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Selective Serotonin Reuptake Inhibitor

Fluoxetine for Post-Traumatic Mental Health in Musculoskeletal Injuries

Q: What additional research has been conducted regarding Fluoxetine?

Presently, 62 clinical trials have been launched to investigate Fluoxetine and 19 of these are currently in the third phase. While Columbia, <a href="https://www.withpower.com/clinical-trials/south-carolina">South carolina</a> is home to most studies on this drug, there are 6472 medical centres running related research.

Q: What are Fluoxetine's common applications?

Fluoxetine is commonly prescribed for the management of myoclonus and other afflictions, including anticonvulsants, unipolar <a href="https://www.withpower.com/clinical-trials/depression">depression</a>, and kidney failure.

Q: How many participants can enroll in this research program?

Yes, according to clinicaltrials.gov, this medical trial is open for recruitment and has been since September 1st 2021. Last edited on November 4th 2022, the study needs 150 volunteers from one research site.

Q: Is there still room for participants in this investigation?

This medical research is currently searching for participants, as evidenced by information housed on clinicaltrials.gov. This trial was initiated on September 1st 2021 and has been recently amended on November 4th 2022.

Phase < 1

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to 12 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Serial mental well-being surveys in the post-injury period for patients with musculoskeletal trauma.

Secondary outcome measures

Patient reported pain scores (PEG score) will be recorded at each visit.

Side effects data

From 2012 Phase 4 trial • 43 Patients • NCT00245635

Stomach Pains

Weight Loss

Nausea

Trouble Sleeping

Insomnia

Nightmares

Menstrual Cramps

Silliness/Feeling too happy

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

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of FloridaLead Sponsor

1,340 Previous Clinical Trials

715,555 Total Patients Enrolled

1 Trials studying Musculoskeletal Injuries

200 Patients Enrolled for Musculoskeletal Injuries

Jennifer Hagen, MDPrincipal InvestigatorUniversity of Florida

Media Library

Fluoxetine (Selective Serotonin Reuptake Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04850222 — Phase < 1

Musculoskeletal Injuries Research Study Groups: Subjects randomized to get Calcium Supplmentation, Subjects randomized to get Fluoxetine therapy

Musculoskeletal Injuries Clinical Trial 2023: Fluoxetine Highlights & Side Effects. Trial Name: NCT04850222 — Phase < 1

Fluoxetine (Selective Serotonin Reuptake Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04850222 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What additional research has been conducted regarding Fluoxetine?

"Presently, 62 clinical trials have been launched to investigate Fluoxetine and 19 of these are currently in the third phase. While Columbia, South carolina is home to most studies on this drug, there are 6472 medical centres running related research."

Answered by AI

What are Fluoxetine's common applications?

"Fluoxetine is commonly prescribed for the management of myoclonus and other afflictions, including anticonvulsants, unipolar depression, and kidney failure."

Answered by AI

How many participants can enroll in this research program?

"Yes, according to clinicaltrials.gov, this medical trial is open for recruitment and has been since September 1st 2021. Last edited on November 4th 2022, the study needs 150 volunteers from one research site."

Answered by AI

Is there still room for participants in this investigation?

"This medical research is currently searching for participants, as evidenced by information housed on clinicaltrials.gov. This trial was initiated on September 1st 2021 and has been recently amended on November 4th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Fluoxetine Mitigation Mental Health Study for Patients With Musculoskeletal Trauma

2021. "Fluoxetine Mitigation Mental Health Study for Patients With Musculoskeletal Trauma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04850222.

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