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Efficacy of repeated intravenous esketamine in adolescents with anxious versus non-anxious depression.

Xiaofeng Lan, Chengyu Wang, Fan Zhang, Haiyan Liu, Ling Fu, Weicheng Li, Yanxiang Ye, Zhibo Hu, Siming Mai, Yuping Ning, Yanling Zhou

General Psychiatry June 21, 2023 DOI: 10.1136/gpsych-2023-101007 (opens in new tab)

Study at a glance

AI-extracted from the abstract
Characteristics Randomized controlled trial Peer reviewed
Sample size 54
Population Adolescents with major depressive disorder and suicidal ideation, classified as anxious (n=33) or non-anxious (n=21)
Interventions Esketamine midazolam
Dose Esketamine 0.25 mg/kg; midazolam 0.045 mg/kg
Duration Three infusions over 5 days, with assessments through 4 weeks post-treatment (days 12, 19, and 33)
Measures Columbia Suicide Severity Rating Scale, Montgomery-Åsberg Depression Rating Scale
Topics Anxiety Depression Esketamine
Keywords Suicidal ideation Adolescent psychiatry Depressive disorder, major
Key findings Among adolescents with MDD and suicidal ideation receiving esketamine, the non-anxious group had higher antisuicidal remission than the anxious group on day 6 (72.7% vs 18.8%) and day 12 (90.9% vs 43.8%), and higher antidepressant remission on day 33 (72.7% vs 26.7%). The authors report the antisuicidal advantage was temporary and not maintained at other time points.

Abstract

Background: Patients with anxious major depressive disorder (MDD) are more likely to have poorer outcomes than those with non-anxious MDD. However, the effect of esketamine on adolescents with anxious versus non-anxious MDD has remained unknown.

Aims: We compared the efficacy of esketamine in adolescents with MDD and suicidal ideation, both anxious and non-anxious.

Methods: Fifty-four adolescents with anxious (n=33) and non-anxious (n=21) MDD received three infusions of esketamine 0.25 mg/kg or active-placebo (midazolam 0.045 mg/kg) over 5 days, with routine inpatient care and treatment. Suicidal ideation and depressive symptoms were assessed using the Columbia Suicide Severity Rating Scale and the Montgomery-Åsberg Depression Rating Scale. Multiple-sample proportional tests were used to compare the differences between groups on treatment outcomes 24 hours after the final infusion (day 6, primacy efficacy endpoint) and throughout the 4-week post-treatment (days 12, 19 and 33).

Results: In subjects who received esketamine, a greater number of patients in the non-anxious group than the anxious group achieved antisuicidal remission on day 6 (72.7% vs 18.8%, p=0.015) and day 12 (90.9% vs 43.8%, p=0.013), and the non-anxious group had a higher antidepressant remission rate compared with the anxious group on day 33 (72.7% vs 26.7%, p=0.045). No significant differences in treatment outcomes were observed between the anxious and non-anxious groups at other time points.

Conclusions: Three infusions of esketamine as an adjunct to routine inpatient care and treatment had a greater immediate post-treatment antisuicidal effect in adolescents with non-anxious MDD than in those with anxious MDD; however, this benefit was temporary and was not maintained over time. Trial registration number: ChiCTR2000041232.

Comparable studies

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

Study Year Design Participants
Meaningful Change in Depression Symptoms Assessed with the Patient Health Questionnaire (PHQ-9) and Montgomery-Åsberg Depression Rating Scale (MADRS) Among Patients with Treatment Resistant Depression in Two, Randomized, Double-blind, Active-controlled Trials of Esketamine Nasal Spray Combined With a New Oral Antidepressant Patients with treatment resistant depression 2020 Randomized controlled trial
Treatment Response With Esketamine Nasal Spray Plus an Oral Antidepressant in Patients With Treatment-Resistant Depression Without Evidence of Early Response Patients with treatment-resistant depression 2021 Pooled post hoc analysis of two phase 3, double-blind, active-controlled studies
Predictors of response and remission in patients with treatment-resistant depression: A post hoc pooled analysis of two acute trials of esketamine nasal spray Patients with treatment-resistant depression 2023 Post hoc analysis of two pooled phase 3 double-blind placebo- and active-controlled trials n = 518
Assessment of health-related quality of life and health status in patients with treatment-resistant depression treated with esketamine nasal spray plus an oral antidepressant Patients aged 18-64 years with treatment-resistant depression 2023 Phase 3, randomized, double-blind, short-term flexibly dosed study n = 223
The effect of esketamine on postoperative anxiety and depression in patients with thyroid cancer: A randomized, double-blind, placebo-controlled, parallel-group trial. Female patients with thyroid cancer scheduled for surgery under general anesthesia 2025 Randomized controlled trial n = 80

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