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Tricyclic Antidepressant

Duloxetine vs Desipramine for Chronic Pain

Phase 4
Recruiting
Led By Vafi Salmasi, MD.
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Persistent pain for more than 3 months
Age of 18 years old or above
Must not have
Contraindication to taking duloxetine or desipramine
Patient refusal
Timeline
Screening 3 weeks
Treatment Varies
Follow Up monthly for 6 months
Awards & highlights
No Placebo-Only Group
Drug Has Already Been Approved
Pivotal Trial

Summary

This trial aims to compare the effectiveness of two commonly used medications for chronic pain, and to evaluate the feasibility of using an open-source learning healthcare system to monitor patients' progress.

Who is the study for?
This trial is for adults over 18 with chronic pain lasting more than 3 months who could benefit from antidepressant treatment. It's not for those who've previously had no success with Duloxetine or Desipramine, have conditions that make these drugs unsafe, or choose not to participate.
What is being tested?
The study compares the effectiveness of two medications, Duloxetine and Desipramine, in reducing chronic pain. Patients will be randomly assigned a medication and monitored using an online system (CHOIR) to track their progress over six months.
What are the potential side effects?
Possible side effects of both Duloxetine and Desipramine can include nausea, dry mouth, drowsiness, constipation, increased sweating, and fatigue. Each patient may experience side effects differently.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had pain for over 3 months.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot take duloxetine or desipramine due to health reasons.
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I have chosen not to participate in this trial.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~monthly for 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and monthly for 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Pain Intensity
Secondary study objectives
Adherence
Anxiety
Depression
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Group I: DuloxetineExperimental Treatment1 Intervention
Duloxetine starting at 20 mg per day and increasing to 60 mg per day as tolerated.
Group II: DesipramineExperimental Treatment1 Intervention
Desipramine starting at 25 mg per day and increasing to 75 mg per day as tolerated.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Desipramine
2002
Completed Phase 4
~870
Duloxetine
2011
Completed Phase 4
~4170

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,483 Previous Clinical Trials
17,516,061 Total Patients Enrolled
39 Trials studying Chronic Pain
9,687 Patients Enrolled for Chronic Pain
Vafi Salmasi, MD.Principal Investigator - Stanford University
Stanford University
1 Previous Clinical Trials
160 Total Patients Enrolled
1 Trials studying Chronic Pain
160 Patients Enrolled for Chronic Pain

Media Library

Desipramine (Tricyclic Antidepressant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03548454 — Phase 4
~27 spots leftby Jul 2025
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