320 Participants Needed

Duloxetine vs Desipramine for Chronic Pain

VS
Overseen ByVafi Salmasi, MD.
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Stanford University
Must be taking: Antidepressants
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drug duloxetine for chronic pain?

Duloxetine has been shown to be effective in relieving pain associated with major depressive disorder and diabetic peripheral neuropathic pain, and it is also used for fibromyalgia, which involves chronic pain. This suggests it may help with chronic pain, although more research is needed to confirm its effectiveness specifically for chronic pain conditions.12345

What safety data exists for duloxetine and desipramine in humans?

Duloxetine has been studied for safety in various conditions, including major depressive disorder, diabetic peripheral neuropathic pain, and fibromyalgia. Common side effects include nausea, headache, dry mouth, insomnia, fatigue, constipation, diarrhea, and dizziness. There is no specific safety data provided for desipramine in the research articles.46789

How does the drug duloxetine differ from other treatments for chronic pain?

Duloxetine is unique because it works by directly affecting pain pathways in the brain, providing both pain relief and antidepressant effects, which is beneficial for conditions like fibromyalgia and diabetic neuropathic pain. It is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI), which means it increases the levels of these neurotransmitters to help reduce pain and improve mood.1011121314

What is the purpose of this trial?

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.

Research Team

VS

Vafi Salmasi, MD.

Principal Investigator

Stanford University

Eligibility Criteria

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.

Inclusion Criteria

I have had pain for over 3 months.
My doctor thinks I should take antidepressants for my pain.

Exclusion Criteria

I have tried duloxetine or desipramine for my condition without success.
I cannot take duloxetine or desipramine due to health reasons.
I have chosen not to participate in this trial.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive either duloxetine or desipramine, with dosages adjusted as tolerated, to assess effectiveness in decreasing pain

6 months
Monthly assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Desipramine
  • Duloxetine
Trial Overview 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.
Participant Groups
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.

Desipramine is already approved in United States for the following indications:

🇺🇸
Approved in United States as Desipramine for:
  • Depression
  • Irritable Bowel Syndrome
  • ADHD
  • Dysautonomia
  • Vulvodynia

Find a Clinic Near You

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials
2,527
Recruited
17,430,000+

Findings from Research

In a study of 622 adult outpatients treated with duloxetine for depression, patients experienced a significant improvement in pain symptoms earlier than mood symptoms, with a mean time to 50% pain response of 6.3 days compared to 7.6 days for mood response.
This finding suggests that duloxetine may provide quicker relief from physical pain associated with depression, which could be important for treatment strategies focusing on both emotional and physical symptoms.
Does pain improve earlier than mood in depressed patients with painful physical symptoms treated with duloxetine?Hegerl, U., Mergl, R., Quail, D., et al.[2015]
Duloxetine, a new antidepressant, has shown potential for pain management due to its effects on both noradrenergic and serotonergic neurotransmitters, as indicated by preclinical studies.
While it may help alleviate pain in patients with major depression, its effectiveness for treating pain disorders in general is not yet established, highlighting the need for further research.
Antidepressant Use in Chronic Pain Management: Is There Evidence of a Role for Duloxetine?Leo, RJ., Barkin, RL.[2020]
In a post-hoc analysis of six trials involving duloxetine for major depressive disorder, significant pain relief was observed within 2 weeks, which occurred faster than the onset of antidepressant effects as measured by the HAMD(17) scale.
The study found that the analgesic effect of duloxetine operates independently from its antidepressant effect, suggesting that the two mechanisms do not influence each other in terms of response time.
The relationship between antidepressant and analgesic responses: findings from six placebo-controlled trials assessing the efficacy of duloxetine in patients with major depressive disorder.Fishbain, DA., Detke, MJ., Wernicke, J., et al.[2019]

References

Does pain improve earlier than mood in depressed patients with painful physical symptoms treated with duloxetine? [2015]
Antidepressant Use in Chronic Pain Management: Is There Evidence of a Role for Duloxetine? [2020]
The relationship between antidepressant and analgesic responses: findings from six placebo-controlled trials assessing the efficacy of duloxetine in patients with major depressive disorder. [2019]
Duloxetine for the treatment of major depressive disorder in older patients. [2022]
Current Opinions about the Use of Duloxetine: Results from a Survey Aimed at Psychiatrists. [2023]
Duloxetine versus routine care in the long-term management of diabetic peripheral neuropathic pain. [2022]
An open-label 52-week clinical extension comparing duloxetine with routine care in patients with diabetic peripheral neuropathic pain. [2022]
Is there a place for duloxetine? [2022]
Safety and tolerability of duloxetine in the treatment of patients with fibromyalgia: pooled analysis of data from five clinical trials. [2021]
10.United Statespubmed.ncbi.nlm.nih.gov
A comparative evaluation of amitriptyline and duloxetine in painful diabetic neuropathy: a randomized, double-blind, cross-over clinical trial. [2022]
Duloxetine: in patients with fibromyalgia. [2021]
Analgesic effect of duloxetine compared to nortryptiline in patients with painful neuropathy: A randomized, double-blind, placebo-controlled trial. [2022]
Efficacy of duloxetine in painful symptoms: an analgesic or antidepressant effect? [2015]
14.United Statespubmed.ncbi.nlm.nih.gov
A review of duloxetine 60 mg once-daily dosing for the management of diabetic peripheral neuropathic pain, fibromyalgia, and chronic musculoskeletal pain due to chronic osteoarthritis pain and low back pain. [2015]
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