Trial Outcomes & Findings for Comparing Effectiveness of Duloxetine and Desipramine in Patients With Chronic Pain: A Pragmatic Trial Using Point of Care Randomization (NCT NCT03548454)
NCT ID: NCT03548454
Last Updated: 2025-11-06
Results Overview
Percent of participants in each arm that had more than 30% reduction in pain intensity. Participants rated their pain on an 11-point scale (0 to 10; 0 = no pain, 10 = worst pain imaginable).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
86 participants
Primary outcome timeframe
baseline and 6 months
Results posted on
2025-11-06
Participant Flow
Patients were equally randomized to duloxetine and desipramine (43 in each arm); however, five patients chose not to take desipramine and crossed over to the duloxetine group before starting study medication.
Participant milestones
| Measure |
Desipramine
Desipramine starting at 25 mg per day and increasing to 75 mg per day as tolerated.
|
Duloxetine
Duloxetine starting at 20 mg per day and increasing to 60 mg per day as tolerated.
|
|---|---|---|
|
Overall Study
STARTED
|
38
|
48
|
|
Overall Study
COMPLETED
|
38
|
48
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Participants with non-missing data
Baseline characteristics by cohort
| Measure |
Desipramine
n=38 Participants
Desipramine starting at 25 mg per day and increasing to 75 mg per day as tolerated.
|
Duloxetine
n=48 Participants
Duloxetine starting at 20 mg per day and increasing to 60 mg per day as tolerated.
|
Total
n=86 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.78 years
STANDARD_DEVIATION 14.36 • n=49 Participants
|
47.25 years
STANDARD_DEVIATION 16.67 • n=50 Participants
|
47.48 years
STANDARD_DEVIATION 15.62 • n=50 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=49 Participants • Participants with non-missing data
|
29 Participants
n=50 Participants • Participants with non-missing data
|
47 Participants
n=50 Participants • Participants with non-missing data
|
|
Sex: Female, Male
Male
|
20 Participants
n=49 Participants • Participants with non-missing data
|
19 Participants
n=50 Participants • Participants with non-missing data
|
39 Participants
n=50 Participants • Participants with non-missing data
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=49 Participants
|
8 Participants
n=50 Participants
|
15 Participants
n=50 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=49 Participants
|
31 Participants
n=50 Participants
|
60 Participants
n=50 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=49 Participants
|
9 Participants
n=50 Participants
|
11 Participants
n=50 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=49 Participants
|
0 Participants
n=50 Participants
|
1 Participants
n=50 Participants
|
|
Race/Ethnicity, Customized
Asian
|
6 Participants
n=49 Participants
|
3 Participants
n=50 Participants
|
9 Participants
n=50 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=49 Participants
|
0 Participants
n=50 Participants
|
1 Participants
n=50 Participants
|
|
Race/Ethnicity, Customized
Unknown/Refused
|
2 Participants
n=49 Participants
|
9 Participants
n=50 Participants
|
11 Participants
n=50 Participants
|
|
Race/Ethnicity, Customized
White
|
18 Participants
n=49 Participants
|
26 Participants
n=50 Participants
|
44 Participants
n=50 Participants
|
|
Race/Ethnicity, Customized
Other
|
10 Participants
n=49 Participants
|
10 Participants
n=50 Participants
|
20 Participants
n=50 Participants
|
|
Region of Enrollment
United States
|
38 Participants
n=49 Participants
|
48 Participants
n=50 Participants
|
86 Participants
n=50 Participants
|
PRIMARY outcome
Timeframe: baseline and 6 monthsPercent of participants in each arm that had more than 30% reduction in pain intensity. Participants rated their pain on an 11-point scale (0 to 10; 0 = no pain, 10 = worst pain imaginable).
