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CompletedPhase 3Results posted

A Long-term Comparison of Esketamine Nasal Spray Versus Quetiapine Extended Release, Both in Combination With a Selective Serotonin Reuptake Inhibitor/Serotonin-Norepinephrine Reuptake Inhibitor, in Participants With Treatment Resistant Major Depressive Disorder

NCT04338321 · ESCAPE-TRD · Janssen-Cilag International NV

Closed to entry
Status
Not accepting participants
Phase 3
Phase
676
Target enrolment
171
Study sites
Outside the US

What it is testing

Summary

The primary purpose of this study is to evaluate the efficacy of flexibly dosed esketamine nasal spray compared with quetiapine extended-release (XR), both in combination with a continuing selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor (SSRI/SNRI), in achieving remission in participants who have treatment-resistant major depressive disorder (MDD) with a current moderate to severe depressive episode.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Percentage of Participants With Remission as Assessed by the Montgomery-Asberg Depression Rating Scale (MADRS) Score at Week 8

    Measured over Week 8

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 74 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: * At screening, each participant must meet Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) diagnostic criteria for single-episode major depressive disorder (MDD) or recurrent MDD, without psychotic features, based on clinical assessment and confirmed by the Mini International Neuropsychiatric Interview (MINI) * At screening and baseline, each participant must have an Inventory of Depressive Symptomatology - Clinician-rated, 30 item (IDS-C30) total score of greater than or equal to (\>=) 34 * Must be on a current antidepressive treatment that includes an selective serotonin reuptake inhibitor (SSRI)/ serotonin-norepinephrine reuptake inhibitor (SNRI) at screening that resulted in nonresponse (less than 25% improvement of symptoms) after having been given at an adequate dosage (based on antidepressive dosages from SmPC \[or local equivalent, if applicable\]) for an adequate duration of at least 6 weeks and having been uptitrated to the maximum tolerated dose; however, at screening the participant must show signs of minimal clinical improvement to be eligible for the study. Clinical improvement of a participant on their current AD treatment will be retrospectively evaluated in a qualified psychiatric interview performed by an experienced clinician. At baseline (Day 1) prior to randomization, the investigator will evaluate any changes in the participant's signs/symptoms of depression since the screening assessment and confirm that the inclusion criteria for the current AD treatment are still met (that is nonresponse and minimal clinical improvement) * The current antidepressive treatment, was immediately preceded by nonresponse to at least 1 but not more than 5 different, consecutive treatments (all within the current moderate to severe antidepressive episode) with anti-depressants (ADs) taken at an adequate dosage for an adequate duration of at least 6 weeks and must be documented * Must have been treated with at least 2 different antidepressive substance classes among the treatments taken at an adequate dosage for an adequate duration of at least 6 weeks resulting in nonresponse in the current moderate to severe depressive episode (including the current treatment with an selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor \[SSRI/SNRI\]) * Must be on a single oral SSRI/SNRI on Day 1 prior to randomization Exclusion Criteria: * Received treatment with esketamine or ketamine in the current moderate to severe depressive episode * Received treatment with quetiapine extended- or immediate-release in the current moderate to severe depressive episode of a dose higher than 50 milligram per day (mg/day) * Had depressive symptoms in the current moderate to severe depressive episode that previously did not respond to an adequate course of treatment with electroconvulsive therapy (ECT), defined as at least 7 treatments with unilateral/bilateral ECT * Has no signs of clinical improvement at all or with a significant improvement on their current AD treatment that includes an SSRI/SNRI as determined at screening by an experienced clinician during the qualified psychiatric interview * Received vagal nerve stimulation or has received deep brain stimulation in the current episode of depression * has a current or prior DSM-5 diagnosis of a psychotic disorder or MDD with psychotic features, bipolar or related disorders (confirmed by the Mini International Neuropsychiatric Interview \[MINI\]), obsessive compulsive disorder (current only), intellectual disability (DSM-5 diagnostic codes 317, 318.0, 318.1, 318.2, 315.8, and 319), autism spectrum disorder, borderline personality disorder, or antisocial personality disorder, histrionic personality disorder, or narcissistic personality disorder * age at onset of first episode of MDD was more than or equal to (\>=) 55 years * has homicidal ideation or intent, per the investigator's clinical judgment; or has suicidal ideation with some intent to act within 1 month prior to screening, per the investigator's clinical judgment; or based on the Columbia-Suicide Severity Rating Scale (C-SSRS), corresponding to a response of "Yes" on Item 4 (active suicidal ideation with some intent to act, without specific plan) or Item 5 (active suicidal ideation with specific plan and intent) for suicidal ideation, or a history of suicidal behavior within the past year prior to screening. Participants reporting suicidal ideation with intent to act or suicidal behavior prior to the start of the acute phase should also be excluded

