Evidence map›Paper›PMID 34865676›Full record

ArticleBJPsych open2021

Repeated, low-dose oral esketamine in patients with treatment-resistant depression: pilot study.

Sanne Y Smith-Apeldoorn, Jolien K E Veraart, Henricus G Ruhé, Marije Aan Het Rot, Jeanine Kamphuis, Marrit K de Boer, Robert A Schoevers

Open access · goldAbstract read
In one paragraph

Article in BJPsych open, 2021. 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
1.6field-weighted citation impact, top 17% 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, 15 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

7 authors at 2 institutions in 1 country.

Sanne Y Smith-ApeldoornDepartment of Psychiatry, University of Groningen, University Medical Center Groningen, The Netherlands.ORCID https://orcid.org/0000-0002-9133-262X
Jolien K E VeraartDepartment of Psychiatry, University of Groningen, University Medical Center Groningen, The Netherlands; and Department of Mood Disorders, PsyQ Haaglanden, Parnassia Psychiatric Institute, The Netherlands.
Henricus G RuhéDepartment of Psychiatry, University of Groningen, University Medical Center Groningen, The Netherlands; and Department of Psychiatry, Radboud University Medical Center, The Netherlands.ORCID https://orcid.org/0000-0001-6072-0358
Marije Aan Het RotDepartment of Psychology, University of Groningen, The Netherlands.
Jeanine KamphuisDepartment of Psychiatry, University of Groningen, University Medical Center Groningen, The Netherlands.
Marrit K de BoerDepartment of Psychiatry, University of Groningen, University Medical Center Groningen, The Netherlands.
Robert A SchoeversDepartment of Psychiatry, University of Groningen, University Medical Center Groningen, The Netherlands.ORCID https://orcid.org/0000-0003-0760-9866
University Medical Center Groningen · NLUniversity of Groningen · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIntravenous infusion of ketamine can produce rapid and large symptom reduction in patients with treatment-resistant depression (TRD) but presents major obstacles to clinical applicability, especially in community settings. Oral esketamine may be a promising addition to our TRD treatment armamentarium.

aimsTo explore the safety, tolerability and potential clinical effectiveness of a 3-week treatment with repeated, low-dose oral esketamine.

methodSeven patients with chronic and severe TRD received 1.25 mg/kg generic oral esketamine daily, over 21 consecutive days. Scores on the Systematic Assessment for Treatment Emergent Events (SAFTEE), Community Assessment of Psychic Experiences (CAPE), Clinician Administered Dissociative States Scale (CADSS) and Hamilton Rating Scale for Depression (HRSD) instruments, as well as blood pressure and heart rate, were repeatedly assessed.

resultsTreatment with oral esketamine was well-tolerated. No serious side-effects occurred, and none of the participants discontinued treatment prematurely. Psychotomimetic effects were the most frequently reported adverse events. Mean HDRS score decreased by 16.5%, from 23.6 to 19.7. Three participants showed reductions in HDRS scores above the minimum clinically important difference (eight-point change), of whom two showed partial response. No participants showed full response or remission.

conclusionsThese results strengthen the idea that oral esketamine is a safe and well-tolerated treatment for patients with chronic and severe TRD, but therapeutic effects were modest. Results were used to design a randomised controlled trial that is currently in progress.

Indexed as

Esketamineoral administrationsafetytolerabilitytreatment-resistant depression

Identifiers

PMID34865676
PMCPMC8693908
OpenAlexW4200025881

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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.