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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03185819
Other study ID # CR108323
Secondary ID 2016-004422-42ES
Status Completed
Phase Phase 2
First received
Last updated
Start date October 5, 2017
Est. completion date March 31, 2023

Study information

Verified date May 2023
Source Janssen Research & Development, LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 147
Est. completion date March 31, 2023
Est. primary completion date March 31, 2023
Accepts healthy volunteers No
Gender All
Age group 9 Years to 17 Years
Eligibility 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 Design


Intervention

Drug:
Intranasal Placebo
Participants will receive placebo as intranasal dose to match intranasal esketamine.
Midazolam Placebo Solution
Participants will receive placebo as oral dose to match midazolam drug.
Midazolam
Participants will receive midazolam solution 0.125 mg/kg as oral dose to match placebo.
Esketamine
Participants will receive esketamine at a dose of 28 mg as intranasal solution.
Esketamine
Participants will receive esketamine at a dose of 56 mg as intranasal solution.
Esketamine
Participants will receive esketamine at a dose of 84 mg as intranasal solution.

Locations

Country Name City State
Belgium Hopital Erasme Brussels
Brazil Hospital Universitario Professor Edgar Santos Bahia
Brazil Trial Tech Tecnologia em Pesquisas com Medicamentos Curitiba
Brazil CEMEC - Centro Multidisciplinar de Estudos Clínicos São Bernardo do Campo
Brazil Hospital São Sebastião Turvo
Bulgaria Mental Health Center - Rousse Ruse
Bulgaria Multiprofile Hospital for Active Treatment - MHAT Sveta Marina EAD Varna
France Hospices Civils de Lyon HCL Bron
France CHRU Lille - Hôpital Fontan 1 Lille
France CHU Nantes Nantes
France Hôpital Robert Debré Paris
France Hopital Sainte Anne Paris
France Hôpital Universitaire Pitié-Salpêtrière Paris
Hungary Vadaskert Gyermek- és Ifjúságpszichiátriai Kórház és Szakambulancia Budapest
Hungary Szegedi Tudomanyegyetem Szeged
Italy Azienda Ospedaliera G. Brotzu Cagliari
Italy OSP RIUNITI-DIP Donna- Bambino Foggia
Italy Ospedale di Merano Merano
Italy Azienda Ospedaliera Universitaria Policlinico G. Martino Messina
Italy Azienda Ospedaliera Universitaria Federico II Napoli
Italy IRCCS C. Mondino, Istituto Neurologico Nazionale, Fondazione Pavia
Italy Irccs Burlo-Garofalo Trieste
Poland Klinika Psychiatrii Dzieci i Mlodziezy, CM UJ Krakow
Poland Dzieciecy Szpital Kliniczny im. Jozefa Polikarpa Brudzinskiego Warszawa
Poland Instytut Psychiatrii i Neurologii Klinika Psychiatrii Dzieci i Mlodziezy Warszawa
Spain Hosp. Clinic I Provincial de Barcelona Barcelona
Spain Hosp. Sant Joan de Deu Esplugues de Llobregat
Spain Hosp. Gral. Univ. Gregorio Marañon Madrid
Spain Hosp. Infantil Univ. Niño Jesus Madrid
Spain Hosp. Univ. Pta. de Hierro Majadahonda Majadahonda
Spain Hosp. Univ. Central de Asturias Oviedo
Spain Clinica Univ. de Navarra Pamplona
Spain Corporacio Sanitari Parc Tauli Sabadell
United States Atlanta Behavioral Research, LLC Atlanta Georgia
United States Sheppard Pratt Health System Baltimore Maryland
United States State University of New York at Buffalo Buffalo New York
United States University North Carolina at Chapel Hill Chapel Hill North Carolina
United States Rush University Medical Center Chicago Illinois
United States University of Cincinnati Hospital Cincinnati Ohio
United States University Hospital of Cleveland Cleveland Ohio
United States Ohio State University Columbus Ohio
United States University of Texas Southwestern Medical Center Dallas Texas
United States CBH Health Gaithersburg Maryland
United States Institute of Living/ Hartford Hospital Hartford Connecticut
United States University of Iowa, Carver College of Medicine Iowa City Iowa
United States Lake Charles Clinical Trials Lake Charles Louisiana
United States Vanderbilt University Medical Center Nashville Tennessee
United States Yale University New Haven Connecticut
United States Beacon Medical Group Clinical Research South Bend Indiana
United States Neuroscience Research Institute Winfield Illinois
United States Wake Forest Baptist Medical Center Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Janssen Research & Development, LLC

Countries where clinical trial is conducted

United States,  Belgium,  Brazil,  Bulgaria,  France,  Hungary,  Italy,  Poland,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change From Baseline in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at 24 Hours Post First Dose The CDRS-R has been widely used for the evaluation of children and adolescents with major depressive disorder (MDD). The CDRS-R total score is the sum of the responses to 17 questions. Each question is graded on a 5- or 7-point scale. The highest possible score is 113 (the most severe measure of depression), and the lowest is 17 (not suffering from depression). Baseline and 24 hours post-administration of first dose on Day 1
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