{"protocolSection":{"identificationModule":{"nctId":"NCT04599855","orgStudyIdInfo":{"id":"CR108741"},"secondaryIdInfos":[{"id":"54135419TRD4005","type":"OTHER","domain":"Janssen Research & Development, LLC"}],"organization":{"fullName":"Janssen Research & Development, LLC","class":"INDUSTRY"},"briefTitle":"A Study of Esketamine Nasal Spray, Administered as Monotherapy, in Adult Participants With Treatment-resistant Depression","officialTitle":"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"},"statusModule":{"statusVerifiedDate":"2025-04","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2020-11-04","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2024-01-31","type":"ACTUAL"},"completionDateStruct":{"date":"2024-01-31","type":"ACTUAL"},"studyFirstSubmitDate":"2020-10-21","studyFirstSubmitQcDate":"2020-10-21","studyFirstPostDateStruct":{"date":"2020-10-23","type":"ACTUAL"},"resultsFirstSubmitDate":"2025-01-29","resultsFirstSubmitQcDate":"2025-02-10","resultsFirstPostDateStruct":{"date":"2025-03-04","type":"ACTUAL"},"lastUpdateSubmitDate":"2025-04-24","lastUpdatePostDateStruct":{"date":"2025-04-25","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Janssen Research & Development, LLC","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"The purpose of this study is to evaluate the efficacy of each individual dose of esketamine nasal spray, 56 milligram (mg) and 84 mg, compared with placebo nasal spray in improving depressive symptoms in participants with treatment resistant depression (TRD), as assessed by the change from baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) total score from Day 1 (prerandomization) to the end of the 4 week double-blind treatment phase (Day 28)."},"conditionsModule":{"conditions":["Depressive Disorder, Treatment-Resistant"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE4"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"DOUBLE","whoMasked":["PARTICIPANT","INVESTIGATOR"]}},"enrollmentInfo":{"count":477,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Esketamine 56 Milligram (mg)","type":"EXPERIMENTAL","description":"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).","interventionNames":["Drug: Esketamine 56 mg"]},{"label":"Esketamine 84 mg","type":"EXPERIMENTAL","description":"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).","interventionNames":["Drug: Esketamine 84 mg"]},{"label":"Placebo","type":"EXPERIMENTAL","description":"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).","interventionNames":["Drug: Placebo"]}],"interventions":[{"type":"DRUG","name":"Esketamine 56 mg","description":"Esketamine 56 mg will be self administered as nasal spray.","armGroupLabels":["Esketamine 56 Milligram (mg)"],"otherNames":["JNJ-54135419"]},{"type":"DRUG","name":"Esketamine 84 mg","description":"Esketamine 84 mg will be self administered as nasal spray.","armGroupLabels":["Esketamine 84 mg"],"otherNames":["JNJ-54135419"]},{"type":"DRUG","name":"Placebo","description":"Matching placebo will be self administered as nasal spray.","armGroupLabels":["Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Double-blind Treatment Phase: Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Day 1 (Pre-randomization) to Day 28","description":"The MADRS was a clinician-rated scale designed to measure depression severity and detect changes due to antidepressant treatment. The scale consisted of 10 items, each of which was scored from 0 (item not present or normal) to 6 (severe or continuous presence of symptoms). MADRS total score was the sum of scores from individual question items, which ranged from 0 to 60, higher scores represented a more severe condition. The MADRS evaluated apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, inability to feel (interest level), pessimistic thoughts, and suicidal thoughts. Negative change in MADRS total score indicated improvement.","timeFrame":"Day 1 (pre-randomization) to Day 28 (end of DB treatment phase)"}],"secondaryOutcomes":[{"measure":"Double-blind Treatment Phase: Change in MADRS Total Score From Day 1 (Pre-randomization) to Day 2 (24 Hours Post First Dose on Day 1)","description":"The MADRS was a clinician-rated scale designed to measure depression severity and detect changes due to antidepressant treatment. The scale consisted of 10 items, each of which was scored from 0 (item not present or normal) to 6 (severe or continuous presence of symptoms). MADRS total score was the sum of scores from individual question items, which ranged from 0 to 60, higher scores represented a more severe