Evidence map›Paper›PMID 37875938›Full record

ArticleTrials2023

The Study of Ketamine for Youth Depression (SKY-D): study protocol for a randomised controlled trial of low-dose ketamine for young people with major depressive disorder.

Orli S Schwartz, Paul Amminger, Bernard T Baune, Gillinder Bedi, Michael Berk, Sue M Cotton, Rothanthi Daglas-Georgiou, Nick Glozier, Ben Harrison, Daniel F Hermens and 13 more

Open access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
0.2field-weighted citation impact, top 38% 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

0 citing papers in PubMed, 1 citations in OpenAlex.

No citing paper in PubMed yet.

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 at 7 institutions in 2 countries.

Orli S SchwartzDepartment of Psychiatry, University of Melbourne, Melbourne, Australia. orli@unimelb.edu.au.ORCID http://orcid.org/0000-0001-7634-3737
Paul AmmingerOrygen, Melbourne, Australia.
Bernard T BauneDepartment of Psychiatry, University of Melbourne, Melbourne, Australia.
Gillinder BediOrygen, Melbourne, Australia.
Michael BerkOrygen, Melbourne, Australia.
Sue M CottonOrygen, Melbourne, Australia.
Rothanthi Daglas-GeorgiouOrygen, Melbourne, Australia.
Nick GlozierCentral Clinical School, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia.
Ben HarrisonDepartment of Psychiatry, University of Melbourne, Melbourne, Australia.
Daniel F HermensThompson Institute, University of the Sunshine Coast, Sunshine Coast, Australia.
Emma JenningsOrygen, Melbourne, Australia.
Jim LagopoulosThompson Institute, University of the Sunshine Coast, Sunshine Coast, Australia.
Colleen LooSchool of Psychiatry, University of New South Wales, Sydney, Australia.
Sumudu MallawaarachchiOrygen, Melbourne, Australia.
Donel MartinBlack Dog Institute, Sydney, Australia.
Bethany PhelanOrygen, Melbourne, Australia.
Nikki ReadOrygen, Melbourne, Australia.
Anthony RodgersThe George Institute for Global Health, University of New South Wales, Sydney, Australia.
Lianne SchmaalOrygen, Melbourne, Australia.
Andrew A SomogyiSchool of Biomedicine, University of Adelaide, Adelaide, Australia.
Lily ThurstonOrygen, Melbourne, Australia.
Amber WellerOrygen, Melbourne, Australia.
Christopher G DaveyDepartment of Psychiatry, University of Melbourne, Melbourne, Australia.
The University of Melbourne · AUBlack Dog Institute · AUUniversity of the Sunshine Coast · AUDeakin University · AUThe University of Adelaide · AUThe University of Sydney · AUUNSW Sydney · AU

Funding

National Health and Medical Research Council 1138736
6 · The paper itself

Abstract

backgroundExisting treatments for young people with severe depression have limited effectiveness. The aim of the Study of Ketamine for Youth Depression (SKY-D) trial is to determine whether a 4-week course of low-dose subcutaneous ketamine is an effective adjunct to treatment-as-usual in young people with major depressive disorder (MDD).

methodsSKY-D is a double-masked, randomised controlled trial funded by the Australian Government's National Health and Medical Research Council (NHMRC). Participants aged between 16 and 25 years (inclusive) with moderate-to-severe MDD will be randomised to receive either low-dose ketamine (intervention) or midazolam (active control) via subcutaneous injection once per week for 4 weeks. The primary outcome is change in depressive symptoms on the Montgomery-Åsberg Depression Rating Scale (MADRS) after 4 weeks of treatment. Further follow-up assessment will occur at 8 and 26 weeks from treatment commencement to determine whether treatment effects are sustained and to investigate safety outcomes. DISCUSSION: Results from this trial will be important in determining whether low-dose subcutaneous ketamine is an effective treatment for young people with moderate-to-severe MDD. This will be the largest randomised trial to investigate the effects of ketamine to treat depression in young people.

trial registrationAustralian and New Zealand Clinical Trials Registry ID: ACTRN12619000683134. Registered on May 7, 2019. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377513 .

Indexed as

KetamineMajor Depressive DisorderAdolescentAustraliaDepressionHumansInfantRandomized Controlled Trials as TopicTreatment OutcomeKetamineAdolescenceDepressionKetamineMajor depressive disorderMental HealthPsychiatryYoung peopleYouth

Identifiers

PMID37875938
PMCPMC10594918
OpenAlexW4387906918

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.