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CompletedPhase 3Results posted

54135419SUI3001: 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

NCT03039192 · Aspire I · Janssen Research & Development, LLC

Closed to entry
Status
Not accepting participants
Phase 3
Phase
226
Target enrolment
56
Study sites
13 US states

What it is testing

Summary

The purpose of the 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 Montgomery Asberg Depression Rating Scale (MADRS) Total Score at 24 Hours After the First Dose (Day 2) (Last Observation Carried Forward [LOCF] Data) During Double-blind 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) * In the physician's opinion, acute psychiatric hospitalization is clinically warranted due to participant's imminent risk of suicide * 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. Note: the response to B3 must refer to the present, whereas the response to B10 may reflect the past 24 hours. If the screening period is longer than 24 hours, assessment of B3 and B10 of MINI must be repeated prior to randomization to confirm eligibility * 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 5 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) * Participant is comfortable with self-administration of intranasal medication and able to follow instructions provided 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. 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 6 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

Where

56 study sites

FacilityCityRegionCountry
UAB Department of Psychiatry and Behavioral NeurobiologyBirminghamAlabamaUnited States
Metropolitan Neuro Behavioral InstituteChandlerArizonaUnited States
Collaborative NeuroScience NetworkGarden GroveCaliforniaUnited States
Yale UniversityNew HavenConnecticutUnited States
Rush UniversityChicagoIllinoisUnited States
Alexian Behavioral Health HospitalHoffman EstatesIllinoisUnited States
University of Louisville Department of PsychiatryLouisvilleKentuckyUnited States
LSU Health Sciences Center New OrleansNew OrleansLouisianaUnited States
Louisiana Clinical ResearchShreveportLouisianaUnited States
Sheppard Pratt Health SystemBaltimoreMarylandUnited States
CBH HealthGaithersburgMarylandUnited States
State University of New YorkBuffaloNew YorkUnited States
Columbia University Medical CenterNew YorkNew YorkUnited States
Clinical Trials of AmericaHickoryNorth CarolinaUnited States
The Ohio State UniversityColumbusOhioUnited States
Medical University of South CarolinaCharlestonSouth CarolinaUnited States
University of Texas Southwestern Medical CenterDallasTexasUnited States
Regional Psychiatric DispanseryBulgariaBulgaria
Mental Health Center Prof. Dr. Ivan TemkovBurgasBulgaria
State Psychiatric Hospital - LovechLovechBulgaria
UMHAT 'Sveti Georgi'-PlovdivPlovdivBulgaria
Military Medical Academy Multiprofile Hospital for Active Treatment SofiaSofiaBulgaria
North Estonian Medical Centre FoundationTallinnEstonia
Tartu University HospitalTartuEstonia
Vivantes Humboldt KlinikumBerlinGermany
Universitatsklinikum FrankfurtFrankfurt am MainGermany
Klinik für Psychiatrie und PsychotherapieFreiburg im BreisgauGermany
Eszak Kozep budai Centrum Uj Szent Janos Korhaz es Szakrendelo Budai CsaladkozpontuBudapestHungary
Semmelweis Egyetem Kútvölgyi Klinikai TömbBudapestHungary
Nyiro Gyula KorhazBudapestHungary
Petz Aladar Megyei Oktato KorhazGyőrHungary
Pecsi Tudomanyegyetem Klinikai KozpontPécsHungary
University Kebangsaan Malaysia Medical CentreCherasMalaysia
Hospital Kuala LumpurKuala LumpurMalaysia
University Malaya Medical CentreKuala LumpurMalaysia
Hospital Tuanku JaafarSerembanMalaysia
Fakultna nemocnica s poliklinikou v ZilineŽilinaSlovakia
Flexivest 14 ResearchCape TownSouth Africa
Juan Schrönen - Western Cape South AfricaWelgemoedSouth Africa
Chonnam National University HospitalGwangjuSouth Korea
Korea University Ansan HospitalGyeonggi-doSouth Korea
Kyung Hee University Medical CenterSeoulSouth Korea
Samsung Medical CenterSeoulSouth Korea
Seoul National University HospitalSeoulSouth Korea
Hosp. Univ. Fundacion AlcorconAlcorcónSpain
Hosp Univ Vall D HebronBarcelonaSpain
Hosp Clinic de BarcelonaBarcelonaSpain
Inst. Internac. Neurociencias AplicadasBarcelonaSpain
Hosp. Univ. de BasurtoBilbaoSpain
Hosp. Univ. Ramon Y CajalMadridSpain
Clinica Univ. de NavarraPamplonaSpain
Benito Menni Comp. Asist. Salut MentalSant Boi de LlobregatSpain
Tri-Service Genaral HospitalNeihu DistrictTaiwan
Taipei Medical University Shuang Ho HospitalNew Taipei CityTaiwan
Chung Shan Medical University HospitalTaichungTaiwan
Taipei Veterans General HospitalTaipeiTaiwan

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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NCT03039192 on ClinicalTrials.gov →

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

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Where this trial sits