Duloxetine in Patients With Diabetic in Peripheral Neuropathic Pain With or Without Co-morbid Major Depressive Disorder

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Without Major Depressive Disorder (MDD-)	Patients with diabetic polyneuropathy and no depression
With Major Depressive Disorder (MDD+)	Patients with diabetic polyneuropathy and depression

Participant Flow:   Overall Study

	Without Major Depressive Disorder (MDD-)	With Major Depressive Disorder (MDD+)
STARTED	78	30
COMPLETED	53	22
NOT COMPLETED	25	8
Adverse Event	17	5
Protocol Violation	1	1
Lost to Follow-up	1	1
Withdrawal by Subject	2	1
Lack of Efficacy	3	0
Other reason (not specified)	1	0

Reporting Groups

	Description
Without Major Depressive Disorder (MDD-)	Patients with diabetic polyneuropathy and no depression
With Major Depressive Disorder (MDD+)	Patients with diabetic polyneuropathy and depression
Total	Total of all reporting groups

Baseline Measures

	Without Major Depressive Disorder (MDD-)	With Major Depressive Disorder (MDD+)	Total
Number of Participants   [units: participants]	78	30	108
Age   [units: Years] Mean ± Standard Deviation	67.5  ± 10.2	66.6  ± 9.8	67.3  ± 10.1
Gender   [units: Participants]
Female	36	15	51
Male	42	15	57

1.  Primary:

Change of Brief Pain Inventory (BPI) Average Interference Score From Baseline to Week 12   [ Time Frame: Baseline and Week 12 ]

2.  Primary:

Change of Brief Pain Inventory (BPI) Average Interference Score From Baseline to Week 12   [ Time Frame: Baseline and Week 12 ]

3.  Secondary:

Change of Brief Pain Inventory (BPI) Average Interference Score From Baseline to Week 6   [ Time Frame: Baseline and Week 6 ]

4.  Secondary:

Change in BPI Worst Pain During Treatment From Baseline to Week 2   [ Time Frame: Baseline and Week 2 ]

5.  Secondary:

Change in Worst Pain (BPI) From Baseline to Week 6   [ Time Frame: Baseline and Week 6 ]

6.  Secondary:

Change in Worst Pain (BPI) From Baseline to Week 12   [ Time Frame: Baseline and Week 12 ]

7.  Secondary:

Change in Least Pain (BPI) From Baseline to Week 2   [ Time Frame: Baseline and Week 2 ]

8.  Secondary:

Change in Least Pain During Treatment (BPI) From Baseline to Week 6   [ Time Frame: Baseline and Week 6 ]

9.  Secondary:

Change in Least Pain (BPI) From Baseline to Week 12   [ Time Frame: Baseline and Week 12 ]

10.  Secondary:

Change in Average Pain (BPI) From Baseline to Week 2   [ Time Frame: Baseline and Week 2 ]

11.  Secondary:

Change in Average Pain During Treatment (BPI) From Baseline to Week 6   [ Time Frame: Baseline and Week 6 ]

12.  Secondary:

Change in Average Pain (BPI) From Baseline to Week 12   [ Time Frame: Baseline and Week 12 ]

13.  Secondary:

Number of Patients With a Reduction in BPI Average Pain at Week 2   [ Time Frame: Baseline and Week 2 ]

14.  Secondary:

Number of Patients With a Reduction in BPI Average Pain at Week 6   [ Time Frame: Baseline and Week 6 ]

15.  Secondary:

Number of Patients With a Reduction in BPI Average Pain at Week 12   [ Time Frame: Baseline and Week 12 ]

16.  Secondary:

Change in Pain During Treatment (BPI) From Baseline to Week 2   [ Time Frame: Baseline and Week 2 ]

17.  Secondary:

Change in Pain (BPI) From Baseline to Week 6   [ Time Frame: Baseline and Week 6 ]

18.  Secondary:

Change in Pain During Treatment (BPI) From Baseline to Week 12   [ Time Frame: Baseline and Week 12 ]

19.  Secondary:

Change in Relief of Pain (BPI) From the Week Before Baseline to the Week Before Week 2   [ Time Frame: Baseline and Week 2 ]

