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AzTrials

Depressive Disorder, Treatment-ResistantPhase 3NCT07716098

A Study of Esketamine Nasal Spray Versus Placebo Spray in Adult Participants With Treatment-resistant Depression

A Phase 3 study testing Esketamine 56 mg and Esketamine 84 mg in people with Depressive Disorder, Treatment-Resistant, run by Janssen Research & Development, LLC at 39 sites in 4 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The purpose of this study is to evaluate how well each individual dose of esketamine (56 milligrams [mg] and 84 mg) works when compared with placebo in improving depressive symptoms in participants with treatment resistant depression (individuals with major depressive disorder [MDD] who have not responded to at least… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Depressive Disorder, Treatment-Resistant
What is being tested?
Esketamine 56 mg and Esketamine 84 mg
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
348 participants
Where
39 sitesin 4 countries
Study dates
23 Jul 2026to 12 Sep 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participant must meet the diagnostic and statistical manual of mental disorders (5th edition) (DSM-5) diagnostic criteria for single-episode major depressive disorder (MDD) (if single episode MDD, the duration of the episode must be greater than or equal to [>=] 12 months) or recurrent MDD, without psychotic features, based upon clinical assessment and confirmed by the mini international neuropsychiatric interview (MINI) as the primary diagnosis. Participant must have had the first onset of depression prior to 55 years of age
  • Participant must have had nonresponse (less than or equal to [<=] 25 percent [%] improvement) to >=2 oral antidepressant treatments in the current episode of depression, assessed using the massachusetts general hospital-antidepressant treatment response questionnaire (MGH-ATRQ), and confirmed by documented records (for example, medical/pharmacy/prescription records or a letter from a treating physician)
  • The participant's current major depressive episode, depression symptom severity, and antidepressant treatment response in the current depressive episode, must be confirmed by the state versus trait, assessability, face validity, ecological validity, rule of three P's (SAFER) Interview
  • Participant must be comfortable with self-administration of nasal spray medication and be able to follow the nasal spray administration instructions provided
  • A female participant of childbearing potential must have a negative highly sensitive serum (β-human chorionic gonadotropin [β-hCG]) at the start of screening and a negative urine pregnancy test must be obtained before the first dose of study drug on Day 1, prior to randomization

Who cannot join

  • The participant has used ketamine/esketamine (lifetime)
  • The participant's depressive symptoms have demonstrated nonresponse in the current major depressive episode to an adequate course of treatment with electroconvulsive therapy (ECT), defined as at least 7 treatments with unilateral/bilateral ECT, or to adequate course of treatment with transcranial magnetic stimulation (TMS), defined as at least 4 weeks of treatment with 5 sessions per week
  • Participant has received vagal nerve stimulation (VNS) or deep brain stimulation (DBS) in the current episode of depression
  • Participant has homicidal ideation/intent, per the investigator's clinical judgment, or has suicidal ideation with some intent to act within 6 months prior to the start of the screening phase, per the investigator's clinical judgment or based on the columbia suicide severity rating scale (C-SSRS), corresponding to a response of "Yes" on Item 4 (active suicidal ideation with some intent to act, without specific plan) or Item 5 (active suicidal ideation with specific plan and intent) for suicidal ideation on the C-SSRS, or a history of suicidal behavior within the past year prior to the start of the screening phase. Participants reporting suicidal ideation with intent to act or suicidal behavior prior to the start of the double-blind treatment phase should be excluded
  • Participant has a history of moderate or severe substance or alcohol use disorder according to DSM-5 criteria, except nicotine or caffeine, within 6 months before the start of the screening phase. a. A history (lifetime) of ketamine, phencyclidine (PCP), lysergic acid diethylamide (LSD), or 3, 4-methylenedioxy-methamphetamine (MDMA) hallucinogen-related use disorder is exclusionary
  • Participant has a current or history of seizures (uncomplicated childhood febrile seizures with no sequelae are not exclusionary)

Trial locations and contacts

39 sites in 4 countries. Contact the study team or a site near you to ask about taking part.

Study Contact contact

844-434-4210

Participate-In-This-Study1@its.jnj.com

39 sites in 4 countries

United States15 sites, 15 recruiting

  • Northwest Clinical Research Center

    Bellevue, Washington, 98007

    Recruiting

  • American Family Research Group

    Cape Coral, Florida, 33909

    Recruiting

  • Neurobehavioral Research Inc

    Cedarhurst, New York, 11516

    Recruiting

  • Ohio State University

    Columbus, Ohio, 43210

    Recruiting

  • University of Connecticut Health Center

    Farmington, Connecticut, 06032

    Recruiting

  • Psych Atlanta, P.C.

