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

NCT03548454 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 44758
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (1)

• 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).

  baseline and 6 months

Secondary Outcomes (5)

• Physical Function

  Baseline and 6 months

• Pain Interference

  Baseline and 6 months

• Depression

  Baseline and 6 months

• Anxiety

  Baseline and 6 months

• Adherence

  Monthly for 6 months

Study Arms (2)

Duloxetine

EXPERIMENTAL

Duloxetine starting at 20 mg per day and increasing to 60 mg per day as tolerated.

Drug: Duloxetine

Desipramine

EXPERIMENTAL

Desipramine starting at 25 mg per day and increasing to 75 mg per day as tolerated.

Drug: Desipramine

Interventions

Duloxetine DRUG

Open label prescription

Also known as: Cymbalta

Duloxetine

Desipramine DRUG

Open label prescription

Also known as: Norpramin

Desipramine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford Pain Management Center

Redwood City, California, 94063, United States

Location

MeSH Terms

Conditions

Chronic Pain

Interventions

Duloxetine Hydrochloride; Desipramine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Dr. Vafi Salmasi
• Organization: Stanford University

vsalmasi@stanford.edu

650-725-0246

Study Officials

• Vafi Salmasi, MD.

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Instructor

Study Record Dates

• First Submitted: April 17, 2018
• First Posted: June 7, 2018
• Study Start: September 20, 2018
• Primary Completion: December 24, 2023
• Study Completion: June 26, 2024
• Last Updated: November 6, 2025
• Results First Posted: November 6, 2025

Record last verified: 2025-10

Locations

US (1)