Duloxetine in Patients With Diabetic in Peripheral Neuropathic Pain With or Without Co-morbid Major Depressive Disorder
- Conditions
- Diabetic NeuropathiesDepressive Disorder, Major
- Interventions
- Registration Number
- NCT00844194
- Lead Sponsor
- Boehringer Ingelheim
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 108
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description DPNP with depression (1) Duloxetine 60 mg QD Patients that have diabetic polyneuropathy and depression and are responder to 60 mg duloxetine QD (\>30% pain reduction after week 6) DPNP without depression (1) Duloxetine 30 mg QD Patients that have diabetic polyneuropathy and no depression and are responder to 60 mg duloxetine QD (\>30% pain reduction after week 6) DPNP without depression (2) Duloxetine 60 mg QD Patients that have diabetic polyneuropathy and no depression and are non-responder to 60 mg duloxetine QD (\<30% pain reduction after week 6) DPNP without depression (2) Duloxetine 120 mg QD Patients that have diabetic polyneuropathy and no depression and are non-responder to 60 mg duloxetine QD (\<30% pain reduction after week 6) DPNP without depression (2) Duloxetine 30 mg QD Patients that have diabetic polyneuropathy and no depression and are non-responder to 60 mg duloxetine QD (\<30% pain reduction after week 6) DPNP without depression (2) Duloxetine 90 mg QD Patients that have diabetic polyneuropathy and no depression and are non-responder to 60 mg duloxetine QD (\<30% pain reduction after week 6) DPNP with depression (2) Duloxetine 60 mg QD Patients that have diabetic polyneuropathy and depression and are non-responder to 60 mg duloxetine QD (\<30% pain reduction after week 6) DPNP with depression (1) Duloxetine 30 mg QD Patients that have diabetic polyneuropathy and depression and are responder to 60 mg duloxetine QD (\>30% pain reduction after week 6) DPNP with depression (2) Duloxetine 90 mg QD Patients that have diabetic polyneuropathy and depression and are non-responder to 60 mg duloxetine QD (\<30% pain reduction after week 6) DPNP with depression (2) Duloxetine 30 mg QD Patients that have diabetic polyneuropathy and depression and are non-responder to 60 mg duloxetine QD (\<30% pain reduction after week 6) DPNP with depression (2) Duloxetine 120 mg QD Patients that have diabetic polyneuropathy and depression and are non-responder to 60 mg duloxetine QD (\<30% pain reduction after week 6) DPNP without depression (1) Duloxetine 60 mg QD Patients that have diabetic polyneuropathy and no depression and are responder to 60 mg duloxetine QD (\>30% pain reduction after week 6)
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Suicidal Thoughts or Behaviours by HAMD-17 at Week 12 Week 12 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 Number of Patients With a Reduction in BPI Average Pain at Week 12 Baseline and Week 12 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 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): 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): 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 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): 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): 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): 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): 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): 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): 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): 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): 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.
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.
Suicidal Thoughts by BDI-II at Week 2 Week 2 Change of Fasting Blood Glucose From Baseline at Week 12 Baseline and Week 12 Ancova analysis controlling for baseline and insulin intake
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 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
Trial Locations
- Locations (25)
1208.34.49001 Boehringer Ingelheim Investigational Site
🇩🇪Bad Mergentheim, Germany
1208.34.49006 Boehringer Ingelheim Investigational Site
🇩🇪Limburgerhof, Germany
1208.34.49029 Boehringer Ingelheim Investigational Site
🇩🇪Wiesbaden, Germany
1208.34.49009 Boehringer Ingelheim Investigational Site
🇩🇪Berlin, Germany
1208.34.49004 Boehringer Ingelheim Investigational Site
🇩🇪Hamburg, Germany
1208.34.49008 Boehringer Ingelheim Investigational Site
🇩🇪Achim bei Bremen, Germany
1208.34.49022 Boehringer Ingelheim Investigational Site
🇩🇪Münster, Germany
1208.34.49015 Boehringer Ingelheim Investigational Site
🇩🇪Hattingen, Germany
1208.34.49005 Boehringer Ingelheim Investigational Site
🇩🇪Berlin, Germany
1208.34.49025 Boehringer Ingelheim Investigational Site
🇩🇪Aschaffenburg, Germany
1208.34.49028 Boehringer Ingelheim Investigational Site
🇩🇪Frankfurt am Main, Germany
1208.34.49020 Boehringer Ingelheim Investigational Site
🇩🇪Hamburg, Germany
1208.34.49023 Boehringer Ingelheim Investigational Site
🇩🇪Hamburg, Germany
1208.34.49027 Boehringer Ingelheim Investigational Site
🇩🇪Heidenheim, Germany
1208.34.49010 Boehringer Ingelheim Investigational Site
🇩🇪Stuhr, Germany
1208.34.49007 Boehringer Ingelheim Investigational Site
🇩🇪Berlin-Steglitz, Germany
1208.34.49002 Boehringer Ingelheim Investigational Site
🇩🇪Berlin, Germany
1208.34.49016 Boehringer Ingelheim Investigational Site
🇩🇪Kelkheim, Germany
1208.34.49018 Boehringer Ingelheim Investigational Site
🇩🇪Baesweiler, Germany
1208.34.49021 Boehringer Ingelheim Investigational Site
🇩🇪Bremen, Germany
1208.34.49019 Boehringer Ingelheim Investigational Site
🇩🇪Neuwied, Germany
1208.34.49012 Boehringer Ingelheim Investigational Site
🇩🇪Gera, Germany
1208.34.49024 Boehringer Ingelheim Investigational Site
🇩🇪St. Ingberg, Germany
1208.34.49013 Boehringer Ingelheim Investigational Site
🇩🇪Unterhaching, Germany
1208.34.49026 Boehringer Ingelheim Investigational Site
🇩🇪Wuppertal, Germany