A Study of Esketamine Nasal Spray Versus Placebo Spray in Adult Participants With Treatment-resistant Depression
27 de agosto de 2026 atualizado por: 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).
Visão geral do estudo
Status
Recrutamento
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Estimado)
348
Estágio
- Fase 3
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Study Contact
- Número de telefone: 844-434-4210
- E-mail: Participate-In-This-Study1@its.jnj.com
Locais de estudo
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California
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Redlands, California, Estados Unidos, 92374
- Recrutamento
- Anderson Clinical Research
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Illinois
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Skokie, Illinois, Estados Unidos, 60076
- Recrutamento
- Psychiatric Medicine Associates LLC
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New York
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New York, New York, Estados Unidos, 10128
- Recrutamento
- The Medical Research Network, LLC
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Kawasaki, Japão, 214-0014
- Recrutamento
- Kishiro Mental Clinic
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Kobe, Japão, 651-0097
- Recrutamento
- Tatsuta Clinic
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Kodaira-shi, Japão, 187-8551
- Recrutamento
- National Center of Neurology and Psychiatry
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Nagasaki, Japão, 852-8137
- Recrutamento
- Arata Clinic
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Sapporo, Japão, 060 8648
- Recrutamento
- Hokkaido University Hospital
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Setagaya Ku, Japão, 154 0004
- Recrutamento
- Sangenjaya neurology-psychosomatic clinic
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Shibuya-ku, Japão, 151-0053
- Recrutamento
- Maynds Tower Mental Clinic
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Tottori, Japão, 683-0824
- Recrutamento
- Tottori University Hospital
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Taichung, Taiwan, 402
- Recrutamento
- Chung Shan Medical University Hospital
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Taipei, Taiwan, 11217
- Recrutamento
- Taipei Veterans General Hospital
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Taipei, Taiwan, 110
- Recrutamento
- Taipei Medical University
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Taoyuan, Taiwan, 333
- Recrutamento
- Linkou Chang Gung Memorial Hospital
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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)
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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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.
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Os participantes se auto-administrarão 56 mg de esketamina como spray intranasal em cada narina.
Outros nomes:
Os participantes se auto-administrarão 84 mg de esketamina como spray intranasal em cada narina.
Outros nomes:
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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.
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Os participantes se auto-administrarão 56 mg de esketamina como spray intranasal em cada narina.
Outros nomes:
Os participantes se auto-administrarão 84 mg de esketamina como spray intranasal em cada narina.
Outros nomes:
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Comparador de Placebo: 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.
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Os participantes se auto-administrarão 56 mg de esketamina como spray intranasal em cada narina.
Outros nomes:
Os participantes se auto-administrarão 84 mg de esketamina como spray intranasal em cada narina.
Outros nomes:
Participants will self-administer placebo as intranasal spray into each nostril.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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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
Prazo: 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.
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Baseline (Day 1 [prerandomization]) up to end of the 4-Week DB treatment phase (Day 28)
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
DB Treatment Phase: Change From Baseline in MADRS Total Score From Day 1 to Day 2
Prazo: 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)
|
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DB Treatment Phase: Percentage of Responders in MADRS Over Time to the End of the 4-Week DB Treatment Phase
Prazo: 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.
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Up to end of the 4-Week DB treatment phase (Day 28)
|
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DB Treatment Phase: Percentage of Participants in Remission in MADRS Over Time to the End of the 4-Week DB Treatment Phase
Prazo: 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.
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Up to end of the 4-Week DB treatment phase (Day 28)
|
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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
Prazo: Baseline up to end of the 4-Week DB treatment phase (Day 28)
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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).
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Baseline up to end of the 4-Week DB treatment phase (Day 28)
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DB Treatment Phase: Change From Baseline in MADRS Total Score Over Time to the End of the 4-Week DB Treatment Phase
Prazo: 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)
|
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DB Treatment Phase: Change From Baseline in Individual MADRS Item Scores Over Time to the End of the 4-Week DB Treatment Phase
Prazo: 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)
|
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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
Prazo: Baseline up to end of the 4-Week DB treatment phase (Day 28)
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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.
