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

27 augustus 2026 bijgewerkt door: Janssen Research & Development, LLC

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

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

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

348

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Japan
      • Kawasaki, Japan, 214-0014
        • Werving
        • Kishiro Mental Clinic
      • Kobe, Japan, 651-0097
        • Werving
        • Tatsuta Clinic
      • Kodaira-shi, Japan, 187-8551
        • Werving
        • National Center of Neurology and Psychiatry
      • Nagasaki, Japan, 852-8137
        • Werving
        • Arata Clinic
      • Sapporo, Japan, 060 8648
        • Werving
        • Hokkaido University Hospital
      • Setagaya Ku, Japan, 154 0004
        • Werving
        • Sangenjaya neurology-psychosomatic clinic
      • Shibuya-ku, Japan, 151-0053
        • Werving
        • Maynds Tower Mental Clinic
      • Tottori, Japan, 683-0824
        • Werving
        • Tottori University Hospital
  • Taiwan
      • Taichung, Taiwan, 402
        • Werving
        • Chung Shan Medical University Hospital
      • Taipei, Taiwan, 11217
        • Werving
        • Taipei Veterans General Hospital
      • Taipei, Taiwan, 110
        • Werving
        • Taipei Medical University
      • Taoyuan, Taiwan, 333
        • Werving
        • Linkou Chang Gung Memorial Hospital
  • Verenigde Staten
    • California
      • Redlands, California, Verenigde Staten, 92374
        • Werving
        • Anderson Clinical Research
    • Illinois
      • Skokie, Illinois, Verenigde Staten, 60076
        • Werving
        • Psychiatric Medicine Associates LLC
    • New York
      • New York, New York, Verenigde Staten, 10128
        • Werving
        • The Medical Research Network, LLC

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusion Criteria:

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

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 DSM-5 criteria, except nicotine or caffeine, within 6 months before the start of the screening phase. a. A history (lifetime) of ketamine, phencyclidine (PCP), lysergic acid diethylamide (LSD), or 3, 4-methylenedioxy-methamphetamine (MDMA) hallucinogen-related use disorder is exclusionary
  • Participant has a current or history of seizures (uncomplicated childhood febrile seizures with no sequelae are not exclusionary)