    Marietta, Georgia, 30060

    Recruiting

  • Pharmax Research Clinic Inc

    Miami, Florida, 33126

    Recruiting

  • The Medical Research Network, LLC

    New York, New York, 10128

    Recruiting

  • Charter Research Orlando

    Orlando, Florida, 32803

    Recruiting

  • Anderson Clinical Research

    Redlands, California, 92374

    Recruiting

  • Midwest Research Group

    Saint Maries, Idaho, 63304

    Recruiting

  • Artemis Institute for Clinical Research

    San Diego, California, 92123

    Recruiting

  • Psychiatric Medicine Associates LLC

    Skokie, Illinois, 60076

    Recruiting

  • Accelerated Clinical Research Group LLC

    Snellville, Georgia, 30078

    Recruiting

  • Adams Clinical Watertown

    Watertown, Massachusetts, 02472

    Recruiting

Other trials in United States

Japan15 sites, 15 recruiting

  • Heart Care Clinic Omachi

    Akita, 010 0921

    Recruiting

  • Rainbow & Sea Hospital

    Karatsu, 847-0031

    Recruiting

  • Kishiro Mental Clinic

    Kawasaki, 214-0014

    Recruiting

  • Tatsuta Clinic

    Kobe, 651-0097

    Recruiting

  • National Center of Neurology and Psychiatry

    Kodaira, 187-8551

    Recruiting

  • Juntendo University Koshigaya Hospital

    Koshigaya, 343-0032

    Recruiting

  • Ichikawa Clinic

    Maebashi, 371-0031

    Recruiting

  • The Jikei University Hospital

    Minatoku, 105-8471

    Recruiting

  • Kyorin University Hospital

    Mitaka, 181-8611

    Recruiting

  • Miyakonojo Shinsei Hospital

    Miyakonojō, 885-0093

    Recruiting

  • Arata Clinic

    Nagasaki, 852-8137

    Recruiting

  • Hokkaido University Hospital

    Sapporo, 060 8648

    Recruiting

  • Sangenjaya neurology-psychosomatic clinic

    Setagaya-ku/Tokyo, 154 0004

    Recruiting

  • Maynds Tower Mental Clinic

    Shibuya Tokyo, 151-0053

    Recruiting

  • Tottori University Hospital

    Tottori, 683-0824

    Recruiting

Other trials in Japan

Taiwan6 sites, 6 recruiting

  • Kaohsiung Medical University Chung Ho Memorial Hospital

    Kaohsiung City, 80756

    Recruiting

  • Chung Shan Medical University Hospital

    Taichung, 402

    Recruiting

  • National Cheng Kung University Hospital

    Tainan, 704

    Recruiting

  • Taipei Medical University

    Taipei, 110

    Recruiting

  • Taipei Veterans General Hospital

    Taipei, 11217

    Recruiting

  • Linkou Chang Gung Memorial Hospital

    Taoyuan, 333

    Recruiting

Other trials in Taiwan

China3 sites, 3 recruiting

  • Beijing Anding Hospital of Capital Medical University

    Beijing, 100088

    Recruiting

  • Beijing Huilongguan Hospital

    Beijing, 102208

    Recruiting

  • Wuhu Hospital of Beijing Anding hospital

    Wuhu, 242407

    Recruiting

Other trials in China

About this study

Official title: A Randomized, Double-blind, Multicenter, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Esketamine Nasal Spray, Administered as Monotherapy, in Adult Participants With Treatment-resistant Depression

The purpose of this study is to evaluate how well each individual dose of esketamine (56 milligrams [mg] and 84 mg) works when compared with placebo in improving depressive symptoms in participants with treatment resistant depression (individuals with major depressive disorder [MDD] who have not responded to at least 2 different antidepressant treatments given at an adequate dose for an adequate duration in the current episode of depression).

Being tested
Esketamine 56 mg, Esketamine 84 mg, Placebo
Medical subject headings
Depressive Disorder, Treatment-Resistant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Esketamine 56 mgDrug

    Also called JNJ-54135419

    Participants will self-administer 56 mg of esketamine as intranasal spray into each nostril.

  • Esketamine 84 mgDrug

    Also called JNJ-54135419

    Participants will self-administer 84 mg of esketamine as intranasal spray into each nostril.

  • PlaceboDrug

    Participants will self-administer placebo as intranasal spray into each nostril.

