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

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03548454
• Other study ID #: 44758
• Status: Recruiting
• Phase: Phase 4
• Start date: September 20, 2018
• Est. completion date: July 31, 2025

Study information

• Verified date: November 2023
• Source: Stanford University
• Contact: Vafi Salmasi, MD.
• Phone: 650-725-0246
• Email: vsalmasi[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 320
• Est. completion date: July 31, 2025
• Est. primary completion date: July 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Drug:
• Duloxetine
Open label prescription
• Desipramine
Open label prescription

Locations

Country	Name	City	State
United States	Stanford Pain Management Center	Redwood City	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Intensity	Average and worst pain intensity reported by participants on a numerical rating scale of 0-10	Monthly for 6 months
Secondary	Physical Function	National Institute of Health Patient Reported Outcomes Measurement Information System Standardized score for physical function	Monthly for 6 months
Secondary	Pain Interference	National Institute of Health Patient Reported Outcomes Measurement Information System Standardized score for pain interference	Monthly for 6 months
Secondary	Depression	National Institute of Health Patient Reported Outcomes Measurement Information System Standardized score for depression	Monthly for 6 months
Secondary	Anxiety	National Institute of Health Patient Reported Outcomes Measurement Information System Standardized score for anxiety	Monthly for 6 months
Secondary	Adherence	Time to stopping either medication in days	Monthly for 6 months