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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 DispanseryBulgaria-Bulgaria
Mental Health Center Prof. Dr. Ivan TemkovBurgas-Bulgaria
State Psychiatric Hospital - LovechLovech-Bulgaria
UMHAT 'Sveti Georgi'-PlovdivPlovdiv-Bulgaria
Military Medical Academy Multiprofile Hospital for Active Treatment SofiaSofia-Bulgaria
North Estonian Medical Centre FoundationTallinn-Estonia
Tartu University HospitalTartu-Estonia
Vivantes Humboldt KlinikumBerlin-Germany
Universitatsklinikum FrankfurtFrankfurt am Main-Germany
Klinik für Psychiatrie und PsychotherapieFreiburg im Breisgau-Germany
Eszak Kozep budai Centrum Uj Szent Janos Korhaz es Szakrendelo Budai CsaladkozpontuBudapest-Hungary
Semmelweis Egyetem Kútvölgyi Klinikai TömbBudapest-Hungary
Nyiro Gyula KorhazBudapest-Hungary
Petz Aladar Megyei Oktato KorhazGyőr-Hungary
Pecsi Tudomanyegyetem Klinikai KozpontPécs-Hungary
University Kebangsaan Malaysia Medical CentreCheras-Malaysia
Hospital Kuala LumpurKuala Lumpur-Malaysia
University Malaya Medical CentreKuala Lumpur-Malaysia
Hospital Tuanku JaafarSeremban-Malaysia
Fakultna nemocnica s poliklinikou v ZilineŽilina-Slovakia
Flexivest 14 ResearchCape Town-South Africa
Juan Schrönen - Western Cape South AfricaWelgemoed-South Africa
Chonnam National University HospitalGwangju-South Korea
Korea University Ansan HospitalGyeonggi-do-South Korea
Kyung Hee University Medical CenterSeoul-South Korea
Samsung Medical CenterSeoul-South Korea
Seoul National University HospitalSeoul-South Korea
Hosp. Univ. Fundacion AlcorconAlcorcón-Spain
Hosp Univ Vall D HebronBarcelona-Spain
Hosp Clinic de BarcelonaBarcelona-Spain
Inst. Internac. Neurociencias AplicadasBarcelona-Spain
Hosp. Univ. de BasurtoBilbao-Spain
Hosp. Univ. Ramon Y CajalMadrid-Spain
Clinica Univ. de NavarraPamplona-Spain
Benito Menni Comp. Asist. Salut MentalSant Boi de Llobregat-Spain
Tri-Service Genaral HospitalNeihu District-Taiwan
Taipei Medical University Shuang Ho HospitalNew Taipei City-Taiwan
Chung Shan Medical University HospitalTaichung-Taiwan
Taipei Veterans General HospitalTaipei-Taiwan

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. The registry also holds the most current version of everything above.

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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 2026-10-06.

Related

Where this trial sits