Evidence map›Paper›PMID 31783823›Full record

ArticleBMC psychiatry2019

Oral esketamine for treatment-resistant depression: rationale and design of a randomized controlled trial.

Sanne Y Smith-Apeldoorn, Jolien K E Veraart, Jeanine Kamphuis, Antoinette D I van Asselt, Daan J Touw, Marije Aan Het Rot, Robert A Schoevers

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

Article in BMC psychiatry, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 20 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 4 pooled it
2.4field-weighted citation impact, top 12% 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

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

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4 · The record

Corrections and comments

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, PO box 30.0001, 9700, RB, Groningen, The Netherlands. s.y.apeldoorn@umcg.nl.ORCID 0000-0002-9133-262X
Jolien K E VeraartDepartment of Psychiatry, University of Groningen, University Medical Center Groningen, PO box 30.0001, 9700, RB, Groningen, The Netherlands.
Jeanine KamphuisDepartment of Psychiatry, University of Groningen, University Medical Center Groningen, PO box 30.0001, 9700, RB, Groningen, The Netherlands.
Antoinette D I van AsseltDepartment of Epidemiology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
Daan J TouwDepartment of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
Marije Aan Het RotDepartment of Psychology, University of Groningen, Groningen, The Netherlands.
Robert A SchoeversDepartment of Psychiatry, University of Groningen, University Medical Center Groningen, PO box 30.0001, 9700, RB, Groningen, The Netherlands.
University Medical Center Groningen · NLUniversity of Groningen · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThere is an urgent need to develop additional treatment strategies for patients with treatment-resistant depression (TRD). The rapid but short-lived antidepressant effects of intravenous (IV) ketamine as a racemic mixture have been shown repeatedly in this population, but there is still a paucity of data on the efficacy and safety of (a) different routes of administration, and (b) ketamine's enantiomers esketamine and arketamine. Given practical advantages of oral over IV administration and pharmacodynamic arguments for better antidepressant efficacy of esketamine over arketamine, we designed a study to investigate repeated administration of oral esketamine in patients with TRD.

methodsThis study features a triple-blind randomized placebo-controlled trial (RCT) comparing daily oral esketamine versus placebo as add-on to regular antidepressant medications for a period of 6 weeks, succeeded by a follow-up of 4 weeks. The methods support examination of the efficacy, safety, tolerability, mechanisms of action, and economic impact of oral esketamine in patients with TRD. DISCUSSION: This is the first RCT investigating repeated oral esketamine administration in patients with TRD. If shown to be effective and tolerated, oral esketamine administration poses important advantages over IV administration.

trial registrationDutch Trial Register, NTR6161. Registered 21 October 2016.

Indexed as

Administration, OralAdultAntidepressive AgentsCost-Benefit AnalysisDepressive Disorder, Treatment-ResistantDrug Therapy, CombinationFemaleHumansKetamineMajor Depressive DisorderMaleRandomized Controlled Trials as TopicTreatment OutcomeAntidepressive AgentsEsketamineKetamineClinical trialEsketamineOral administrationTreatment-resistant depression

Identifiers

PMID31783823
PMCPMC6884875
OpenAlexW2991384921

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.