Last updated on March 2019

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


Brief description of study

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.

Detailed Study Description

This study will enroll participants with major depressive disorder (MDD) presenting with suicidal ideation who are assessed to be at imminent risk for suicide. The study will be conducted in 4 phases: a screening evaluation performed within 48 hours prior to Day 1 intranasal dose; a 25-day double-blind treatment phase (Days 1-25); an 8week initial post-treatment phase (Days 25-81); and a subsequent phase to complete a full 6month post-treatment follow-up (Days 81-200). Efficacy, safety, pharmacokinetic, biomarker, and pharmacogenomic evaluations will be performed in the study at defined schedule. The duration of the participant's participation will be approximately 29 weeks. If you or a loved one are having thoughts of suicide, please seek immediate medical help. Go to the emergency room or call the National Suicide Prevention Lifeline at 1-800-273-8255.

Clinical Study Identifier: NCT03185819

Contact Investigators or Research Sites near you

Start Over

Study Contact

University of California, San Francisco
San Francisco, CA United States
  Connect »

Study Contact

Institute of Living/ Hartford Hospital
Hartford, CT United States
  Connect »

Study Contact

Yale University
New Haven, CT United States
  Connect »

Study Contact

Atlanta Center for Medical Research
Atlanta, GA United States
  Connect »

Study Contact

Rush University Medical Center
Chicago, IL United States
  Connect »

Study Contact

SIU School of Medicine
Springfield, IL United States
  Connect »

Study Contact

University of Iowa, Carver College of Medicine
Iowa City, IA United States
  Connect »

Study Contact

Lake Charles Clinical Trials
Lake Charles, LA United States
  Connect »

Study Contact

Sheppard Pratt Health System
Baltimore, MD United States
  Connect »

Study Contact

Johns Hopkins Hospital, Child and Adolescent Psychiatry
Baltimore, MD United States
  Connect »

Study Contact

State University of New York at Buffalo
Buffalo, NY United States
  Connect »

Study Contact

Columbia University Medical Center
New York, NY United States
  Connect »

Study Contact

University North Carolina at Chapel Hill
Chapel Hill, NC United States
  Connect »

Study Contact

Wake Forest Baptist Medical Center
Winston-Salem, NC United States
  Connect »

Study Contact

University of Cincinnati Hospital
Cincinnati, OH United States
  Connect »

Study Contact

University Hospital of Cleveland
Cleveland, OH United States
  Connect »

Study Contact

Ohio State University
Columbus, OH United States
  Connect »

Study Contact

University of Texas Southwestern Medical Center
Dallas, TX United States
  Connect »

Study Contact

Hopital Erasme
Brussels, Belgium
  Connect »

Study Contact

Hospital Infantil Pequeno Pr ncipe - Associa o Hospitalar de Prote o Inf ncia Dr. Raul Car
Curitiba, Brazil
  Connect »

Study Contact

Bioserv SMO - HSVP ( Hospital S o Vicente de Paulo)
Passo Fundo, Brazil
  Connect »

Study Contact

Hospital de Cl nicas de Porto Alegre/ HCPA / UFRGS
Porto Alegre, Brazil
  Connect »

Study Contact

Mental Health Center - Rousse
Rousse, Bulgaria
  Connect »

Study Contact

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

Study Contact

H pital Universitaire Piti -Salp tri re
Paris, France
  Connect »

Study Contact

H pital Robert Debr
Paris, France
  Connect »

Study Contact

CHU Saint-etienne
Saint-Priest-En-Jarez, France
  Connect »

Study Contact

Vadaskert Gyermek- s Ifj s gpszichi triai K rh z s Szakambulancia
Budapest, Hungary
  Connect »

Study Contact

Szegedi Tudomanyegyetem
Szeged, Hungary
  Connect »

Study Contact

Klinika Psychiatrii Dzieci i Mlodziezy, CM UJ
Krakow, Poland
  Connect »

Study Contact

Wojew dzki Szpital Specjalistyczny im. J. Gromkowskiego, Oddzia Psychiatryczny Dzieci i M odzie
Wroclaw, Poland
  Connect »

Study Contact

Hosp. Clinic I Provincial de Barcelona
Barcelona, Spain
  Connect »

Study Contact

Hosp. Gral. Univ. Gregorio Maranon
Madrid, Spain
  Connect »

Study Contact

Clinica Univ. de Navarra
Pamplona, Spain
  Connect »

Study Contact

Tennessee State University
Johnson City, TN United States
  Connect »

Study Contact

Vanderbilt University Medical Center
Nashville, TN United States
  Connect »

Study Contact

Azienda Ospedaliera G. Brotzu
Cagliari, Italy
  Connect »

Study Contact

Ospedale di Merano
Merano, Italy
  Connect »

Study Contact

Azienda Ospedaliera Universitaria Policlinico G. Martino
Messina, Italy
  Connect »

Study Contact

Azienda Ospedaliera Universitaria Federico II
Napoli, Italy
  Connect »

Study Contact

IRCCS C. Mondino, Istituto Neurologico Nazionale, Fondazione
Pavia, Italy
  Connect »

Study Contact

Ospedale Pediatrico Bambin Ges
Roma, Italy
  Connect »

Study Contact

CHU Nantes
Nantes, France
  Connect »

Study Contact

Hosp. Infantil Univ. Ni o Jesus
Madrid, Spain
  Connect »

Study Contact

Corporacio Sanitari Parc Tauli
Sabadell, Spain
  Connect »

Study Contact

Hosp. Sant Joan de Deu
Esplugues De Llobregat, Spain
  Connect »

Study Contact

Riley Hospital for Children at Indiana University Health
Indianapolis, IN United States
  Connect »

Study Contact

Hospital Universitario Professor Edgar Santos
Bahia, Brazil
  Connect »

Study Contact

Hospices Civils de Lyon HCL
Bron, France
  Connect »

Study Contact

Hospital S o Sebasti o
Turvo, Brazil
  Connect »

Study Contact

OSP RIUNITI-DIP Donna- Bambino
Foggia, Italy
  Connect »

Study Contact

Irccs Burlo-Garofalo
Trieste, Italy
  Connect »

Study Contact

Trial Tech Tecnologia em Pesquisas com Medicamentos
Curitiba, Brazil
  Connect »

Study Contact

Hospital Estadual Mario covas
Santo André, Brazil
  Connect »

Study Contact

Hosp. Univ. Fundacion Alcorcon
Alcorcón, Spain
  Connect »

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


Receive Emails About New Clinical Trials!

Sign up for our FREE service to receive email notifications when clinical trials are posted in the medical category of interest to you.