← Back to Search

NMDA receptor antagonist

Esketamine for Major Depressive Disorder

Phase 2
Waitlist Available
Research Sponsored by Janssen Research & Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (predose on day 1) and 24 hours post first dose on day 1 (i.e., day 2)
Awards & highlights

Study Summary

This trial will test if a single dose of intranasal esketamine can rapidly reduce symptoms of major depressive disorder, including suicidal ideation, in adolescents at imminent risk for suicide.

Eligible Conditions
  • Major Depressive Disorder

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (predose on day 1) and 24 hours post first dose on day 1 (i.e., day 2)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (predose on day 1) and 24 hours post first dose on day 1 (i.e., day 2) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change From Baseline in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at 24 Hours Post First Dose (Day 2)

Side effects data

From 2018 Phase 3 trial • 226 Patients • NCT03039192
35%
Dizziness
29%
Dissociation
20%
Nausea
19%
Headache
19%
Somnolence
17%
Blood Pressure Increased
14%
Dysgeusia
13%
Constipation
9%
Vision Blurred
7%
Vomiting
7%
Hypoaesthesia
6%
Insomnia
6%
Sedation
6%
Vertigo
5%
Dizziness Postural
5%
Anxiety
2%
Depression Suicidal
1%
Diabetic Ketoacidosis
1%
Depression
1%
Suicide Attempt
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo Plus SOC Antidepressant Treatment
Esketamine 84 mg Plus SOC Antidepressant Treatment

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Oral Placebo + Esketamine 84 mgExperimental Treatment2 Interventions
Participants will receive intranasal esketamine 84 mg as 3 intranasal doses of esketamine in each nostril (each dose contains 14 mg of esketamine) along with oral placebo 2 times per week for 4 weeks.
Group II: Oral Placebo + Esketamine 56 mgExperimental Treatment2 Interventions
Participants will receive intranasal esketamine 56 mg as 2 intranasal doses of esketamine in each nostril (each dose contains 14 mg of esketamine) along with oral placebo 2 times per week for 4 weeks.
Group III: Oral Placebo + Esketamine 28 mgExperimental Treatment2 Interventions
Participants will receive intranasal esketamine 28 mg as 1 intranasal doses of esketamine in each nostril (each dose contains 14 mg of esketamine) along with oral placebo 2 times per week for 4 weeks.
Group IV: Oral Midazolam + Intranasal PlaceboPlacebo Group2 Interventions
Participants will receive midazolam solution 0.125 milligram per kilogram (mg/kg) orally 2 times per week for 4 weeks and 3 intranasal doses of matched placebo to esketamine.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Esketamine
2015
Completed Phase 3
~2520
Midazolam Placebo Solution
2017
Completed Phase 2
~150

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
975 Previous Clinical Trials
6,384,161 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
745 Previous Clinical Trials
3,959,758 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age requirement for participation in this experiment restricted to those over 18 years?

"The age criteria for this medical research is nine years or older and no more than seventeen."

Answered by AI

Is this research actively recruiting participants?

"This trial is currently not recruiting any more participants; it was initially posted in October of 2017 and last updated on November 9th, 2022. If you would like to explore other possibilities for clinical trials related to psychosis, involutional depression or Esketamine, there are presently 1451 open studies that could use your participation."

Answered by AI

What potential hazards accompany the use of Esketamine?

"There is some evidence of Esketamine's safety, so it was assigned a score of 2. However, there are no clinical trials that offer proof of its efficacy yet."

Answered by AI

How many participants can the trial accommodate at maximum capacity?

"This clinical trial is not presently taking on new participants. It was first posted as of October 5th, 2017 and has been recently updated on November 9th, 2022. If you are seeking alternative studies, there are currently 1451 ongoing trials related to psychosis or involutional disorders; additionally, 88 investigations involving Esketamine are actively recruiting individuals for participation."

Answered by AI

Are there a number of medical establishments in the US that are conducting this clinical experiment?

"This medical trial has 5 recruiting sites, such as Yale University in New Haven and Vanderbilt Univeristy Medical Center in Nashville. Additionally, Atlanta Behavioral Research, LLC is enlisting patients from the greater Atlanta area along with other centers nationwide."

Answered by AI

What medical conditions is Esketamine typically prescribed to treat?

"Esketamine is typically used to treat central nervous system depressants, yet it may also be prescribed as a preoperative sedative, for management of status asthmaticus and in anaesthesia therapy."

Answered by AI

Is my profile compatible with the entrance criteria for this trial?

"This clinical trial is in search of 147 youths between the ages 9-17 that are diagnosed with involutional psychosis. Eligibility criteria require these patients to meet DSM-5 diagnostic standards for major depressive disorder without psychotic features, a CDRS-R total score greater than or equal to 58 on Day 1, and confirmation via MINI KID assessment."

Answered by AI

Have there been previous experiments to determine the efficacy of Esketamine?

"In 2009, the Shaare Zedek Medical Center initiated research into esketamine. Since then, there have been 606 clinical investigations completed and 88 active medical trials being conducted worldwide; a majority of which are located in New Haven, Connecticut."

Answered by AI

Who else is applying?

What state do they live in?
Rhode Island
North Carolina
Other
Tennessee
How old are they?
18 - 65
What site did they apply to?
Yale University
Atlanta Behavioral Research, LLC
Vanderbilt University Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
0

Why did patients apply to this trial?

I have tried multiple treatments: Full course of TMS, 18 ECT treatments, multiple medications, therapy, residential treatment x 5 months.
PatientReceived no prior treatments
I have had depression since middle school. I take cymbalta now, but of course it isn’t working just like the past 100 medications I’ve tried. I just feel like giving up on finding something that works for me. I would love to be involved in this trial… It would mean a lot to me.
PatientReceived no prior treatments

How responsive is this trial?

Average response time
  • < 2 Days
Typically responds via
Email
Most responsive sites:
  1. Vanderbilt University Medical Center: < 48 hours
Recent research and studies
clinicaltrials.govStudy
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
2017. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03185819.
~20 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top