A Phase 3 interventional study of Esketamine and Midazolam in Depressive Disorder, Major, sponsored by Janssen Research & Development, LLC. Recruiting at 49 sites in 7 countries. Open to participants aged 12 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Janssen Research & Development, LLC (part of Johnson & Johnson) · Phase 3, Interventional, and Treatment
Among 17 studies testing esketamine in Depressive Disorder, Major — 5 open to participants now, 5 under way, 2 of them phase 3. Esketamine · Depressive Disorder, Major.
Among the 17 studies testing esketamine in Depressive Disorder, Major, this one is the 3rd largest by planned enrollment, is the only one that started in 2026, is one of 7 in phase 3, and was the 17th registered.
3,046 studies on the registry are indexed under Depressive Disorder, Major; 592 are open to participants now.
Browse Depressive Disorder, Major studies →5 of the 17 studies testing esketamine in Depressive Disorder, Major are open now, in 12 countries. Recruiting first, the newest first:
Dr. Inge Winter · Sites in Austria, Germany, Greece and 3 more countries
Ages 18–65
Royal North Shore Hospital · Sites in Australia
Ages 18–65
Massachusetts General Hospital · Sites in United States
Ages 18–70
Medical University of Vienna · Sites in Austria
Ages 18–55 · Healthy volunteers
By country, each count listing its studies:
Esketamine: first FDA approval 2019 (SPRAVATO), first EMA approval 2019. What it is approved for, and how studies give it, is on its page →
Of the 412 Depressive Disorder, Major studies recruiting now, 93 (23%) set no upper age limit and 293 (71%) stop at 75 or younger; 55 take children under 18; 98 take healthy volunteers.
This study: 12 Years to 17 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
17 studies; the count open now beside each. This study's row is marked.
First in 2012; this study’s year is marked. 1 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 258 is above the median of 80 across 2,532 interventional studies indexed under Depressive Disorder, Major.
Median enrollment 147 across the 17 interventional studies. Of the 9 that completed or were terminated, 6 (67%) have results posted.
This tab as a report to print or save as PDF → With an account.
9 of 17 have an industry lead sponsor. The 10 most frequent:
This study is registered under Janssen Research & Development, LLC, one of the names counted as Johnson & Johnson. Under that name alone:
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.
59 studies in Depressive Disorder, Major by Johnson & Johnson: 5 open now, 5 under way, 5 of them phase 3. Of 53 finished, 25 (47%) have results posted.
Among the 59 studies in Depressive Disorder, Major by Johnson & Johnson, this one is the 20th largest by planned enrollment of the 52 interventional ones that give a count, is one of 3 that started in 2026, is one of 23 in phase 3, and was the 56th registered.
Johnson & Johnson’s Depressive Disorder, Major studies by the year they started, since 2002.
1 of the studies testing esketamine in Depressive Disorder, Major that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05450432Massachusetts General HospitalLong-Term Maintenance With Ketamine and Esketamine for Reduction of Suicide in High-Risk Patients With Depression | 2027-05-01 |
Add it to your calendar (.ics) → With an account.
Among the 17 studies testing esketamine in Depressive Disorder, Major, from their registry updates:
Among Johnson & Johnson’s 59 in Depressive Disorder, Major:
This tab as a report to print or save as PDF → With an account.
The purpose of this study is to evaluate how well JNJ-54135419 works (efficacy) in addition to comprehensive standard of care (SoC) in rapidly reducing the symptoms of major depressive disorder (MDD, a mental disorder characterized by a persistent feeling of sadness and loss of interest in activities) as compared with psychoactive placebo (does not contain JNJ-54135419) plus SoC in adolescent participants with acute suicidal ideation or behavior.
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.
Exclusion Criteria:
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.
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.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive intranasal esketamine 84 milligrams (mg) along with oral placebo solution twice weekly for 4 weeks (Days 1, 4, 8, 11, 15, 18, 22, and 25). On Day 4 a decrease to intranasal esketamine 56 mg (in a blinded fashion per investigator's judgment) is permitted. Thereafter, dose may be flexed between 56 mg and 84 mg during the treatment period.
Drug: Esketamine · Other: Oral Placebo
Participants will receive oral midazolam (0.0625 milligrams per kilograms \[mg/kg\]) and intranasal placebo twice weekly for 4 weeks (Days 1, 4, 8, 11, 15, 18, 22, and 25). On Day 4 a sham decrease to esketamine 56 mg dose (in a blinded fashion per investigator's judgment) is permitted. Thereafter, sham dose may be flexed between 56 mg and 84 mg during the treatment period.
Drug: Midazolam · Other: Intranasal Placebo
Esketamine will be administered as intranasal solution.
Also known as: JNJ-54135419
Midazolam will be administered as oral solution.
Placebo will be administered as oral solution.
Intranasal placebo will be administered as nasal solution.
