Chronic PainPhase 4NCT03548454
Comparing Effectiveness of Duloxetine and Desipramine in Patients With Chronic Pain: A Pragmatic Trial Using Point of Care Randomization
A Phase 4 study testing Duloxetine and Desipramine in people with Chronic Pain, run by Stanford University at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Duloxetine and Desipramine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2018to 26 Jun 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age of 18 years old or above
- Persistent pain for more than 3 months
- Candidate for treatment by anti-depressant based on treating pain provider
Who cannot join
- Prior failure of duloxetine and/or desipramine (patients who have failed other TCAs or SNRIs can be considered for the trial based on the reason for previous medication failure)
- Contraindication to taking duloxetine or desipramine
- Patient refusal
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford Pain Management Center
Redwood City, California, 94063
About this study
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.
- Conditions
- Chronic Pain
- Being tested
- Duloxetine, Desipramine
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DuloxetineDrug
Also called Cymbalta
Open label prescription
DesipramineDrug
Also called Norpramin
Open label prescription
| Study group | Role | What they receive |
|---|---|---|
| Duloxetine | Experimental | Duloxetine starting at 20 mg per day and increasing to 60 mg per day as tolerated. Receives: Drug: Duloxetine |
| Desipramine | Experimental | Desipramine starting at 25 mg per day and increasing to 75 mg per day as tolerated. Receives: Drug: Desipramine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: baseline and 6 months
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 6 months
Adherence
Number of participants who completed 6-month therapy based on prescription records.
Measured: Monthly for 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2018
- Study start20 Sep 2018
- Primary completion24 Dec 2023
- Study completion26 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vafi Salmasi, Stanford University
- Investigators
- Vafi Salmasi, MD., Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03548454
- Sponsor's protocol ID
- 44758
- Status last verified
- Oct 2025
- First submitted
- 17 Apr 2018
- Last updated
- 6 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Effectiveness of Duloxetine and Desipramine in Patients With Chronic Pain: A Pragmatic Trial Using Point of Care Randomization
- ClinicalTrials.gov ID
- NCT03548454
- Acronym / sponsor ID
- 44758
- Conditions
- Chronic Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 20 Sep 2018 (actual)
- Primary completion
- 24 Dec 2023 (actual)
- Study completion
- 26 Jun 2024 (actual)
- First posted
- 7 Jun 2018 (actual)
- Results
- Posted 6 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Duloxetine | Experimental | Drug: DuloxetineDuloxetine starting at 20 mg per day and increasing to 60 mg per day as tolerated. |
| Desipramine | Experimental | Drug: DesipramineDesipramine starting at 25 mg per day and increasing to 75 mg per day as tolerated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age of 18 years old or above
- Persistent pain for more than 3 months
- Candidate for treatment by anti-depressant based on treating pain provider
Key exclusion criteria (3 listed)
- Prior failure of duloxetine and/or desipramine (patients who have failed other TCAs or SNRIs can be considered for the trial based on the reason for previous medication failure)
- Contraindication to taking duloxetine or desipramine
- Patient refusal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DuloxetineAlso: CymbaltaOpen label prescription | Drug | Duloxetine |
| DesipramineAlso: NorpraminOpen label prescription | Drug | Desipramine |
Primary outcome
Pain Intensity
Time frame: baseline and 6 months
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).
5 secondary outcomes
Physical Function
Time frame: Baseline and 6 months
Pain Interference
Time frame: Baseline and 6 months
Depression
Time frame: Baseline and 6 months
Anxiety
Time frame: Baseline and 6 months
Adherence
Time frame: Monthly for 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vafi Salmasi, MD. principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Duloxetine and Desipramine in people with Chronic Pain, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (time frame: baseline and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2025.