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CompletedPhase 3Results posted

54135419SUI3002: A 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 Participants Assessed to be at Imminent Risk for Suicide

NCT03097133 · Aspire II · Janssen Research & Development, LLC

Closed to entry
Status
Not accepting participants
Phase 3
Phase
230
Target enrolment
61
Study sites
13 US states

What it is testing

Summary

The purpose of this study is to evaluate the efficacy of intranasal esketamine 84 milligram (mg) compared with intranasal placebo in addition to comprehensive standard of care in reducing the symptoms of Major Depressive Disorder (MDD), including suicidal ideation, in participants who are assessed to be at imminent risk for suicide, as measured by the change from baseline on the Montgomery-Asberg Depression Rating Scale (MADRS) total score at 24 hours post first dose.

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

  • Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at 24 Hours Post First Dose (Last Observation Carried Forward [LOCF] Data): Double-blind (DB) Treatment Phase

    Measured over Baseline (Day 1, predose) and 24 hours first post dose (Day 2)

  • Change From Baseline in Clinical Global Impression-Severity of Suicidality - Revised (CGI-SS-R) Scale at 24 Hours Post First Dose (LOCF Data): DB Treatment Phase

    Measured over Baseline (Day 1, predose) and 24 hours first post dose (Day 2)

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 64 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: * Participant must meet Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-5) diagnostic criteria for major depressive disorder (MDD), without psychotic features, based upon clinical assessment and confirmed by the Mini International Psychiatric Interview (MINI) * Participants must have current suicidal ideation with intent, confirmed by a "Yes" response to Question B3 \[Think (even momentarily) about harming or of hurting or of injuring yourself: with at least some intent or awareness that you might die as a result; or think about suicide (ie, about killing yourself)?\] AND Question B10 \[Intend to act on thoughts of killing yourself?\] obtained from the MINI * In the physician's opinion, acute psychiatric hospitalization is clinically warranted due to participant's imminent risk of suicide * Participant has a Montgomery Asberg Depression Rating Scale (MADRS) total score of greater than (\>) 28 predose on Day 1 * As part of standard of care treatment, participant agrees to be hospitalized voluntarily for a recommended period of 14 days after randomization (may be shorter or longer if clinically warranted in the investigator's opinion) and take prescribed non-investigational antidepressant therapy(ies) for at least the duration of the double-blind treatment phase (Day 25) Exclusion Criteria: * Participant has a current DSM-5 diagnosis of bipolar (or related disorders), antisocial personality disorder, or obsessive compulsive disorder * Participant currently meets DSM-5 criteria for borderline personality disorder. Note: Participant not meeting full DSM-5 criteria for borderline personality disorder but exhibiting recurrent suicidal gestures, threats, or self-mutilating behaviors should also be excluded * Participant has a current clinical diagnosis of autism, dementia, or intellectual disability * Participant has a current or prior DSM-5 diagnosis of a psychotic disorder, or MDD with psychotic features * Participant meets the DSM-5 severity criteria for moderate or severe substance or alcohol use disorder, (except for nicotine or caffeine), within the 12 months before Screening. A history (lifetime) of ketamine, phencyclidine (PCP), lysergic acid diethylamide (LSD), or 3, 4-methylenedioxy-methamphetamine (MDMA) hallucinogen-related use disorder is exclusionary * Participant has a history or current signs and symptoms of liver or renal insufficiency, clinically significant cardiac (including unstable coronary artery disease and congestive heart failure, tachyarrhythmias and recent myocardial infarction) or vascular, pulmonary, gastrointestinal, endocrine (including uncontrolled hyperthyroidism), neurologic (including current or past history of seizures except uncomplicated childhood febrile seizures with no sequelae), hematologic, rheumatologic, or metabolic (including severe dehydration/ hypovolemia) disease * Participant has known allergies, hypersensitivity, intolerance or contraindications to esketamine or ketamine or its excipients

