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Selective Serotonin Reuptake Inhibitor

Fluoxetine for Post-Traumatic Mental Health in Musculoskeletal Injuries

Phase 2

Waitlist Available

Led By Jennifer Hagen, MD

Research Sponsored by University of Florida

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

patients with Traumatic Brain Injury or a past medical history of bipolar or other mental health conditions on current medical management will be excluded

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trialwill look at how to help trauma victims with lasting mental health issues. It will create a treatment strategy that can be safely implemented by non-mental health care providers. #MusculoskeletalTrauma #MentalHealth #TreatmentStrategy

Who is the study for?

This trial is for adults over 18 with musculoskeletal trauma needing surgery, under the care of UF Orthopedic Trauma Division. It's not for those with traumatic brain injury, bipolar disorder or other managed mental health conditions, or who live too far from Gainesville to follow up.

What is being tested?

The study tests if Fluoxetine (an antidepressant) and Calcium can help improve mental health in patients recovering from musculoskeletal injuries. The goal is to find a treatment that surgical teams can manage without specialized mental health providers.

What are the potential side effects?

Fluoxetine may cause nausea, headaches, sleep disturbances, anxiety and in some cases increased risk of bleeding when taken after surgery. Calcium generally has mild side effects like bloating or constipation.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I do not have a traumatic brain injury or a managed mental health condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2012 Phase 4 trial • 43 Patients • NCT00245635

Weight Loss

Stomach Pains

Silliness/Feeling too happy

Trouble Sleeping

Nausea

Menstrual Cramps

Insomnia

Nightmares

Emotional

Suicidal Behavior

Lit Paper on Fire

Fatigue

Decreased Appetite

Sweating

Agitated/Restlessness

Dry Mouth

Headache

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Fluoxetine

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Subjects randomized to get Fluoxetine therapyExperimental Treatment1 Intervention

Subjects will be randomized to take Fluoxetine (10mg by mouth per day). The randomized drug will be prescribed by the orthopedic team on the day randomization so that the patient may be monitored for side effects during the remainder of their hospitalization. The patient will be prescribed the randomized medication on the day of discharge and a 90 day supply will be provided by the inpatient research pharmacy.

Group II: Subjects randomized to get Calcium SupplmentationActive Control1 Intervention

Subjects will be randomized to take Calcium supplementation (1000mg by mouth per day). The randomized drug will be prescribed by the orthopedic team on the day randomization so that the patient may be monitored for side effects during the remainder of their hospitalization. The patient will be prescribed the randomized medication on the day of discharge and a 90 day supply will be provided by the inpatient research pharmacy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fluoxetine

2005

Completed Phase 4

~2370

0 / 1Eligibility criteria met