Serotonin-norepinephrine Reuptake Inhibitor in Prophylaxis of Depression Following Fragility Fractures

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-08

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The goal of this pilot study is to learn about the feasibility about prescribing anti-depressants at discharge in patients aged 50 years and older with a lower extremity fragility fracture. The main questions it aims to answer are:

* What are the obstacles to enrolling patients and prescribing anti-depressants among older adults?
* Is it possible to start prescribing SNRI medication upon discharge?
* What is the prevalence of depressive symptoms amongst patients with different types of injuries and weightbearing status?
* What is a transition of care plan for patients who have geriatric depression and require further care?

Participants will:

* Undergo screening using the Geriatric Depression Scale
* Start on Duloxetine 30mg daily at time of discharge
* Report medication compliance and complete re-screening monthly
* Complete patient reported outcome measures and 3 months, 6 months, and 1 year
* Receive a referral to behavioral health, primary care, or psychiatrist for evaluation if they screen positive at any timepoint

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Identifying and Treating Depression in the Orthopaedic Trauma Population

NCT05976347

Depression

RECRUITING PHASE4

Antidepressant Response in the Treatment of Depressive Symptoms and Frailty Characteristics in Older Adults

NCT01973283

Major Depressive Disorder Dysthymic Disorder Depressive Disorder, NOS

COMPLETED PHASE4

Preventing the Return of Depression in Elderly Patients

NCT00000377

Depression

COMPLETED NA

Effect of Brain Lesion Severity on Treatment Response in Late-Life Depression

NCT00339066

Depression

COMPLETED NA

Treating Alcohol Use In Older Adults With Depression

NCT00018824

Alcoholism Depression

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

As with many mental health diagnoses, there continues to be a stigma against receiving treatment and potentially even more so receiving prophylaxis16. Identifying these hurdles at the patient level will allow us to better educate patients and physicians about the benefits of this intervention. Secondly, this pilot study will help us determine if it is possible to start prescribing SNRI medication upon discharge. It will allow us to navigate the procurement of medications through Medicare, prescribing practices at discharge and address patient concerns regarding starting a new medication.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Depression in Old Age Fragility Fracture

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

geriatric patients with operative lower extremity fragility fractures that will be started on Serotonin-norepinephrine reuptake inhibitor (SNRI) medication immediately after obtaining consent at index hospitalization or first post operative clinic appointment

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Duloxetine 30mg

Duloxetine 30mg daily 90 day supply and 3 refills

Group Type EXPERIMENTAL

Duloxetine 30 mg

Intervention Type DRUG

Duloxetine 30mg daily prescribed at discharge

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Duloxetine 30 mg

Duloxetine 30mg daily prescribed at discharge

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Common brands: Irenka, Cymbalta

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Geriatric (greater than or equal to 65 years old)
* Lower extremity fragility fractures managed operatively

Exclusion Criteria

* Polytrauma
* Pathological fractures
* Patients on hospice
* Patients with previously diagnosed psychiatric disorders
* Patients with previously diagnosed dementia
* Patients already taking Selective serotonin reuptake inhibitors (SSRI)s and Serotonin- norepinephrine reuptake inhibitors (SNRI)s
* Patients already taking mood stabilizing medication
* Unable to provide informed consent (no use of a legal authorized representative)
* Patients with pre-existing life limiting diagnoses (cancer, etc.)

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No