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RecruitingNCT07716098Updated Nov 3, 2026

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

A Phase 3 interventional study of Esketamine 56 mg and Esketamine 84 mg in Depressive Disorder, Treatment-Resistant, sponsored by Janssen Research & Development, LLC. Recruiting at 39 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.

Sponsored by Janssen Research & Development, LLC (part of Johnson & Johnson) · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2026; still recruiting 3 months later.
Updated Nov 3, 2026First site in China27 sites added+1 moreGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
348
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 2 different antidepressant treatments given at an adequate dose for an adequate duration in the current episode of depression).

02

Conditions studied

  • Depressive Disorder, Treatment-Resistant
03

In context

Depressive Disorder, Treatment-Resistant

448 studies on the registry are indexed under Depressive Disorder, Treatment-Resistant; 147 are open to participants now.

This study's planned enrollment of 348 is above the median of 59 across 372 interventional studies indexed under Depressive Disorder, Treatment-Resistant.

Browse Depressive Disorder, Treatment-Resistant studies →

Lead sponsor

Janssen Research & Development, LLC is the lead sponsor of 932 studies on the registry; 76 are open to participants now.

Of its 285 completed or terminated interventional studies of FDA-regulated products, 136 (48%) have results posted.

Browse Janssen Research & Development, LLC studies →All Johnson & Johnson studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Participant must meet the (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 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

Exclusion criteria

Exclusion Criteria:

  • 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 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)
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
348 participants (estimated)

Study arms

  • Experimental
    Esketamine 56 milligram (mg)

    Participants 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.

    Drug: Esketamine 56 mg · Drug: Esketamine 84 mg

  • Experimental
    Esketamine 84 mg

    Participants 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.

    Drug: Esketamine 56 mg · Drug: Esketamine 84 mg

  • Placebo comparator
    Placebo

    Participants 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.

    Drug: Esketamine 56 mg · Drug: Esketamine 84 mg · Drug: Placebo

Interventions

  • DrugEsketamine 56 mg

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

    Also known as: JNJ-54135419

  • DrugEsketamine 84 mg

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

    Also known as: JNJ-54135419

  • DrugPlacebo

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

06

What researchers measure

Primary outcomes

  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.

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

Secondary outcomes

  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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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).

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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).

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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).

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: Up to 12 Weeks

Other outcomes

  1. DB Treatment Phase: Number of Participants with Abnormalities in Blood Oxygen Saturation (SpO2)

    Number of participants who experience abnormally low blood oxygen saturation will be reported.

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

  2. DB Treatment Phase: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

    An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. TEAEs are defined as any adverse event occurring at or after the administration of study intervention.

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

  3. DB Treatment Phase: Suicidal Ideation and Behavior as Assessed Using the Columbia Suicide Severity Rating Scale (C-SSRS)

    The C-SSRS is a clinical interview providing a summary of both ideation and behavior that can be administered during any evaluation or risk assessment to identify the level and type of suicidality present. The C-SSRS can also be used during treatment to monitor for clinical worsening.

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

  4. DB Treatment Phase: Number of Participants with Effects on Dissociative Symptoms As Measured Using the Clinician Administered Dissociative States Scale (CADSS)

    The CADSS will be administered to assess treatment-emergent dissociative symptoms. It comprises 23 subjective items, divided into 3 components: depersonalization (items 3-7, 20, 23), derealization (items 1-2, 8-13, 16-19, 21) and amnesia (items 14-15, 22). Participant's responses are coded on a 5-point scale (0 = "Not at all" through to 4 = "Extremely"). A higher score indicates a more severe condition.

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

  5. DB Treatment Phase: Number of Participants with Abnormalities in Physical Examination

    Number of participants with abnormalities in physical examination will be reported.

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

  6. DB Treatment Phase: Number of Participants with Abnormalities in Vital Signs

    Number of participants with abnormalities in vital signs (blood pressure, pulse/heart rate measurements, and temperature) will be reported.