20.  Secondary:

Change in Relief of Pain (BPI) From the Week Before Baseline to the Week Before Week 6   [ Time Frame: Baseline and Week 6 ]

21.  Secondary:

Change in Relief of Pain (BPI) From the Week Before Baseline to the Week Before Week 12   [ Time Frame: Baseline and Week 12 ]

22.  Secondary:

Change in Interference of Pain With General Activity (BPI) From Baseline to Week 2   [ Time Frame: Baseline and Week 2 ]

23.  Secondary:

Change in Interference of Pain With General Activity (BPI) From Baseline to Week 6   [ Time Frame: Baseline and Week 6 ]

24.  Secondary:

Change in Interference of Pain With General Activity (BPI) From Baseline to Week 12   [ Time Frame: Baseline and Week 12 ]

25.  Secondary:

Change in Interference of Pain With Mood (BPI) From Baseline to Week 2   [ Time Frame: Baseline and Week 2 ]

26.  Secondary:

Change in Interference of Pain With Mood (BPI) From Baseline to Week 6   [ Time Frame: Baseline and Week 6 ]

27.  Secondary:

Change in Interference of Pain With Mood (BPI) From Baseline to Week 12   [ Time Frame: Baseline and Week 12 ]

28.  Secondary:

Change in Interference of Pain With Walking Ability (BPI) From Baseline to Week 2   [ Time Frame: Baseline and Week 2 ]

29.  Secondary:

Change in Interference of Pain With Walking Ability (BPI) From Baseline to Week 6   [ Time Frame: Baseline and Week 6 ]

30.  Secondary:

Change in Interference of Pain With Walking Ability (BPI) From Baseline to Week 12   [ Time Frame: Baseline and Week 12 ]

31.  Secondary:

Change in Interference of Pain With Normal Work (BPI) From Baseline to Week 2   [ Time Frame: Baseline and Week 2 ]

32.  Secondary:

Change in Interference of Pain With Normal Work (BPI) From Baseline to Week 6   [ Time Frame: Baseline and Week 6 ]

33.  Secondary:

Change in Interference of Pain With Normal Work (BPI) From Baseline to Week 12   [ Time Frame: Baseline and Week 12 ]

34.  Secondary:

Change in Interference of Pain With Relations to Other People (BPI) From Baseline to Week 2   [ Time Frame: Baseline and Week 2 ]

35.  Secondary:

Change in Interference of Pain With Relations to Other People (BPI) From Baseline to Week 6   [ Time Frame: Baseline and Week 6 ]

36.  Secondary:

Change in Interference of Pain With Relations to Other People (BPI) From Baseline to Week 12   [ Time Frame: Baseline and Week 12 ]

37.  Secondary:

Change in Interference of Pain With Sleep (BPI) From Baseline to Week 2   [ Time Frame: Baseline and Week 2 ]

38.  Secondary:

Change in Interference of Pain With Sleep (BPI) From Baseline to Week 6   [ Time Frame: Baseline and Week 6 ]

39.  Secondary:

Change in Interference of Pain With Sleep (BPI) From Baseline to Week 12   [ Time Frame: Baseline and Week 12 ]

40.  Secondary:

Change in Interference of Pain With Enjoyment of Life (BPI) From Baseline to Week 2   [ Time Frame: Baseline and Week 2 ]

41.  Secondary:

Change in Interference of Pain With Enjoyment of Life (BPI) From Baseline to Week 6   [ Time Frame: Baseline and Week 6 ]

42.  Secondary:

Change in Interference of Pain With Enjoyment of Life (BPI) From Baseline to Week 12   [ Time Frame: Baseline and Week 12 ]

43.  Secondary:

Patient Global Impression - Improvement (PGI-I) at Week 2   [ Time Frame: Baseline and Week 2 ]

44.  Secondary:

Patient Global Impression - Improvement (PGI-I) at Week 6   [ Time Frame: Baseline and Week 6 ]

45.  Secondary:

Patient Global Impression - Improvement (PGI-I) at Week 12   [ Time Frame: Baseline and Week 12 ]

