A Study to Evaluate the Efficacy and Safety of Esketamine for Reduction of Symptoms of Major Depressive Disorder
Recruiting · NCT07227454 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
The purpose of this study is to evaluate how well JNJ-54135419 works (efficacy) in addition to comprehensive standard of care (SoC) in rapidly reducing the symptoms of major depressive disorder (MDD, a mental disorder characterized by a persistent feeling of sadness and loss of interest in activities) as compared with psychoactive placebo (does not contain JNJ-54135419) plus SoC in adolescent participants with acute suicidal ideation or behavior.
Who can take part
Age range
12 Years to 17 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Must meet diagnostic and statistical manual of mental disorders (5th edition) (DSM-5) diagnostic criteria for major depressive disorder (MDD) based upon clinical assessment and confirmed by the mini-international neuropsychiatric interview for children and adolescents (MINI-KID)
- Must have a clinical global impression - severity of suicidality - revised (CGI-SS-R) score of "Markedly" or greater (that is, greater than or equal to \[\>=\] 4) at both screening and baseline (predose) visits
- Must have a children's depression rating scale - revised (CDRS-R) total score \>= 58 at baseline (predose)
- In the physician's opinion, acute psychiatric hospitalization is clinically warranted due to subject's acute suicidality
- Must be medically stable based on physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening
Exclusion criteria
- Participant has a current DSM-5 diagnosis of bipolar (or related disorders), intellectual disability, autism spectrum disorder, conduct disorder, oppositional defiant disorder
- Participant currently meets DSM-5 criteria for borderline personality disorder
- Participant has a current or prior DSM-5 diagnosis of a psychotic disorder, or MDD with psychosis
- Participant has a history of seizure disorder
- Participant has known allergies, hypersensitivity, intolerance or contraindications to midazolam, esketamine or ketamine, or their excipients
Where it is running
39 locations listed across 10 US states.
- University of Alabama at Birmingham - Birmingham, Alabama, United States
- Children's National Medical Center - Washington D.C., District of Columbia, United States
- Peachford Hospital-Atlanta Behavioral Research - Atlanta, Georgia, United States
- Endeavor Health Evanston Hospital - Evanston, Illinois, United States
- Johns Hopkins University - Baltimore, Maryland, United States
- Boston Childrens Hospital - Boston, Massachusetts, United States
- Mayo Clinic - Rochester, Minnesota, United States
- University of Cincinnati - Cincinnati, Ohio, United States
- Bradley Hospital - East Providence, Rhode Island, United States
- John S Dunn Behavioral Sciences Center at UTHealth Houston - Houston, Texas, United States
- Presidio Ospedaliero Santa Marta e Santa Venera - Acireale, Italy
- Hosp Univ Vall D Hebron - Barcelona, Spain
- Hosp. Clinic de Barcelona - Barcelona, Spain
- Azienda Ospedaliera G. Brotzu - Cagliari, Italy
- Spitalul Clinic de Urgenta pentru Copii Cluj Napoca - Cluj-Napoca, Romania
- Sociedade Literaria e Caritativa Santo Agostinho Hospital Sao Jose - Criciúma, Brazil
- Debreceni Egyetem Klinikai Kozpont - Debrecen, Hungary
- Hosp. Sant Joan de Deu - Esplugues de Llobregat, Spain
- AOU Meyer - Florence, Italy
- Azienda Ospedaliera Universitaria Policlinico Riuniti di Foggia - Foggia, Italy
- Petz Aladar Megyei Oktato Korhaz - Győr, Hungary
- Hosp. Gral. Univ. Gregorio Maranon - Madrid, Spain
- Fundacio Althaia Xarxa Assistencial Universitaria de Manresa - Manresa, Spain
- Azienda Ospedaliera Universitaria Federico II - Naples, Italy
- Universidade Federal do Rio Grande do Norte Hospital Universitario Onofre Lopes - Natal, Brazil
- Mackay Memorial Hospital Tamsui Branch - New Taipei City, Taiwan
- Hosp. Univ. Central de Asturias - Oviedo, Spain
- Clinica Univ. de Navarra - Pamplona, Spain
- Hosp.Univ.Parc Tauli - Sabadell, Spain
- Instituto Apice - Salvador, Brazil
- Azienda Ospedaliero Universitaria di Sassari - Sassari, Italy
- Szegedi Tudomanyegyetem - Szeged, Hungary
- Centro Integrado Facili - São Bernardo do Campo, Brazil
- Instituto de Pesquisa Pensi Sandra Mutarelli Setubal - São Paulo, Brazil
- Hospital Das Clinicas Da Faculdade De Medicina Da USP - São Paulo, Brazil
- National Taiwan University Hospital - Taipei, Taiwan
- Taipei Medical University Hospital - Taipei, Taiwan
- Taipei Veterans General Hospital - Taipei, Taiwan
- Tri-Service General Hospital - Taipei, Taiwan