ArticlePilot and feasibility studies2022
Can fluoxetine mitigate mental health decline in musculoskeletal trauma patients: a pilot single-center randomized clinical trial.
Article in Pilot and feasibility studies, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04850222 (Can Fluoxetine Mitigate the Mental Health Decline Seen in Patients With Musculoskeletal Trauma?), which is not on this map. Cited by 2 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Can Fluoxetine Mitigate the Mental Health Decline Seen in Patients With Musculoskeletal Trauma?
Who cites it
2 citing papers in PubMed, 1 synthesis or guideline pooled it, 2 citations in OpenAlex.
- Early pharmacological interventions for prevention of post-traumatic stress disorder (PTSD) in individuals experiencing acute traumatic stress symptoms.The Cochrane database of systematic reviews · 2024Pooled it
- Prevalence, resources, provider insights, and outcomes: a review of patient mental health in orthopaedic trauma.Journal of orthopaedic surgery and research · 2024Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 1 institution in 1 country.
Funding
Abstract
backgroundMusculoskeletal trauma is one of the leading causes of disability in the USA and its negative quality of life impact extends beyond that of physical recovery. More than 50% of victims of musculoskeletal trauma suffer lasting mental health issues and post-traumatic stress disorder (PTSD) symptomology following their injury. These symptoms can develop across all spectrums of patients and are independent predictors of poor outcome. Access to mental health care is limited, expensive, and time intensive, and a large majority of the trauma population do not get to utilize this valuable resource. This leaves the burden of management on the orthopedic team, as they are often the only point of contact for the patient within the medical system.
methodsThis is a single-center, repeated measures, randomized controlled pilot study including up to 100 orthopedic trauma patients aged between 18 and 85 years of age. Subjects are approached during their index hospitalization and are randomized to one of two pharmaceutical interventions, fluoxetine (also known as Prozac) or calcium, for 9 months. Fluoxetine is a selective serotonin reuptake inhibitor (SSRI) that is supported for the treatment of PTSD by the American Psychiatric Association. It is low-cost and has minimal side effects and withdrawal symptoms if stopped suddenly. Calcium is a supplement with minimal side effects that is used in our study for its bone-healing potential. Feasibility will be indexed by recruitment feasibility, randomization feasibility, medical adherence, anti-depressant side effects, and fracture union rate. Subjects will complete physical and mental health surveys at baseline, 2 weeks, 6 weeks, 3 months, 6 months, and 1 year. DISCUSSION: The goals of this exploratory clinical trial are to: develop a safe, feasible, and time-limited protocol effect of immediate (post-injury) treatment with fluoxetine for use by orthopedic providers and other non-mental health care providers treating victims of musculoskeletal trauma (Aim 1), and test the for preliminary effects of the protocol on development of PTSD symptomology and physical recovery in these patients (Aim 2). This study is novel in that it strives to prevent the development of symptomology from the time of injury and empowers surgeons to manage their patients in a more holistic manner.
trial registrationClinicalTrials.gov, NCT04850222 . Registered on April 20, 2021.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.