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

  7. DB Treatment Phase: Number of Participants Reporting Clinically Meaningful Changes in Body Weight

    Number of participants reporting clinically meaningful changes in body weight will be reported.

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

  8. DB Treatment Phase: Number of Participants with Abnormalities in 12-lead Electrocardiogram (ECG)

    Number of participants with abnormalities in 12-lead ECG will be reported.

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

  9. OL Treatment Phase: Number of Participants with Abnormalities in SpO2

    Number of participants who experience abnormally low blood oxygen saturation will be reported.

    Time frame: Up to 12 Weeks

  10. OL Treatment Phase: Number of Participants With TEAEs

    An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. TEAEs are defined as any adverse event occurring at or after the administration of study intervention.

    Time frame: Up to 12 Weeks

  11. OL Treatment Phase: Suicidal Ideation and Behavior as Assessed Using the C-SSRS

    The C-SSRS is a clinical interview providing a summary of both ideation and behavior that can be administered during any evaluation or risk assessment to identify the level and type of suicidality present. The C-SSRS can also be used during treatment to monitor for clinical worsening.

    Time frame: Up to 12 Weeks

  12. OL Treatment Phase: Number of Participants with Abnormalities in Vital Signs

    Number of participants with abnormalities in vital signs (blood pressure, pulse/heart rate measurements, and temperature) will be reported.

    Time frame: Up to 12 Weeks

  13. OL Treatment Phase: Number of Participants Reporting Clinically Meaningful Changes in Body Weight

    Number of participants reporting clinically meaningful changes in body weight will be reported.

    Time frame: Up to 12 Weeks

  14. OL Treatment Phase: Number of Participants with Abnormalities in 12-lead ECG

    Number of participants with abnormalities in 12-lead ECG will be reported.

    Time frame: Up to 12 Weeks

  15. OL Treatment Phase: Number of Participants with Potential Withdrawal Symptoms After Stopping Study Drug Treatment as Measured by the Physician Withdrawal Checklist (PWC-20)

    The PWC-20 is a 20-item simple and accurate method to assess potential development of discontinuation symptoms after stopping of study medication. The PWC-20 is a reliable and sensitive instrument for the assessment of discontinuation symptoms.

    Time frame: Up to 12 Weeks

07

Study locations

39 of 39 sites recruiting
08

References and documents

Individual participant data

Plan to share: 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

Data sharing details ↗ · innovativemedicine.jnj.com

No publications or documents are linked to this record.

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2026 (actual). Primary completion is estimated for Dec 2028, 29 months after the start.

