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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

NCT03185819 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 147

Last updated 2025-04-29

Study results available
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Summary

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.

Conditions

  • Depressive Disorder, Major

Interventions

DRUG

Intranasal Placebo

Participants will receive placebo as intranasal dose to match intranasal esketamine.

DRUG

Midazolam Placebo Solution

Participants will receive placebo as oral dose to match midazolam drug.

DRUG

Midazolam

Participants will receive midazolam solution 0.125 mg/kg as oral dose to match placebo.

DRUG

Esketamine

Participants will receive esketamine at a dose of 28 mg as intranasal solution.

DRUG

Esketamine

Participants will receive esketamine at a dose of 56 mg as intranasal solution.

DRUG

Esketamine

Participants will receive esketamine at a dose of 84 mg as intranasal solution.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
9 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-05
Primary Completion
2023-03-31
Completion
2023-03-31
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Brazil
  • Bulgaria
  • France
  • Hungary
  • Italy
  • Poland
  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03185819 on ClinicalTrials.gov