Clinical Trials List
Protocol Number54135419TRD3013
NCT Number(ClinicalTrials.gov Identfier)NCT04338321
Completed
2020-01-13 - 2022-06-07
Phase III
Recruiting10
A Randomized, Open-label, Rater-Blinded, Active-Controlled, International, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Flexibly Dosed Esketamine Nasal Spray Compared With Quetiapine Extended-Release in Adult and Elderly Participants With Treatment-Resistant Major Depressive Disorder Who Are Continuing a Selective Serotonin Reuptake Inhibitor/Serotonin-Norepinephrine Reuptake Inhibitor
-
Trial Applicant
Johnson & Johnson
-
Sponsor
Janssen-Cilag International NV
-
Trial scale
Multi-Regional Multi-Center
-
Update
2026/02/01
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 吳明恭 Division of Psychiatry
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 陳苡芃 Division of Psychiatry
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Ya-Mei Bai Division of Psychiatry
- W. C. LIN Division of Psychiatry
- T.P. SU Division of Psychiatry
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- HUNG-KUANG SU Division of Psychiatry
- Tzung-Jeng Hwang Division of Psychiatry
- YI-TING LIN Division of Psychiatry
- 吳其炘 Division of Psychiatry
- 徐勝駿 Division of Psychiatry
- YI-LING CHIEN Division of Psychiatry
- 廖士程 Division of Psychiatry
- 王宗揚 Division of Psychiatry
- 謝明憲 Division of Psychiatry
- 吳建昌 Division of Psychiatry
- 陳宜明 Division of Psychiatry
- Chen-Chung Liu Division of Psychiatry
- CHIH-MIN LIU Division of Psychiatry
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Kuo-Hsuan Chung Division of Psychiatry
- HSIN-CHIEN LEE Division of Psychiatry
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Major Depressive Disorder
Objectives
The primary purpose 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/serotonin-norepinephrine reuptake inhibitor (SSRI/SNRI), in achieving remission in participants who have treatment-resistant major depressive disorder (MDD) with a current moderate to severe depressive episode.
Test Drug
ESKETAMINE
Active Ingredient
ESKETAMINE
Dosage Form
nasal spray
Dosage
140 mg/ml
Endpoints
Percentage of Participants with Remission as Assessed by the Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: Week 8 ]
Percentage of participants with remission as assessed by the MADRS (total score of <= 10) will be reported.
Percentage of participants with remission as assessed by the MADRS (total score of <= 10) will be reported.
Inclution Criteria
•male or female, 18 years (or older if the minimum legal age of consent in the country in which the study is taking place is >18 years) to 74 years of age, inclusive, at the time of signing the ICF.
•at screening, each participant must meet DSM-5 diagnostic criteria for single-episode MDD or recurrent MDD, without psychotic features, based on clinical assessment and confirmed by the MINI
•at screening and baseline, each participant must have an IDS-C30 total score of ≧34
•must be on a current antidepressive treatment that includes an SSRI/SNRI at screening that resulted in nonresponse (less than 25% improvement of symptoms) after having been given at an adequate dosage (been uptitrated to maximum tolerated dose; based on antidepressive dosages from SmPC [or local equivalent, if applicable]) for an adequate duration of at least 6 weeks; however, at screening the participant must show signs of minimal clinical im-provement to be eligible for the study.
•must be documented during screening that in addition to the current antidepressive treat-ment, the participant has had nonresponse within the current moderate to severe depressive episode to at least 1 but not more than 5 different, previous consecutive treatments with ADs taken at an adequate dosage for an adequate duration of at least 6 weeks and that each prior AD treatment did not produce any significant improvement (less than 25% improve-ment of symptoms).
•must have been treated with at least 2 different antidepressive substance classes among the failed treatments in the current moderate to severe depressive episode (including the current treatment with an SSRI/SNRI).
must be on a single oral SSRI/SNRI on Day 1 prior to randomization.
•Participants who are taking combination ADs and/or augmentationa at screening are eligible for the study. All AD treatments, including any augmenting substances, must be stopped prior to randomization on Day 1 according to applicable SmPCs (or local equivalents, if ap-plicable), except the SSRI/SNRI to be continued; investigator guidance for discontinuing other AD treatment(s) is provided in Section 6.5, Concomitant Therapy.
a.Other than quetiapine XR which is exclusionary at doses >50 mg/day for the current mod-erate to severe depressive episode; see exclusion criterion 2.
•must be medically stable based on physical examination, medical history, vital signs (includ-ing blood pressure) at screening. If there are any abnormalities that are not specified in the inclusion and exclusion criteria, their clinical significance must be determined by the investi-gator and recorded in the participant’s source documents.
•must be comfortable with self-administration of nasal medication and be able to follow the nasal administration instructions provided.
•must sign an ICF indicating that he or she understands the purpose of, and procedures re-quired for, the study and is willing to participate in the study.
