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Multiple peripheral inflammatory markers in adolescents with major depressive disorder treated with repeated esketamine infusions: results from a randomized controlled trial.

Xiaofeng Lan, Zitao Wu, Chengyu Wang, Guanxi Liu, Muqin Zhang, Weicheng Li, Zhanjie Luo, Junhao Shen, Ziying Chen, Yuping Ning, Yanling Zhou

Journal of Affective Disorders February 23, 2026 DOI: 10.1016/j.jad.2026.121488 (opens in new tab)

Study at a glance

AI-extracted from the abstract
Characteristics Randomized, double-blind trial Peer reviewed
Sample size 49
Population Adolescents with major depressive disorder
Interventions Esketamine Midazolam
Duration Three infusions over five days; assessments at baseline, Day 6, and Day 12
Measures Columbia Suicide Severity Rating Scale (C-SSRS), Montgomery-Åsberg Depression Rating Scale (MADRS), plasma levels of 10 inflammatory markers
Topics Depression Esketamine Ketamine
Keywords Humans Inflammation Midazolam Antidepressive agents Interleukin-8 Cytokines Double-blind method Adolescent Female Suicidal ideation Biomarkers
Key findings Esketamine and midazolam did not differ significantly in their effects on 10 inflammatory markers; most changes reflected time effects in both groups. In the esketamine group, changes in IL-8 correlated with reduced suicidal ideation intensity at Day 6, and changes in IFN-γ correlated with reduced depression severity and suicidal ideation intensity at Day 12. Baseline C4 was negatively related to symptom reductions. The authors propose IL-8, IFN-γ, and C4 as candidate biomarkers warranting further study.

Abstract

Objective: While inflammatory dysregulation is well-documented in major depressive disorder (MDD), its response to esketamine treatment in adolescents remains poorly understood. We aimed to examine the effects of esketamine on the inflammatory cytokines in adolescent MDD.

Methods: This randomized, double-blind trial assigned 49 adolescents with MDD to receive three infusions of esketamine or midazolam over five days between December 2020 and April 2022. Suicidal ideation (measured by Columbia Suicide Severity Rating Scale, C-SSRS), depressive symptoms (measured by Montgomery-Åsberg Depression Rating Scale, MADRS) and plasma levels of 10 inflammatory markers were assessed at baseline, Day 6, and Day 12.

Results: Linear mixed model revealed significant time effects for all markers, but no significant drug main effect was observed. In esketamine group, alterations in IL-8 were associated with the reduction of C-SSRS Intensity at Day 6 (r = 0.444, p = 0.026), and alterations in IFN-γ were correlated with the reduction of MADRS (r = 0.399, p = 0.048) and C-SSRS Intensity (r = 0.427, p = 0.033) at Day 12. Baseline C4 negatively related to the reductions of MADRS and C-SSRS Ideation at Day 6 and 12 (all p < 0.005).

Conclusions: Our study found no significant drug main effects for inflammatory markers, with most changes representing time effects observed in both groups. Exploratory results indicate that IL-8, IFN-γ, and C4 may warrant further investigation as potential biomarkers of esketamine response in adolescent MDD.

Comparable studies

Other randomized controlled trials on esketamine for depression, most cited first.

Study Year Design Participants
Efficacy and Safety of Flexibly Dosed Esketamine Nasal Spray Combined With a Newly Initiated Oral Antidepressant in Treatment-Resistant Depression: A Randomized Double-Blind Active-Controlled Study Adults with moderate to severe nonpsychotic depression and a history of nonresponse to... 2019 Phase 3, double-blind, active-controlled, multicenter randomized controlled trial n = 227
Efficacy of Esketamine Nasal Spray Plus Oral Antidepressant Treatment for Relapse Prevention in Patients With Treatment-Resistant Depression Adults with treatment-resistant depression who achieved stable remission or stable... 2019 Phase 3, multicenter, double-blind, randomized withdrawal study n = 297
Efficacy and Safety of Intranasal Esketamine Adjunctive to Oral Antidepressant Therapy in Treatment-Resistant Depression Adults with DSM-IV-TR diagnosis of major depressive disorder and history of inadequate... 2017 Phase 2, double-blind, doubly randomized, delayed-start, placebo-controlled study n = 67
Efficacy and Safety of Intranasal Esketamine for the Rapid Reduction of Symptoms of Depression and Suicidality in Patients at Imminent Risk for Suicide: Results of a Double-Blind, Randomized, Placebo-Controlled Study Depressed patients at imminent risk for suicide 2018 Randomized controlled trial n = 68
Efficacy and Safety of Fixed-Dose Esketamine Nasal Spray Combined With a New Oral Antidepressant in Treatment-Resistant Depression: Results of a Randomized, Double-Blind, Active-Controlled Study (TRANSFORM-1) Adults with moderate-to-severe depression and nonresponse to at least two... 2019 Randomized controlled trial n = 346

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