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

2026年8月27日 更新者：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).

調査の概要

状態

募集

条件

介入・治療

研究の種類

介入

入学 (推定)

348

段階

  • フェーズ 3

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

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

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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)

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：ダブル

武器と介入

参加者グループ / アーム
介入・治療
実験的：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.
薬：エスカミン56 mg
参加者は、各鼻孔への鼻腔内スプレーとして56 mgのエスケタミンを自己投与します。
他の名前：
  • JNJ-54135419
薬：エスカミン84 mg
参加者は、各鼻孔への鼻腔内スプレーとして84 mgのエスケタミンを自己投与します。
他の名前：
  • JNJ-54135419
実験的：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.
薬：エスカミン56 mg
参加者は、各鼻孔への鼻腔内スプレーとして56 mgのエスケタミンを自己投与します。
他の名前：
  • JNJ-54135419
薬：エスカミン84 mg
参加者は、各鼻孔への鼻腔内スプレーとして84 mgのエスケタミンを自己投与します。
他の名前：
  • JNJ-54135419
プラセボコンパレーター：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.
薬：エスカミン56 mg
参加者は、各鼻孔への鼻腔内スプレーとして56 mgのエスケタミンを自己投与します。
他の名前：
  • JNJ-54135419
薬：エスカミン84 mg
参加者は、各鼻孔への鼻腔内スプレーとして84 mgのエスケタミンを自己投与します。
他の名前：
  • JNJ-54135419
薬：Placebo
Participants will self-administer placebo as intranasal spray into each nostril.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
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
時間枠：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)

二次結果の測定

結果測定
メジャーの説明
時間枠
DB Treatment Phase: Change From Baseline in MADRS Total Score From Day 1 to Day 2
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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

その他の成果指標

結果測定
メジャーの説明
時間枠
DB Treatment Phase: Number of Participants with Abnormalities in Blood Oxygen Saturation (SpO2)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Janssen Research & Development, LLC

捜査官

  • スタディディレクター：Janssen Research & Development, LLC Clinical Trial、Janssen Research & Development, LLC

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年7月23日

一次修了 (推定)

2028年12月27日

研究の完了 (推定)

2029年9月12日

試験登録日

最初に提出

2026年7月15日

QC基準を満たした最初の提出物

2026年7月15日

最初の投稿 (実際)

2026年7月21日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月28日

QC基準を満たした最後の更新が送信されました

2026年8月27日

最終確認日

2026年8月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • 54135419TRD3015

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

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

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

はい

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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