A Double-blind, Randomized, Psychoactive Placebo-controlled Study to Evaluate the Efficacy and Safety of Intranasal Esketamine 84 mg in Addition to Comprehensive Standard of Care for the Rapid Reduction of the Symptoms of Major Depressive Disorder in Adolescent Participants With Acute Suicidal Ideation or Behavior
Status: Recruiting
Location: See all (27) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 17
Healthy Volunteers: f
View:
• 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
Locations
United States
Alabama
University of Alabama at Birmingham
RECRUITING
Birmingham
Georgia
Peachford Hospital-Atlanta Behavioral Research
RECRUITING
Atlanta
Ohio
University of Cincinnati
RECRUITING
Cincinnati
Rhode Island
Bradley Hospital
RECRUITING
East Providence
Other Locations
Brazil
Sociedade Literaria e Caritativa Santo Agostinho Hospital Sao Jose
RECRUITING
Criciúma
Instituto Apice
RECRUITING
Salvador
Centro Integrado Facili
RECRUITING
São Bernardo Do Campo
Fundacao Faculdade de Medicina Hospital da Clinicas da Faculdade de Medicina de Sao Paulo
RECRUITING
São Paulo
Instituto de Pesquisa Pensi Sandra Mutarelli Setubal
RECRUITING
São Paulo
Hungary
Debreceni Egyetem Klinikai Kozpont
RECRUITING
Debrecen
Petz Aladar Megyei Oktato Korhaz
RECRUITING
Győr
Szegedi Tudomanyegyetem
RECRUITING
Szeged
Italy
Presidio Ospedaliero Santa Marta e Santa Venera
RECRUITING
Acireale
AOU Meyer
RECRUITING
Florence
Azienda Ospedaliera Universitaria Policlinico Riuniti di Foggia
RECRUITING
Foggia
Azienda Ospedaliera Universitaria Federico II
RECRUITING
Naples
Azienda Ospedaliero Universitaria di Sassari
RECRUITING
Sassari
Spain
Hosp. Clinic de Barcelona
RECRUITING
Barcelona
Fundacio Althaia Xarxa Assistencial Universitaria de Manresa
Participants will receive intranasal esketamine 84 milligrams (mg) along with oral placebo solution twice weekly for 4 weeks (Days 1, 4, 8, 11, 15, 18, 22, and 25). On Day 4 a decrease to intranasal esketamine 56 mg (in a blinded fashion per investigator's judgment) is permitted. Thereafter, dose may be flexed between 56 mg and 84 mg during the treatment period.
Participants will receive oral midazolam (0.0625 milligrams per kilograms \[mg/kg\]) and intranasal placebo twice weekly for 4 weeks (Days 1, 4, 8, 11, 15, 18, 22, and 25). On Day 4 a sham decrease to esketamine 56 mg dose (in a blinded fashion per investigator's judgment) is permitted. Thereafter, sham dose may be flexed between 56 mg and 84 mg during the treatment period.