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

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  • Additional Information
    • Source:
      Publisher: Blackwell Science Country of Publication: Australia NLM ID: 9513551 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1440-1819 (Electronic) Linking ISSN: 13231316 NLM ISO Abbreviation: Psychiatry Clin Neurosci Subsets: MEDLINE
    • Publication Information:
      Original Publication: Carlton, Vic., Australia : Blackwell Science,
    • Subject Terms:
      Ketamine*/administration & dosage ; Ketamine*/adverse effects ; Ketamine*/pharmacology ; Depressive Disorder, Treatment-Resistant*/drug therapy ; Antidepressive Agents*/administration & dosage ; Antidepressive Agents*/adverse effects ; Antidepressive Agents*/pharmacology ; Administration, Intravenous*; Humans ; Male ; Double-Blind Method ; Female ; Adult ; Middle Aged ; Japan ; Outcome Assessment, Health Care ; Treatment Outcome ; East Asian People
    • 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.
      (© 2024 The Author(s). Psychiatry and Clinical Neurosciences published by John Wiley & Sons Australia, Ltd on behalf of Japanese Society of Psychiatry and Neurology.)
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    • Grant Information:
      SENSHIN Medical Research Foundation; 22H03001 Japan Society for the Promotion of Science; 22K15793 Japan Society for the Promotion of Science; 21K07508 Japan Society for the Promotion of Science; 23KJ1898 Japan Society for the Promotion of Science; 22KJ2687 Japan Society for the Promotion of Science; 18H02755 Japan Society for the Promotion of Science; 22H03002 Japan Society for the Promotion of Science; 23K14824 Japan Society for the Promotion of Science; Japan Research Foundation for Clinical Pharmacology; Takeda Science Foundation; Keio Next-Generation Research Project Program; JPMJFS2140 Japan Science and Technology Agency
    • Contributed Indexing:
      Keywords: ethnicity; ketamine; major depressive disorder; repeated doses; treatment‐resistant depression
    • Accession Number:
      690G0D6V8H (Ketamine)
      0 (Antidepressive Agents)
    • Publication Date:
      Date Created: 20240830 Date Completed: 20241203 Latest Revision: 20241205
    • Publication Date:
      20241209
    • Accession Number:
      PMC11612546
    • Accession Number:
      10.1111/pcn.13734
    • Accession Number:
      39210712