Efficacy and safety of intravenous ketamine treatment in Japanese patients with treatment-resistant depression: A double-blind, randomized, placebo-controlled trial.

IF 5 3区 医学 Q1 CLINICAL NEUROLOGY Psychiatry and Clinical Neurosciences Pub Date : 2024-08-30 DOI:10.1111/pcn.13734
Yohei Ohtani, Hideaki Tani, Kie Nomoto-Takahashi, Taisuke Yatomi, Kengo Yonezawa, Sota Tomiyama, Nobuhiro Nagai, Keisuke Kusudo, Shiori Honda, Sotaro Moriyama, Shinichiro Nakajima, Takashige Yamada, Hiroshi Morisaki, Yu Iwabuchi, Masahiro Jinzaki, Kimio Yoshimura, Tsuyoshi Eiro, Sakiko Tsugawa, Sadamitsu Ichijo, Yu Fujimoto, Tomoyuki Miyazaki, Takuya Takahashi, Hiroyuki Uchida
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Abstract

Aim: Although the antidepressant effect of ketamine on treatment-resistant depression (TRD) has been frequently reported in North American and European countries, evidence is scarce among the Asian population. We aimed to evaluate the efficacy and safety of intravenous ketamine in Japanese patients with TRD.

Methods: In this double-blind randomized placebo-controlled trial, 34 Japanese patients with TRD were randomized to receive either intravenous ketamine (0.5 mg/kg) or placebo, administered over 40 min, twice a week, for 2 weeks. The primary outcome was the change in the Montgomery Åsberg Depression Rating Scale (MADRS) total score from baseline to post-treatment. Secondary outcomes included changes in other depressive symptomatology scores and remission, response, and partial response rates. We also examined the association between baseline clinical demographic characteristics and changes in the MADRS total score.

Results: Intention-to-treat analysis indicated no significant difference in the decrease in MADRS total score between the groups (-8.1 ± 10.0 vs -2.5 ± 5.2, t[32] = 2.02, P = 0.052), whereas per-protocol analysis showed a significant reduction in the ketamine group compared to the placebo group (-9.1 ± 10.2 vs -2.7 ± 5.3, t[29] = 2.22, P = 0.034). No significant group differences were observed in other outcomes. Adverse events were more frequent in the ketamine group than in the placebo group, and no serious adverse events were reported. A higher baseline MADRS total score and body mass index were associated with a greater reduction in the MADRS total score.

Conclusion: Intravenous ketamine outperformed placebo in Japanese patients with TRD who completed the study, suggesting that ketamine could alleviate depressive symptoms of TRD across diverse ethnic populations.

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静脉注射氯胺酮治疗日本难治性抑郁症患者的疗效和安全性:双盲、随机、安慰剂对照试验。
目的:尽管氯胺酮对治疗耐药抑郁症(TRD)的抗抑郁作用在北美和欧洲国家屡有报道,但在亚洲人群中却鲜有证据。我们旨在评估氯胺酮静脉注射对日本TRD患者的疗效和安全性:在这项双盲随机安慰剂对照试验中,34名日本TRD患者被随机分配接受静脉注射氯胺酮(0.5毫克/千克)或安慰剂,每周两次,每次40分钟,持续2周。主要结果是蒙哥马利-奥斯伯格抑郁量表(MADRS)总分从基线到治疗后的变化。次要结果包括其他抑郁症状评分的变化以及缓解率、反应率和部分反应率。我们还研究了基线临床人口统计学特征与 MADRS 总分变化之间的关系:意向治疗分析表明,两组间 MADRS 总分的下降无显著差异(-8.1 ± 10.0 vs -2.5 ± 5.2,t[32] = 2.02,P = 0.052),而按协议分析表明,氯胺酮组比安慰剂组显著下降(-9.1 ± 10.2 vs -2.7 ± 5.3,t[29] = 2.22,P = 0.034)。其他结果无明显组间差异。氯胺酮组的不良反应发生率高于安慰剂组,但无严重不良反应报告。基线MADRS总分和体重指数越高,MADRS总分的降低幅度越大:结论:在完成研究的日本TRD患者中,静脉注射氯胺酮的疗效优于安慰剂,这表明氯胺酮可以缓解不同种族人群的TRD抑郁症状。
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来源期刊
CiteScore
7.40
自引率
4.20%
发文量
181
审稿时长
6-12 weeks
期刊介绍: PCN (Psychiatry and Clinical Neurosciences) Publication Frequency: Published 12 online issues a year by JSPN Content Categories: Review Articles Regular Articles Letters to the Editor Peer Review Process: All manuscripts undergo peer review by anonymous reviewers, an Editorial Board Member, and the Editor Publication Criteria: Manuscripts are accepted based on quality, originality, and significance to the readership Authors must confirm that the manuscript has not been published or submitted elsewhere and has been approved by each author
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