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Background <p>Treatment-resistant depression (TRD) is often characterized by inadequate response to ≥ 2 oral antidepressant treatments of adequate dose and duration during a major depressive episode (MDE). Esketamine nasal spray (ESK) was approved by the US Food and Drug Administration in 2019 for TRD in conjunction with an oral antidepressant under a Risk Evaluation and Mitigation Strategy (<a href="https://www.spravatorems.com/">https://www.spravatorems.com/</a>). While there are extensive clinical trial data demonstrating the efficacy and safety of esketamine use in TRD, the real-world data are limited. This study evaluated the change in depressive symptoms following esketamine initiation among patients with TRD in real-world settings.</p> Methods <p>Patients with TRD treated with esketamine between 2019 and 2022 were identified from the PremiOM™ Major Depressive Disorder (MDD) Dataset, which includes &gt; 440,000 patients in the US with linked claims and electronic medical record (EMR) data. Depressive symptoms were assessed using the 9-item Patient Health Questionnaire (PHQ-9). Baseline scores were within 6 months prior to the first esketamine prescription (“index date”) and were compared to the most recent scores at &gt; 0-3-months and &gt; 3–6 months after index.</p> Results <p>163 patients were included (mean age 49.5 years, 58.3% female). Among patients with baseline and follow-up scores, statistically significant reductions in mean PHQ-9 scores were observed at &gt; 0–3 months of -3.2 points, (95% CI: -4.5, -2.0; <i>p</i> &lt; 0.001); and &gt; 3–6 months of -4.4 points (95% CI: -5.7, -3.2; <i>p</i> &lt; 0.001). The percentage of patients with moderately severe or severe depression at baseline was 55.8%. This decreased to 37.1% at &gt; 0–3 months and 25.0% at &gt; 3–6 months. Concomitantly, the percentages of patient with minimal depression and patients with mild to minimal depression increased.</p> Conclusions <p>Among patients with TRD treated with esketamine in real-world settings, significant improvements in depressive symptoms were observed over the six months following treatment initiation.</p>

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Real-world evaluation of change in depressive symptoms among patients with treatment-resistant depression treated with esketamine

  • 期刊论文

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  • 发表日期：

    2025年11月27日

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  • Carl D. Marci,
  • Kruti Joshi,
  • Stevan Geoffrey Severtson,
  • Janis L. Breeze,
  • Manish K. Jha

摘要

Background

Treatment-resistant depression (TRD) is often characterized by inadequate response to ≥ 2 oral antidepressant treatments of adequate dose and duration during a major depressive episode (MDE). Esketamine nasal spray (ESK) was approved by the US Food and Drug Administration in 2019 for TRD in conjunction with an oral antidepressant under a Risk Evaluation and Mitigation Strategy (https://www.spravatorems.com/). While there are extensive clinical trial data demonstrating the efficacy and safety of esketamine use in TRD, the real-world data are limited. This study evaluated the change in depressive symptoms following esketamine initiation among patients with TRD in real-world settings.

Methods

Patients with TRD treated with esketamine between 2019 and 2022 were identified from the PremiOM™ Major Depressive Disorder (MDD) Dataset, which includes > 440,000 patients in the US with linked claims and electronic medical record (EMR) data. Depressive symptoms were assessed using the 9-item Patient Health Questionnaire (PHQ-9). Baseline scores were within 6 months prior to the first esketamine prescription (“index date”) and were compared to the most recent scores at > 0-3-months and > 3–6 months after index.

Results

163 patients were included (mean age 49.5 years, 58.3% female). Among patients with baseline and follow-up scores, statistically significant reductions in mean PHQ-9 scores were observed at > 0–3 months of -3.2 points, (95% CI: -4.5, -2.0; p < 0.001); and > 3–6 months of -4.4 points (95% CI: -5.7, -3.2; p < 0.001). The percentage of patients with moderately severe or severe depression at baseline was 55.8%. This decreased to 37.1% at > 0–3 months and 25.0% at > 3–6 months. Concomitantly, the percentages of patient with minimal depression and patients with mild to minimal depression increased.

Conclusions

Among patients with TRD treated with esketamine in real-world settings, significant improvements in depressive symptoms were observed over the six months following treatment initiation.