Study groups in NCT07716098
Study groupRoleWhat they receive
Esketamine 56 milligram (mg)ExperimentalParticipants will be randomized to receive double-blind (DB) treatment with esketamine 56 mg, twice a week for 4 weeks. Participants who complete the DB treatment phase on Day 28 may be eligible to participate in an open-label treatment phase and receive either esketamine 56 or 84 mg.
Receives: Drug: Esketamine 56 mg; Drug: Esketamine 84 mg
Esketamine 84 mgExperimentalParticipants will be randomized to receive DB treatment with esketamine 84 mg, twice a week for 4 weeks. Participants who complete the DB treatment phase on Day 28 may be eligible to participate in an open-label treatment phase and receive either esketamine 56 or 84 mg.
Receives: Drug: Esketamine 56 mg; Drug: Esketamine 84 mg
PlaceboPlacebo comparatorParticipants will be randomized to receive DB treatment with placebo twice a week for 4 weeks. Participants who complete the DB treatment phase on Day 28 may be eligible to participate in an open-label treatment phase and receive either esketamine 56 mg or 84 mg.
Receives: Drug: Esketamine 56 mg; Drug: Esketamine 84 mg; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Double-Blind (DB) Treatment Phase: Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Day 1 to the End of the 4-Week Double-Blind Treatment Phase

    The MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The scale consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 60. Higher scores represent a more severe condition.

    Measured: Baseline (Day 1 [prerandomization]) up to end of the 4-Week DB treatment phase (Day 28)

Secondary outcomes (21)

  1. DB Treatment Phase: Change From Baseline in MADRS Total Score From Day 1 to Day 2

    The MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The scale consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 60. Higher scores represent a more severe condition.

    Measured: Baseline (Day 1 [prerandomization]) up to Day 2 (approximately 24 hours after the first dose)

  2. DB Treatment Phase: Percentage of Responders in MADRS Over Time to the End of the 4-Week DB Treatment Phase

    Percentage of responders (greater than or equal to [>=] 50 percent [%] reduction from baseline in MADRS total score) over time to the end of the 4-week DB treatment phase will be reported. The MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The scale consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 60. Higher scores represent a more severe condition.

    Measured: Up to end of the 4-Week DB treatment phase (Day 28)

  3. DB Treatment Phase: Percentage of Participants in Remission in MADRS Over Time to the End of the 4-Week DB Treatment Phase

    Percentage of participants in remission (MADRS less than or equal to [<=] 10 and MADRS <= 12) over time to the end of the 4-week DB treatment phase will be reported. The MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The scale consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 60. Higher scores represent a more severe condition.

    Measured: Up to end of the 4-Week DB treatment phase (Day 28)

  4. DB Treatment Phase: Change From Baseline in Clinical Global Impression-Severity (CGI-S) Over Time to the End of the 4-Week DB Treatment Phase

    Change from baseline in CGI-S over time to the end of the 4-week DB treatment phase will be reported. The CGI-S is a clinician-rated scale that measures illness severity. The CGI has proved to be a robust measure of efficacy in many clinical drug trials and is easy and quick to administer. The CGI-S is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (among the most severely ill participants).

    Measured: Baseline up to end of the 4-Week DB treatment phase (Day 28)

  5. DB Treatment Phase: Change From Baseline in MADRS Total Score Over Time to the End of the 4-Week DB Treatment Phase

    Change from baseline in MADRS total score over time to the end of the 4-week DB treatment phase will be reported. The MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The scale consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 60. Higher scores represent a more severe condition.

    Measured: Baseline up to end of the 4-Week DB treatment phase (Day 28)

  6. DB Treatment Phase: Change From Baseline in Individual MADRS Item Scores Over Time to the End of the 4-Week DB Treatment Phase

    Change from baseline in individual MADRS item scores over time to the end of the 4-week DB treatment phase will be reported. The MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The scale consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 60. Higher scores represent a more severe condition.

    Measured: Baseline up to end of the 4-Week DB treatment phase (Day 28)

  7. DB Treatment Phase: Change From Baseline in Anhedonia Symptoms Over Time to the End of the 4-Week DB Treatment Phase As Assessed by MADRS Anhedonia Factor Score

    Change from baseline in anhedonia symptoms over time to the end of the 4-week DB treatment phase as assessed by MADRS anhedonia factor score will be reported. The MADRS anhedonia factor is a widely used 5-item subscale of the MADRS used to specifically measure the lack of pleasure (anhedonia) in depression, combining items for apparent sadness, reported sadness, concentration difficulties, lassitude (tiredness), and inability to feel. The sum of these five items (each scored 0-6), resulting in a score from 0 to 30, with higher scores indicating more severe anhedonia. This score helps assess treatment effectiveness for anhedonia, correlates with functional improvement, and provides a deeper look beyond the total depression score, showing significant clinical relevance in major depressive disorder (MDD) trials.