46.  Secondary:

Change in Beck Depression Inventory Total Score (BDI-II) From Baseline to Week 2   [ Time Frame: Baseline and Week 2 ]

47.  Secondary:

Change in Beck Depression Inventory Total Score (BDI-II) From Baseline to Week 6   [ Time Frame: Baseline and Week 6 ]

48.  Secondary:

Change in Beck Depression Inventory Total Score (BDI-II) From Baseline to Week 12   [ Time Frame: Baseline and Week 12 ]

49.  Secondary:

Change in Hospital Anxiety and Depression Scale (HADS) Anxiety Total Score From Baseline to Week 2   [ Time Frame: Baseline and Week 2 ]

50.  Secondary:

Change in HADS Anxiety Total Score From Baseline to Week 6   [ Time Frame: Baseline and Week 6 ]

51.  Secondary:

Change in HADS Anxiety Total Score From Baseline to Week 12   [ Time Frame: Baseline and Week 12 ]

52.  Secondary:

Change in HADS Depression Total Score From Baseline to Week 2   [ Time Frame: Baseline and Week 2 ]

53.  Secondary:

Change in HADS Depression Total Score From Baseline to Week 6   [ Time Frame: Baseline and Week 6 ]

54.  Secondary:

Change in HADS Depression Total Score From Baseline to Week 12   [ Time Frame: Baseline and Week 12 ]

55.  Secondary:

Change in Short Form Health Survey (SF-12) - Physical Component Summary From Baseline to Week 6   [ Time Frame: Baseline and Week 6 ]

56.  Secondary:

Change in Short Form Health Survey (SF-12) - Physical Component Summary From Baseline to Week 12   [ Time Frame: Baseline and Week 12 ]

57.  Secondary:

Change in Short Form Health Survey (SF-12) - Mental Component Summary From Baseline to Week 6   [ Time Frame: Baseline and Week 6 ]

58.  Secondary:

Change in Short Form Health Survey (SF-12) - Mental Component Summary From Baseline to Week 12   [ Time Frame: Baseline and Week 12 ]

59.  Secondary:

Change in Multidimensional Pain Inventory (MPI): Interference of Pain (With Subjective Well-being) From Baseline to Week 6   [ Time Frame: Baseline and Week 6 ]

60.  Secondary:

Change in Multidimensional Pain Inventory (MPI): Interference of Pain From Baseline to Week 12   [ Time Frame: Baseline and Week 12 ]

61.  Secondary:

Change in Multidimensional Pain Inventory (MPI): Support From Baseline to Week 6   [ Time Frame: Baseline and Week 6 ]

62.  Secondary:

Change in Multidimensional Pain Inventory (MPI): Support Which the Patient Received From Baseline to Week 12   [ Time Frame: Baseline and Week 12 ]

63.  Secondary:

Change in Multidimensional Pain Inventory (MPI): Pain Severity From Baseline to Week 6   [ Time Frame: Baseline and Week 6 ]

64.  Secondary:

Change in Multidimensional Pain Inventory (MPI): Pain Severity From Baseline to Week 12   [ Time Frame: Baseline and Week 12 ]

65.  Secondary:

Change in Multidimensional Pain Inventory (MPI): Life Control From Baseline to Week 6   [ Time Frame: Baseline and Week 6 ]

66.  Secondary:

Change in Multidimensional Pain Inventory (MPI): Life Control From Baseline to Week 12   [ Time Frame: Baseline and Week 12 ]

67.  Secondary:

Change in Multidimensional Pain Inventory (MPI): Affective Distress From Baseline to Week 6   [ Time Frame: Baseline and Week 6 ]

68.  Secondary:

Change in Multidimensional Pain Inventory (MPI): Affective Distress From Baseline to Week 12   [ Time Frame: Baseline and Week 12 ]

69.  Secondary:

Change in Multidimensional Pain Inventory (MPI): Negative Responses From Baseline to Week 6   [ Time Frame: Baseline and Week 6 ]

70.  Secondary:

Change in Multidimensional Pain Inventory (MPI): Negative Responses From Baseline to Week 12   [ Time Frame: Baseline and Week 12 ]

