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

This double-blind, randomized, psychoactive placebo-controlled trial (n=147) assessed the efficacy and safety of 3 fixed doses (28 mg, 56 mg, and 84 mg) of intranasal esketamine in addition to comprehensive standard of care for rapidly reducing the symptoms of major depressive disorder (MDD), including suicidal ideation, in pediatric subjects aged 12 to less than 18 years who were assessed to be at imminent risk for suicide.

Participants with MDD presenting suicidal ideation were enrolled, and the study was conducted over four phases: a screening evaluation within 48 hours before the first intranasal dose; a 25-day double-blind treatment phase; an 8-week initial post-treatment phase; and a subsequent phase to complete a full 6-month post-treatment follow-up.

The study evaluated efficacy, safety, pharmacokinetic, biomarker, and pharmacogenomic aspects. The study involved oral midazolam as a psychoactive placebo comparator.

The primary outcome measure was the change from baseline in Children’s Depression Rating Scale-Revised (CDRS-R) total score at 24 hours post-first dose.

The trial started on October 5, 2017, and was completed on March 31, 2023. The study was conducted in various locations across the United States and internationally in countries such as Belgium, Brazil, Bulgaria, France, Hungary, Italy, Poland, and Spain. Janssen Research & Development, LLC sponsored the study.

Topic Depression Suicidality Adolescence and Psychedelics Safety
Compound Placebo Ketamine
Country Belgium Brazil France Italy Poland Spain
Visit trial
Status Completed
Results Published Yes
Start date 05 October 2017
End date 31 March 2023
Phase Phase II
Design Blinded
Type Interventional
Generation First
Participants 144
Sex All
Age 9- 17
Therapy Yes

Trial Details

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.

Trial Number NCT03185819

Sponsors & Collaborators

Johnson & Johnson
One of the largest pharmaceutical companies in the world, Johnson & Johnson are responsible for bringing esketamine to market in the form of Spravato.

Data attribution

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