A Phase 4 interventional study of Duloxetine and Desipramine in Chronic Pain, sponsored by Stanford University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-06.
Sponsored by Stanford University · Phase 4, Interventional, and Health services research
Over 100 million Americans suffer from chronic pain resulting in annual cost of roughly $635 billion. Limited treatments are available for this widespread disease. The data supporting these treatments lack generalizability to patients with more serious medical and psychological comorbidities who are often excluded from explanatory efficacy trials. Our work aims to integrate randomized comparative effectiveness research with patient care. The investigators will randomize the patients and collect data using an open-source learning healthcare system already in use in our department to monitor patients' progress: Collaborative Health Outcomes Information Registry (CHOIR). Collaborative Health Outcomes Information Registry uses the National Institute of Health Patient Reported Outcomes Measurement Information System item banks for comparative metrics through computer adaptive testing. The investigators will leverage the advantage of this novel system to compare effectiveness of duloxetine and desipramine in decreasing pain in patients with chronic pain. The investigators will also compare adherence of patients to these two commonly used medications over a period of six months. This will evaluate feasibility of integrating randomized comparative effectiveness research with patient care in subspecialty clinics. Collaborative Health Outcomes Information Registry can then be applied for numerous future trials to advance our knowledge in perioperative and pain medicine.
2,930 studies on the registry are indexed under Chronic Pain; 701 are open to participants now.
This study's enrollment of 86 is above the median of 60 across 2,161 interventional studies indexed under Chronic Pain.
Browse Chronic Pain studies →Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.
Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
Duloxetine starting at 20 mg per day and increasing to 60 mg per day as tolerated.
Drug: Duloxetine
Desipramine starting at 25 mg per day and increasing to 75 mg per day as tolerated.
Drug: Desipramine
Open label prescription
Also known as: Cymbalta
Open label prescription
Also known as: Norpramin
Pain Intensity
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).
Time frame: baseline and 6 months
Physical Function
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.
Time frame: Baseline and 6 months
Pain Interference
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.
Time frame: Baseline and 6 months
Depression
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.
Time frame: Baseline and 6 months
Anxiety
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.
Time frame: Baseline and 6 months
Adherence
Number of participants who completed 6-month therapy based on prescription records.
Time frame: Monthly for 6 months
| Milestone | Desipramine | Duloxetine |
|---|---|---|
| Started | 38 | 48 |
| Completed | 38 | 48 |
| Not completed | 0 | 0 |
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).
| Participants | Desipramine | Duloxetine |
|---|---|---|
| Pain Intensity | 11 | 29 |
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.
| T-score | Desipramine | Duloxetine |
|---|---|---|
| Baseline | 39.29 ± 7.63 | 39.07 ± 6.33 |
| 6-month | 41.9 ± 8.91 | 39.39 ± 6.98 |
| Change from baseline at 6-month | 2.54 ± 5.83 | 1.36 ± 3.88 |
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.
| T-score | Desipramine | Duloxetine |
|---|---|---|
| Baseline | 64.37 ± 7.1 | 64.93 ± 6.48 |
| 6-month | 60.82 ± 7.1 | 62.11 ± 6.98 |
| Change from baseline at 6-month | -4.29 ± 7.57 | -4.06 ± 7.51 |
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.
| T-score | Desipramine | Duloxetine |
|---|---|---|
| Baseline | 52.98 ± 9.40 | 54.24 ± 8.89 |
| 6-month | 52.54 ± 9.7 | 53.39 ± 11.93 |
| Change from baseline at 6-month | -3.24 ± 6.58 | -1.14 ± 12.83 |
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.
| T-score | Desipramine | Duloxetine |
|---|---|---|
| Baseline | 54.39 ± 10.21 | 54.65 ± 8.99 |
| 6-month | 54.97 ± 9.65 | 54.01 ± 11.72 |
| Change from baseline at 6-month | -1.2 ± 7.11 | -1.29 ± 11.89 |
Number of participants who completed 6-month therapy based on prescription records.
| Participants | Desipramine | Duloxetine |
|---|---|---|
| Adherence | 18 | 24 |
Collected over During 6 months duration of the study. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Desipramine | 0/38 (0%) | 0/38 (0%) | 6/38 (15.8%) |
| Duloxetine | 0/48 (0%) | 0/48 (0%) | 4/48 (8.3%) |
| Event | Desipramine | Duloxetine |
|---|---|---|
| Did not tolerateInvestigations | 1/38 | 0/48 |
| ConstipationGastrointestinal disorders | 1/38 | 0/48 |
| DrowsinessNervous system disorders | 1/38 | 0/48 |
| CoagulopathyBlood and lymphatic system disorders | 1/38 | 0/48 |
| Urinary frequencyRenal and urinary disorders | 1/38 | 0/48 |
| Urinary retentionRenal and urinary disorders | 1/38 | 0/48 |
| InsomniaNervous system disorders | 0/38 | 1/48 |
| Increased painNervous system disorders | 0/38 | 1/48 |
| DiarrheaGastrointestinal disorders | 0/38 | 1/48 |
| NauseaGastrointestinal disorders | 0/38 | 1/48 |
| Age, Continuous(years) | Desipramine | Duloxetine | Total |
|---|---|---|---|
| Mean | 47.78 ± 14.36 | 47.25 ± 16.67 | 47.48 ± 15.62 |
| Sex: Female, Male(Participants) | Desipramine | Duloxetine | Total |
|---|---|---|---|
| Female | 18 | 29 | 47 |
| Male | 20 | 19 | 39 |
| Ethnicity (NIH/OMB)(Participants) | Desipramine | Duloxetine | Total |
|---|---|---|---|
| Hispanic or Latino | 7 | 8 | 15 |
| Not Hispanic or Latino | 29 | 31 | 60 |
| Unknown or Not Reported | 2 | 9 | 11 |
| Race/Ethnicity, Customized(Participants) | Desipramine | Duloxetine | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 6 | 3 | 9 |
| Black or African American | 1 | 0 | 1 |
| Unknown/Refused | 2 | 9 | 11 |
| White | 18 | 26 | 44 |
| Other | 10 | 10 | 20 |
| Region of Enrollment(Participants) | Desipramine | Duloxetine | Total |
|---|---|---|---|
| United States | 38 | 48 | 86 |
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