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Geneesmiddel: Esketamine 56 mg
Deelnemers zullen zelf 56 mg esketamine als intranasale spray in elk neusgatspray administreren.
Andere namen:
  • JNJ-54135419
Geneesmiddel: Esketamine 84 mg
Deelnemers zullen zelf 84 mg esketamine als intranasale spray in elk neusgatspray toelaten.
Andere namen:
  • JNJ-54135419
Experimenteel: 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.
Geneesmiddel: Esketamine 56 mg
Deelnemers zullen zelf 56 mg esketamine als intranasale spray in elk neusgatspray administreren.
Andere namen:
  • JNJ-54135419
Geneesmiddel: Esketamine 84 mg
Deelnemers zullen zelf 84 mg esketamine als intranasale spray in elk neusgatspray toelaten.
Andere namen:
  • JNJ-54135419
Placebo-vergelijker: 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.
Geneesmiddel: Esketamine 56 mg
Deelnemers zullen zelf 56 mg esketamine als intranasale spray in elk neusgatspray administreren.
Andere namen:
  • JNJ-54135419
Geneesmiddel: Esketamine 84 mg
Deelnemers zullen zelf 84 mg esketamine als intranasale spray in elk neusgatspray toelaten.
Andere namen:
  • JNJ-54135419
Geneesmiddel: Placebo
Participants will self-administer placebo as intranasal spray into each nostril.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
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
Tijdsspanne: Baseline (Day 1 [prerandomization]) up to end of the 4-Week DB treatment phase (Day 28)
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.
Baseline (Day 1 [prerandomization]) up to end of the 4-Week DB treatment phase (Day 28)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
DB Treatment Phase: Change From Baseline in MADRS Total Score From Day 1 to Day 2
Tijdsspanne: Baseline (Day 1 [prerandomization]) up to Day 2 (approximately 24 hours after the first dose)
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.
Baseline (Day 1 [prerandomization]) up to Day 2 (approximately 24 hours after the first dose)
DB Treatment Phase: Percentage of Responders in MADRS Over Time to the End of the 4-Week DB Treatment Phase
Tijdsspanne: Up to end of the 4-Week DB treatment phase (Day 28)
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.
Up to end of the 4-Week DB treatment phase (Day 28)
DB Treatment Phase: Percentage of Participants in Remission in MADRS Over Time to the End of the 4-Week DB Treatment Phase
Tijdsspanne: Up to end of the 4-Week DB treatment phase (Day 28)
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.
Up to end of the 4-Week DB treatment phase (Day 28)
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
Tijdsspanne: Baseline up to end of the 4-Week DB treatment phase (Day 28)
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).
Baseline up to end of the 4-Week DB treatment phase (Day 28)
DB Treatment Phase: Change From Baseline in MADRS Total Score Over Time to the End of the 4-Week DB Treatment Phase
Tijdsspanne: Baseline up to end of the 4-Week DB treatment phase (Day 28)
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.
Baseline up to end of the 4-Week DB treatment phase (Day 28)
DB Treatment Phase: Change From Baseline in Individual MADRS Item Scores Over Time to the End of the 4-Week DB Treatment Phase
Tijdsspanne: Baseline up to end of the 4-Week DB treatment phase (Day 28)
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.
Baseline up to end of the 4-Week DB treatment phase (Day 28)
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
Tijdsspanne: Baseline up to end of the 4-Week DB treatment phase (Day 28)
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.
Baseline up to end of the 4-Week DB treatment phase (Day 28)
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
Tijdsspanne: Baseline up to end of the 4-Week DB treatment phase (Day 28)
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).
Baseline up to end of the 4-Week DB treatment phase (Day 28)
DB Treatment Phase: Change From Baseline in PHQ-9 Total Score Over Time to the End of the 4-Week DB Treatment Phase
Tijdsspanne: Baseline up to end of the 4-Week DB treatment phase (Day 28)
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.
Baseline up to end of the 4-Week DB treatment phase (Day 28)
DB Treatment Phase: Percentage of Responders in PHQ-9 Over Time to the End of the 4-Week DB Treatment Phase
Tijdsspanne: Up to end of the 4-Week DB treatment phase (Day 28)
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.
Up to end of the 4-Week DB treatment phase (Day 28)
DB Treatment Phase: Percentage of Participants in Remission in PHQ-9 Over Time to the End of the 4-Week DB Treatment Phase
Tijdsspanne: Up to end of the 4-Week DB treatment phase (Day 28)
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.
Up to end of the 4-Week DB treatment phase (Day 28)
Open-Label (OL) Treatment Phase: Percentage of Responders in MADRS Over Time to the End of the OL Treatment Phase
Tijdsspanne: Up to 12 Weeks
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.
Up to 12 Weeks
OL Treatment Phase: Percentage of Participants in Remission in MADRS Over Time to the End of the OL Treatment Phase
Tijdsspanne: Up to 12 Weeks
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.
Up to 12 Weeks
OL Treatment Phase: Change From Baseline in CGI-S Over Time to the End of the OL Treatment Phase
Tijdsspanne: Baseline (Day 28) up to 12 Weeks
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).
Baseline (Day 28) up to 12 Weeks
OL Treatment Phase: Change From Baseline in MADRS Total Score Over Time to the End of the OL Treatment Phase
Tijdsspanne: Baseline (Day 28) up to 12 Weeks
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.
Baseline (Day 28) up to 12 Weeks
OL Treatment Phase: Change From Baseline in Individual MADRS Item Scores Over Time to the End of the OL Treatment Phase
Tijdsspanne: Baseline (Day 28) up to 12 Weeks
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.
Baseline (Day 28) up to 12 Weeks
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
Tijdsspanne: Baseline (Day 28) up to 12 Weeks
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.
Baseline (Day 28) up to 12 Weeks
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
Tijdsspanne: Baseline (Day 28) up to 12 Weeks
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.
Baseline (Day 28) up to 12 Weeks
OL Treatment Phase: Change From Baseline in PHQ-9 Total Score Over Time to the End of the OL Treatment Phase
Tijdsspanne: Baseline (Day 28) up to 12 Weeks
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.
Baseline (Day 28) up to 12 Weeks
OL Treatment Phase: Percentage of Responders in PHQ-9 Over Time to the End of the OL Treatment Phase
Tijdsspanne: Up to 12 Weeks
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.
Up to 12 Weeks
OL Treatment Phase: Percentage of Participants in Remission in PHQ-9 Over Time to the End of the OL Treatment Phase
Tijdsspanne: Up to 12 Weeks
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.
Up to 12 Weeks

