Evidence map›Paper›PMID 38108319›Full record

Trial reportThe British journal of psychiatry : the journal of mental science2023

Efficacy and safety of a 4-week course of repeated subcutaneous ketamine injections for treatment-resistant depression (KADS study): randomised double-blind active-controlled trial.

Colleen Loo, Nick Glozier, David Barton, Bernhard T Baune, Natalie T Mills, Paul Fitzgerald, Paul Glue, Shanthi Sarma, Veronica Galvez-Ortiz, Dusan Hadzi-Pavlovic and 28 more

Open access · hybridAbstract readRandomized Controlled TrialMulticenter StudyClinical Trial, Phase III
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The British journal of psychiatry : the journal of mental science, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 34 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed, 4 pooled it
14.5field-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.

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

34 citing papers in PubMed, 4 syntheses or guidelines pooled it, 60 citations in OpenAlex.

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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

38 authors at 20 institutions in 5 countries.

Colleen LooBlack Dog Institute, University of New South Wales, Randwick, New South Wales, Australia; and George Institute for Global Health, Newtown, New South Wales, Australia.ORCID 0000-0003-3267-0554
Nick GlozierCentral Clinical School, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia; and Australian Research Council Centre of Excellence for Children and Families over the Life Course, University of Sydney, Sydney, New South Wales, Australia.ORCID 0000-0002-0476-9146
David BartonAustralian Centre for Heart Health, Royal Melbourne Hospital, North Melbourne, Victoria, Australia; and NeuroCentrix, South Carlton, Victoria, Australia.
Bernhard T BauneDepartment of Psychiatry, University of Münster, Münster, Germany; Department of Psychiatry, Melbourne Medical School, University of Melbourne, Melbourne, Victoria, Australia; and Florey Institute of Neuroscience and Mental Health, Parkville, Victoria, Australia.
Natalie T MillsDiscipline of Psychiatry, University of Adelaide, Adelaide, South Australia, Australia.
Paul FitzgeraldAustralian National University School of Medicine and Psychology, Canberra, Australian Capital Territory, Australia.
Paul GlueDunedin School of Medicine, University of Otago, Dunedin, New Zealand.
Shanthi SarmaMental Health and Specialist Services, Gold Coast Health, Bond University, Robina, Queensland, Australia.
Veronica Galvez-OrtizDepartment of Psychiatry and Mental Health, Hospital Universitari Parc Tauli, Sabadell, Spain; and Institut Investigacio I Innovacio Parc Tauli, Sabadell, Spain.
Dusan Hadzi-PavlovicDiscipline of Psychiatry and Mental Health, University of New South Wales, Sydney, New South Wales, Australia.
Angelo AlonzoDiscipline of Psychiatry and Mental Health, University of New South Wales, Sydney, New South Wales, Australia; University of New South Wales, Randwick, New South Wales, Australia; and George Institute for Global Health, Newtown, New South Wales, Australia.
Vanessa DongDiscipline of Psychiatry and Mental Health, University of New South Wales, Sydney, New South Wales, Australia; University of New South Wales, Randwick, New South Wales, Australia; and George Institute for Global Health, Newtown, New South Wales, Australia.
Donel MartinDiscipline of Psychiatry and Mental Health, University of New South Wales, Sydney, New South Wales, Australia; University of New South Wales, Randwick, New South Wales, Australia; and George Institute for Global Health, Newtown, New South Wales, Australia.
Stevan NikolinDiscipline of Psychiatry and Mental Health, University of New South Wales, Sydney, New South Wales, Australia; University of New South Wales, Randwick, New South Wales, Australia; and George Institute for Global Health, Newtown, New South Wales, Australia.ORCID 0000-0003-4440-9273
Philip B MitchellDiscipline of Psychiatry and Mental Health, University of New South Wales, Sydney, New South Wales, Australia.ORCID 0000-0002-7954-5235
Michael BerkInstitute for Mental and Physical Health and Clinical Translation (IMPACT), School of Medicine, Barwon Health, Deakin University, Geelong, Australia.
Gregory CarterCollege of Health, Medicine and Wellbeing, School of Medicine and Public Health, University of Newcastle, Callaghan, New South Wales, Australia.
Maree HackettGeorge Institute for Global Health, Newtown, New South Wales, Australia.
John LeydenRoyal North Shore Hospital, St Leonards, New South Wales, Australia; and Northern Sydney Anaesthetic Research Institute, St Leonards, New South Wales, Australia.
Sean HoodDivision of Psychiatry, University of Western Australia, Perth, Western Australia, Australia.ORCID 0000-0003-2852-7923
Andrew A SomogyiDiscipline of Pharmacology, School of Biomedicine, Faculty of Health and Medical Sciences, University of Adelaide, Adelaide, Australia.
Kyle LapidusAffective Care, Northwell Health, New York, New York, USA.
Elizabeth StrattonFaculty of Medicine and Health, Central Clinical School, University of Sydney, Sydney, New South Wales, Australia.
Kirsten GainsfordEpworth Centre for Innovation in Mental Health, Epworth Healthcare and Monash University, Camberwell, Victoria, Australia.
Deepak GargMental Health and Specialist Services, Gold Coast Health, Bond University, Robina, Queensland, Australia.
Nicollette L R ThorntonCentral Clinical School, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia; and Australian Research Council Centre of Excellence for Children and Families over the Life Course, University of Sydney, Sydney, New South Wales, Australia.ORCID 0000-0002-5939-1339
Célia FourrierDiscipline of Psychiatry, University of Adelaide, Adelaide, South Australia, Australia; and Lysosomal Health in Ageing, Hopwood Centre for Neurobiology, South Australian Health and Medical Research Institute, Adelaide, South Australia, Australia.
Karyn RichardsonBrainPark, Turner Institute for Brain and Mental Health, Monash University, Clayton, Victoria, Australia; and Epworth Centre for Innovation in Mental Health, Epworth Healthcare and Monash University, Camberwell, Victoria, Australia.
Demi RozakisNeuroCentrix, Noble Park, Victoria, Australia.
Anish ScariaGeorge Institute for Global Health, Newtown, New South Wales, Australia.
Cathrine MihalopoulosSchool of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia; and School of Health and Social Development, Deakin University, Geelong, Australia.
Mary Lou ChattertonSchool of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.
William M McDonaldDepartment of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, Georgia, USA.
Philip BoyceSpecialty of Psychiatry, Westmead Institute of Medical Research, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.ORCID 0000-0002-9816-7356
Paul E HoltzheimerDepartment of Psychiatry, Geisel School of Medicine at Dartmouth, Lebanon, New Hampshire, USA; and Department of Surgery, Geisel School of Medicine at Dartmouth, Lebanon, New Hampshire, USA.
F Andrew KozelDepartment of Behavioral Sciences and Social Medicine, Florida State University College of Medicine, Tallahassee, Florida, USA.
Patricio Riva-PosseDepartment of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, Georgia, USA.
Anthony RodgersGeorge Institute for Global Health, Newtown, New South Wales, Australia.
UNSW Sydney · AUThe University of Sydney · AUThe George Institute for Global Health · AUBond University · AUEmory University · USEpworth Hospital · AUThe University of Adelaide · AUAustralian National University · AUBarwon Health · AUBlack Dog Institute · AUDartmouth College · USDeakin University · AUFlorida State University · USInstitute of Research and Innovation Parc Tauli · ESMonash University · AUNorthwell Health · USParks Victoria · AURoyal North Shore Hospital · AUSouth Australian Health and Medical Research Institute · AUThe Royal Melbourne Hospital · AU

