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

NCT ID: NCT03548454

Last Updated: 2025-11-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-20
• Study Completion Date: 2024-06-26

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Duloxetine

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

Group Type: EXPERIMENTAL

Duloxetine

Intervention Type: DRUG

Open label prescription

Desipramine

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

Group Type: EXPERIMENTAL

Desipramine

Intervention Type: DRUG

Open label prescription

Interventions

Duloxetine

Open label prescription

Intervention Type: DRUG

Desipramine

Open label prescription

Intervention Type: DRUG

Other Intervention Names

Cymbalta; Norpramin

Eligibility Criteria

Inclusion Criteria

1. Age of 18 years old or above

2. Persistent pain for more than 3 months

3. Candidate for treatment by anti-depressant based on treating pain provider

Exclusion Criteria

1. 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)

2. Contraindication to taking duloxetine or desipramine

3. Patient refusal

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Vafi Salmasi

Clinical Instructor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vafi Salmasi, MD.

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford Pain Management Center

Redwood City, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan: Original Statistical Analysis Plan

View Document

Document Type: Statistical Analysis Plan: Revised Statistical Analysis Plan

View Document

Other Identifiers

44758

Identifier Type: -

Identifier Source: org_study_id