Evidence map›Paper›PMID 35212235›Full record

Trial reportJournal of psychopharmacology (Oxford, England)2022

The effects of intranasal esketamine on on-road driving performance in patients with major depressive disorder or persistent depressive disorder.

Francis M Dijkstra, Aurora Jae van de Loo, Smedra Abdulahad, Else R Bosma, Mitch Hartog, Hendrikje Huls, Dianne C Kuijper, Esther de Vries, Bhavna Solanki, Jaskaran Singh and 5 more

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of psychopharmacology (Oxford, England), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 2 pooled it
1.9field-weighted citation impact, top 16% 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

6 citing papers in PubMed, 2 syntheses or guidelines pooled it, 14 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Review
  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

15 authors at 4 institutions in 3 countries.

Francis M DijkstraCentre for Human Drug Research (CHDR), Leiden, The Netherlands.ORCID 0000-0001-5804-0708
Aurora Jae van de LooInstitute for Risk Assessment Sciences (IRAS), Utrecht University, Utrecht, The Netherlands.
Smedra AbdulahadInstitute for Risk Assessment Sciences (IRAS), Utrecht University, Utrecht, The Netherlands.
Else R BosmaInstitute for Risk Assessment Sciences (IRAS), Utrecht University, Utrecht, The Netherlands.
Mitch HartogInstitute for Risk Assessment Sciences (IRAS), Utrecht University, Utrecht, The Netherlands.
Hendrikje HulsInstitute for Risk Assessment Sciences (IRAS), Utrecht University, Utrecht, The Netherlands.
Dianne C KuijperInstitute for Risk Assessment Sciences (IRAS), Utrecht University, Utrecht, The Netherlands.
Esther de VriesInstitute for Risk Assessment Sciences (IRAS), Utrecht University, Utrecht, The Netherlands.
Bhavna SolankiJanssen Research & Development, La Jolla, CA, USA.
Jaskaran SinghJanssen Research & Development, La Jolla, CA, USA.
Leah AluisioJanssen Research & Development, La Jolla, CA, USA.
Peter ZannikosJanssen Research & Development, LLC, Raritan, NJ, USA.
Frederik E StuurmanCentre for Human Drug Research (CHDR), Leiden, The Netherlands.ORCID 0000-0002-0013-8355
Gabriël E JacobsCentre for Human Drug Research (CHDR), Leiden, The Netherlands.
Joris C VersterInstitute for Risk Assessment Sciences (IRAS), Utrecht University, Utrecht, The Netherlands.ORCID 0000-0002-6455-2096
Utrecht University · NLJanssen (United States) · USLeiden University Medical Center · NLCentre for Human Drug Research · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIntranasal esketamine demonstrates rapid improvement of depressive symptoms. However, transient adverse effects (dissociation, sedation and dizziness) may occur, which could impact driving performance.

aimsTo evaluate the effects of 84 mg intranasal esketamine on driving performance in unipolar major depressive disorder (MDD) or persistent depressive disorder (PDD) patients.

methodsThe study consisted of two parts. Part A was a single-blind, double-dummy, randomized three-period, cross-over study to compare effects of esketamine versus placebo on next morning driving, 18 ± 2 h post-treatment. Alcohol was administered to demonstrate assay sensitivity. In Part B, same-day driving, 6 ± 0.5 hours post-treatment, was assessed during twice weekly esketamine administration for 3 weeks. Twenty-seven patients with mild-to-moderate MDD or PDD without psychotic features completed a 100 km on-the-road driving test on a public highway in normal traffic. The primary outcome was standard deviation of lateral position (SDLP; cm; weaving of car).

resultsIn Part A, alcohol impaired driving performance compared to placebo: Least-square means (95% CI),

conclusionsIn this study, esketamine did not impair on-road driving performance the next morning following a single dose, or on same day after repeated administration.

Indexed as

Automobile DrivingMajor Depressive DisorderAntidepressive AgentsCross-Over StudiesDouble-Blind MethodHumansKetaminePsychomotor PerformanceSingle-Blind MethodAntidepressive AgentsEsketamineKetaminedrivingesketamine nasal sprayMajor depressive disorderpersistent depressive disorderSDLP

Identifiers

PMID35212235
PMCPMC9112620
OpenAlexW4214501787

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.