Evidence map›Paper›PMID 31786030›Full record

Trial reportJournal of affective disorders2020

Efficacy and safety of adjunctive therapy using esketamine or racemic ketamine for adult treatment-resistant depression: A randomized, double-blind, non-inferiority study.

Fernanda S Correia-Melo, Gustavo C Leal, Flávia Vieira, Ana Paula Jesus-Nunes, Rodrigo P Mello, Guilherme Magnavita, Ana Teresa Caliman-Fontes, Mariana V F Echegaray, Igor D Bandeira, Samantha S Silva and 11 more

Registry-linked trialAbstract readRandomized Controlled TrialEquivalence Trial
PubMed Publisher
In one paragraph

Trial report in Journal of affective disorders, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05698394 (Effect of Intravenous Low-dose Esketamine on Maternal Depression at 3 Years After Childbirth in Women With Prenatal Depression), which is not on this map. Cited by 81 papers, 12 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
81citing papers in PubMed, 12 pooled it
14.4field-weighted citation impact, top 1% of its field
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.

NCT05698394 phase4active not recruitingnot on this mapstarted 2023, after this paper: background citation

Effect of Intravenous Low-dose Esketamine on Maternal Depression at 3 Years After Childbirth in Women With Prenatal Depression: 3-year Follow-up of a Randomized Controlled Trial

TypeinterventionalSponsorPeking University First HospitalRan2023 to 2025Enrolled364ConditionsPrenatal Depression, Ketamine, Postpartum DepressionArmsEsketamine, Placebo
3 · Its place in the literature

Who cites it

81 citing papers in PubMed, 12 syntheses or guidelines pooled it, 176 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Ketamine in fibromyalgia: a systematic review.Advances in rheumatology (London, England) · 2024
    Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Pooled it
  8. Pooled it
  9. Pooled it
  10. Pooled it
  11. Pooled it
  12. Pooled it
  13. Trial
  14. Trial
  15. Trial
  16. Trial
  17. Trial
  18. Trial
  19. Trial
  20. Trial

21 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

21 authors at 5 institutions in 3 countries.

