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<p>Strong heterogeneity limits precision medicine in youth with mood disorders during major depressive episodes (MDE). Here we propose and evaluate a neurobiomarker-guided repetitive transcranial magnetic stimulation (rTMS) strategy in a double-blind randomized controlled trial. Using multicenter resting-state functional magnetic resonance imaging data (<i>N</i> = 2,328), we validated functional imbalance along the sensorimotor–association axis as a robust neurobiomarker distinguishing two neurosubtypes—archetypal and atypical. We then conducted a double-blind randomized controlled trial (2 August 2022–20 January 2024) in 219 youth with MDE. Participants were classified into subtypes and randomly assigned to subtype-specific active rTMS or sham stimulation. The primary outcome was depressive symptom improvement measured by the 17-item Hamilton Depression Rating Scale; secondary outcomes assessed neurobiological effects using functional magnetic resonance imaging. The trial met its prespecified primary endpoint. The active rTMS showed greater symptom improvement than sham (adjusted mean difference of −2.34, 95% confidence interval −3.80 to −0.87, <i>P</i> = 0.002), with significant effects observed in both subtypes. However, the clinical efficacy was moderate, with only the anxiety/somatization factor showing significantly higher rates of partial response and response. The archetypal subtype exhibited increased fluctuation amplitude in the visual cortex following active rTMS compared with sham, meeting the prespecified secondary endpoint. By contrast, no significant neurobiological effects were observed in the atypical subtype. Symptom improvement was associated with functional activity alterations along the sensorimotor–association axis. These findings provide preliminary support for biologically driven, neurosubtype-specific treatments in youth with MDE (ClinicalTrials.gov, <a href="https://clinicaltrials.gov/ct2/show/NCT05465928">NCT05465928</a>).</p>

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Neurobiomarker-guided neuromodulation for youth with major depressive episodes: a double-blind randomized trial

  • 期刊论文

  • 发表日期：

    2026年6月24日

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  • Juan Liu,
  • Yao Xiao,
  • Junjie Zheng,
  • Pengfei Zhao,
  • Lifei Wang,
  • Rui Tang,
  • Jia Duan,
  • Haoyu Zheng,
  • Dongtao Wei,
  • Jiang Qiu,
  • Peng Xie,
  • Yong He,
  • Mingrui Xia,
  • Rongxin Zhu,
  • Xiaohong Gong,
  • Xizhe Zhang,
  • Fei Wang

摘要

Strong heterogeneity limits precision medicine in youth with mood disorders during major depressive episodes (MDE). Here we propose and evaluate a neurobiomarker-guided repetitive transcranial magnetic stimulation (rTMS) strategy in a double-blind randomized controlled trial. Using multicenter resting-state functional magnetic resonance imaging data (N = 2,328), we validated functional imbalance along the sensorimotor–association axis as a robust neurobiomarker distinguishing two neurosubtypes—archetypal and atypical. We then conducted a double-blind randomized controlled trial (2 August 2022–20 January 2024) in 219 youth with MDE. Participants were classified into subtypes and randomly assigned to subtype-specific active rTMS or sham stimulation. The primary outcome was depressive symptom improvement measured by the 17-item Hamilton Depression Rating Scale; secondary outcomes assessed neurobiological effects using functional magnetic resonance imaging. The trial met its prespecified primary endpoint. The active rTMS showed greater symptom improvement than sham (adjusted mean difference of −2.34, 95% confidence interval −3.80 to −0.87, P = 0.002), with significant effects observed in both subtypes. However, the clinical efficacy was moderate, with only the anxiety/somatization factor showing significantly higher rates of partial response and response. The archetypal subtype exhibited increased fluctuation amplitude in the visual cortex following active rTMS compared with sham, meeting the prespecified secondary endpoint. By contrast, no significant neurobiological effects were observed in the atypical subtype. Symptom improvement was associated with functional activity alterations along the sensorimotor–association axis. These findings provide preliminary support for biologically driven, neurosubtype-specific treatments in youth with MDE (ClinicalTrials.gov, NCT05465928).