Evidence map›Paper›PMID 36525338›Full record

Trial reportThe international journal of neuropsychopharmacology2023

Adverse Events and Measurement of Dissociation After the First Dose of Esketamine in Patients With TRD.

David Williamson, Ibrahim Turkoz, Ewa Wajs, Jaskaran B Singh, Stephane Borentain, Wayne C Drevets

Registry-linked trialOpen access · goldFull text readClinical Trial
In one paragraph

Trial report in The international journal of neuropsychopharmacology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02497287 (An Open-label, Long-term, Safety and Efficacy Study of Intranasal Esketamine in Treatment-resistant Depression), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.9field-weighted citation impact, top 15% 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.

NCT02497287 phase3completednot on this map

An Open-label, Long-term, Safety and Efficacy Study of Intranasal Esketamine in Treatment-resistant Depression

TypeinterventionalSponsorJanssen Research & Development, LLCRan2015 to 2017Enrolled802ConditionsTreatment-resistant DepressionArmsEsketamine (Intranasal Spray), Duloxetine (Oral Antidepressant), Escitalopram (Oral Antidepressant), Sertraline (Oral Antidepressant), Venlafaxine Extended Release (XR) (Oral Antidepressant)
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 11 citations in OpenAlex.

  1. Article
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  5. Review
  6. Article
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

6 authors at 4 institutions in 2 countries.

David WilliamsonJanssen Scientific Affairs, LLC, Titusville, New Jersey, USA.
Ibrahim TurkozDepartment of Statistics and Decision Sciences, Janssen Research & Development, LLC, Titusville, New Jersey, USA.
Ewa WajsDepartment of Neuroscience, Janssen Research & Development Belgium, Beerse, Belgium.
Jaskaran B SinghNeurocrine Biosciences, San Diego, California, USA.
Stephane BorentainDepartment of Global Medical Affairs, Janssen Research & Development LLC, Titusville, New Jersey, USA.
Wayne C DrevetsDepartment of Neuroscience, Janssen Research & Development, LLC, San Diego, California, USA.
Janssen (United States) · USJanssen (Belgium) · BEJanssen Scientific Affairs (United States)Neurocrine Biosciences (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

background"Dissociation" comprises distinct phenomena, some of which are associated with esketamine treatment and some may overlap with positive symptoms of psychosis. Relationships between dissociation and psychotic symptoms assessed by -clinician report vs conventional rating scales were investigated in a post hoc analysis of data from the initial treatment session in an -open-label, -long-term safety, phase 3 study of esketamine plus a newly initiated oral antidepressant in patients with treatment-resistant depression.

methodsAdverse events of dissociation or psychosis were examined via investigator report and the Clinician Administered Dissociative States Scale (CADSS) and Brief Psychiatric Rating Scale-Plus, respectively, 40 minutes post first esketamine dose. The range of CADSS total scores associated with investigator-reported severity of dissociation was determined by equipercentile linking. Logistic regression models and receiver operating curve analysis explored the CADSS cutoff point for determining presence/absence of dissociation. Frequency of response to specific CADSS items was examined to investigate qualitative differences in the pattern of symptoms reported across investigator-reported levels of adverse event severity.

resultsDissociation was reported as an adverse event in 14.3% (109/764) of patients. Severity of most CADSS items increased with the severity of investigator-reported dissociation. No CADSS cutoff point discriminated well between the presence and absence of dissociation events. Hallucinations were reported as adverse events in 5 patients; none reported delusions.

conclusionsCADSS scores and severity of dissociation adverse events move generally in the same direction; however, there is substantial variability in this relationship. No signature profile of dissociative experiences was revealed, and psychotic symptoms were uncommon.

trial registrationClinical Trials.gov identifier: NCT02497287.

Indexed as

Depressive Disorder, Treatment-ResistantKetaminePsychotic DisordersAntidepressive AgentsHallucinationsHumansAntidepressive AgentsEsketamineKetamineBPRS+CADSSdissociationesketaminepsychosis

Identifiers

PMID36525338
PMCPMC10032296
OpenAlexW4311675122

What OpenQuestion holds

Textfull text, public
LicenceCC BY
measurements read26
reference markers read24
identifiers read2
Read underepoch 390

Registered trials

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.