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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age12-17
SponsorJanssen Research & Development, LLC

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Esketamine
  • Midazolam
  • Oral Placebo
  • Intranasal Placebo

Treatment groups

258 Participants
are divided into 2 treatment groups