Fernanda S Correia-MeloLaboratory of Neuropsychopharmacology, Federal University of Bahia, Salvador, Brazil; Postgraduate Program in Medicine and Health, Medical School of Bahia, Federal University of Bahia, Salvador, Brazil. Electronic address: lcq@ufba.br.
Gustavo C LealLaboratory of Neuropsychopharmacology, Federal University of Bahia, Salvador, Brazil; Postgraduate Program in Medicine and Health, Medical School of Bahia, Federal University of Bahia, Salvador, Brazil; Division of Psychiatry, Professor Edgard Santos University Hospital, Federal University of Bahia, Salvador, Brazil.
Flávia VieiraLaboratory of Neuropsychopharmacology, Federal University of Bahia, Salvador, Brazil; Postgraduate Program in Medicine and Health, Medical School of Bahia, Federal University of Bahia, Salvador, Brazil.
Ana Paula Jesus-NunesLaboratory of Neuropsychopharmacology, Federal University of Bahia, Salvador, Brazil; Postgraduate Program in Medicine and Health, Medical School of Bahia, Federal University of Bahia, Salvador, Brazil.
Rodrigo P MelloLaboratory of Neuropsychopharmacology, Federal University of Bahia, Salvador, Brazil; Postgraduate Program in Medicine and Health, Medical School of Bahia, Federal University of Bahia, Salvador, Brazil.
Guilherme MagnavitaLaboratory of Neuropsychopharmacology, Federal University of Bahia, Salvador, Brazil.
Ana Teresa Caliman-FontesLaboratory of Neuropsychopharmacology, Federal University of Bahia, Salvador, Brazil.
Mariana V F EchegarayLaboratory of Neuropsychopharmacology, Federal University of Bahia, Salvador, Brazil.
Igor D BandeiraLaboratory of Neuropsychopharmacology, Federal University of Bahia, Salvador, Brazil; Postgraduate Program in Medicine and Health, Medical School of Bahia, Federal University of Bahia, Salvador, Brazil.
Samantha S SilvaLaboratory of Neuropsychopharmacology, Federal University of Bahia, Salvador, Brazil.
Diogo E CavalcantiDivision of Psychiatry, Professor Edgard Santos University Hospital, Federal University of Bahia, Salvador, Brazil.
Lucas Araújo-de-FreitasLaboratory of Neuropsychopharmacology, Federal University of Bahia, Salvador, Brazil; Postgraduate Program in Medicine and Health, Medical School of Bahia, Federal University of Bahia, Salvador, Brazil.
Luciana M SarinDepartment of Psychiatry, Federal University of São Paulo, São Paulo, Brazil.
Marco A TuenaDepartment of Psychiatry, Federal University of São Paulo, São Paulo, Brazil.
Carolina NakahiraDepartment of Psychiatry, Federal University of São Paulo, São Paulo, Brazil.
Aline S SampaioLaboratory of Neuropsychopharmacology, Federal University of Bahia, Salvador, Brazil; Department of Neuroscience and Mental Health, Medical School of Bahia, Federal University of Bahia, Salvador, Brazil.
José A Del-PortoDepartment of Psychiatry, Federal University of São Paulo, São Paulo, Brazil.
Gustavo TureckiMcGill Group for Suicide Studies, Douglas Mental Health University Institute & Department of Psychiatry, McGill University, Montreal, Canada.
Colleen LooSchool of Psychiatry, University of New South Wales, Sydney, Australia; Black Dog Institute, Sydney, Australia; St George Hospital, South Eastern Sydney Health, Sydney, Australia.
Acioly L T LacerdaDepartment of Psychiatry, Federal University of São Paulo, São Paulo, Brazil; Interdisciplinary Laboratory of Clinical Neurosciences, Federal University of São Paulo, São Paulo, Brazil; Sinapse Institute of Clinical Neurosciences, Campinas, Brazil.
Lucas C QuarantiniLaboratory of Neuropsychopharmacology, Federal University of Bahia, Salvador, Brazil; Postgraduate Program in Medicine and Health, Medical School of Bahia, Federal University of Bahia, Salvador, Brazil; Division of Psychiatry, Professor Edgard Santos University Hospital, Federal University of Bahia, Salvador, Brazil; Department of Neuroscience and Mental Health, Medical School of Bahia, Federal University of Bahia, Salvador, Brazil.
Universidade Federal da Bahia · BRUniversidade Federal de São Paulo · BRComplexo Hospitalar Universitário Professor Edgard Santos · BRMcGill University · CASt George Hospital · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundKetamine and its enantiomers have recently been highlighted as one of the most effective therapeutic options in refractory depression. However, racemic ketamine and esketamine have not been directly compared. The aim of this study is to assess the efficacy and safety of esketamine compared to ketamine in patients with treatment-resistant depression (TRD).

methodsThis is a randomized, double-blind, active-controlled, bicentre, non-inferiority clinical trial, with two parallel groups. Participants were randomly assigned to a 40-min single intravenous infusion of ketamine 0.5 mg/kg or esketamine 0.25 mg/kg. The primary outcome was the difference in remission rates for depression 24 h following intervention using the Montgomery-Åsberg Depression Rating Scale (MADRS), with a non-inferiority margin of 20%.

results63 subjects were included and randomly assigned (29 to receive ketamine and 34 to receive esketamine). At 24 h, 24.1% of participants in the ketamine group and 29.4% of participants in the esketamine group showed remission, with a difference of 5.3% (95% CILB -13.6%), confirming non-inferiority. MADRS scores improved from 33 (SD 9.3) to 16.2 (SD 10.7) in the ketamine group and from 33 (SD 5.3) to 17.5 (SD 12.2) in the esketamine one, with a difference of -5.27% (95% CILB, -13.6). Both groups presented similar mild side effects.

conclusionsEsketamine was non-inferior to ketamine for TRD 24 h following infusion. Both treatments were effective, safe, and well tolerated.

trial registrationRegistered in Japan Primary Registries Network: UMIN000032355.

Indexed as

Depressive Disorder, Treatment-ResistantKetamineAdultAntidepressive AgentsDepressionDouble-Blind MethodHumansJapanTreatment OutcomeAntidepressive AgentsEsketamineKetamineEsketamineKetamineMajor depressive disorderNon-inferiorityTreatment resistant depressionUnipolar depression

Identifiers

PMID31786030
OpenAlexW2986296475

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

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.