Where

171 study sites

FacilityCityRegionCountry
Fundacion para el Estudio y Tratamiento de las Enfermedades MentalesBuenos Aires-Argentina
FunDaMosBuenos Aires-Argentina
CEN Consultorios Especializados en NeurocienciasCórdoba-Argentina
Fundacion LennoxCórdoba-Argentina
Instituto Medico DAMICCórdoba-Argentina
Sanatorio Prof Leon S Morra S ACórdoba-Argentina
Instituto de Neurociencias San AgustinLa Plata-Argentina
C I A P Centro de investigacion y Asistencia en PsiquiatriaRosario-Argentina
Medical University GrazGraz-Austria
Schmitz and SchmitzVienna-Austria
Medical University Vienna MUVVienna-Austria
AnimaAlken-Belgium
Pz DuffelDuffel-Belgium
Clinique Psychiatrique des Frères AlexiensHenri-Chapelle-Belgium
Sint-FranciskusziekenhuisHeusden-Zolder-Belgium
ARIADNELede-Belgium
CHU de LiegeLiège-Belgium
CPN - Centro de Pesquisa em Neurociências LtdaBelo Horizonte-Brazil
Trial Tech Tecnologia em Pesquisas com MedicamentosCuritiba-Brazil
Ruschel Medicina e Pesquisa Clínica LtdaRio de Janeiro-Brazil
C J S Carvalho & Carvalho LTDA (Viver - Centro De Desospitalizacao Humana)São Paulo-Brazil
BR TrialsSão Paulo-Brazil
State Psychiatric Hospital KardzhaliKardzhali-Bulgaria
UMHAT 'Dr. Georgi Stranski', EADPleven-Bulgaria
Mental Health Center - PlovdivPlovdiv-Bulgaria
Mental Health Center - RousseRousse-Bulgaria
Multiprofile Hospital for Active Treatment in Neurology and Psychiatry Sveti NaumSofia-Bulgaria
MHC - Sofia, EOODSofia-Bulgaria
Centre for Mental Health Prof.N.Shipkovenski EOODSofia-Bulgaria
University Multiprofile Hospital for Active Treatment - UMHAT Alexandrovska EADSofia-Bulgaria
Psychiatricka ambulance Saint Anne s.r.o.Brno-Czechia
Psychiatricka ambulance, MUDr. Marta HolanovaBrno-Czechia
NeuropsychiatrieHK, s.r.o.Hradec Kralove-Vekose-Czechia
A Shine S R OPilsen-Czechia
Clintrial s r oPrague-Czechia
AD71 s.r.o.Prague-Czechia
Medical Services Prague S R OPrague-Czechia
Institut Neuropsychiatricke pecePrague-Czechia
Aalborg University HospitalAalborg-Denmark
Psykiatrien i Region SyddanmarkEsbjerg N-Denmark
Mederon LTD at ARTESHelsinki-Finland
Psykiatrinen Palvelukeskus Solvum OyHelsinki-Finland
Savon PsykiatripalveluKuopio-Finland
Universitaetsklinikum der RWTH AachenAachen-Germany
Rheinhessen Fachklinik AlzeyAlzey-Germany
Emovis GmbHBerlin-Germany
Charite Campus Benjamin FranklinBerlin-Germany
Medizinisches Versorgungszentrum LiO GmbHBerlin-Germany
Alexander Schulze - GermanyBerlin-Germany
Praxis Dr. med. Kirsten HahnBerlin-Germany
Vivantes Klinikum SpandauBerlin-Germany
Universitatsklinikum BonnBonn-Germany
Klinikum Chemnitz gGmbHChemnitz-Germany
Carl-Thiem-Klinikum Cottbus gGmbHCottbus-Germany
Klinikum Dortmund gGmbHDortmund-Germany
Universitatsklinikum Carl Gustav Carcus DresdenDresden-Germany
Universitatsklinikum FrankfurtFrankfurt am Main-Germany
Universitätsklinikum Freiburg - Abteilung für Psychiatrie u. Psychotherapie mit PoliklinikFreiburg im Breisgau-Germany
SRH Waldklinikum Gera GmbHGera-Germany
Georg August Universitat Universitatsmedizin GottingenGöttingen-Germany
Evangelisches Krankenhaus Bethanien gGmbHGreifswald-Germany
Universitaetsklinik Hamburg-EppendorfHamburg-Germany
Klinische Forschung HamburgHamburg-Germany
Klinische Forschung Hannover-Mitte GmbHHanover-Germany
Medizinische Hochschule HannoverHanover-Germany
Universität HeidelbergHeidelberg-Germany
Oberhavel Kliniken GmbHHennigsdorf-Germany
Universitätsklinikum des SaarlandesHomburg-Germany
Universitatsklinikum JenaJena-Germany
Panakeia - Arzneimittelforschung GmbHLeipzig-Germany
Universitaetsklinikum Magdeburg A.oe.RMagdeburg-Germany
Universitatsmedizin der Johannes Gutenberg Universitat MainzMainz-Germany
Pharmakologisches Studienzentrum Chemnitz GmbHMittweida-Germany
Universitatsklinikum MunsterMünster-Germany
Ruppiner KlinikenNeuruppin-Germany
Praxis Prof. SteinwachsNuremberg-Germany
Johanniter Krankenhaus OberhausenOberhausen-Germany
Danuvius Klinik Pfaffenhofen Fachklinik für Psychiatrie, Psychotherapie und PsychosomatikPfaffenhofen-Germany
Somni Bene GmbHSchwerin-Germany
Klinische Forschung Schwerin GmbHSchwerin-Germany

Showing the first 80 of 171

On the registry

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NCT04338321 on ClinicalTrials.gov →

Last updated in the registry 2025-04-29. Registry records change; this page reflects the data build of 2026-10-06.

Related

Where this trial sits