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

April 25, 2025 updated by: Janssen Research & Development, LLC

A Double-blind, Randomized, Psychoactive Placebo-controlled, Study to Evaluate the Efficacy and Safety of 3 Fixed Doses (28 mg, 56 mg and 84 mg) 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 Subjects Assessed to be at Imminent Risk for Suicide

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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 8-week initial post-treatment phase (Days 25-81); and a subsequent phase to complete a full 6-month 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
147

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Expanded Access

Expanded Access

A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved by the U.S. Food and Drug Administration (FDA). Also called compassionate use. There are different expanded access types.
Approved

Approved

  • Available: Expanded access is currently available for this investigational treatment, and patients who are not participants in the clinical study may be able to gain access to the drug, biologic, or medical device being studied.
  • No longer available: Expanded access was available for this intervention previously but is not currently available and will not be available in the future.
  • Temporarily not available: Expanded access is not currently available for this intervention but is expected to be available in the future.
  • Approved for marketing: The intervention has been approved by the U.S. Food and Drug Administration for use by the public.
 for sale to the public. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1070
        • Hopital Erasme
  • Brazil
      • Curitiba, Brazil, 80240-280
        • Trial Tech Tecnologia em Pesquisas com Medicamentos
      • Salvador, Brazil, 40110-060
        • Hospital Universitario Professor Edgar Santos
      • Sao Bernardo do Campo, Brazil, 09715-090
        • CEMEC - Centro Multidisciplinar de Estudos Clínicos
      • Turvo, Brazil, 88930-000
        • Hospital São Sebastião
  • Bulgaria
      • Ruse, Bulgaria, 7003
        • Mental Health Center - Rousse
      • Varna, Bulgaria
        • Multiprofile Hospital for Active Treatment - MHAT Sveta Marina EAD
  • France
      • Bron, France, 69677
        • Hospices Civils de Lyon HCL
      • Lille, France, 59000
        • CHRU Lille - Hôpital Fontan 1
      • Nantes, France, 44093
        • CHU Nantes
      • Paris, France, 75019
        • Hôpital Robert Debré
      • Paris, France, 75013
        • Hôpital Universitaire Pitié-Salpêtrière
      • Paris, France, 75014
        • Hopital Sainte Anne
  • Hungary
      • Budapest, Hungary
        • Vadaskert Gyermek es Ifjusagpszichiatriai Korhaz es Szakambulancia
      • Szeged, Hungary
        • Szegedi Tudomanyegyetem
  • Italy
      • Cagliari, Italy, 09134
        • Azienda Ospedaliera G. Brotzu
      • Foggia, Italy, 71122
        • OSP RIUNITI-DIP Donna- Bambino
      • Merano, Italy, 39012
        • Ospedale di Merano
      • Messina, Italy, 98125
        • Azienda Ospedaliera Universitaria Policlinico G. Martino
      • Napoli, Italy, 80138
        • Azienda Ospedaliera Universitaria Federico II
      • Pavia, Italy, 27100
        • IRCCS C. Mondino, Istituto Neurologico Nazionale, Fondazione
      • Trieste, Italy, 34137
        • Irccs Burlo-Garofalo
  • Poland
      • Krakow, Poland, 31-501
        • Klinika Psychiatrii Dzieci i Mlodziezy, CM UJ
      • Warszawa, Poland, 02-957
        • Instytut Psychiatrii i Neurologii Klinika Psychiatrii Dzieci i Mlodziezy
      • Warszawa, Poland, 02 091
        • Dzieciecy Szpital Kliniczny im Jozefa Polikarpa Brudzinskiego
  • Spain
      • Barcelona, Spain, 08036
        • Hosp Clinic de Barcelona
      • Esplugues de Llobregat, Spain, 08950
        • Hosp. Sant Joan de Deu
      • Madrid, Spain, 28007
        • Hosp. Gral. Univ. Gregorio Maranon
      • Madrid, Spain, 28009
        • Hosp. Infantil Univ. Nino Jesus
      • Majadahonda, Spain, 28222
        • Hosp. Univ. Pta. de Hierro Majadahonda
      • Oviedo, Spain, 33011
        • Hosp. Univ. Central de Asturias
      • Pamplona, Spain, 31008
        • Clinica Univ. de Navarra
      • Sabadell, Spain, 08208
        • Corporacio Sanitari Parc Tauli
  • United States
    • Connecticut
      • Hartford, Connecticut, United States, 06106
        • Institute of Living/ Hartford Hospital
      • New Haven, Connecticut, United States, 06520
        • Yale University
    • Georgia
      • Atlanta, Georgia, United States, 30338
        • Atlanta Behavioral Research, LLC
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Winfield, Illinois, United States, 60190
        • Neuroscience Research Institute
    • Indiana
      • South Bend, Indiana, United States, 46617
        • Beacon Medical Group Clinical Research
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa, Carver College of Medicine
    • Louisiana
      • Lake Charles, Louisiana, United States, 70629
        • Lake Charles Clinical Trials
    • Maryland
      • Baltimore, Maryland, United States, 21204
        • Sheppard Pratt Health System
      • Gaithersburg, Maryland, United States, 20877
        • CBH Health
    • New York
      • Buffalo, New York, United States, 14215
        • State University of New York at Buffalo
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University North Carolina at Chapel Hill
      • Winston-Salem, North Carolina, United States, 27103
        • Wake Forest Baptist Medical Center
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • University of Cincinnati Hospital
      • Cleveland, Ohio, United States, 44106
        • University Hospital of Cleveland
      • Columbus, Ohio, United States, 43210
        • Ohio State University
    • Tennessee
      • Nashville, Tennessee, United States, 37212
        • Vanderbilt University Medical Center
    • Texas
      • Dallas, Texas, United States, 75390-9063
        • University of Texas Southwestern Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

