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

15. Juli 2026 aktualisiert von: 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).

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

348

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Taiwan
      • Taipei, Taiwan, 110
        • Taipei Medical University

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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)

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Esketamine 56 milligram (mg)
Participants will be randomized to receive double-blind (DB) treatment with esketamine 56 mg, twice a week for 4 weeks. Participants who complete the DB treatment phase on Day 28 may be eligible to participate in an open-label treatment phase and receive either esketamine 56 or 84 mg.
Arzneimittel: Esketamin 56 mg
Die Teilnehmer werden 56 mg Esketamin als intranasales Spray in jedes Nasenloch selbst verabschiedet.
Andere Namen:
  • JNJ-54135419
Arzneimittel: Esketamin 84 mg
Die Teilnehmer werden 84 mg Esketamin als intranasales Spray in jedes Nasenloch selbst verabschiedet.
Andere Namen:
  • JNJ-54135419
Experimental: Esketamine 84 mg
Participants will be randomized to receive DB treatment with esketamine 84 mg, twice a week for 4 weeks. Participants who complete the DB treatment phase on Day 28 may be eligible to participate in an open-label treatment phase and receive either esketamine 56 or 84 mg.
Arzneimittel: Esketamin 56 mg
Die Teilnehmer werden 56 mg Esketamin als intranasales Spray in jedes Nasenloch selbst verabschiedet.
Andere Namen:
  • JNJ-54135419
Arzneimittel: Esketamin 84 mg
Die Teilnehmer werden 84 mg Esketamin als intranasales Spray in jedes Nasenloch selbst verabschiedet.
Andere Namen:
  • JNJ-54135419
Placebo-Komparator: 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.
Arzneimittel: Esketamin 56 mg
Die Teilnehmer werden 56 mg Esketamin als intranasales Spray in jedes Nasenloch selbst verabschiedet.
Andere Namen:
  • JNJ-54135419
Arzneimittel: Esketamin 84 mg
Die Teilnehmer werden 84 mg Esketamin als intranasales Spray in jedes Nasenloch selbst verabschiedet.
Andere Namen:
  • JNJ-54135419
Arzneimittel: Placebo
Participants will self-administer placebo as intranasal spray into each nostril.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
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
Zeitfenster: 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)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
DB Treatment Phase: Change From Baseline in MADRS Total Score From Day 1 to Day 2
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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 Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
DB Treatment Phase: Number of Participants with Abnormalities in Blood Oxygen Saturation (SpO2)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Janssen Research & Development, LLC

Ermittler

  • Studienleiter: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

3. August 2026

Primärer Abschluss (Geschätzt)

27. Dezember 2028

Studienabschluss (Geschätzt)

12. September 2029

Studienanmeldedaten

Zuerst eingereicht

15. Juli 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

15. Juli 2026

Zuerst gepostet (Tatsächlich)

21. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

21. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

15. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 54135419TRD3015

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

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

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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