    Measured: Baseline up to end of the 4-Week DB treatment phase (Day 28)

  8. DB Treatment Phase: Change From Baseline in Patient-Reported Anhedonia Symptoms Over Time to the End of the 4-Week DB Treatment Phase As Assessed by Patient Health Questionnaire 9-item (PHQ-9) Item 1 Score

    Change from baseline in patient-reported anhedonia symptoms over time to the end of the 4-week DB treatment phase as assessed by PHQ-9 item 1 score (little interest/pleasure in things) will be reported. The PHQ-9 is a participant-reported outcome measure that will be used to assess depressive symptoms. The scale scores each of the 9 symptom domains of the diagnostic and statistical manual of mental disorders (5th edition) (DSM-5) MDD criteria and it has been used both as a screening tool and a measure of response to treatment for depression. Each item is rated on a 4-point scale (0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day).

    Measured: Baseline up to end of the 4-Week DB treatment phase (Day 28)

  9. DB Treatment Phase: Change From Baseline in PHQ-9 Total Score Over Time to the End of the 4-Week DB Treatment Phase

    Change from baseline in PHQ-9 total score over time to the end of the 4-week DB treatment phase will be reported. The PHQ-9 is a participant-reported outcome measure that will be used to assess depressive symptoms. The scale scores each of the 9 symptom domains of the DSM-5 MDD criteria and it has been used both as a screening tool and a measure of response to treatment for depression. Each item is rated on a 4-point scale (0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day). The participant's item responses are summed to provide a total score (range of 0 to 27) with higher scores indicating greater severity of depressive symptoms.

    Measured: Baseline up to end of the 4-Week DB treatment phase (Day 28)

  10. DB Treatment Phase: Percentage of Responders in PHQ-9 Over Time to the End of the 4-Week DB Treatment Phase

    Percentage of responders (>= 50% reduction from baseline in PHQ-9 total score) over time to the end of the 4-week DB treatment phase will be reported. The PHQ-9 is a participant-reported outcome measure that will be used to assess depressive symptoms. The scale scores each of the 9 symptom domains of the DSM-5 MDD criteria and it has been used both as a screening tool and a measure of response to treatment for depression. Each item is rated on a 4-point scale (0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day). The participant's item responses are summed to provide a total score (range of 0 to 27) with higher scores indicating greater severity of depressive symptoms.

    Measured: Up to end of the 4-Week DB treatment phase (Day 28)

  11. DB Treatment Phase: Percentage of Participants in Remission in PHQ-9 Over Time to the End of the 4-Week DB Treatment Phase

    Percentage of participants in remission (PHQ-9 total score < 5) over time to the end of the 4-week DB treatment phase will be reported. The PHQ-9 is a participant-reported outcome measure that will be used to assess depressive symptoms. The scale scores each of the 9 symptom domains of the DSM-5 MDD criteria and it has been used both as a screening tool and a measure of response to treatment for depression. Each item is rated on a 4-point scale (0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day). The participant's item responses are summed to provide a total score (range of 0 to 27) with higher scores indicating greater severity of depressive symptoms.

    Measured: Up to end of the 4-Week DB treatment phase (Day 28)

  12. Open-Label (OL) Treatment Phase: Percentage of Responders in MADRS Over Time to the End of the OL Treatment Phase

    Percentage of responders (>= 50% reduction from baseline in MADRS total score) over time to the end of the OL treatment phase will be reported. The MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The scale consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 60. Higher scores represent a more severe condition.

    Measured: Up to 12 Weeks

  13. OL Treatment Phase: Percentage of Participants in Remission in MADRS Over Time to the End of the OL Treatment Phase

    Percentage of participants in remission (MADRS <= 10 and MADRS <= 12) over time to the end of the OL treatment phase will be reported. The MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The scale consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 60. Higher scores represent a more severe condition.

    Measured: Up to 12 Weeks

  14. OL Treatment Phase: Change From Baseline in CGI-S Over Time to the End of the OL Treatment Phase

    Change from baseline in CGI-S over time to the end of the OL treatment phase will be reported. The CGI-S is a clinician-rated scale that measures illness severity. The CGI has proved to be a robust measure of efficacy in many clinical drug trials and is easy and quick to administer. The CGI-S is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (among the most severely ill participants).

    Measured: Baseline (Day 28) up to 12 Weeks

  15. OL Treatment Phase: Change From Baseline in MADRS Total Score Over Time to the End of the OL Treatment Phase

    Change from baseline in MADRS total score over time to the end of the OL treatment phase will be reported. The MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The scale consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 60. Higher scores represent a more severe condition.