•must sign a separate ICF at baseline (Day 1) visit if he or she agrees to provide optional bi-omarker and/or genomic (DNA and RNA) samples for research (where local regulations permit). Refusal to give consent for the optional biomarker and/or genomic DNA and RNA research samples does not exclude a participant from participation in the main study.
•a woman of childbearing potential must have a negative highly sensitive serum pregnancy test at screening and a negative urine pregnancy test prior to the first dose of study interven-tion on Day 1.
•a woman must be
a. Not of childbearing potential
b. Of childbearing potential and practicing a highly effective, preferably userindependent method of contraception (failure rate of <1% per year when used consistently and correctly) and agrees to remain on a highly effective method while receiving study intervention and until at least 6 weeks after last dose – the end of relevant systemic exposure.
•a man who is sexually active with a woman of childbearing potential during the study (ie, from Day 1 prior to first dosing) and for a minimum of 1 spermatogenesis cycle (defined as approximately 90 days) after receiving the last dose of study intervention (ie, esketamine nasal spray or quetiapine XR, both in combination with continuing SSRI/SNRI), 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.
-must agree not to donate sperm.
Note: If the childbearing potential changes after start of the study, a female partner of a
male study participant, must begin a highly effective method of birth control, as described above. Contraceptive use by men or women should be consistent with local regulations regarding the use of contraceptive methods for participants participating in clinical studies.
•willing and able to adhere to the lifestyle restrictions specified in this protocol
•at screening, each participant must meet DSM-5 diagnostic criteria for single-episode MDD or recurrent MDD, without psychotic features, based on clinical assessment and confirmed by the MINI
•at screening and baseline, each participant must have an IDS-C30 total score of ≧34
•must be on a current antidepressive treatment that includes an SSRI/SNRI at screening that resulted in nonresponse (less than 25% improvement of symptoms) after having been given at an adequate dosage (been uptitrated to maximum tolerated dose; based on antidepressive dosages from SmPC [or local equivalent, if applicable]) for an adequate duration of at least 6 weeks; however, at screening the participant must show signs of minimal clinical im-provement to be eligible for the study.
•must be documented during screening that in addition to the current antidepressive treat-ment, the participant has had nonresponse within the current moderate to severe depressive episode to at least 1 but not more than 5 different, previous consecutive treatments with ADs taken at an adequate dosage for an adequate duration of at least 6 weeks and that each prior AD treatment did not produce any significant improvement (less than 25% improve-ment of symptoms).
•must have been treated with at least 2 different antidepressive substance classes among the failed treatments in the current moderate to severe depressive episode (including the current treatment with an SSRI/SNRI).
must be on a single oral SSRI/SNRI on Day 1 prior to randomization.
•Participants who are taking combination ADs and/or augmentationa at screening are eligible for the study. All AD treatments, including any augmenting substances, must be stopped prior to randomization on Day 1 according to applicable SmPCs (or local equivalents, if ap-plicable), except the SSRI/SNRI to be continued; investigator guidance for discontinuing other AD treatment(s) is provided in Section 6.5, Concomitant Therapy.
a.Other than quetiapine XR which is exclusionary at doses >50 mg/day for the current mod-erate to severe depressive episode; see exclusion criterion 2.
•must be medically stable based on physical examination, medical history, vital signs (includ-ing blood pressure) at screening. If there are any abnormalities that are not specified in the inclusion and exclusion criteria, their clinical significance must be determined by the investi-gator and recorded in the participant’s source documents.
•must be comfortable with self-administration of nasal medication and be able to follow the nasal administration instructions provided.
•must sign an ICF indicating that he or she understands the purpose of, and procedures re-quired for, the study and is willing to participate in the study.
•must sign a separate ICF at baseline (Day 1) visit if he or she agrees to provide optional bi-omarker and/or genomic (DNA and RNA) samples for research (where local regulations permit). Refusal to give consent for the optional biomarker and/or genomic DNA and RNA research samples does not exclude a participant from participation in the main study.
•a woman of childbearing potential must have a negative highly sensitive serum pregnancy test at screening and a negative urine pregnancy test prior to the first dose of study interven-tion on Day 1.
•a woman must be
a. Not of childbearing potential
b. Of childbearing potential and practicing a highly effective, preferably userindependent method of contraception (failure rate of <1% per year when used consistently and correctly) and agrees to remain on a highly effective method while receiving study intervention and until at least 6 weeks after last dose – the end of relevant systemic exposure.
•a man who is sexually active with a woman of childbearing potential during the study (ie, from Day 1 prior to first dosing) and for a minimum of 1 spermatogenesis cycle (defined as approximately 90 days) after receiving the last dose of study intervention (ie, esketamine nasal spray or quetiapine XR, both in combination with continuing SSRI/SNRI), 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.
-must agree not to donate sperm.
Note: If the childbearing potential changes after start of the study, a female partner of a
male study participant, must begin a highly effective method of birth control, as described above. Contraceptive use by men or women should be consistent with local regulations regarding the use of contraceptive methods for participants participating in clinical studies.
