Evidence map›Paper›PMID 39819527›Full record

Trial reportCNS spectrums2025

Esketamine nasal spray versus quetiapine XR in adults with treatment-resistant depression: a secondary analysis of the ESCAPE-TRD randomized clinical trial.

Roger S McIntyre, Gregory Mattingly, Yordan Godinov, Jozefine Buyze, Ibrahim Turkoz, Patricia Cabrera, Manish Patel, Larry Martinez, Mai Himedan, Oliver Lopena

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase III
In one paragraph

Trial report in CNS spectrums, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04338321 (A Randomized, Open-label, Rater-Blinded, Active-Controlled, International, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Flexibly Dosed Esketamine Nasal Spray Compared With Quetiapine Extended-Release in Adult and Elderly Participants With Treatment-Resistant Major Depressive Disorder Who Are Continuing a Selective Serotonin Reuptake Inhibitor/Serotonin-Norepinephrine Reuptake Inhibitor), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
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.

NCT04338321 phase3completednot on this map

A Randomized, Open-label, Rater-Blinded, Active-Controlled, International, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Flexibly Dosed Esketamine Nasal Spray Compared With Quetiapine Extended-Release in Adult and Elderly Participants With Treatment-Resistant Major Depressive Disorder Who Are Continuing a Selective Serotonin Reuptake Inhibitor/Serotonin-Norepinephrine Reuptake Inhibitor

TypeinterventionalSponsorJanssen-Cilag International NVRan2020 to 2022Enrolled676ConditionsDepressive Disorder, MajorArmsEsketamine 28 mg, Esketamine 56 mg, Esketamine 84 mg, Quetiapine XR 50 mg, Quetiapine XR 100 mg
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Review
  2. Article
  3. Article
  4. 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

10 authors.

Roger S McIntyreDepartment of Psychiatry, University of Toronto, Toronto, ON, Canada.ORCID 0000-0003-4733-2523
Gregory MattinglyMidwest Research Group, St. Charles, MO, USA.ORCID 0000-0002-0234-6860
Yordan GodinovJanssen EMEA, Sofia, Bulgaria.
Jozefine BuyzeJanssen Pharmaceutica NV, Beerse, Belgium.
Ibrahim TurkozJanssen Research and Development, LLC, a Johnson & Johnson company, Titusville, NJ, USA.
Patricia CabreraJanssen Scientific Affairs, LLC, a Johnson & Johnson company, Titusville, NJ, USA.
Manish PatelJanssen Scientific Affairs, LLC, a Johnson & Johnson company, Titusville, NJ, USA.
Larry MartinezJanssen Scientific Affairs, LLC, a Johnson & Johnson company, Titusville, NJ, USA.
Mai HimedanJanssen Scientific Affairs, LLC, a Johnson & Johnson company, Titusville, NJ, USA.
Oliver LopenaJanssen Scientific Affairs, LLC, a Johnson & Johnson company, Titusville, NJ, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveEsketamine nasal spray (ESK) is approved in combination with an oral antidepressant (OAD) for the treatment of adults with treatment-resistant depression (TRD); however, direct comparisons with atypical antipsychotics for TRD are limited. This secondary analysis of the ESCAPE-TRD study compared rates of remission and response, and improvements in depressive symptoms over time, between ESK and quetiapine extended-release (XR) in patients with TRD treated in accordance with US prescribing information (USPI).

methodsESCAPE-TRD (NCT04338321) was a randomized, open-label, rater-blinded phase 3b trial investigating ESK versus quetiapine XR for acute and maintenance treatment of patients with TRD. This secondary analysis included patients aged 18-64 years who were treated/dosed according to USPI. The primary endpoint was remission, defined as Montgomery-Åsberg Depression Rating Scale (MADRS) total score ≤ 10. Treatment-emergent adverse events (TEAEs) leading to discontinuation were summarized descriptively.

resultsAmong 636 patients in this secondary analysis (ESK, n = 316; quetiapine XR, n = 320), significantly more ESK-treated patients achieved remission starting at week 8 (28.3% versus 18.6%;

conclusionsConsistent with the primary analysis, this secondary analysis demonstrated that ESK improves short- and long-term outcomes compared with quetiapine XR in patients with TRD treated according to USPI.

Indexed as

Antidepressive AgentsAntipsychotic AgentsDepressive Disorder, Treatment-ResistantKetamineQuetiapine FumarateAdolescentAdultDelayed-Action PreparationsFemaleHumansMaleMiddle AgedNasal SpraysTreatment OutcomeYoung AdultAntidepressive AgentsAntipsychotic AgentsDelayed-Action PreparationsEsketamineKetamineNasal SpraysQuetiapine FumarateEsketaminemajor depressive disorderquetiapineremissiontreatment-resistant depression

Identifiers

PMID39819527
PMCPMC13064706

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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.