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CompletedPhase 2Results posted

Study to Evaluate the Efficacy and Safety of 3 Fixed Doses 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 Pediatric Participants Assessed to be at Imminent Risk for Suicide

NCT03185819 · Janssen Research & Development, LLC

Closed to entry
Status
Not accepting participants
Phase 2
Phase
147
Target enrolment
51
Study sites
12 US states

What it is testing

Summary

The purpose of this study is to assess the efficacy of a single (first) dose of 3 fixed doses of intranasal esketamine {28 milligram (mg), 56 mg, and 84 mg} compared with psychoactive placebo (oral midazolam) in rapidly reducing the symptoms of major depressive disorder (MDD) including suicidal ideation in participants 12 to less than 18 years of age who are assessed to be at imminent risk for suicide.

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 Children's Depression Rating Scale-Revised (CDRS-R) Total Score at 24 Hours Post First Dose (Day 2)

    Measured over Baseline (predose on Day 1) and 24 hours post first dose on Day 1 (i.e., 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

9 Years to 17 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: * Participants 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 neuropsychiatric interview for children and adolescents (MINI KID) * Participant must have a children's depression rating scale-revised (CDRS-R) total score of equal or more than (\>=) 58 predose on Day 1 * As part of standard of care treatment, participant must agree 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) * As part of the newly initiated or optimized standard of care treatment, participant must agree to take one of the prescribed non-investigational antidepressant medications (fluoxetine, escitalopram, sertraline; and 9-11 years old participants at US-sites only: fluoxetin \[preferred\], sertraline) at least during the double-blind treatment phase (Day 25) * As part of standard of care treatment, participant must agree to participate in a specific psychological intervention (individual cognitive behavioral therapy \[CBT\], interpersonal therapy, family therapy or psychodynamic psychotherapy) at least through the initial 8-week post-treatment follow-up period (Day 81) Exclusion Criteria: * Participants has a current DSM-5 diagnosis of bipolar (or related disorders), intellectual disability, autism spectrum disorder, conduct disorder, anorexia nervosa, oppositional defiant disorder, or obsessive compulsive disorder * Participants currently meets DSM-5 criteria for borderline personality disorder. Participants 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 or prior DSM-5 diagnosis of a psychotic disorder or MDD with psychosis * 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 * Participant has a history of seizure disorder

Where

51 study sites

FacilityCityRegionCountry
Institute of Living/ Hartford HospitalHartfordConnecticutUnited States
Yale UniversityNew HavenConnecticutUnited States
Atlanta Behavioral Research, LLCAtlantaGeorgiaUnited States
Rush University Medical CenterChicagoIllinoisUnited States
Neuroscience Research InstituteWinfieldIllinoisUnited States
Beacon Medical Group Clinical ResearchSouth BendIndianaUnited States
University of Iowa, Carver College of MedicineIowa CityIowaUnited States
Lake Charles Clinical TrialsLake CharlesLouisianaUnited States
Sheppard Pratt Health SystemBaltimoreMarylandUnited States
CBH HealthGaithersburgMarylandUnited States
State University of New York at BuffaloBuffaloNew YorkUnited States
University North Carolina at Chapel HillChapel HillNorth CarolinaUnited States
Wake Forest Baptist Medical CenterWinston-SalemNorth CarolinaUnited States
University of Cincinnati HospitalCincinnatiOhioUnited States
University Hospital of ClevelandClevelandOhioUnited States
Ohio State UniversityColumbusOhioUnited States
Vanderbilt University Medical CenterNashvilleTennesseeUnited States
University of Texas Southwestern Medical CenterDallasTexasUnited States
Hopital ErasmeBrusselsBelgium
Trial Tech Tecnologia em Pesquisas com MedicamentosCuritibaBrazil
Hospital Universitario Professor Edgar SantosSalvadorBrazil
CEMEC - Centro Multidisciplinar de Estudos ClínicosSão Bernardo do CampoBrazil
Hospital São SebastiãoTurvoBrazil
Mental Health Center - RousseRousseBulgaria
Multiprofile Hospital for Active Treatment - MHAT Sveta Marina EADVarnaBulgaria
Hospices Civils de Lyon HCLBronFrance
CHRU Lille - Hôpital Fontan 1LilleFrance
CHU NantesNantesFrance
Hôpital Universitaire Pitié-SalpêtrièreParisFrance
Hopital Sainte AnneParisFrance
Hôpital Robert DebréParisFrance
Vadaskert Gyermek es Ifjusagpszichiatriai Korhaz es SzakambulanciaBudapestHungary
Szegedi TudomanyegyetemSzegedHungary
Azienda Ospedaliera G. BrotzuCagliariItaly
OSP RIUNITI-DIP Donna- BambinoFoggiaItaly
Ospedale di MeranoMeranoItaly
Azienda Ospedaliera Universitaria Policlinico G. MartinoMessinaItaly
Azienda Ospedaliera Universitaria Federico IINaplesItaly
IRCCS C. Mondino, Istituto Neurologico Nazionale, FondazionePaviaItaly
Irccs Burlo-GarofaloTriesteItaly
Klinika Psychiatrii Dzieci i Mlodziezy, CM UJKrakowPoland
Dzieciecy Szpital Kliniczny im Jozefa Polikarpa BrudzinskiegoWarsawPoland
Instytut Psychiatrii i Neurologii Klinika Psychiatrii Dzieci i MlodziezyWarsawPoland
Hosp Clinic de BarcelonaBarcelonaSpain
Hosp. Sant Joan de DeuEsplugues de LlobregatSpain
Hosp. Gral. Univ. Gregorio MaranonMadridSpain
Hosp. Infantil Univ. Nino JesusMadridSpain
Hosp. Univ. Pta. de Hierro MajadahondaMajadahondaSpain
Hosp. Univ. Central de AsturiasOviedoSpain
Clinica Univ. de NavarraPamplonaSpain
Corporacio Sanitari Parc TauliSabadellSpain

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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NCT03185819 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