Change from Baseline in Depressive Symptoms Measured by Children's Depression Rating Scale - Revised (CDRS-R) Total Score at 24 Hours Post First Dose
The CDRS-R is a 17-item, clinician-reported outcome measure of children's depressive symptom severity. Out of the 17-item, 3 items were non-verbal behavior (listless speech, hypoactivity, and depressed affect) rated on a 5 point scale from 1 (no depression) to 5 (severe depression) and 14 items were rated on a 7-point scale from 1 (no depression) to 7 (severe depression), where higher score indicated more severe depression. The CDRS-R total score was the sum of the 17-tems score and it ranged from 17 (normal) to 113 (severe depression). Higher score indicated more severe depression and worse outcome.
Time frame: Baseline (pre-dose on Day 1) and 24 hours post first dose (i.e., Day 2)
Change from Baseline in CDRS-R Total Score at Day 25
The CDRS-R is a 17-item, clinician-reported outcome measure of children's depressive symptom severity. Out of the 17-item, 3 items were non-verbal behavior (listless speech, hypoactivity, and depressed affect) rated on a 5-point scale from 1 (no depression) to 5 (severe depression) and 14 items were rated on a 7-point scale from 1 (no depression) to 7 (severe depression), where higher score indicated more severe depression. The CDRS-R total score was the sum of the 17-tems score and it ranged from 17 (normal) to 113 (severe depression). Higher score indicated more severe depression and worse outcome.
Time frame: Baseline (predose on Day 1) and Day 25 (4 hours post dose)
Change from Baseline in Clinical Global Impression - Severity of Suicidality - Revised (CGI-SS-R) Score at 24 Hours Post First Dose
The CGI-SS-R is a single item clinician-rated measure of the severity of participants' suicidality. The CGI-SS-R asks clinicians to rate the severity of a participant's suicidality using a 7-point scale that ranges from 0 (normal, not at all suicidal) to 6 (among the most extremely suicidal patients). Higher scores indicate greater severity.
Time frame: Baseline (pre-dose on Day 1) and 24 hours post first dose (i.e., Day 2)
Change From Baseline in Symptoms of MDD During the Double-Blind (DB) Treatment Phase as Measured by CDRS-R Total Score
The CDRS-R is a 17-item, clinician-reported outcome measure of children's depressive symptom severity. Out of the 17-item, 3 items were non-verbal behavior (listless speech, hypoactivity, and depressed affect) rated on a 5-point scale from 1 (no depression) to 5 (severe depression) and 14 items were rated on a 7-point scale from 1 (no depression) to 7 (severe depression), where higher score indicated more severe depression. The CDRS-R total score was the sum of the 17-tems score and it ranged from 17 (normal) to 113 (severe depression). Higher score indicated more severe depression and worse outcome.
Time frame: From Baseline up to Day 25
Percentage of Participants with Remission of Depressive Symptoms During the DB Treatment Phase
Remission of depressive symptoms is defined as a CDRS-R total score of both less than or equal to (\<=) 28 and \<= 34 during the DB treatment phase. The CDRS-R is a 17-item, clinician-reported outcome measure of children's depressive symptom severity. Out of the 17-item, 3 items were non-verbal behavior (listless speech, hypoactivity, and depressed affect) rated on a 5 point scale from 1 (no depression) to 5 (severe depression) and 14 items were rated on a 7-point scale from 1 (no depression) to 7 (severe depression), where higher score indicated more severe depression. The CDRS-R total score was the sum of the 17-tems score and it ranged from 17 (normal) to 113 (severe depression). Higher score indicated more severe depression and worse outcome.
Time frame: Up to Day 25
Percentage of Responders on Depressive Symptoms During the DB Treatment Phase
Responders on depressive symptoms is defined as \>= 50 percent (%) improvement in CDRS-R total score from baseline during the DB treatment phase. The CDRS-R is a 17-item, clinician-reported outcome measure of children's depressive symptom severity. Out of the 17-item, 3 items were non-verbal behavior (listless speech, hypoactivity, and depressed affect) rated on a 5 point scale from 1 (no depression) to 5 (severe depression) and 14 items were rated on a 7-point scale from 1 (no depression) to 7 (severe depression), where higher score indicated more severe depression. The CDRS-R total score was the sum of the 17-tems score and it ranged from 17 (normal) to 113 (severe depression). Higher score indicated more severe depression and worse outcome.
Time frame: Up to Day 25
Percentage of Participants with Resolution of Suicidality During the DB Treatment Phase
Participants with resolution of suicidality is defined as a score of 0 (normal, not at all suicidal) or 1 (questionably suicidal) on CGI SS-R, during the DB treatment phase. The CGI-SS-R asks clinicians to rate the severity of a participant's suicidality using a 7-point scale that ranges from 0 (normal, not at all suicidal) to 6 (among the most extremely suicidal patients). Higher score indicate greater severity.