    Measured: Baseline (Day 28) up to 12 Weeks

  16. OL Treatment Phase: Change From Baseline in Individual MADRS Item Scores Over Time to the End of the OL Treatment Phase

    Change from baseline in individual MADRS item scores over time to the end of the OL treatment phase will be reported. The MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The scale consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 60. Higher scores represent a more severe condition.

    Measured: Baseline (Day 28) up to 12 Weeks

  17. OL Treatment Phase: Change From Baseline in Anhedonia Symptoms Over Time to the End of the OL Treatment Phase As Assessed by MADRS Anhedonia Factor Score

    Change from baseline in anhedonia symptoms over time to the end of the OL treatment phase as assessed by MADRS anhedonia factor score will be reported. The MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The scale consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 60. Higher scores represent a more severe condition.

    Measured: Baseline (Day 28) up to 12 Weeks

  18. OL Treatment Phase: Change From Baseline in Patient-Reported Anhedonia Symptoms Over Time to the End of the OL Treatment Phase As Assessed by PHQ-9 Item 1 Score

    Change from baseline in patient-reported anhedonia symptoms over time to the end of the OL treatment phase as assessed by PHQ-9 item 1 score will be reported. The PHQ-9 is a participant-reported outcome measure that will be used to assess depressive symptoms. The scale scores each of the 9 symptom domains of the DSM-5 MDD criteria and it has been used both as a screening tool and a measure of response to treatment for depression. Each item is rated on a 4-point scale (0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day). The participant's item responses are summed to provide a total score (range of 0 to 27) with higher scores indicating greater severity of depressive symptoms.

    Measured: Baseline (Day 28) up to 12 Weeks

  19. OL Treatment Phase: Change From Baseline in PHQ-9 Total Score Over Time to the End of the OL Treatment Phase

    Change from baseline in PHQ-9 total score over time to the end of the OL treatment phase will be reported. The PHQ-9 is a participant-reported outcome measure that will be used to assess depressive symptoms. The scale scores each of the 9 symptom domains of the DSM-5 MDD criteria and it has been used both as a screening tool and a measure of response to treatment for depression. Each item is rated on a 4-point scale (0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day). The participant's item responses are summed to provide a total score (range of 0 to 27) with higher scores indicating greater severity of depressive symptoms.

    Measured: Baseline (Day 28) up to 12 Weeks

  20. OL Treatment Phase: Percentage of Responders in PHQ-9 Over Time to the End of the OL Treatment Phase

    Percentage of responders (>= 50% reduction from baseline in PHQ-9 total score) over time to the end of the OL treatment phase will be reported. The PHQ-9 is a participant-reported outcome measure that will be used to assess depressive symptoms. The scale scores each of the 9 symptom domains of the DSM-5 MDD criteria and it has been used both as a screening tool and a measure of response to treatment for depression. Each item is rated on a 4-point scale (0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day). The participant's item responses are summed to provide a total score (range of 0 to 27) with higher scores indicating greater severity of depressive symptoms.

    Measured: Up to 12 Weeks

  21. OL Treatment Phase: Percentage of Participants in Remission in PHQ-9 Over Time to the End of the OL Treatment Phase

    Percentage of participants in remission (PHQ-9 total score < 5) over time to the end of the OL treatment phase will be reported. The PHQ-9 is a participant-reported outcome measure that will be used to assess depressive symptoms. The scale scores each of the 9 symptom domains of the DSM-5 MDD criteria and it has been used both as a screening tool and a measure of response to treatment for depression. Each item is rated on a 4-point scale (0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day). The participant's item responses are summed to provide a total score (range of 0 to 27) with higher scores indicating greater severity of depressive symptoms.

    Measured: Up to 12 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2026
  2. Study start23 Jul 2026
  3. Primary completion27 Dec 2028 (estimated)
  4. Study completion12 Sep 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
348 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07716098
Sponsor's protocol ID
54135419TRD3015
Status last verified
Nov 2026
First submitted
15 Jul 2026
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The data sharing policy of Johnson \& Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Esketamine 56 mg and Esketamine 84 mg in people with Depressive Disorder, Treatment-Resistant, run by Janssen Research & Development, LLC at 39 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 sites in United States, Japan, Taiwan, China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Study Contact (844-434-4210, Participate-In-This-Study1@its.jnj.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Double-Blind (DB) Treatment Phase: Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Day 1 to the End of the 4-Week Double-Blind Treatment Phase (time frame: Baseline (Day 1 [prerandomization]) up to end of the 4-Week DB treatment phase (Day 28)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07716098.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

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