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Your genes may decide if fibromyalgia drug duloxetine works

NCT ID NCT06866444

Knowledge-focused Sponsor: University of Utah Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 25, 2026 · Last updated Sep 25, 2026

Summary

Fibromyalgia causes widespread pain, fatigue, and sleep problems, and the antidepressant duloxetine helps some people but not others. Researchers at the University of Utah are studying 100 adults with fibromyalgia who take 60 mg of duloxetine daily. They will collect blood samples to check genetic variants that control drug-metabolizing enzymes and to measure duloxetine levels, then compare those results with symptom questionnaires. The goal is to understand whether gene types and drug concentrations explain why the medicine works differently for different people.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
duloxetine, an antidepressant used to treat fibromyalgia
What this could lead to
If researchers link gene types to duloxetine levels and symptom relief, doctors could one day use a genetic test to predict who benefits most from the drug.
What could go wrong
This observational study cannot prove cause and effect, and it only includes people who already take duloxetine and tolerate it. Results may not apply to those who stopped the drug or never tried it.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients treated at the Pain Management Center (PMC) at the University of Utah who meet inclusion criteria.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Adults 18+ * Meeting diagnostic criteria for Fibromyalgia * Patients taking Duloxetine 60 mg/day for at least 8 weeks Exclusion Criteria: * Pregnant patients per verbal confirmation * Patients that have a history of physician diagnosed kidney or liver disfunction or history of renal dialysis. * Patients requiring an interpreter to communicate * Patient's with progressive illnesses other than fibromyalgia that have a chronic pain and fatigue component (e.g., cancer patients receiving antineoplastic treatment, Parkinson's disease, Multiple Sclerosis).

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Conditions

The condition(s) this trial relates to.

fibromyalgia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Duloxetine Fibromyalgia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Pain Management Center and Pain Research Center at the University of Utah

    RECRUITING

    Salt Lake City, Utah, 84132, United States

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