Evidence map›Paper›PMID 39210712›Full record

Trial reportPsychiatry and clinical neurosciences2024

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

Yohei Ohtani, Hideaki Tani, Kie Nomoto-Takahashi, Taisuke Yatomi, Kengo Yonezawa, Sota Tomiyama, Nobuhiro Nagai, Keisuke Kusudo, Shiori Honda, Sotaro Moriyama and 13 more

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Psychiatry and clinical neurosciences, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

23 authors.

Yohei OhtaniDepartment of Neuropsychiatry, Keio University School of Medicine, Tokyo, Japan.
Hideaki TaniDepartment of Neuropsychiatry, Keio University School of Medicine, Tokyo, Japan.
Kie Nomoto-TakahashiDepartment of Neuropsychiatry, Keio University School of Medicine, Tokyo, Japan.
Taisuke YatomiDepartment of Neuropsychiatry, Keio University School of Medicine, Tokyo, Japan.
Kengo YonezawaDepartment of Neuropsychiatry, Keio University School of Medicine, Tokyo, Japan.
Sota TomiyamaDepartment of Neuropsychiatry, Keio University School of Medicine, Tokyo, Japan.
Nobuhiro NagaiDepartment of Neuropsychiatry, Keio University School of Medicine, Tokyo, Japan.
Keisuke KusudoDepartment of Neuropsychiatry, Keio University School of Medicine, Tokyo, Japan.
Shiori HondaDepartment of Neuropsychiatry, Keio University School of Medicine, Tokyo, Japan.
Sotaro MoriyamaDepartment of Neuropsychiatry, Keio University School of Medicine, Tokyo, Japan.
Shinichiro NakajimaDepartment of Neuropsychiatry, Keio University School of Medicine, Tokyo, Japan.
Takashige YamadaDepartment of Anesthesiology, Keio University School of Medicine, Tokyo, Japan.ORCID https://orcid.org/0000-0002-1152-9853
Hiroshi MorisakiDepartment of Anesthesiology, Keio University School of Medicine, Tokyo, Japan.
Yu IwabuchiDepartment of Radiology, Keio University School of Medicine, Tokyo, Japan.
Masahiro JinzakiDepartment of Radiology, Keio University School of Medicine, Tokyo, Japan.
Kimio YoshimuraDepartment of Health Policy and Management, Keio University School of Medicine, Tokyo, Japan.
Tsuyoshi EiroDepartment of Physiology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.
Sakiko TsugawaDepartment of Neuropsychiatry, Keio University School of Medicine, Tokyo, Japan.
Sadamitsu IchijoDepartment of Physiology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.
Yu FujimotoDepartment of Physiology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.
Tomoyuki MiyazakiDepartment of Physiology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.
Takuya TakahashiDepartment of Physiology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.
Hiroyuki UchidaDepartment of Neuropsychiatry, Keio University School of Medicine, Tokyo, Japan.ORCID https://orcid.org/0000-0002-0628-7036

Funding

Japan Research Foundation for Clinical PharmacologyJapan Science and Technology Agency JPMJFS2140Japan Society for the Promotion of Science 18H02755Japan Society for the Promotion of Science 21K07508Japan Society for the Promotion of Science 22H03001Japan Society for the Promotion of Science 22H03002Japan Society for the Promotion of Science 22K15793Japan Society for the Promotion of Science 22KJ2687Japan Society for the Promotion of Science 23K14824Japan Society for the Promotion of Science 23KJ1898Keio Next-Generation Research Project ProgramSENSHIN Medical Research FoundationTakeda Science Foundation
6 · The paper itself

Abstract

aimAlthough 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.

methodsIn 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.

resultsIntention-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.

conclusionIntravenous 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.

Indexed as

Administration, IntravenousAntidepressive AgentsDepressive Disorder, Treatment-ResistantKetamineAdultDouble-Blind MethodEast Asian PeopleFemaleHumansJapanMaleMiddle AgedOutcome Assessment, Health CareTreatment OutcomeAntidepressive AgentsKetamineethnicityketaminemajor depressive disorderrepeated dosestreatment‐resistant depression

Identifiers

PMID39210712
PMCPMC11612546

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.