condition. The MADRS evaluated apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, inability to feel (interest level), pessimistic thoughts, and suicidal thoughts. Negative change in MADRS total score indicated improvement.","timeFrame":"Day 1 (pre-randomization) to Day 2 of DB treatment phase (24 hours post first dose on Day 1)"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* 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\n* 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)\n* Participant must have an Inventory of Depressive Symptomatology-Clinician rated, 30-item (IDS-C30) total score of \\>=34\n* 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 vs. Trait, Assessibility, Face Validity, Ecological Validity, Rule of Three P's (SAFER) Interview\n* Participant must be medically stable on the basis of physical examination, medical history, vital signs (including blood pressure), and 12-lead electrocardiogram (ECG) performed in the screening phase. If there are any abnormalities that are not specified in the inclusion and exclusion criteria, the determination of their clinical significance must be determined by the investigator and recorded in the participant's source documents and initiated by the investigator\n* Participant must be medically stable on the basis of clinical laboratory tests performed in the screening phase. If the results of the serum chemistry panel, hematology, or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator: (a) Participants with a pre-existing history of thyroid disease/disorder who are treated with thyroid hormones must be on a stable dosage for 3 months prior to the start of the screening phase; (b) For any participant (regardless of thyroid history), if the thyroid-stimulating hormone (TSH) value is out of range, a free thyroxine (FT4) will be conducted. If the FT4 value is abnormal and considered to be clinically significant (after discussion with the medical monitor), the participant is not eligible\n* Participant must be comfortable with self-administration of nasal spray medication and be able to follow the nasal spray administration instructions provided\n\nExclusion Criteria:\n\n* The participant has used ketamine/esketamine (lifetime)\n* The participant's depressive symptoms have previously demonstrated nonresponse to an adequate course of treatment with electroconvulsive therapy (ECT) in the current major depressive episode, defined as at least 7 treatments with unilateral/bilateral ECT\n* Participant has received vagal nerve stimulation (VNS) or has received deep brain stimulation (DBS) in the current episode of depression\n* Participant has a current or history of seizures (uncomplicated childhood febrile seizures with no sequelae are not exclusionary)\n* Participant has any anatomical or medical condition that, per the investigator's clinical judgment based on assessment, may impede delivery or absorption of nasal spray study drug","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Janssen Research & Development, LLC Clinical Trial","affiliation":"Janssen Research & Development, LLC","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"UAB Department of Psychiatry and Behavioral Neurobiology","city":"Birmingham","state":"Alabama","zip":"35294","country":"United States","geoPoint":{"lat":33.52066,"lon":-86.80249}},{"facility":"UAB Huntsville Regional Medical Campus","city":"Huntsville","state":"Alabama","zip":"35801","country":"United States","geoPoint":{"lat":34.7304,"lon":-86.58594}},{"facility":"Preferred Research Partners","city":"Little Rock","state":"Arkansas","zip":"72211","country":"United States","geoPoint":{"lat":34.74648,"lon":-92.28959}},{"facility":"Behavioral Research Specialists 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Nancy Friend Pritzker Psychiatry Building","city":"San Francisco","state":"California","zip":"94143","country":"United States","geoPoint":{"lat":37.77493,"lon":-122.41942}},{"facility":"Velocity Clinical Research","city":"Santa Ana","state":"California","zip":"91704","country":"United States","geoPoint":{"lat":33.74557,"lon":-117.86783}},{"facility":"CMB Clinical Trials","city":"Santee","state":"California","zip":"92071","country":"United States","geoPoint":{"lat":32.83838,"lon":-116.97392}},{"facility":"University of Connecticut Health Center","city":"Farmington","state":"Connecticut","zip":"06032","country":"United States","geoPoint":{"lat":41.71982,"lon":-72.83204}},{"facility":"Velocity Clinical Research, Hallandale Beach","city":"Hallandale","state":"Florida","zip":"33009","country":"United States","geoPoint":{"lat":25.9812,"lon":-80.14838}},{"facility":"Accel Research Sites","city":"Lakeland","state":"Florida","zip":"33803","country":"United 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Medical School of Brown University - Butler Hospital","city":"Providence","state":"Rhode Island","zip":"02906","country":"United States","geoPoint":{"lat":41.82399,"lon":-71.41283}},{"facility":"BioBehavioral Research of Austin PC","city":"Austin","state":"Texas","zip":"78759","country":"United States","geoPoint":{"lat":30.26715,"lon":-97.74306}},{"facility":"Relaro Medical Trials","city":"Dallas","state":"Texas","zip":"75243","country":"United States","geoPoint":{"lat":32.78306,"lon":-96.80667}},{"facility":"University of Texas Southwestern Medical Center","city":"Dallas","state":"Texas","zip":"75247","country":"United States","geoPoint":{"lat":32.78306,"lon":-96.80667}},{"facility":"Brain Health Consultants and TMS Center","city":"Houston","state":"Texas","zip":"77046","country":"United States","geoPoint":{"lat":29.76328,"lon":-95.36327}},{"facility":"The University of Texas Health Science Center at Houston","city":"Houston","state":"Texas","zip":"77054","country":"United 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Esketamine Monotherapy in Adults With Treatment-Resistant Depression: A Randomized Clinical Trial. JAMA Psychiatry. 2025 Sep 1;82(9):877-887. doi: 10.1001/jamapsychiatry.2025.1317."},{"pmid":"39428602","type":"DERIVED","citation":"Vekhova KA, Namiot ED, Jonsson J, Schioth HB. Ketamine and Esketamine in Clinical Trials: FDA-Approved and Emerging Indications, Trial Trends With Putative Mechanistic Explanations. Clin Pharmacol Ther. 2025 Feb;117(2):374-386. doi: 10.1002/cpt.3478. Epub 2024 Oct 20."}]}},"resultsSection":{"participantFlowModule":{"recruitmentDetails":"Adult participants with recurrent or single (duration greater than or equal to \\[\\>=\\] 2 years) episode major depressive disorder (DSM-5 criteria) without psychotic features who experienced inadequate response (less than or equal to \\[\\<=\\] 25 percent \\[%\\] improvement) to \\>=2 oral antidepressants during the current depressive episode were randomized in the study.","groups":[{"id":"FG000","title":"Placebo","description":"In the double-blind (DB) phase, participants received placebo nasal spray (matching to esketamine) twice a week for 4 weeks on Days 1, 4, 8, 11, 15, 18, 22, and 25. After completion of the DB phase (including Day 28 visit), participants opted to enter the open-label (OL) phase (treatment/observation phase). Participants who opted OL treatment phase received esketamine 56 milligrams (mg) nasal spray on Day 28 regardless of the treatment assignment in the DB phase and received subsequent doses at the same or adjusted (56 mg or 84 mg) dose level based on efficacy and tolerability with dosing frequency: twice weekly from Weeks 5 to 8 followed by once weekly from Weeks 9 to 12 and then weekly or every other week from Weeks 13 to 16 based on clinical judgment and was individualized to the least frequent dosing to maintain remission/response. During this period participants were given the option to receive standard-of-care treatment for depression. Participants who opted OL observation phase were only observed without esketamine nasal spray treatment but received standard-of-care treatment for depression. All participants underwent 1-week follow-up phase for safety assessment after their last dose of study treatment in DB or OL treatment phase."},{"id":"FG001","title":"Esketamine 56 mg","description":"In the DB phase, participants received esketamine 56 mg nasal spray twice a week for 4 weeks on Days 1, 4, 8, 11, 15, 18, 22, and 25. After completion of the DB phase (including Day 28 visit), participants opted to enter the OL phase (treatment/observation phase). Participants who opted OL treatment phase received esketamine 56 mg nasal spray on Day 28 regardless of the treatment assignment in the DB phase and received subsequent doses at the same or adjusted (56 mg or 84 mg) dose level based on efficacy and tolerability with dosing frequency: twice weekly from Weeks 5 to 8 followed by once weekly from Weeks 9 to 12 and then weekly or every other week from Weeks 13 to 16 based on clinical judgment and was individualized to the least frequent dosing to maintain remission/response. During this period participants were given the option to receive standard-of-care treatment for depression. Participants who opted OL observation phase were only observed without esketamine nasal spray treatment but received standard-of-care treatment for depression. All participants underwent 1-week follow-up phase for safety assessment after their last dose of study treatment in DB or OL treatment phase."