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Nine months of fluoxetine reduces post-traumatic stress symptoms and pain following traumatic musculoskeletal injury

In a non-blinded RCT, 33 patients receiving fluoxetine for 9 months after traumatic musculoskeletal injury showed a significant decrease in PTSD symptoms (estimate = -0.2, 95% CI: -0.4, -0.0) and pain (estimate = -0.1, 95% CI: -0.1, -0.0) over one year, while 35 patients receiving placebo (calcium) showed no significant change. No significant effects were found on depression, anxiety, or social isolation.

Last updated: Jul 15, 2026•1 RCTs•📖 Read as article →

Evidence Score

Evidence Score44/100
Human RCT★★☆☆☆
Meta-analysis☆☆☆☆☆
Mechanism★★★★★
Safety★★★★☆
Confidencelow

Study Evidence

Study 1. Nine Months of Fluoxetine Aids in the Reduction of Posttraumatic Stress Symptoms following a Traumatic Musculoskeletal Injury: A Randomized Controlled Trial.

observational

Pazik M, Vasilopoulos T, de Faria L, Rijo D, Horodyski M, Mathews C, Hagen J · Journal of orthopaedic trauma (2026)

Participants: N/A
Duration: 12 months (9 months treatment, outcomes at 2 weeks, 6 weeks, 3, 6, and 12 months)
Intervention: 9 months of fluoxetine (Prozac) prescribed by orthopaedic providers immediately post-injury
Outcome: Post-traumatic stress symptoms (PSS-SR), pain (PEG), depression (BDI-II), anxiety (BAI), sleep (PSQI), social participation (PROMIS)
Effect Size: PTSD: estimate = -0.2 (95% CI: -0.4, -0.0); Pain: estimate = -0.1 (95% CI: -0.1, -0.0)
Population: Adult survivors of high-energy traumatic musculoskeletal injuries admitted to a Level 1 trauma center (mean age ~42 years, 43% female)

Result:

PubMed: 42441660DOI: 10.1097/BOT.0000000000003243

Mechanism Graph

Fluoxetine increases serotonin availability
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Modulates stress response circuits
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Reduces hyperarousal and re-experiencing symptoms
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Result: Decreased PTSD symptom severity and pain over 12 months

Limitations

  • ⚠Non-blinded design (open-label) may introduce bias
  • ⚠Small sample size (n=68 total)
  • ⚠Single-center study limits generalizability
  • ⚠No significant effects on depression or anxiety, suggesting selective symptom improvement

Frequently Asked Questions

How long did patients take fluoxetine in this study?▼

Patients were randomized to receive fluoxetine or placebo for 9 months following their injury.

Did fluoxetine improve sleep in this trial?▼

Sleep was measured via the Pittsburgh Sleep Quality Index (PSQI), but the abstract does not report significant changes in sleep outcomes.

Was this study blinded?▼

No, this was a non-blinded (open-label) prospective randomized clinical trial.

What type of injuries were included?▼

High-energy musculoskeletal trauma, excluding injuries from ground-level falls or less.

Products

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References

  1. 1.Pazik M, Vasilopoulos T, de Faria L, Rijo D, Horodyski M, Mathews C, Hagen J. "Nine Months of Fluoxetine Aids in the Reduction of Posttraumatic Stress Symptoms following a Traumatic Musculoskeletal Injury: A Randomized Controlled Trial.." Journal of orthopaedic trauma, 2026. PMID: 42441660 DOI: 10.1097/BOT.0000000000003243
Disclaimer: This content is for educational purposes only and is not medical advice. Evidence scores reflect the quality and quantity of available research, not clinical recommendations. Always consult a healthcare professional before starting any supplement or intervention.