Clinical Trials List
Protocol Number54135419TRD4010
NCT Number(ClinicalTrials.gov Identfier)NCT04829318
Completed
2021-04-26 - 2024-07-22
Phase III
Recruiting1
Terminated2
A Long-term Comparison of Esketamine Nasal Spray Versus Quetiapine Extended-Release, Both in Combination With a Selective Serotonin Reuptake Inhibitor/Serotonin-Norepinephrine Reuptake Inhibitor, in Participants With Treatment-Resistant Major Depressive Disorder
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Trial Applicant
Johnson & Johnson
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Sponsor
JOHNSON & JOHNSON TAIWAN LTD
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- T.P. SU Division of Psychiatry
- Ya-Mei Bai Division of Psychiatry
- W. C. LIN Division of Psychiatry
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 王宗揚 Division of Psychiatry
- 廖士程 Division of Psychiatry
- CHIH-MIN LIU Division of Psychiatry
- 吳其炘 Division of Psychiatry
- HUNG-KUANG SU Division of Psychiatry
- 黃薇嘉 Division of Psychiatry
- 陳宜明 Division of Psychiatry
- YI-LING CHIEN Division of Psychiatry
The Actual Total Number of Participants Enrolled
0 Completed
The Actual Total Number of Participants Enrolled
0 Completed
Condition/Disease
Major Depressive Disorder
Objectives
The primary objective of this study is to evaluate the efficacy of flexibly dosed esketamine nasal spray compared with quetiapine extended-release(XR), both in combination with a continuing selective serotonin reuptake inhibitor(SSRI)/serotonin-norepinephrine reuptake inhibitor(SNRI), in achieving remission in participants who have treatment-resistant MDD with a current moderate to severe depressive episode.
Test Drug
ESKETAMINE
Active Ingredient
ESKETAMINE
Dosage Form
nasal spray
Dosage
140 mg/ml
Endpoints
1. Percentage of participants with adverse events (AEs) during the intervention: AEs during the intervention refer to AEs that occurred or worsened in severity after the trial intervention started. An AE is any adverse medical event attributable to the trial drug among participants receiving the trial drug.
2. Percentage of participants with AEs (AESI) arising from interventions of special concern: The percentage of participants with AEs (AESI) arising from interventions of special concern will be divided by category (reported sedation, dissociation, events indicating potential abuse , cystitis, liver insufficiency, and suicide [including suicidal ideation and behavior]).
3. Suicidal ideation and behavior as assessed by the Columbia-Suicide Severity Scale (C-SSRS) score: Suicidal ideation or behavior will be measured by the C-SSRS score. The C-SSRS is a clinician's scoring assessment of suicidal behavior and/or intentions. The scale consists of 28 items in 4 sections: suicidal behavior, actual attempts, suicidal ideation, and intensity of ideation. Suicidal ideation is made up of 5 yes/no items: wishing to die; non-specific active suicidal ideation; any way (no plan) of active suicidal ideation, but without any intention to act; active suicidal ideation, somewhat wanting to act, and No specific plan; active suicidal ideation, and has a specific plan and idea. Worsening of suicidal ideation will increase the severity of suicidal ideation from the baseline period.
2. Percentage of participants with AEs (AESI) arising from interventions of special concern: The percentage of participants with AEs (AESI) arising from interventions of special concern will be divided by category (reported sedation, dissociation, events indicating potential abuse , cystitis, liver insufficiency, and suicide [including suicidal ideation and behavior]).
3. Suicidal ideation and behavior as assessed by the Columbia-Suicide Severity Scale (C-SSRS) score: Suicidal ideation or behavior will be measured by the C-SSRS score. The C-SSRS is a clinician's scoring assessment of suicidal behavior and/or intentions. The scale consists of 28 items in 4 sections: suicidal behavior, actual attempts, suicidal ideation, and intensity of ideation. Suicidal ideation is made up of 5 yes/no items: wishing to die; non-specific active suicidal ideation; any way (no plan) of active suicidal ideation, but without any intention to act; active suicidal ideation, somewhat wanting to act, and No specific plan; active suicidal ideation, and has a specific plan and idea. Worsening of suicidal ideation will increase the severity of suicidal ideation from the baseline period.