Outcome measures
| Measure |
Desipramine
n=38 Participants
Desipramine starting at 25 mg per day and increasing to 75 mg per day as tolerated.
|
Duloxetine
n=48 Participants
Duloxetine starting at 20 mg per day and increasing to 60 mg per day as tolerated.
|
|---|---|---|
|
Pain Intensity
|
11 Participants
|
29 Participants
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsPopulation: Participants with data at the respective time point
National Institute of Health Patient Reported Outcomes Measurement Information System Standardized score for physical function. Raw scores were converted to T-scores with a population mean of 50 with standard deviation of 10. Overall score range: 0 to 100, higher scores correspond to better function.
Outcome measures
| Measure |
Desipramine
n=38 Participants
Desipramine starting at 25 mg per day and increasing to 75 mg per day as tolerated.
|
Duloxetine
n=48 Participants
Duloxetine starting at 20 mg per day and increasing to 60 mg per day as tolerated.
|
|---|---|---|
|
Physical Function
Change from baseline at 6-month
|
2.54 T-score
Standard Deviation 5.83
|
1.36 T-score
Standard Deviation 3.88
|
|
Physical Function
Baseline
|
39.29 T-score
Standard Deviation 7.63
|
39.07 T-score
Standard Deviation 6.33
|
|
Physical Function
6-month
|
41.9 T-score
Standard Deviation 8.91
|
39.39 T-score
Standard Deviation 6.98
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsPopulation: Participants with data at the respective time point
National Institute of Health Patient Reported Outcomes Measurement Information System Standardized score for pain interference. Raw scores were converted to T-scores with a population mean of 50 with standard deviation of 10. Overall score range: 0 to 100, higher scores correspond to worse pain interference.
Outcome measures
| Measure |
Desipramine
n=38 Participants
Desipramine starting at 25 mg per day and increasing to 75 mg per day as tolerated.
|
Duloxetine
n=48 Participants
Duloxetine starting at 20 mg per day and increasing to 60 mg per day as tolerated.
|
|---|---|---|
|
Pain Interference
Baseline
|
64.37 T-score
Standard Deviation 7.1
|
64.93 T-score
Standard Deviation 6.48
|
|
Pain Interference
6-month
|
60.82 T-score
Standard Deviation 7.1
|
62.11 T-score
Standard Deviation 6.98
|
|
Pain Interference
Change from baseline at 6-month
|
-4.29 T-score
Standard Deviation 7.57
|
-4.06 T-score
Standard Deviation 7.51
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsPopulation: Participants with data at the respective time point
National Institute of Health Patient Reported Outcomes Measurement Information System Standardized score for depression. Raw scores were converted to T-scores with a population mean of 50 with standard deviation of 10. Overall score range: 0 to 100, higher scores correspond to more severe depression.
Outcome measures
| Measure |
Desipramine
n=38 Participants
Desipramine starting at 25 mg per day and increasing to 75 mg per day as tolerated.
|
Duloxetine
n=48 Participants
Duloxetine starting at 20 mg per day and increasing to 60 mg per day as tolerated.
|
|---|---|---|
|
Depression
Baseline
|
52.98 T-score
Standard Deviation 9.40
|
54.24 T-score
Standard Deviation 8.89
|
|
Depression
6-month
|
52.54 T-score
Standard Deviation 9.7
|
53.39 T-score
Standard Deviation 11.93
|
|
Depression
Change from baseline at 6-month
|
-3.24 T-score
Standard Deviation 6.58
|
-1.14 T-score
Standard Deviation 12.83
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsPopulation: Participants with data at the respective time point
National Institute of Health Patient Reported Outcomes Measurement Information System Standardized score for anxiety. Raw scores were converted to T-scores with a population mean of 50 with standard deviation of 10. Overall score range: 0 to 100, higher scores correspond to more severe anxiety.
Outcome measures
| Measure |
Desipramine
n=38 Participants
Desipramine starting at 25 mg per day and increasing to 75 mg per day as tolerated.
|
Duloxetine
n=48 Participants
Duloxetine starting at 20 mg per day and increasing to 60 mg per day as tolerated.
|
|---|---|---|
|
Anxiety
Baseline
|
54.39 T-score
Standard Deviation 10.21
|
54.65 T-score
Standard Deviation 8.99
|
|
Anxiety
6-month
|
54.97 T-score
Standard Deviation 9.65
|
54.01 T-score
Standard Deviation 11.72
|
|
Anxiety
Change from baseline at 6-month
|
-1.2 T-score
Standard Deviation 7.11
|
-1.29 T-score
Standard Deviation 11.89
|
SECONDARY outcome
Timeframe: Monthly for 6 monthsNumber of participants who completed 6-month therapy based on prescription records.
Outcome measures
| Measure |
Desipramine
n=38 Participants
Desipramine starting at 25 mg per day and increasing to 75 mg per day as tolerated.
|
Duloxetine
n=48 Participants
Duloxetine starting at 20 mg per day and increasing to 60 mg per day as tolerated.
|
|---|---|---|
|
Adherence
|
18 Participants
|
24 Participants
|
Adverse Events
Desipramine
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Duloxetine
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Desipramine
n=38 participants at risk
Desipramine starting at 25 mg per day and increasing to 75 mg per day as tolerated.
|
Duloxetine
n=48 participants at risk
Duloxetine starting at 20 mg per day and increasing to 60 mg per day as tolerated.
|
|---|---|---|
|
Investigations
Did not tolerate
|
2.6%
1/38 • Number of events 1 • During 6 months duration of the study
All participants were systematically inquired about presence of adverse events during each study survey
|
0.00%
0/48 • During 6 months duration of the study
All participants were systematically inquired about presence of adverse events during each study survey
|
|
Gastrointestinal disorders
Constipation
|
2.6%
1/38 • Number of events 1 • During 6 months duration of the study
All participants were systematically inquired about presence of adverse events during each study survey
|
0.00%
0/48 • During 6 months duration of the study
All participants were systematically inquired about presence of adverse events during each study survey
|
|
Nervous system disorders
Drowsiness
|
2.6%
1/38 • Number of events 1 • During 6 months duration of the study
All participants were systematically inquired about presence of adverse events during each study survey
|
0.00%
0/48 • During 6 months duration of the study
All participants were systematically inquired about presence of adverse events during each study survey
|
|
Blood and lymphatic system disorders
Coagulopathy
|
2.6%
1/38 • Number of events 1 • During 6 months duration of the study
All participants were systematically inquired about presence of adverse events during each study survey
|
0.00%
0/48 • During 6 months duration of the study
All participants were systematically inquired about presence of adverse events during each study survey
|
|
Renal and urinary disorders
Urinary frequency
|
2.6%
1/38 • Number of events 1 • During 6 months duration of the study
All participants were systematically inquired about presence of adverse events during each study survey
|
0.00%
0/48 • During 6 months duration of the study
All participants were systematically inquired about presence of adverse events during each study survey
|
|
Renal and urinary disorders
Urinary retention
|
2.6%
1/38 • Number of events 1 • During 6 months duration of the study
All participants were systematically inquired about presence of adverse events during each study survey
|
0.00%
0/48 • During 6 months duration of the study
All participants were systematically inquired about presence of adverse events during each study survey
|
|
Nervous system disorders
Insomnia
|
0.00%
0/38 • During 6 months duration of the study
All participants were systematically inquired about presence of adverse events during each study survey
|
2.1%
1/48 • Number of events 1 • During 6 months duration of the study
All participants were systematically inquired about presence of adverse events during each study survey
|
|
Nervous system disorders
Increased pain
|
0.00%
0/38 • During 6 months duration of the study
All participants were systematically inquired about presence of adverse events during each study survey
|
2.1%
1/48 • Number of events 1 • During 6 months duration of the study
All participants were systematically inquired about presence of adverse events during each study survey
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/38 • During 6 months duration of the study
All participants were systematically inquired about presence of adverse events during each study survey
|
2.1%
1/48 • Number of events 1 • During 6 months duration of the study
All participants were systematically inquired about presence of adverse events during each study survey
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/38 • During 6 months duration of the study
All participants were systematically inquired about presence of adverse events during each study survey
|
2.1%
1/48 • Number of events 1 • During 6 months duration of the study
All participants were systematically inquired about presence of adverse events during each study survey
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place