Evidence map›Paper›PMID 32861217›Full record

Trial reportThe international journal of neuropsychopharmacology2021

Esketamine Nasal Spray for Rapid Reduction of Depressive Symptoms in Patients With Major Depressive Disorder Who Have Active Suicide Ideation With Intent: Results of a Phase 3, Double-Blind, Randomized Study (ASPIRE II).

Dawn F Ionescu, Dong-Jing Fu, Xin Qiu, Rosanne Lane, Pilar Lim, Siegfried Kasper, David Hough, Wayne C Drevets, Husseini Manji, Carla M Canuso

2 registry-linked trialsOpen access · goldAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The international journal of neuropsychopharmacology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 116 papers, 13 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
116citing papers in PubMed, 13 pooled it
44.8field-weighted citation impact, top 1% 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.

NCT03097133 phase3completednot on this map

A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of Intranasal Esketamine in Addition to Comprehensive Standard of Care for the Rapid Reduction of the Symptoms of Major Depressive Disorder, Including Suicidal Ideation, in Adult Subjects Assessed to be at Imminent Risk for Suicide

TypeinterventionalSponsorJanssen Research & Development, LLCRan2017 to 2019Enrolled230ConditionsDepressive Disorder, MajorArmsEsketamine, Placebo, Standard of Care
NCT07610343 phase4not yet recruitingnot on this mapstarted 2026, after this paper: background citation

Impact of Intranasal Dexmedetomidine-esketamine on Sleep Quality and Cognitive Function in Older Adults With Mild-to-moderate Cognitive Impairment: a Randomized, Double-blind, and Placebo-controlled Trial

TypeinterventionalSponsorPeking University First HospitalRan2026 to 2027Enrolled60ConditionsOlder Adults, Cognitive Impairment, Sleep Disorders, DexmedetomidineArmsDexmedetomidine-esketamine combination, Placebo
3 · Its place in the literature

Who cites it

116 citing papers in PubMed, 13 syntheses or guidelines pooled it, 396 citations in OpenAlex.

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56 more citing papers are in PubMed but not listed here.

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 at 2 institutions in 2 countries.

Dawn F IonescuDepartment of Neuroscience, Janssen Research and Development, LLC, San Diego, CA.
Dong-Jing FuDepartment of Neuroscience, Janssen Research and Development, LLC, Titusville, NJ.
Xin QiuDepartment of Statistics, Janssen Research and Development, LLC, Raritan, NJ.
Rosanne LaneDepartment of Statistics, Janssen Research and Development, LLC, Titusville, NJ.
Pilar LimDepartment of Statistics, Janssen Research and Development, LLC, Titusville, NJ.
Siegfried KasperCenter of Brain Research, Medical University of Vienna, Vienna, Austria.
David HoughDepartment of Neuroscience, Janssen Research and Development, LLC, Titusville, NJ.
Wayne C DrevetsDepartment of Neuroscience, Janssen Research and Development, LLC, San Diego, CA.
Husseini ManjiDepartment of Neuroscience, Janssen Research and Development, LLC, Titusville, NJ.
Carla M CanusoDepartment of Neuroscience, Janssen Research and Development, LLC, Titusville, NJ.
Janssen (United States) · USMedical University of Vienna · AT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPatients with major depressive disorder (MDD) having active suicidal ideation with intent require immediate treatment.

methodsThis double-blind study (ASPIRE II) randomized adults (aged 18-64 years) with MDD having active suicidal ideation with intent to esketamine 84 mg or placebo nasal spray twice weekly for 4 weeks, given with comprehensive standard of care (hospitalization ≥5 days and newly initiated or optimized oral antidepressant[s]). Change from baseline to 24 hours post-first dose in Montgomery-Asberg Depression Rating Scale total score (primary efficacy endpoint) was analyzed using ANCOVA. Clinical Global Impression-Severity of Suicidality-revised (key secondary endpoint) was analyzed using ANCOVA on ranks of change.

resultsOf 230 patients who were randomized (115 per arm), 227 received study drug and were included in efficacy/safety analyses; 184 (80.0%) completed double-blind treatment. Greater improvement in Montgomery-Asberg Depression Rating Scale total score was observed with esketamine (mean [SD]: -15.7 [11.56]) vs placebo (-12.4 [10.43]), each with standard of care, at 24 hours (least-squares mean difference [SE]: -3.9 [1.39], 95% CI: -6.60, -1.11; 2-sided P = .006). This was also noted at the earlier (4-hour) timepoint (least-squares mean difference -4.2, 95% CI: -6.38, -1.94). Patients in both treatment groups experienced rapid reduction in Clinical Global Impression-Severity of Suicidality-revised score; the between-group difference was not statistically significant. The most common adverse events among esketamine-treated patients were dizziness, dissociation, nausea, dysgeusia, somnolence, headache, and paresthesia.

conclusionThis study confirmed rapid and robust reduction of depressive symptoms with esketamine nasal spray in severely ill patients with MDD who have active suicidal ideation with intent. Trial Registration: Clinical Trials.gov identifier: NCT03097133.

Indexed as

Suicidal IdeationAdministration, IntranasalAdolescentAdultAntidepressive AgentsDouble-Blind MethodFemaleHumansKetamineMajor Depressive DisorderMaleMiddle AgedNasal SpraysOutcome Assessment, Health CarePatient AcuityYoung AdultAntidepressive AgentsEsketamineKetamineNasal SpraysdepressionEsketaminesuicidal ideationsuicide risk

Identifiers

PMID32861217
PMCPMC7816667
OpenAlexW3082490768

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.