Inclution Criteria
Inclusion Criteria:
Completed the maintenance phase (Week 32) of Study 54135419TRD3013 (NCT04338321) and had esketamine nasal spray in combination with continuing selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor (SSRI/SNRI) administered through Week 30 (every 2 week dosing) or Week 31 (once weekly dosing) of Study 54135419TRD3013, and continues to be willing to be treated with esketamine nasal spray
Must, in the opinion of the investigator, be benefiting from continuation of esketamine nasal spray in combination with their current SSRI/SNRI based on efficacy and tolerability assessed on Day 1 of this study
Must be medically stable based on the investigator's judgment
A woman of childbearing potential must have a negative urine pregnancy test on Day 1
Male participants who are sexually active with a woman of childbearing potential must agree to the following during the intervention period and for at least 1 spermatogenesis cycle (defined as approximately 90 days) after receiving the last dose of study intervention (that is, esketamine nasal spray), must fulfill the following criteria: must be practicing a highly effective method of contraception with his female partner, must use a condom if his partner is pregnant, and must agree not to donate sperm
Completed the maintenance phase (Week 32) of Study 54135419TRD3013 (NCT04338321) and had esketamine nasal spray in combination with continuing selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor (SSRI/SNRI) administered through Week 30 (every 2 week dosing) or Week 31 (once weekly dosing) of Study 54135419TRD3013, and continues to be willing to be treated with esketamine nasal spray
Must, in the opinion of the investigator, be benefiting from continuation of esketamine nasal spray in combination with their current SSRI/SNRI based on efficacy and tolerability assessed on Day 1 of this study
Must be medically stable based on the investigator's judgment
A woman of childbearing potential must have a negative urine pregnancy test on Day 1
Male participants who are sexually active with a woman of childbearing potential must agree to the following during the intervention period and for at least 1 spermatogenesis cycle (defined as approximately 90 days) after receiving the last dose of study intervention (that is, esketamine nasal spray), must fulfill the following criteria: must be practicing a highly effective method of contraception with his female partner, must use a condom if his partner is pregnant, and must agree not to donate sperm
Exclusion Criteria
Exclusion Criteria:
Has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
Completed Study 54135419TRD3013 while presenting adverse events deemed clinically relevant by the investigator, and which may interfere with safety and well-being of the participant
Has developed during participation in Study 54135419TRD3013 any of the following cardiovascular-related conditions where an increase in blood pressure or intracranial pressure poses a serious risk: cerebrovascular disease following stroke or transient ischemic attack, aneurysmal vascular disease (including intracranial, thoracic, or abdominal aorta, or peripheral arterial vessels), intracerebral hemorrhage, coronary artery disease following myocardial infarction, unstable angina, or revascularization procedure (example, coronary angioplasty or bypass graft surgery), uncontrolled brady- or tachyarrhythmias that lead to hemodynamic instability, hemodynamically significant valvular heart disease such as mitral regurgitation, aortic stenosis, or aortic regurgitation or heart failure (New York Heart Association [NYHA] Class III-IV) of any etiology
Significant pulmonary insufficiency, including chronic obstructive pulmonary disease
Has homicidal ideation or intent, per the investigator's clinical judgment; or has suicidal ideation with some intent to act within 1 month prior to Day 1, per the investigator's clinical judgment; or based on the Columbia-suicide severity rating scale (C-SSRS) performed at Week 32 visit of Study 54135419TRD3013, 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
Pregnant, or breast-feeding, or planning to become pregnant while enrolled in this study or within 90 days after the last dose of study intervention
Has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
Completed Study 54135419TRD3013 while presenting adverse events deemed clinically relevant by the investigator, and which may interfere with safety and well-being of the participant
Has developed during participation in Study 54135419TRD3013 any of the following cardiovascular-related conditions where an increase in blood pressure or intracranial pressure poses a serious risk: cerebrovascular disease following stroke or transient ischemic attack, aneurysmal vascular disease (including intracranial, thoracic, or abdominal aorta, or peripheral arterial vessels), intracerebral hemorrhage, coronary artery disease following myocardial infarction, unstable angina, or revascularization procedure (example, coronary angioplasty or bypass graft surgery), uncontrolled brady- or tachyarrhythmias that lead to hemodynamic instability, hemodynamically significant valvular heart disease such as mitral regurgitation, aortic stenosis, or aortic regurgitation or heart failure (New York Heart Association [NYHA] Class III-IV) of any etiology
Significant pulmonary insufficiency, including chronic obstructive pulmonary disease
Has homicidal ideation or intent, per the investigator's clinical judgment; or has suicidal ideation with some intent to act within 1 month prior to Day 1, per the investigator's clinical judgment; or based on the Columbia-suicide severity rating scale (C-SSRS) performed at Week 32 visit of Study 54135419TRD3013, 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
Pregnant, or breast-feeding, or planning to become pregnant while enrolled in this study or within 90 days after the last dose of study intervention
The Estimated Number of Participants
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Taiwan
7 participants
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Global
183 participants
