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Phase 4 N=86 Randomized Health Services Research

Comparing Effectiveness of Duloxetine and Desipramine in Patients With Chronic Pain: A Pragmatic Trial Using Point of Care Randomization

Chronic Pain

Enrolled (actual)
86
Serious AEs
0.0%
Results posted
Nov 2025
Primary outcome: Primary: Pain Intensity — 11; 29 Participants

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Duloxetine (Drug); Desipramine (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Stanford University
Primary completion
Dec 2023

Outcome Measures

OutcomeResultp-value
PRIMARY
Pain Intensity
11; 29
SECONDARY
Physical Function
39.29; 39.07; 41.9; 39.39; 2.54; 1.36
SECONDARY
Pain Interference
64.37; 64.93; 60.82; 62.11; -4.29; -4.06
SECONDARY
Depression
52.98; 54.24; 52.54; 53.39; -3.24; -1.14
SECONDARY
Anxiety
54.39; 54.65; 54.97; 54.01; -1.2; -1.29
SECONDARY
Adherence
18; 24

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 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.

Eligibility Criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03548454). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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