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A Study to Evaluate the Efficacy and Safety of Esketamine for Reduction of Symptoms of Major Depressive Disorder
A Study to Evaluate the Efficacy and Safety of Esketamine for Reduction of Symptoms of Major Depressive Disorder

NCT07227454

RecruitingPhase 3

Sponsor: Janssen Research & Development, LLC

Conditions: Depressive Disorder, Major

Interventions: Esketamine, Midazolam, Oral Placebo, Intranasal Placebo

Countries: United States, Brazil, Hungary, Italy, Romania, Spain, Taiwan

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 overview

Sex: ALL

Age: 12 Years to 17 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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
Locations (35)
  • Birmingham, Alabama, United States
  • Washington D.C., District of Columbia, United States
  • Atlanta, Georgia, United States
  • Evanston, Illinois, United States
  • Rochester, Minnesota, United States
  • Cincinnati, Ohio, United States
  • East Providence, Rhode Island, United States
  • Houston, Texas, United States
  • Criciúma, Brazil
  • Salvador, Brazil
  • São Bernardo do Campo, Brazil
  • São Paulo, Brazil
  • São Paulo, Brazil
  • Debrecen, Hungary
  • Győr, Hungary
  • Szeged, Hungary
  • Acireale, Italy
  • Cagliari, Italy
  • Florence, Italy
  • Foggia, Italy
  • Naples, Italy
  • Sassari, Italy
  • Cluj-Napoca, Romania
  • Barcelona, Spain
  • Barcelona, Spain
  • Esplugues de Llobregat, Spain
  • Manresa, Spain
  • Oviedo, Spain
  • Pamplona, Spain
  • Sabadell, Spain
  • + 5 more on CT.gov