Study to Evaluate the Efficacy and Safety of 3 Fixed Doses of Intranasal Esketamine in Addition to Comprehensive Standard of Care for the Rapid Reduction of the Symptoms of Major Depressive Disorder, Including Suicidal Ideation, in Pediatric Participants Assessed to be at Imminent Risk for Suicide

Completed · Phase 2 · Has a placebo group

Conditions studied: Depressive Disorder, Major

In brief

The purpose of this study is to assess the efficacy of a single (first) dose of 3 fixed doses of intranasal esketamine {28 milligram (mg), 56 mg, and 84 mg} compared with psychoactive placebo (oral midazolam) in rapidly reducing the symptoms of major depressive disorder (MDD) including suicidal ideation in participants 12 to less than 18 years of age who are assessed to be at imminent risk for suicide.

Key facts

Study ID

NCT03185819

Run by

Janssen Research & Development, LLC

People needed

147

Starts

2017-10-05

Expected to finish

2023-03-31

Last updated by the study team

2025-04-29

Who can join

Age: 9 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants must meet diagnostic and statistical manual of mental disorders (5th edition) {DSM-5} diagnostic criteria for major depressive disorder (MDD), without psychotic features, based upon clinical assessment and confirmed by the mini international neuropsychiatric interview for children and adolescents (MINI KID)
• Participant must have a children's depression rating scale-revised (CDRS-R) total score of equal or more than (>=) 58 predose on Day 1
• As part of standard of care treatment, participant must agree to be hospitalized voluntarily for a recommended period of 5 days after randomization (may be shorter or longer if clinically warranted in the investigator's opinion)
• As part of the newly initiated or optimized standard of care treatment, participant must agree to take one of the prescribed non-investigational antidepressant medications (fluoxetine, escitalopram, sertraline; and 9-11 years old participants at US-sites only: fluoxetin [preferred], sertraline) at least during the double-blind treatment phase (Day 25)
• As part of standard of care treatment, participant must agree to participate in a specific psychological intervention (individual cognitive behavioral therapy [CBT], interpersonal therapy, family therapy or psychodynamic psychotherapy) at least through the initial 8-week post-treatment follow-up period (Day 81)

You may not qualify if…

• Participants has a current DSM-5 diagnosis of bipolar (or related disorders), intellectual disability, autism spectrum disorder, conduct disorder, anorexia nervosa, oppositional defiant disorder, or obsessive compulsive disorder
• Participants currently meets DSM-5 criteria for borderline personality disorder. Participants not meeting full DSM-5 criteria for borderline personality disorder but exhibiting recurrent suicidal gestures, threats, or self-mutilating behaviors should also be excluded
• Participant has a current or prior DSM-5 diagnosis of a psychotic disorder or MDD with psychosis
• Participant meets the DSM-5 severity criteria for moderate or severe substance or alcohol use disorder (except for nicotine or caffeine) within the 6 months before screening. A history (lifetime) of ketamine, phencyclidine (PCP), lysergic acid diethylamide (LSD), or 3, 4-methylenedioxy-methamphetamine (MDMA) hallucinogen-related use disorder is exclusionary
• Participant has a history of seizure disorder

Where it is running

• Yale University — New Haven, Connecticut, United States
• Atlanta Behavioral Research, LLC — Atlanta, Georgia, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Neuroscience Research Institute — Winfield, Illinois, United States
• Beacon Medical Group Clinical Research — South Bend, Indiana, United States
• University of Iowa, Carver College of Medicine — Iowa City, Iowa, United States
• Lake Charles Clinical Trials — Lake Charles, Louisiana, United States
• Sheppard Pratt Health System — Baltimore, Maryland, United States
• CBH Health — Gaithersburg, Maryland, United States
• State University of New York at Buffalo — Buffalo, New York, United States
• University North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
• Wake Forest Baptist Medical Center — Winston-Salem, North Carolina, United States
• University of Cincinnati Hospital — Cincinnati, Ohio, United States
• University Hospital of Cleveland — Cleveland, Ohio, United States
• Ohio State University — Columbus, Ohio, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• University of Texas Southwestern Medical Center — Dallas, Texas, United States
• Hopital Erasme — Brussels, Belgium
• Trial Tech Tecnologia em Pesquisas com Medicamentos — Curitiba, Brazil
• Hospital Universitario Professor Edgar Santos — Salvador, Brazil
• CEMEC - Centro Multidisciplinar de Estudos Clínicos — São Bernardo do Campo, Brazil
• Hospital São Sebastião — Turvo, Brazil
• Mental Health Center - Rousse — Rousse, Bulgaria
• Multiprofile Hospital for Active Treatment - MHAT Sveta Marina EAD — Varna, Bulgaria
• Institute of Living/ Hartford Hospital — Hartford, Connecticut, United States

Full record on ClinicalTrials.gov

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