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Baseline up to end of the 4-Week DB treatment phase (Day 28)
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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
Prazo: Baseline up to end of the 4-Week DB treatment phase (Day 28)
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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)
|
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DB Treatment Phase: Change From Baseline in PHQ-9 Total Score Over Time to the End of the 4-Week DB Treatment Phase
Prazo: 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.
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Baseline up to end of the 4-Week DB treatment phase (Day 28)
|
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DB Treatment Phase: Percentage of Responders in PHQ-9 Over Time to the End of the 4-Week DB Treatment Phase
Prazo: 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.
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Up to end of the 4-Week DB treatment phase (Day 28)
|
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DB Treatment Phase: Percentage of Participants in Remission in PHQ-9 Over Time to the End of the 4-Week DB Treatment Phase
Prazo: 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)
|
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Open-Label (OL) Treatment Phase: Percentage of Responders in MADRS Over Time to the End of the OL Treatment Phase
Prazo: 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
|
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OL Treatment Phase: Percentage of Participants in Remission in MADRS Over Time to the End of the OL Treatment Phase
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
DB Treatment Phase: Number of Participants with Abnormalities in Blood Oxygen Saturation (SpO2)
Prazo: 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.
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Up to end of the 4-Week DB treatment phase (Day 28)
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DB Treatment Phase: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Prazo: 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.
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Up to end of the 4-Week DB treatment phase (Day 28)
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DB Treatment Phase: Suicidal Ideation and Behavior as Assessed Using the Columbia Suicide Severity Rating Scale (C-SSRS)
Prazo: 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.
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Up to end of the 4-Week DB treatment phase (Day 28)
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DB Treatment Phase: Number of Participants with Effects on Dissociative Symptoms As Measured Using the Clinician Administered Dissociative States Scale (CADSS)
Prazo: 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.
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Up to end of the 4-Week DB treatment phase (Day 28)
|
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DB Treatment Phase: Number of Participants with Abnormalities in Physical Examination
Prazo: Up to end of the 4-Week DB treatment phase (Day 28)
|
Number of participants with abnormalities in physical examination will be reported.
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Up to end of the 4-Week DB treatment phase (Day 28)
|
|
DB Treatment Phase: Number of Participants with Abnormalities in Vital Signs
Prazo: 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.
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Up to end of the 4-Week DB treatment phase (Day 28)
|
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DB Treatment Phase: Number of Participants Reporting Clinically Meaningful Changes in Body Weight
Prazo: 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.
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Up to end of the 4-Week DB treatment phase (Day 28)
|
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DB Treatment Phase: Number of Participants with Abnormalities in 12-lead Electrocardiogram (ECG)
Prazo: Up to end of the 4-Week DB treatment phase (Day 28)
|
Number of participants with abnormalities in 12-lead ECG will be reported.
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Up to end of the 4-Week DB treatment phase (Day 28)
|
|
OL Treatment Phase: Number of Participants with Abnormalities in SpO2
Prazo: Up to 12 Weeks
|
Number of participants who experience abnormally low blood oxygen saturation will be reported.
|
Up to 12 Weeks
|
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OL Treatment Phase: Number of Participants With TEAEs
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: Up to 12 Weeks
|
Number of participants with abnormalities in 12-lead ECG will be reported.
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Up to 12 Weeks
|
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OL Treatment Phase: Number of Participants with Potential Withdrawal Symptoms After Stopping Study Drug Treatment as Measured by the Physician Withdrawal Checklist (PWC-20)
Prazo: 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
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Diretor de estudo: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
23 de julho de 2026
Conclusão Primária (Estimado)
27 de dezembro de 2028
Conclusão do estudo (Estimado)
12 de setembro de 2029
Datas de inscrição no estudo
Enviado pela primeira vez
15 de julho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
15 de julho de 2026
Primeira postagem (Real)
21 de julho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
28 de agosto de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
27 de agosto de 2026
Última verificação
1 de agosto de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 54135419TRD3015
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
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
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Sim
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .