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<p>Treatment for major depressive disorder (MDD) remains challenging as only 30–50% of patients respond to first-line antidepressant medications in primary care. Here we developed algorithms using predictors of response to sertraline and bupropion from a multisite study, and tested such markers in an independent, prospective clinical trial involving unmedicated individuals with MDD (<a href="https://clinicaltrials.gov/ct2/show/NCT05537584">NCT05537584</a>). Leave-one-out cross-validation models achieved good performance in the training sample (area under the curve of 0.66–0.86). In the preregistered clinical trial, no significant differences in treatment outcomes emerged for those assigned a drug consistent versus inconsistent with their biomarkers. However, significant differences emerged in symptom reduction trajectories for those with positive markers for both medications (response rate: 71.4%) or either drug (65.4%) compared with those with two negative markers (42.9%). This is the first study using biobehavioral markers to prospectively guide assignment to two widely used antidepressants, yielding a 66.8% boost in response rate and providing foundations for larger personalized treatment studies of MDD.</p>

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A precision medicine trial of bupropion and sertraline for major depressive disorder using a biomarker-guided sequential multiple-assignment design

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年7月6日

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  • Peter Zhukovsky,
  • Manuel Kuhn,
  • Lauren R. Borchers,
  • Boyu Ren,
  • Sarah E. Woronko,
  • Mohan Li,
  • Choi Sze Tracy Lam,
  • Ethan M. Zhang,
  • Kerry J. Ressler,
  • Brian P. Brennan,
  • Gordana Vitaliano,
  • Diego A. Pizzagalli

摘要

Treatment for major depressive disorder (MDD) remains challenging as only 30–50% of patients respond to first-line antidepressant medications in primary care. Here we developed algorithms using predictors of response to sertraline and bupropion from a multisite study, and tested such markers in an independent, prospective clinical trial involving unmedicated individuals with MDD (NCT05537584). Leave-one-out cross-validation models achieved good performance in the training sample (area under the curve of 0.66–0.86). In the preregistered clinical trial, no significant differences in treatment outcomes emerged for those assigned a drug consistent versus inconsistent with their biomarkers. However, significant differences emerged in symptom reduction trajectories for those with positive markers for both medications (response rate: 71.4%) or either drug (65.4%) compared with those with two negative markers (42.9%). This is the first study using biobehavioral markers to prospectively guide assignment to two widely used antidepressants, yielding a 66.8% boost in response rate and providing foundations for larger personalized treatment studies of MDD.