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Can your bone doctor treat your depression?

NCT ID NCT05976347

Symptom relief Sponsor: Wake Forest University Health Sciences 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether orthopaedic surgeons can safely screen for depression in patients recovering from a broken bone and offer treatment with common antidepressants like Prozac or Cymbalta. About 100 adults who score at least 5 on a depression questionnaire will be offered medication or a referral to behavioral health. The goal is to see if this approach improves depressive symptoms and is practical in a trauma clinic.

What this could mean

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

Active substance
Fluoxetine (Prozac) or Duloxetine (Cymbalta)
What this could lead to
If successful, this could show that orthopaedic surgeons can effectively treat depression after a serious injury, improving recovery and quality of life.
What could go wrong
This is a small pilot study (100 people) testing existing drugs, not a new breakthrough. Results may not apply to all patients, and antidepressants have side effects.

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.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 100 people

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

Started

Jun 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.

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: * Patients presenting to an Orthopaedic trauma clinic for the first time following operative extremity fracture or any pelvis fracture * A score of greater than or equal to 5 on the Patient Health Questionnaire-9 (PHQ-9) at first post- operative visit * Age 18 or older * Speak English or Spanish Exclusion Criteria: * Currently taking medication to treat depression * Contraindication/allergy to one of the study medications * Bipolar disorder of psychotic disorder * Endorse suicidal ideation

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Conditions

The condition(s) this trial relates to.

Depression depressive disorder

As listed by the trial registrant

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

Depression

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

  • Wake Forest University Health Sciences

    RECRUITING

    Winston-Salem, North Carolina, 27157, United States

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