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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 belowSelect...
I have been diagnosed with depression without psychosis, first occurred before I was 55.
Select...
I have tried at least two antidepressants without much improvement.
Select...
I can use a nasal spray by myself and follow the instructions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to day 28
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to day 28
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
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Esketamine, an NMDA receptor antagonist, works by modulating glutamate activity in the brain, which can lead to rapid antidepressant effects. This is particularly important for treatment-resistant depression, where traditional antidepressants may fail.
Other common treatments include SSRIs and SNRIs, which increase serotonin and norepinephrine levels, respectively, to improve mood and emotional regulation. Tricyclic antidepressants also increase these neurotransmitters but have a broader mechanism of action.
Understanding these mechanisms helps patients and clinicians choose the most effective treatment, especially when rapid symptom relief is needed or when other treatments have failed.
Efficacy and safety of esketamine nasal spray by sex in patients with treatment-resistant depression: findings from short-term randomized, controlled trials.Consistently Modest Antidepressant Effects in Clinical Trials: the Role of Regulatory Requirements.
Efficacy and safety of esketamine nasal spray by sex in patients with treatment-resistant depression: findings from short-term randomized, controlled trials.Consistently Modest Antidepressant Effects in Clinical Trials: the Role of Regulatory Requirements.
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Who is running the clinical trial?
Janssen Research & Development, LLCLead Sponsor
978 Previous Clinical Trials
6,384,617 Total Patients Enrolled
45 Trials studying Depression
11,762 Patients Enrolled for Depression
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
747 Previous Clinical Trials
3,960,195 Total Patients Enrolled
37 Trials studying Depression
10,291 Patients Enrolled for Depression
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a condition that might affect how my body uses a nasal spray medication.I have been diagnosed with depression without psychosis, first occurred before I was 55.My health is stable based on recent exams and tests.I have tried at least two antidepressants without much improvement.My depression and treatment response have been confirmed by a specific interview.I can use a nasal spray by myself and follow the instructions.I have used ketamine or esketamine at some point in my life.My depression didn't improve after 7 or more ECT treatments.I have had VNS or DBS for my current depression episode.I have a history of seizures, but not simple childhood febrile seizures.
Research Study Groups:
This trial has the following groups:- Group 1: Esketamine 84 mg
- Group 2: Esketamine 56 Milligram (mg)
- Group 3: Placebo
Awards:
This trial has 2 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Depression Patient Testimony for trial: Trial Name: NCT04599855 — Phase 4
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