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
DB Treatment Phase: Number of Participants with Abnormalities in Blood Oxygen Saturation (SpO2)
Tijdsspanne: Up to end of the 4-Week DB treatment phase (Day 28)
Number of participants who experience abnormally low blood oxygen saturation will be reported.
Up to end of the 4-Week DB treatment phase (Day 28)
DB Treatment Phase: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Tijdsspanne: Up to end of the 4-Week DB treatment phase (Day 28)
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.
Up to end of the 4-Week DB treatment phase (Day 28)
DB Treatment Phase: Suicidal Ideation and Behavior as Assessed Using the Columbia Suicide Severity Rating Scale (C-SSRS)
Tijdsspanne: Up to end of the 4-Week DB treatment phase (Day 28)
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.
Up to end of the 4-Week DB treatment phase (Day 28)
DB Treatment Phase: Number of Participants with Effects on Dissociative Symptoms As Measured Using the Clinician Administered Dissociative States Scale (CADSS)
Tijdsspanne: Up to end of the 4-Week DB treatment phase (Day 28)
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.
Up to end of the 4-Week DB treatment phase (Day 28)
DB Treatment Phase: Number of Participants with Abnormalities in Physical Examination
Tijdsspanne: Up to end of the 4-Week DB treatment phase (Day 28)
Number of participants with abnormalities in physical examination will be reported.
Up to end of the 4-Week DB treatment phase (Day 28)
DB Treatment Phase: Number of Participants with Abnormalities in Vital Signs
Tijdsspanne: Up to end of the 4-Week DB treatment phase (Day 28)
Number of participants with abnormalities in vital signs (blood pressure, pulse/heart rate measurements, and temperature) will be reported.
Up to end of the 4-Week DB treatment phase (Day 28)
DB Treatment Phase: Number of Participants Reporting Clinically Meaningful Changes in Body Weight
Tijdsspanne: Up to end of the 4-Week DB treatment phase (Day 28)
Number of participants reporting clinically meaningful changes in body weight will be reported.
Up to end of the 4-Week DB treatment phase (Day 28)
DB Treatment Phase: Number of Participants with Abnormalities in 12-lead Electrocardiogram (ECG)
Tijdsspanne: Up to end of the 4-Week DB treatment phase (Day 28)
Number of participants with abnormalities in 12-lead ECG will be reported.
Up to end of the 4-Week DB treatment phase (Day 28)
OL Treatment Phase: Number of Participants with Abnormalities in SpO2
Tijdsspanne: Up to 12 Weeks
Number of participants who experience abnormally low blood oxygen saturation will be reported.
Up to 12 Weeks
OL Treatment Phase: Number of Participants With TEAEs
Tijdsspanne: Up to 12 Weeks
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.
Up to 12 Weeks
OL Treatment Phase: Suicidal Ideation and Behavior as Assessed Using the C-SSRS
Tijdsspanne: Up to 12 Weeks
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.
Up to 12 Weeks
OL Treatment Phase: Number of Participants with Abnormalities in Vital Signs
Tijdsspanne: Up to 12 Weeks
Number of participants with abnormalities in vital signs (blood pressure, pulse/heart rate measurements, and temperature) will be reported.
Up to 12 Weeks
OL Treatment Phase: Number of Participants Reporting Clinically Meaningful Changes in Body Weight
Tijdsspanne: Up to 12 Weeks
Number of participants reporting clinically meaningful changes in body weight will be reported.
Up to 12 Weeks
OL Treatment Phase: Number of Participants with Abnormalities in 12-lead ECG
Tijdsspanne: Up to 12 Weeks
Number of participants with abnormalities in 12-lead ECG will be reported.
Up to 12 Weeks
OL Treatment Phase: Number of Participants with Potential Withdrawal Symptoms After Stopping Study Drug Treatment as Measured by the Physician Withdrawal Checklist (PWC-20)
Tijdsspanne: Up to 12 Weeks
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.
Up to 12 Weeks

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Janssen Research & Development, LLC

Onderzoekers

  • Studie directeur: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

23 juli 2026

Primaire voltooiing (Geschat)

27 december 2028

Studie voltooiing (Geschat)

12 september 2029

Studieregistratiedata

Eerst ingediend

15 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

15 juli 2026

Eerst geplaatst (Werkelijk)

21 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

28 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

27 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 54135419TRD3015

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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