Funding

National Health and Medical Research Council APP1105089
6 · The paper itself

Abstract

backgroundPrior trials suggest that intravenous racemic ketamine is a highly effective for treatment-resistant depression (TRD), but phase 3 trials of racemic ketamine are needed.

aimsTo assess the acute efficacy and safety of a 4-week course of subcutaneous racemic ketamine in participants with TRD. Trial registration: ACTRN12616001096448 at www.anzctr.org.au.

methodThis phase 3, double-blind, randomised, active-controlled multicentre trial was conducted at seven mood disorders centres in Australia and New Zealand. Participants received twice-weekly subcutaneous racemic ketamine or midazolam for 4 weeks. Initially, the trial tested fixed-dose ketamine 0.5 mg/kg versus midazolam 0.025 mg/kg (cohort 1). Dosing was revised, after a Data Safety Monitoring Board recommendation, to flexible-dose ketamine 0.5-0.9 mg/kg or midazolam 0.025-0.045 mg/kg, with response-guided dosing increments (cohort 2). The primary outcome was remission (Montgomery-Åsberg Rating Scale for Depression score ≤10) at the end of week 4.

resultsThe final analysis (those who received at least one treatment) comprised 68 in cohort 1 (fixed-dose), 106 in cohort 2 (flexible-dose). Ketamine was more efficacious than midazolam in cohort 2 (remission rate 19.6%

conclusionsAdequately dosed subcutaneous racemic ketamine was efficacious and safe in treating TRD over a 4-week treatment period. The subcutaneous route is practical and feasible.

Indexed as

Depressive Disorder, Treatment-ResistantKetamineAustraliaDepressionHumansMidazolamKetamineMidazolamaffective disorders.clinical drug studiesKetamine/esketaminemajor depressive disorderneuroscience

Identifiers

PMID38108319
PMCPMC10727911
OpenAlexW4384153740

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

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.