},{"id":"FG002","title":"Esketamine 84 mg","description":"In the DB phase, participants received esketamine 84 mg nasal spray twice a week for 4 weeks on Days 1, 4, 8, 11, 15, 18, 22, and 25. After completion of the DB phase (including Day 28 visit), participants opted to enter the OL phase (treatment/observation phase). Participants who opted OL treatment phase received esketamine 56 mg nasal spray on Day 28 regardless of the treatment assignment in the DB phase and received subsequent doses at the same or adjusted (56 mg or 84 mg) dose level based on efficacy and tolerability with dosing frequency: twice weekly from Weeks 5 to 8 followed by once weekly from Weeks 9 to 12 and then weekly or every other week from Weeks 13 to 16 based on clinical judgment and was individualized to the least frequent dosing to maintain remission/response. During this period participants were given the option to receive standard-of-care treatment for depression. Participants who opted OL observation phase were only observed without esketamine nasal spray treatment but received standard-of-care treatment for depression. All participants underwent 1-week follow-up phase for safety assessment after their last dose of study treatment in DB or OL treatment phase."}],"periods":[{"title":"Double Blind Period (Day 1 to Day 28)","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"250"},{"groupId":"FG001","numSubjects":"106"},{"groupId":"FG002","numSubjects":"121"}]},{"type":"Treated","achievements":[{"groupId":"FG000","numSubjects":"250"},{"groupId":"FG001","numSubjects":"105"},{"groupId":"FG002","numSubjects":"121"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"238"},{"groupId":"FG001","numSubjects":"101"},{"groupId":"FG002","numSubjects":"107"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"12"},{"groupId":"FG001","numSubjects":"5"},{"groupId":"FG002","numSubjects":"14"}]}],"dropWithdraws":[{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"5"}]},{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"5"}]},{"type":"Lack of Efficacy","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"2"}]},{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"Pregnancy","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"Other","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"}]},{"type":"Randomized but not treated","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}]}]},{"title":"Period Title: OL Period (Week 5 to 16)","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"237"},{"groupId":"FG001","numSubjects":"99"},{"groupId":"FG002","numSubjects":"106"}]},{"type":"Participants Who Entered OL Treatment Phase","achievements":[{"groupId":"FG000","numSubjects":"237"},{"groupId":"FG001","numSubjects":"99"},{"groupId":"FG002","numSubjects":"105"}]},{"type":"Participants Who Entered OL Observation Phase","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"204"},{"groupId":"FG001","numSubjects":"87"},{"groupId":"FG002","comment":"Included one participant who entered OL observation phase.","numSubjects":"95"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"33"},{"groupId":"FG001","numSubjects":"12"},{"groupId":"FG002","numSubjects":"11"}]}],"dropWithdraws":[{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"8"},{"groupId":"FG001","numSubjects":"5"},{"groupId":"FG002","numSubjects":"6"}]},{"type":"Lack of Efficacy","reasons":[{"groupId":"FG000","numSubjects":"10"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"2"}]},{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"1"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"2"}]},{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"Other","reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"Safety analysis set included all randomized participants (participants who met and did not meet nonresponse criteria) who received at least 1 dose of DB study intervention.","groups":[{"id":"BG000","title":"Placebo","description":"In the double-blind (DB) phase, participants received placebo nasal spray (matching to esketamine) twice a week for 4 weeks on Days 1, 4, 8, 11, 15, 18, 22, and 25. After completion of the DB phase (including Day 28 visit), participants opted to enter the open-label (OL) phase (treatment/observation phase). Participants who opted OL treatment phase received esketamine 56 milligrams (mg) nasal spray on Day 28 regardless of the treatment