71.  Secondary:

Change in Multidimensional Pain Inventory (MPI): Solicitous Responses From Baseline to Week 6   [ Time Frame: Baseline and Week 6 ]

72.  Secondary:

Change in Multidimensional Pain Inventory (MPI): Solicitous Responses From Baseline to Week 12   [ Time Frame: Baseline and Week 12 ]

73.  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   [ Time Frame: Baseline and Week 6 ]

74.  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   [ Time Frame: Baseline and Week 12 ]

75.  Secondary:

Change in Multidimensional Pain Inventory (MPI): Household Chores From Baseline to Week 6   [ Time Frame: Baseline and Week 6 ]

76.  Secondary:

Change in Multidimensional Pain Inventory (MPI): Household Chores From Baseline to Week 12   [ Time Frame: Baseline and Week 12 ]

77.  Secondary:

Change in Multidimensional Pain Inventory (MPI): Outdoor Work From Baseline to Week 6   [ Time Frame: Baseline and Week 6 ]

78.  Secondary:

Change in Multidimensional Pain Inventory (MPI): Outdoor Work From Baseline to Week 12   [ Time Frame: Baseline and Week 12 ]

79.  Secondary:

Change in Multidimensional Pain Inventory (MPI): Social Activities From Baseline to Week 6   [ Time Frame: Baseline and Week 6 ]

80.  Secondary:

Change in Multidimensional Pain Inventory (MPI): Social Activities From Baseline to Week 12   [ Time Frame: Baseline and Week 12 ]

81.  Secondary:

Change in Multidimensional Pain Inventory (MPI): General Activities From Baseline to Week 6   [ Time Frame: Baseline and Week 6 ]

82.  Secondary:

Change in Multidimensional Pain Inventory (MPI): General Activities From Baseline to Week 12   [ Time Frame: Baseline and Week 12 ]

83.  Secondary:

Change in Clinical Global Impression - Severity Pain From Baseline to Week 2   [ Time Frame: Baseline and Week 2 ]

84.  Secondary:

Change in Clinical Global Impression - Severity Pain From Baseline to Week 6   [ Time Frame: Baseline and Week 6 ]

85.  Secondary:

Change in Clinical Global Impression - Severity Pain From Baseline to Week 12   [ Time Frame: Baseline and Week 12 ]

86.  Secondary:

Change in Hamilton Depression Score From Baseline to Week 2   [ Time Frame: Baseline and Week 2 ]

87.  Secondary:

Change in Hamilton Depression Score From Baseline to Week 6   [ Time Frame: Baseline and Week 6 ]

88.  Secondary:

Change in Hamilton Depression Score From Baseline to Week 12   [ Time Frame: Baseline and Week 12 ]

89.  Secondary:

Suicidal Thoughts by BDI-II at Week 2   [ Time Frame: Week 2 ]

90.  Secondary:

Suicidal Thoughts by BDI-II at Week 6   [ Time Frame: Week 6 ]

91.  Secondary:

Suicidal Thoughts by BDI-II at Week 12   [ Time Frame: Week 12 ]

92.  Secondary:

Suicidal Thoughts or Behaviours by HAMD-17 at Week 2   [ Time Frame: Week 2 ]

93.  Secondary:

Suicidal Thoughts or Behaviours by HAMD-17 at Week 6   [ Time Frame: Week 6 ]

94.  Secondary:

Suicidal Thoughts or Behaviours by HAMD-17 at Week 12   [ Time Frame: Week 12 ]

95.  Secondary:

Change of Fasting Blood Glucose From Baseline at Week 12   [ Time Frame: Baseline and Week 12 ]

96.  Secondary:

Change of Glycosylated Hemoglobin A1c (HbA1c) From Baseline at Week 12   [ Time Frame: Baseline and Week 12 ]

97.  Secondary:

Change of Systolic Blood Pressure From Baseline at Week 12   [ Time Frame: Baseline and Week 12 ]

98.  Secondary:

Change of Diastolic Blood Pressure From Baseline at Week 12   [ Time Frame: Baseline and Week 12 ]

99.  Secondary:

Change of Pulse Rate From Baseline at Week 12   [ Time Frame: Baseline and Week 12 ]