9 years to 17 years (Child)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Oral Midazolam + Intranasal Placebo
Participants will receive midazolam solution 0.125 milligram per kilogram (mg/kg) orally 2 times per week for 4 weeks and 3 intranasal doses of matched placebo to esketamine.
Drug: Intranasal Placebo
Participants will receive placebo as intranasal dose to match intranasal esketamine.
Drug: Midazolam
Participants will receive midazolam solution 0.125 mg/kg as oral dose to match placebo.
Experimental: Oral Placebo + Esketamine 84 mg
Participants will receive intranasal esketamine 84 mg as 3 intranasal doses of esketamine in each nostril (each dose contains 14 mg of esketamine) along with oral placebo 2 times per week for 4 weeks.
Drug: Midazolam Placebo Solution
Participants will receive placebo as oral dose to match midazolam drug.
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.
Experimental: Oral Placebo + Esketamine 56 mg
Participants will receive intranasal esketamine 56 mg as 2 intranasal doses of esketamine in each nostril (each dose contains 14 mg of esketamine) along with oral placebo 2 times per week for 4 weeks.
Drug: Midazolam Placebo Solution
Participants will receive placebo as oral dose to match midazolam drug.
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.
Experimental: Oral Placebo + Esketamine 28 mg
Participants will receive intranasal esketamine 28 mg as 1 intranasal doses of esketamine in each nostril (each dose contains 14 mg of esketamine) along with oral placebo 2 times per week for 4 weeks.
Drug: Midazolam Placebo Solution
Participants will receive placebo as oral dose to match midazolam drug.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at 24 Hours Post First Dose (Day 2)
Time Frame: Baseline (predose on Day 1) and 24 hours post first dose on Day 1 (i.e., Day 2)
The CDRS-R is a validated 17- item, clinician-rated instrument developed to assess depressive symptomatology in children. Scores were based on interviews with both the child and their caregiver. Of the 17-item, 3 items were non-verbal behavior (listless speech, hypoactivity, and depressed affect) rated on a 5-point scale from 1 (no depression) to 5 (severe depression) and 14 items were rated on a 7-point scale from 1 (no depression) to 7 (severe depression), where higher score indicated more severe depression. The CDRS-R total score was the sum of the 17-tems score and it ranged from 17 (normal) to 113 (severe depression). Higher score indicated more severe depression and worse outcome.
Baseline (predose on Day 1) and 24 hours post first dose on Day 1 (i.e., Day 2)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen Research & Development, LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 5, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 12, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 12, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 14, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 29, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR108323
  • 2016-004422-42 (EudraCT Number)
  • ESKETINSUI2002 (Other Identifier: Janssen Research & Development, LLC)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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