assignment in the DB phase and received subsequent doses at the same or adjusted (56 mg or 84 mg) dose level based on efficacy and tolerability with dosing frequency: twice weekly from Weeks 5 to 8 followed by once weekly from Weeks 9 to 12 and then weekly or every other week from Weeks 13 to 16 based on clinical judgment and was individualized to the least frequent dosing to maintain remission/response. During this period participants were given the option to receive standard-of-care treatment for depression. Participants who opted OL observation phase were only observed without esketamine nasal spray treatment but received standard-of-care treatment for depression. All participants underwent 1-week follow-up phase for safety assessment after their last dose of study treatment in DB or OL treatment phase."},{"id":"BG001","title":"Esketamine 56 mg","description":"In the DB phase, participants received esketamine 56 mg nasal spray twice a week for 4 weeks on Days 1, 4, 8, 11, 15, 18, 22, and 25. After completion of the DB phase (including Day 28 visit), participants opted to enter the OL phase (treatment/observation phase). Participants who opted OL treatment phase received esketamine 56 mg nasal spray on Day 28 regardless of the treatment assignment in the DB phase and received subsequent doses at the same or adjusted (56 mg or 84 mg) dose level based on efficacy and tolerability with dosing frequency: twice weekly from Weeks 5 to 8 followed by once weekly from Weeks 9 to 12 and then weekly or every other week from Weeks 13 to 16 based on clinical judgment and was individualized to the least frequent dosing to maintain remission/response. During this period participants were given the option to receive standard-of-care treatment for depression. Participants who opted OL observation phase were only observed without esketamine nasal spray treatment but received standard-of-care treatment for depression. All participants underwent 1-week follow-up phase for safety assessment after their last dose of study treatment in DB or OL treatment phase."},{"id":"BG002","title":"Esketamine 84 mg","description":"In the DB phase, participants received esketamine 84 mg nasal spray twice a week for 4 weeks on Days 1, 4, 8, 11, 15, 18, 22, and 25. After completion of the DB phase (including Day 28 visit), participants opted to enter the OL phase (treatment/observation phase). Participants who opted OL treatment phase received esketamine 56 mg nasal spray on Day 28 regardless of the treatment assignment in the DB phase and received subsequent doses at the same or adjusted (56 mg or 84 mg) dose level based on efficacy and tolerability with dosing frequency: twice weekly from Weeks 5 to 8 followed by once weekly from Weeks 9 to 12 and then weekly or every other week from Weeks 13 to 16 based on clinical judgment and was individualized to the least frequent dosing to maintain remission/response. During this period participants were given the option to receive standard-of-care treatment for depression. Participants who opted OL observation phase were only observed without esketamine nasal spray treatment but received standard-of-care treatment for depression. All participants underwent 1-week follow-up phase for safety assessment after their last dose of study treatment in DB or OL treatment phase."},{"id":"BG003","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"250"},{"groupId":"BG001","value":"105"},{"groupId":"BG002","value":"121"},{"groupId":"BG003","value":"476"}]}],"measures":[{"title":"Age, Categorical","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"<=18 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]},{"title":"Between 18 and 65 years","measurements":[{"groupId":"BG000","value":"229"},{"groupId":"BG001","value":"95"},{"groupId":"BG002","value":"107"},{"groupId":"BG003","value":"431"}]},{"title":">=65 years","measurements":[{"groupId":"BG000","value":"21"},{"groupId":"BG001","value":"10"},{"groupId":"BG002","value":"14"},{"groupId":"BG003","value":"45"}]}]}]},{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"45.4","spread":"13.72"},{"groupId":"BG001","value":"45.1","spread":"13.92"},{"groupId":"BG002","value":"45.1","spread":"14.75"},{"groupId":"BG003","value":"45.3","spread":"14.01"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"147"},{"groupId":"BG001","value":"60"},{"groupId":"BG002","value":"77"},{"groupId":"BG003","value":"284"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"103"},{"groupId":"BG001","value":"45"},{"groupId":"BG002","value":"44"},{"groupId":"BG003","value":"192"