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

PHASE2CompletedINTERVENTIONAL
Enrollment

147

Participants

Timeline

Start Date

October 5, 2017

Primary Completion Date

March 31, 2023

Study Completion Date

March 31, 2023

Conditions
Depressive Disorder, Major
Interventions
DRUG

Intranasal Placebo

Participants will receive placebo as intranasal dose to match intranasal esketamine.

DRUG

Midazolam Placebo Solution

Participants will receive placebo as oral dose to match midazolam drug.

DRUG

Midazolam

Participants will receive midazolam solution 0.125 mg/kg as oral dose to match placebo.

DRUG

Esketamine

Participants will receive esketamine at a dose of 28 mg as intranasal solution.

DRUG

Esketamine

Participants will receive esketamine at a dose of 56 mg as intranasal solution.

DRUG

Esketamine

Participants will receive esketamine at a dose of 84 mg as intranasal solution.

Trial Locations (51)

1070

Hopital Erasme, Brussels

7003

Mental Health Center - Rousse, Rousse

14215

State University of New York at Buffalo, Buffalo

20877

CBH Health, Gaithersburg

21204

Sheppard Pratt Health System, Baltimore

27100

IRCCS C. Mondino, Istituto Neurologico Nazionale, Fondazione, Pavia

27103

Wake Forest Baptist Medical Center, Winston-Salem

27599

University North Carolina at Chapel Hill, Chapel Hill

28007

Hosp. Gral. Univ. Gregorio Maranon, Madrid

28009

Hosp. Infantil Univ. Nino Jesus, Madrid

28222

Hosp. Univ. Pta. de Hierro Majadahonda, Majadahonda

30338

Atlanta Behavioral Research, LLC, Atlanta

31008

Clinica Univ. de Navarra, Pamplona

33011

Hosp. Univ. Central de Asturias, Oviedo

34137

Irccs Burlo-Garofalo, Trieste

37212

Vanderbilt University Medical Center, Nashville

39012

Ospedale di Merano, Merano

43210

Ohio State University, Columbus

44093

CHU Nantes, Nantes

44106

University Hospital of Cleveland, Cleveland

45219

University of Cincinnati Hospital, Cincinnati

46617

Beacon Medical Group Clinical Research, South Bend

52242

University of Iowa, Carver College of Medicine, Iowa City

59000

CHRU Lille - Hôpital Fontan 1, Lille

60190

Neuroscience Research Institute, Winfield

60612

Rush University Medical Center, Chicago

69677

Hospices Civils de Lyon HCL, Bron

70629

Lake Charles Clinical Trials, Lake Charles

71122

OSP RIUNITI-DIP Donna- Bambino, Foggia

75013

Hôpital Universitaire Pitié-Salpêtrière, Paris

75014

Hopital Sainte Anne, Paris

75019

Hôpital Robert Debré, Paris

80138

Azienda Ospedaliera Universitaria Federico II, Napoli

98125

Azienda Ospedaliera Universitaria Policlinico G. Martino, Messina

06106

Institute of Living/ Hartford Hospital, Hartford

06520

Yale University, New Haven

75390-9063

University of Texas Southwestern Medical Center, Dallas

80240-280

Trial Tech Tecnologia em Pesquisas com Medicamentos, Curitiba

40110-060

Hospital Universitario Professor Edgar Santos, Salvador

09715-090

CEMEC - Centro Multidisciplinar de Estudos Clínicos, São Bernardo do Campo

88930-000

Hospital São Sebastião, Turvo

Unknown

Multiprofile Hospital for Active Treatment - MHAT Sveta Marina EAD, Varna

Vadaskert Gyermek es Ifjusagpszichiatriai Korhaz es Szakambulancia, Budapest

Szegedi Tudomanyegyetem, Szeged

09134

Azienda Ospedaliera G. Brotzu, Cagliari

31-501

Klinika Psychiatrii Dzieci i Mlodziezy, CM UJ, Krakow

02 091

Dzieciecy Szpital Kliniczny im Jozefa Polikarpa Brudzinskiego, Warsaw

02-957

Instytut Psychiatrii i Neurologii Klinika Psychiatrii Dzieci i Mlodziezy, Warsaw

08036

Hosp Clinic de Barcelona, Barcelona

08950

Hosp. Sant Joan de Deu, Esplugues de Llobregat

08208

Corporacio Sanitari Parc Tauli, Sabadell

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY

NCT03185819 - 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 | Biotech Hunter | Biotech Hunter