Time frame: Up to Day 25
Change From Baseline in Severity of Suicidality As Measured by Clinical Global Impression - Severity of Suicidality - Revised (CGI-SS-R) During the DB Treatment Phase
The CGI-SS-R is a single item clinician-rated measure of the severity of participants' suicidality. The CGI-SS-R asks clinicians to rate the severity of a participant's suicidality using a 7-point scale that ranges from 0 (normal, not at all suicidal) to 6 (among the most extremely suicidal patients). Higher score indicate greater severity.
Time frame: From Baseline up to Day 25
Change From Baseline in Clinician-Reported Frequency of Suicidal Thinking (FoST-ClinRO) During the DB Treatment Phase
FoST-ClinRO is a clinician-rated measure used to assess a participant's frequency of suicidal thinking assessed during the DB treatment phase. The measure uses a 6-point Likert scale that ranges from 0=Never, to 5=All of the time to assess suicidal thinking frequency, where higher scores indicate a more severe condition.
Time frame: From Baseline up to Day 25
Change from baseline in Patient-Reported Frequency of Suicidal Thinking (FoST-PRO) During the DB Treatment Phase
FoST-PRO is a single item participant reported measure of the frequency of one's suicidal thinking right now. The single item asks participants to rate the frequency with which they have suicidal thoughts (0 = I have no suicidal thoughts, 1 = I have suicidal thoughts a little of the time, 2 = I have suicidal thoughts some of the time, 3 = I have suicidal thoughts most of the time, and 4 = I have suicidal thoughts all of the time). Higher scores indicate greater severity.
Time frame: From Baseline up to Day 25
Change from Baseline in Patient Health Questionnaire, 9-item Modified for Adolescents (PHQ-A) Total Score During the DB Treatment Phase
The PHQ-A is a modified version of the PHQ-9 scale, specifically designed to measure depressive symptom severity in adolescents. A 10-item version of the PHQ-A will be used in this study; the first 9 items assess depressive symptoms. Adolescents use a 4 point Likert scale to rate the severity of their symptoms over the past 2 weeks (range: 0 = not at all to 3 = nearly every day). The PHQ-A total score is the sum of all item responses. The total score can be used to classify adolescents based on the severity of their depressive symptoms: 0-4 (no or minimal depression), 5-9 (mild depression), 10-14 (moderate depression), 15-19 (moderately severe depression), and 20-27 (severe depression). The tenth PHQ-A item measures the degree to which adolescents experience functional difficulties due to their depressive symptoms. Higher scores indicate greater depressive symptoms.
Time frame: From Baseline up to Day 25
Change From Baseline in KIDSCREEN-10 Total Score During the DB Treatment Phase
KIDSCREEN-10 is a global patient-reported outcome (PRO) measure of well-being and health-related quality of life in children and adolescents aged 8-18 years. It includes 10 items that measure the subjective health and psychological, mental and social well-being experiences of children and adolescents over the past week. The scores for the 10 items are summed to produce a total score. This total score can then be transformed into a T-score or percentile rank, based on normative data, to facilitate interpretation. The higher the total score, the better the reported health-related quality of life (HRQoL).
Time frame: From Baseline up to Day 25
Change from Baseline in Patient Global Impression of Severity (PGI-S) Depressive Symptoms at 24 Hours Post First Dose
The PGI-S is a single PRO item that captures one's perceptions of the severity of his/her depressive symptoms over the past 24 hours. Participants will be asked to rate their disease severity using the following 5-point scale: 1 = None, 2 = Mild, 3 = Moderate, 4 = Severe, and 5 = Very severe. Higher scores indicate greater disease severity.
Time frame: Baseline (predose on Day 1) and 24 hours post first dose (i.e., Day 2)
Change from Baseline in Clinical Global Impression - Severity Scale (CGI-S) Depressive Symptoms at 24 Hours Post First Dose
The CGI-S provides an overall clinician-determined summary measure of the severity of the participant's illness that considers all available information, including knowledge of the participant's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the participant's ability to function. The CGI-S will be used to rate the overall severity of illness on a scale of 1 to 7. Considering total clinical experience with the depression population, a participant is assessed on severity of illness at the time of rating according to the following scale: 1=normal (not at all ill); 2=borderline ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients. Higher scores indicate greater severity.
Time frame: Baseline (pre-dose on Day 1) and 24 hours post first dose (i.e., Day 2)
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.
Started Jan 2026 (actual). Primary completion is estimated for Apr 2031, 63 months after the start.
Of 95 industry-sponsored phase 3 interventional studies under Depressive Disorder, Major, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 33. This study's planned 63 months is above that.
Counting every sponsor, half of 124 studies reached it within 27 months; a quarter within 21 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
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 ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Esketamine
Janssen Research & Development, LLC →