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NCT05851898 · ClinicalTrials.gov registry record · Phase 4

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

A Phase 4 study of Fragility Fracture and Depression in Old Age, sponsored by Wake Forest University Health Sciences.

Recruiting
Registry status
Phase 4
Development phase
100
Enrollment target
1
Study location

NCT05851898: Recruiting Phase 4 study of Fragility Fracture and Depression in Old Age, sponsored by Wake Forest University Health Sciences.

NCT05851898 is a Phase 4 study of Fragility Fracture and Depression in Old Age that is actively recruiting participants, run by Wake Forest University Health Sciences. The registered enrollment target is 100 participants, below the 1,186-participant average among 4 other Fragility Fracture trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05851898, a Phase 4 study of Fragility Fracture and Depression in Old Age, is actively recruiting participants, sponsored by Wake Forest University Health Sciences.

RECRUITING
Registry status
Phase 4
Development phase
100 participants
Enrollment target
1
Study location

Study Summary

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

Primary Outcome

This scale will be used as the primary outcome in this study as an indicator of patients who develop depression post-operatively. Scores range from 1-15. A score of 5 or greater indicates depression.

Interventions

  • DRUG Duloxetine 30 mg

Study Locations (1)

North Carolina

  • Wake Forest University Health Sciences - Winston-Salem

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2024-04-08
Est. Completion 2028-12
Phase Phase 4
Wake Forest University Health Sciences

1,140 total trials

What NCT05851898 shows while recruiting

NCT05851898 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 1,186-participant average among 4 other Fragility Fracture trials with a reported enrollment target (92% lower).

The record links to 2 conditions, with Fragility Fracture appearing as the primary indexed condition, and to 1 intervention - of which Duloxetine 30 mg is the first listed.

NCT05851898 reports a single indexed study location in North Carolina.

Frequently Asked Questions

What is clinical trial NCT05851898 about?

NCT05851898 is a clinical study titled "Serotonin-norepinephrine Reuptake Inhibitor in Prophylaxis of Depression Following Fragility Fractures". 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...

What is the current status of trial NCT05851898?

This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 100 participants. The study started on 2024-04-08. Estimated completion is 2028-12.

What conditions does trial NCT05851898 study?

This clinical trial studies the following conditions: Fragility Fracture, Depression in Old Age.

What interventions are being tested in trial NCT05851898?

The interventions under investigation include: Duloxetine 30 mg (DRUG).

Who is sponsoring clinical trial NCT05851898?

This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05851898 being conducted?

This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT05851898, the US trial registry maintained by the National Library of Medicine. NCT05851898 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.