Of 24 phase 3 interventional studies under Depressive Disorder, Treatment-Resistant, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 59. This study's planned 29 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 15, 2026
First posted
Jul 21, 2026
StartActual
Jul 23, 2026
Primary completionEst.
Dec 27, 2028
CompletionEst.
Sep 12, 2029
Last update
Nov 3, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
27 sites added, 3 sites removed — first site in China
Show 27 added (12 United States, 10 Japan, 3 China, 2 Taiwan)
  • Artemis Institute for Clinical Research · San Diego, United States
  • Psych Atlanta, P.C. · Marietta, United States
  • Neurobehavioral Research Inc · Cedarhurst, United States
  • Northwest Clinical Research Center · Bellevue, United States
  • Ichikawa Clinic · Maebashi, Japan
  • The Jikei University Hospital · Minatoku, Japan
  • Kyorin University Hospital · Mitaka, Japan
  • University of Connecticut Health Center · Farmington, United States
  • American Family Research Group · Cape Coral, United States
  • Pharmax Research Clinic Inc · Miami, United States
  • Charter Research Orlando · Orlando, United States
  • Accelerated Clinical Research Group LLC · Snellville, United States
  • Midwest Research Group · Saint Maries, United States
  • Adams Clinical Watertown · Watertown, United States
  • Ohio State University · Columbus, United States
  • Beijing Anding Hospital of Capital Medical University · Beijing, China
  • Beijing Huilongguan Hospital · Beijing, China
  • Wuhu Hospital of Beijing Anding hospital · Wuhu, China
  • Heart Care Clinic Omachi · Akita, Japan
  • Rainbow & Sea Hospital · Karatsu, Japan
  • National Center of Neurology and Psychiatry · Kodaira, Japan
  • Juntendo University Koshigaya Hospital · Koshigaya, Japan
  • Miyakonojo Shinsei Hospital · Miyakonojō, Japan
  • Sangenjaya neurology-psychosomatic clinic · Setagaya-ku/Tokyo, Japan
  • Maynds Tower Mental Clinic · Shibuya Tokyo, Japan
  • Kaohsiung Medical University Chung Ho Memorial Hospital · Kaohsiung City, Taiwan
  • National Cheng Kung University Hospital · Tainan, Taiwan
Show 3 removed
  • National Center of Neurology and Psychiatry · Kodaira-shi, Japan
  • Sangenjaya neurology-psychosomatic clinic · Setagaya Ku, Japan
  • Maynds Tower Mental Clinic · Shibuya-ku, Japan
across 2 updates, Sep 25, 2026 – Nov 3, 2026
Show all 2 updates
  1. Nov 3, 2026
    20 sites added, 3 sites removed — first site in China
    Show 20 added (8 United States, 7 Japan, 3 China, 2 Taiwan)
    • University of Connecticut Health Center · Farmington, United States
    • American Family Research Group · Cape Coral, United States
    • Pharmax Research Clinic Inc · Miami, United States
    • Charter Research Orlando · Orlando, United States
    • Accelerated Clinical Research Group LLC · Snellville, United States
    • Midwest Research Group · Saint Maries, United States
    • Adams Clinical Watertown · Watertown, United States
    • Ohio State University · Columbus, United States
    • Beijing Anding Hospital of Capital Medical University · Beijing, China
    • Beijing Huilongguan Hospital · Beijing, China
    • Wuhu Hospital of Beijing Anding hospital · Wuhu, China
    • Heart Care Clinic Omachi · Akita, Japan
    • Rainbow & Sea Hospital · Karatsu, Japan
    • National Center of Neurology and Psychiatry · Kodaira, Japan
    • Juntendo University Koshigaya Hospital · Koshigaya, Japan
    • Miyakonojo Shinsei Hospital · Miyakonojō, Japan
    • Sangenjaya neurology-psychosomatic clinic · Setagaya-ku/Tokyo, Japan
    • Maynds Tower Mental Clinic · Shibuya Tokyo, Japan
    • Kaohsiung Medical University Chung Ho Memorial Hospital · Kaohsiung City, Taiwan
    • National Cheng Kung University Hospital · Tainan, Taiwan
    Show 3 removed
    • National Center of Neurology and Psychiatry · Kodaira-shi, Japan
    • Sangenjaya neurology-psychosomatic clinic · Setagaya Ku, Japan
    • Maynds Tower Mental Clinic · Shibuya-ku, Japan
    + 1 other change: verification date
  2. Sep 25, 2026
    7 sites added
    Show 7 added (4 United States, 3 Japan)
    • Artemis Institute for Clinical Research · San Diego, United States
    • Psych Atlanta, P.C. · Marietta, United States
    • Neurobehavioral Research Inc · Cedarhurst, United States
    • Northwest Clinical Research Center · Bellevue, United States
    • Ichikawa Clinic · Maebashi, Japan
    • The Jikei University Hospital · Minatoku, Japan
    • Kyorin University Hospital · Mitaka, Japan
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07716098
Lead sponsor
Janssen Research & Development, LLC
Responsible party
Sponsor
First posted
Jul 21, 2026
Start date
Jul 23, 2026
Primary completion
Dec 27, 2028 (estimated)
Completion
Sep 12, 2029 (estimated)
Last update
Nov 3, 2026

Study contacts

Study Contact
Contact
Participate-In-This-Study1@its.jnj.com
844-434-4210
Janssen Research & Development, LLC Clinical Trial
study director · Janssen Research & Development, LLC

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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