Evidence map›Paper›PMID 37963146›Full record

Trial reportPloS one2023

Subcutaneous ketamine infusion in palliative patients for major depressive disorder (SKIPMDD)-Phase II single-arm open-label feasibility study.

Wei Lee, Caitlin Sheehan, Richard Chye, Sungwon Chang, Adam Bayes, Colleen Loo, Brian Draper, Meera R Agar, David C Currow

Open access · goldAbstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in PloS one, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.9field-weighted citation impact, top 14% 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

5 citing papers in PubMed, 8 citations in OpenAlex.

  1. Review
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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

9 authors at 5 institutions in 1 country.

Wei LeeUniversity of Technology Sydney, Ultimo, NSW, Australia.ORCID 0000-0002-8018-9362
Caitlin SheehanCalvary Hospital, Kogarah, NSW, Australia.
Richard ChyeUniversity of Technology Sydney, Ultimo, NSW, Australia.ORCID 0000-0003-1506-9572
Sungwon ChangUniversity of Technology Sydney, Ultimo, NSW, Australia.
Adam BayesUniversity of New South Wales, Randwick, NSW, Australia.
Colleen LooUniversity of New South Wales, Randwick, NSW, Australia.
Brian DraperUniversity of New South Wales, Randwick, NSW, Australia.
Meera R AgarUniversity of Technology Sydney, Ultimo, NSW, Australia.
David C CurrowUniversity of Wollongong, Wollongong, NSW, Australia.
University of Technology Sydney · AUBlack Dog Institute · AUCalvary Hospital · AUUniversity of Wollongong · AUUNSW Sydney · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundKetamine at subanaesthetic dosages (≤0.5mg/kg) exhibits rapid onset (over hours to days) antidepressant effects against major depressive disorder in people who are otherwise well. However, its safety, tolerability and efficacy are not known for major depressive disorder in people with advanced life-limiting illnesses.

objectiveTo determine the feasibility, safety, tolerability, acceptability and any antidepressant signal/activity to justify and inform a fully powered study of subcutaneous ketamine infusions for major depressive disorder in the palliative setting.

methodsThis was a single arm, open-label, phase II feasibility study (Australian New Zealand Clinical Trial Registry Number-ACTRN12618001586202). We recruited adults (≥ 18-years-old) with advanced life-limiting illnesses referred to four palliative care services in Sydney, Australia, diagnosed with major depressive disorder from any care setting. Participants received weekly subcutaneous ketamine infusion (0.1-0.4mg/kg) over two hours using individual dose-titration design. Outcomes assessed were feasibility, safety, tolerability and antidepressant activity.

resultsOut of ninety-nine referrals, ten participants received ketamine and were analysed for responses. Accrual rate was 0.54 participants/month across sites with 50% of treated participants achieving ≥ 50% reduction in baseline Montgomery-Åsberg Depression Rating Scale, meeting feasibility criteria set a priori. There were no clinically relevant harms encountered.

conclusionsA future definitive trial exploring the effectiveness of subcutaneous infusion of ketamine for major depressive disorder in the palliative care setting may be feasible by addressing identified study barriers. Individual dose-titration of subcutaneous ketamine infusions over two hours from 0.1mg/kg can be well-tolerated and appears to produce transient antidepressant signals over hours to days.

Indexed as

Depressive Disorder, Treatment-ResistantKetamineMajor Depressive DisorderAdolescentAdultAntidepressive AgentsAustraliaFeasibility StudiesHumansInfusions, IntravenousInfusions, SubcutaneousTreatment OutcomeAntidepressive AgentsKetamine

Identifiers

PMID37963146
PMCPMC10645343
OpenAlexW4388667470

What OpenQuestion holds

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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.