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NMDA receptor antagonist

Esketamine Nasal Spray for Depression

Phase 4
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
Participant must meet the Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-5) diagnostic criteria for single-episode MDD or recurrent MDD, without psychotic features, based upon clinical assessment and confirmed by the MINI. Participants 65 years of age or older must have had the first onset of depression prior to 55 years of age
Participant must have had nonresponse (<=25% improvement) to >=2 oral antidepressant treatments in the current episode of depression, assessed using the MGH-ATRQ, and confirmed by documented records (example, medical/pharmacy/prescription records or a letter from a treating physician)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to day 28
Awards & highlights

Study Summary

This trial is testing if a nasal spray of esketamine can help improve depressive symptoms in people who haven't responded to other treatments.

Who is the study for?
Adults with treatment-resistant depression, who haven't responded to at least two oral antidepressants in their current episode, can join this trial. They must be medically stable and able to self-administer nasal spray medication. People over 65 should have had their first depression onset before age 55. Those with significant medical conditions or a history of seizures are excluded.Check my eligibility
What is being tested?
The study is testing esketamine nasal spray doses (56 mg and 84 mg) against a placebo to see if they improve symptoms of depression after four weeks. Participants' depressive symptoms will be measured using the MADRS scale from the start until Day 28.See study design
What are the potential side effects?
Esketamine may cause side effects such as dissociation, dizziness, nausea, sedation, increased blood pressure, anxiety, lack of energy, vomiting and feeling drunk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with depression without psychosis, first occurred before I was 55.
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I have tried at least two antidepressants without much improvement.
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I can use a nasal spray by myself and follow the instructions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to day 28
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to day 28 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 Montgomery-Asberg Depression Rating Scale (MADRS) Total Score from Day 1 (Pre-randomization) to the End of the 4-week Double-Blind Treatment Phase (Day 28)
Secondary outcome measures
Change from Baseline in MADRS Total Score from Day 1 (Pre-randomization) to Day 2

Trial Design

3Treatment groups
Experimental Treatment
Group I: PlaceboExperimental Treatment1 Intervention
Participants will receive nasal spray treatment with placebo twice a week for 4 weeks. Participants may participate in an open-label treatment/observation phase, following completion of the double-blind treatment phase assessments (which includes the Day 28 MADRS assessment).
Group II: Esketamine 84 mgExperimental Treatment1 Intervention
Participants will receive nasal spray treatment with esketamine 84 mg twice a week for 4 weeks. Participants may participate in an open-label treatment/observation phase, following completion of the double-blind treatment phase assessments (which includes the Day 28 MADRS assessment).
Group III: Esketamine 56 Milligram (mg)Experimental Treatment1 Intervention
Participants will receive nasal spray treatment with esketamine 56 mg twice a week for 4 weeks. Participants may participate in an open-label treatment/observation phase, following completion of the double-blind treatment phase assessments (which includes the Day 28 Montgomery-Asberg Depression Rating Scale [MADRS] assessment).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Esketamine 56 mg
2020
Completed Phase 4
~1520
Esketamine 84 mg
2020
Completed Phase 4
~1570
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
975 Previous Clinical Trials
6,383,831 Total Patients Enrolled
45 Trials studying Depression
11,783 Patients Enrolled for Depression
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
745 Previous Clinical Trials
3,959,428 Total Patients Enrolled
37 Trials studying Depression
10,312 Patients Enrolled for Depression

Media Library

Esketamine (NMDA receptor antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT04599855 — Phase 4
Depression Research Study Groups: Esketamine 84 mg, Esketamine 56 Milligram (mg), Placebo
Depression Clinical Trial 2023: Esketamine Highlights & Side Effects. Trial Name: NCT04599855 — Phase 4
Esketamine (NMDA receptor antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04599855 — Phase 4
Depression Patient Testimony for trial: Trial Name: NCT04599855 — Phase 4

Frequently Asked Questions

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

What other scholarly investigations have focused on the efficacy of Esketamine 56 mg?

"Esketamine 56 mg was first investigated in 2016 at NCT02782104. Since then, there have been 18365 completed clinical studies and 24 active trials throughout the world with a notable concentration of these investigations taking place in Lakeland, Florida."

Answered by AI

To what extent has enrolment grown in this clinical trial?

"To successfully complete this study, 450 candidates with appropriate qualifications must partake. For convenience, Accel Research Sites in Lakeland, Florida and Family Psychiatry of The Woodlands in The Woodlands, Texas are two sites available for participation."

Answered by AI

Is there potential for harm when administering Esketamine 56 mg to individuals?

"Our team at Power has assigned Esketamine 56 mg a rating of 3 due to the fact that it is currently approved and considered safe, as indicated by its Phase 4 status."

Answered by AI

At how many sites is this research endeavor being conducted?

"At the moment, patients can be recruited from 51 medical sites, including Lakeland, The Woodlands and Santa Ana. To reduce travel requirements for enrolled individuals it is suggested to pick a centre closest to your location."

Answered by AI

Are recruitment efforts ongoing for this research project?

"Indeed, the clinicaltrials.gov website affirms that this study is actively enlisting participants. This medical trial was first advertised on November 4th 2020 and has been amended most recently on the 9th of November 2022. The experiment requires 450 patients to be enrolled at 51 distinct sites."

Answered by AI

What is the traditional application of Esketamine 56 mg?

"Esketamine 56mg is primarily used to manage unipolar depression, however it also has applications in pain relief, asthma exacerbations and enhancing muscle relaxation."

Answered by AI

Has this kind of medical experiment ever been attempted before?

"Currently, 24 experiments related to Esketamine 56 mg are being conducted across 95 urban areas and 31 nations. This investigation was first initiated by Janssen Research & Development in 2016 with 1148 participants going through Phase 3 clinical trials. Since then, 18365 other studies have been completed or are still underway."

Answered by AI

Who else is applying?

What state do they live in?
California
Texas
Florida
Other
How old are they?
18 - 65
What site did they apply to?
CalNeuro Research
Brain Health Consultants and TMS Center
UCSF Nancy Friend Pritzker Psychiatry Building
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
2
0
3+

Why did patients apply to this trial?

On 150.mg of serg. I need my life back. to get help now that im up in ages.
PatientReceived 1 prior treatment
I’ve tried so many different treatments. Frustration with past treatment attempts.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

What is the age cut-off? How long do the visits take? Do you offer transport to the study sight?
PatientReceived 1 prior treatment
How many minutes are the sessions in general? How is this similar or different than ketamine?
PatientReceived 1 prior treatment

How responsive is this trial?

Typically responds via
Phone Call
Email
Most responsive sites:
  1. UAB Department of Psychiatry and Behavioral Neurobiology: < 24 hours
  2. UCSF Nancy Friend Pritzker Psychiatry Building: < 24 hours
  3. Psychiatric Medicine Associates LLC: < 24 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
A Study of Esketamine Nasal Spray, Administered as Monotherapy, in Adult Participants With Treatment-resistant Depression
2020. "A Study of Esketamine Nasal Spray, Administered as Monotherapy, in Adult Participants With Treatment-resistant Depression". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04599855.
~108 spots leftby Apr 2025
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