Where

61 study sites

FacilityCityRegionCountry
University of California San Diego/PsychiatrySan DiegoCaliforniaUnited States
Sharp Mesa Vista HospitalSan DiegoCaliforniaUnited States
University of Conneticut School of MedicineFarmingtonConnecticutUnited States
University of Miami Health SystemMiamiFloridaUnited States
Innovative Clinical Research IncNorth MiamiFloridaUnited States
University of South FloridaTampaFloridaUnited States
Atlanta Behavioral Research, LLCAtlantaGeorgiaUnited States
Memorial Medical CenterSpringfieldIllinoisUnited States
Neuroscience Research InstituteWinfieldIllinoisUnited States
Lake Charles Clinical TrialsLake CharlesLouisianaUnited States
John Hopkins HospitalBaltimoreMarylandUnited States
Altea Research InstituteLas VegasNevadaUnited States
The Zucker Hillside HospitalGlen OaksNew YorkUnited States
Stony Brook University Medical CenterStony BrookNew YorkUnited States
University of North CarolinaChapel HillNorth CarolinaUnited States
University of Cincinnati, Dept of Psychiatry & Behavioral NeuroscienceCincinnatiOhioUnited States
East Tennessee State UniversityJohnson CityTennesseeUnited States
University of Wisconsin Medical CenterMadisonWisconsinUnited States
Clínica Privada Banfield S.ABanfieldArgentina
Hospital FleniCiudad de Buenos AiresArgentina
Sanatorio Prof. Leon S. MorraCórdobaArgentina
Clinica Privada de Salud Mental Santa Teresa de ÁvilaLa PlataArgentina
Medical University Vienna MUVViennaAustria
Klinikum Wels GrieskirchenWelsAustria
AZ Sint Jan Brugge Oostende AVBrugesBelgium
UZ GentGhentBelgium
ARIADNELedeBelgium
Universidade Federal De Minas Gerais - Hospital das ClínicasBelo HorizonteBrazil
Universidade Federal Do CearaFortalezaBrazil
Instituto Bairral de PsiquiatriaItapiraBrazil
Hospital Universitario Professor Edgar SantosSalvadorBrazil
CEMEC - Centro Multidisciplinar de Estudos ClínicosSanto AndréBrazil
Hospital Das Clinicas Da Faculdade De Medicina Da USPSão PauloBrazil
St. Michael's HospitalTorontoOntarioCanada
Institut universitaire en sante mentale de MontrealMontrealQuebecCanada
Fakultni nemocnice BrnoBrnoCzechia
Nemocnice s pol. Havirov, p.o.HavířovCzechia
Narodni ustav dusevniho zdraviKlecanyCzechia
Vseobecna Fakultní NemocnicePragueCzechia
Ústrední vojenské nemocnice PrahaPragueCzechia
Hôpital de BoharsBoharsFrance
CHRU Montpellier Hopital LapeyronieMontpellierFrance
CHU CaremeauNîmesFrance
Hopital Sainte AnneParisFrance
CHU Saint Etienne Hopital NordSaint-Priest-en-JarezFrance
CHU ToulouseToulouseFrance
Hospital of Lithuanian University of Health Sciences Kaunas ClinicsKaunasLithuania
Republic Kaunas HospitalKaunas CountyLithuania
Vilnius Mental Health CenterVilniusLithuania
Uniwersyteckie Centrum KliniczneGdanskPoland
Szpital Specjalistyczny im H Klimontowicza Oddzial PsychiatrycznyGorlicePoland
SPZOZ CSK UM w Lodzi Klinika Zaburzen Afektywnych i PsychotycznychLodzPoland
Klinika Psychiatryczna WUM Mazowieckie Specjalistyczne Centrum Zdrowia im prof Jana MazurkiewiczaPruszkówPoland
Hosp Univ Vall D HebronBarcelonaSpain
Inst. Internac. Neurociencias AplicadasBarcelonaSpain
Hosp. Univ. de BasurtoBilbaoSpain
Clinica Univ. de NavarraPamplonaSpain
Bursa Sevket Yilmaz Research and Training HospitalBursaTurkey (Türkiye)
Uludag University Medical FacultyBursaTurkey (Türkiye)
Sisli Etfal Research Training HospitalIstanbulTurkey (Türkiye)
Samsun Psychiatric HospitalSamsunTurkey (Türkiye)

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

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NCT03097133 on ClinicalTrials.gov →

Last updated in the registry 2025-04-29. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits