HAMD-17 at Week 6 | Thoughts of possible death to self | 0 Participants |