Esketamine plus standard care for adolescents with major depressive disorder and acute suicidal thoughts or behavior

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3, randomized, double-blind trial compares intranasal esketamine plus comprehensive standard of care (SoC) versus a psychoactive placebo plus SoC in adolescent participants hospitalized for acute suicidal ideation or behavior. Eligible participants must meet DSM-5 criteria for major depressive disorder and high severity thresholds (CDRS-R ≥58 and CGI-SS-R ≥4) and be medically stable for participation. The psychoactive placebo arm includes an active agent to preserve blinding, and outcomes focus on rapid reduction of depressive symptoms and suicidality after dosing in the inpatient setting. The trial is conducted at multiple U.S. centers and uses standardized rating scales and clinician assessments to measure safety and efficacy.

Why it matters

Who can join: the full rules

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's running

• University of Alabama at Birmingham
  Birmingham, Alabama, United States Recruiting
• Yale Child Study Center
  New Haven, Connecticut, United States Recruiting
• Children's National Medical Center
  Washington D.C., District of Columbia, United States Recruiting
• Peachford Hospital-Atlanta Behavioral Research
  Atlanta, Georgia, United States Recruiting
• Endeavor Health Evanston Hospital
  Evanston, Illinois, United States Recruiting
• Johns Hopkins University
  Baltimore, Maryland, United States Recruiting

Study contacts

• Study coordinator: Study Contact
• Email: Participate-In-This-Study1@its.jnj.com
• Phone: 844-434-4210

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.