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"25"},{"groupId":"BG001","value":"9"},{"groupId":"BG002","value":"8"},{"groupId":"BG003","value":"42"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"221"},{"groupId":"BG001","value":"95"},{"groupId":"BG002","value":"112"},{"groupId":"BG003","value":"428"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"6"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"1"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"6"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"5"},{"groupId":"BG003","value":"14"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"2"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"17"},{"groupId":"BG001","value":"7"},{"groupId":"BG002","value":"11"},{"groupId":"BG003","value":"35"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"217"},{"groupId":"BG001","value":"91"},{"groupId":"BG002","value":"102"},{"groupId":"BG003","value":"410"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"6"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"2"},{"groupId":"BG003","value":"9"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"5"}]}]}]},{"title":"Region of Enrollment","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"250"},{"groupId":"BG001","value":"105"},{"groupId":"BG002","value":"121"},{"groupId":"BG003","value":"476"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Double-blind Treatment Phase: Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Day 1 (Pre-randomization) to Day 28","description":"The MADRS was a clinician-rated scale designed to measure depression severity and detect changes due to antidepressant treatment. The scale consisted of 10 items, each of which was scored from 0 (item not present or normal) to 6 (severe or continuous presence of symptoms). MADRS total score was the sum of scores from individual question items, which ranged from 0 to 60, higher scores represented a more severe condition. The MADRS evaluated apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, inability to feel (interest level), pessimistic thoughts, and suicidal thoughts. Negative change in MADRS total score indicated improvement.","populationDescription":"Full efficacy analysis set included all randomized participants who met nonresponse criteria and received at least 1 dose of DB study intervention. Here 'N' (overall number of participants analyzed) refers to the number of participants evaluable for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Score on a scale","timeFrame":"Day 1 (pre-randomization) to Day 28 (end of DB treatment phase)","groups":[{"id":"OG000","title":"DB: Placebo","description":"In the double-blind (DB) phase, participants received placebo nasal spray (matching to esketamine) twice a week for 4 weeks on Days 1, 4, 8, 11, 15, 18, 22, and 25. All participants underwent 1-week follow-up phase for safety assessment after their last dose of study treatment in DB phase."},{"id":"OG001","title":"DB: Esketamine 56 mg","description":"In the DB phase, participants received esketamine 56 mg nasal spray twice a week for 4 weeks on Days 1, 4, 8, 11, 15, 18, 22, and 25. All participants underwent 1-week follow-up phase for safety assessment after their last dose of study treatment in DB phase."},{"id":"OG002","title":"DB: Esketamine 84 mg","description":"In the DB phase, participants received esketamine 84 mg nasal spray twice a week for 4 weeks on Days 1, 4, 8, 11, 15, 18, 22, and 25. All participants underwent 1-week follow-up phase for safety assessment after their last dose of study treatment in DB phase."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"185"},{"groupId":"OG001","value":"82"},{"groupId":"OG002","value":"89"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-7.0","spread":"10.07"},{"groupId":"OG001","value":"-12.7","spread":"11.82"},{"groupId":"OG002","value":"-13.9","spread":"11.89"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed model for repeated measures","paramType":"least square (LS) means difference","paramValue":"-5.1","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-7.91","ciUpperLimit":"-2.33","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"1.42"},{"groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed model for repeated measures","paramType":"LS means difference","paramValue":"-6.8","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-9.48","ciUpperLimit":"-4.07","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"1.38"}]},{"type":"SECONDARY","title":"Double-blind Treatment Phase: Change in MADRS Total Score From Day 1 (Pre-randomization) to Day 2 (24 Hours Post First Dose on Day 1)","description":"The MADRS was a clinician-rated scale designed to measure depression severity and detect changes due to antidepressant treatment. The scale consisted of 10 items, each of which was scored from 0 (item not present or normal) to 6 (severe or continuous presence of symptoms). MADRS total score was the sum of scores from individual question items, which ranged from 0 to 60, higher scores represented a more severe condition. The MADRS evaluated apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, inability to feel (interest level), pessimistic thoughts, and suicidal thoughts. Negative change in MADRS total score indicated improvement.","populationDescription":"Full efficacy analysis set included all randomized participants who met nonresponse criteria and received at least 1 dose of DB study intervention. Here 'N' (overall number of participants analyzed) refers to the number of participants evaluable for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Score on a scale","timeFrame":"Day 1 (pre-randomization) to Day 2 of DB treatment phase (24 hours post first dose on Day 1)","groups":[{"id":"OG000","title":"DB: Placebo","description":"In the double-blind (DB) phase, participants received placebo nasal spray (matching to esketamine) twice a week for 4 weeks on Days 1, 4, 8, 11, 15, 18, 22, and 25. All participants underwent 1-week follow-up phase for safety assessment after their last dose of study treatment in DB phase."},{"id":"OG001","title":"DB: Esketamine 56 mg","description":"In the DB phase, participants received esketamine 56 mg nasal spray twice a week for 4 weeks on Days 1, 4, 8, 11, 15, 18, 22, and 25. 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All participants underwent 1-week follow-up phase for safety assessment after their last dose of study treatment in DB phase."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"195"},{"groupId":"OG001","value":"84"},{"groupId":"OG002","value":"93"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-9.7","spread":"10.27"},{"groupId":"OG001","value":"-13.9","spread":"10.15"},{"groupId":"OG002","value":"-13.0","spread":"9.68"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"=0.004","statisticalMethod":"Mixed model for repeated measures","paramType":"LS means difference","paramValue":"-3.8","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-6.29","ciUpperLimit":"-1.22","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"1.29"},{"groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"=0.006","statisticalMethod":"Mixed model for repeated measures","paramType":"LS means difference","paramValue":"-3.4","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-5.89","ciUpperLimit":"-1.00","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"1.24"}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"Double-blind (DB) phase: From Day 1 (post-dose) to Day 28; Open-label (OL) phase: From Week 5 to Week 16; Follow-up (FU) phase: Up to 1 week after last dose of study drug in DB phase (Week 5) or OL treatment phase (Week 17)","description":"All cause mortality:Randomized analysis set:all randomized participants; serious adverse events (AE)/other AE:DB:Safety analysis set(SAS):all randomized participants who received at least 1 dose of DB intervention; OL arms:OL analysis set:all participants who received at least 1 dose of OL esketamine; OL observation arm:Observation analysis set:all participants who entered observation phase but did not receive OL esketamine; FU:SAS. 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As planned, OL phase adverse events analysis was performed by treatment groups assigned in the DB phase, irrespective of the OL phase adjusted doses.","deathsNumAffected":0,"deathsNumAtRisk":105,"seriousNumAffected":0,"seriousNumAtRisk":105,"otherNumAffected":44,"otherNumAtRisk":105},{"id":"EG006","title":"OL Observation Period","description":"After completion of DB treatment phase, participants who opted OL observation phase were only observed without esketamine nasal spray treatment but received standard-of-care treatment for depression.","deathsNumAffected":0,"deathsNumAtRisk":1,"seriousNumAffected":0,"seriousNumAtRisk":1,"otherNumAffected":0,"otherNumAtRisk":1},{"id":"EG007","title":"Follow up: All Participants","description":"Participants who received at least 1 dose of study treatment in the DB or OL treatment phase entered into 1- week follow-up phase after their last dose of study 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