•willing and able to adhere to the lifestyle restrictions specified in this protocol
Exclusion Criteria
•received treatment with esketamine or ketamine in the current moderate to severe depressive episode.
•received treatment with quetiapine extended- or immediate-release in the current moderate to severe depressive episode of a dose higher than 50 mg/day.
Note: If participants are receiving quetiapine (extended- or immediate-release) of ≤50 mg in the current episode, it needs to be stopped (wash-out period) at least 7 days prior to randomization.
•had depressive symptoms in the current moderate to severe depressive episode that previ-ously did not respond to an adequate course of treatment with electroconvulsive therapy (ECT), defined as at least 7 treatments with unilateral/bilateral ECT.
•has no signs of clinical improvement at all or with a significant improvement on their cur-rent AD treatment that includes an SSRI/SNRI as determined at screening by an experienced clinician during the qualified psychiatric interview.
Note: If a participant does not show signs of minimal clinical improvement at screening
on their current treatment with AD that includes an SSRI/SNRI, they may be rescreened (1 time) on the next consecutive line of treatment with AD (if it includes an SSRI/SNRI) after they have taken it at an adequate dosage for an adequate duration of at least 6 weeks.
•received vagal nerve stimulation or has received deep brain stimulation in the current epi-sode of depression.
•has a current or prior DSM-5 diagnosis of a psychotic disorder or MDD with psychotic fea-tures, bipolar or related disorders (confirmed by the MINI), intellectual disability, autism spectrum disorder, borderline personality disorder, or antisocial personality disorder.
•age at onset of first episode of MDD was 55 years.
•has homicidal ideation or intent, per the investigator’s clinical judgment; or has suicidal ide-ation with some intent to act within 1 month prior to screening, per the investigator’s clini-cal judgment; or based on the C-SSRS, corresponding to a response of “Yes” on Item 4 (ac-tive suicidal ideation with some intent to act, without specific plan) or Item 5 (active suicidal ideation with specific plan and intent) for suicidal ideation, or a history of suicidal behavior within the past year prior to screening. Participants reporting suicidal ideation with intent to act or suicidal behavior prior to the start of the acute phase should also be excluded.
•history of moderate or severe substance use disorder or severe alcohol use disorder accord-ing to DSM-5 criteria, except nicotine or caffeine, within 6 months before the start of the screening or current clinical signs.
•history (lifetime) of ketamine, PCP, lysergic acid diethylamide (LSD), or 3,4-methylenedioxy-methamphetamine (MDMA) hallucinogen-related use disorder.
•has a neurodegenerative disorder (eg, Alzheimer’s disease, vascular dementia, Parkinson’s disease with clinical evidence of cognitive impairment) or evidence of mild cognitive impair-ment.
•is currently suffering from seizures, has a history of epilepsy, Neuroleptic Malignant Syn-drome, or Tardive Dyskinesia.
•has one of the following cardiovascular-related conditions:
-cerebrovascular disease with a history of stroke or transient ischemic attack.
-aneurysmal vascular disease (including intracranial, thoracic, or abdominal aorta, or pe-ripheral arterial vessels).
-history of intracerebral hemorrhage.
-coronary artery disease with myocardial infarction, unstable angina, or revascularization procedure (eg, coronary angioplasty or bypass graft surgery) within 12 months before baseline (Day 1). Participants who have had a revascularization performed >12 months prior to screening and are clinically stable and symptom-free, per investigator’s clinical judgment, can be included.
-uncontrolled brady- or tachyarrhythmias that lead to hemodynamic instability.
-hemodynamically significant valvular heart disease such as mitral regurgitation, aortic stenosis, or aortic regurgitation.
-New York Heart Association Class III-IV heart failure of any etiology.
•has clinically significant or unstable respiratory conditions, including, but not limited to:
-significant pulmonary insufficiency, including chronic obstructive pulmonary disease.
-sleep apnea with morbid obesity (body mass index ≥35).
•uncontrolled hypertension despite diet, exercise, or antihypertensive therapy on Day 1 or any history of hypertensive crisis or ongoing evidence of uncontrolled hypertension defined as a supine SBP >140 mmHg or DBP >90 mmHg.
Note: On Day 1 (prior to initiation of study intervention) a supine SBP >140 mmHg or DBP >90 mmHg is exclusionary.
Potential participants may have their current antihypertensive medication(s) adjusted during the screening phase and be re-evaluated to assess their blood pressure control prior to randomization.
•history of additional risk factors for torsade des pointes (eg, heart failure, hypokalemia, or family history of long QT syndrome).
•history of, or symptoms and signs suggestive of, liver cirrhosis (eg, esophageal varices, asci-tes, and increased prothrombin time) or alanine aminotransferase (ALT) or aspartate ami-notransferase (AST) values ≧3 × the upper limit of normal in routine laboratory test or medical record or at screening.
•has a fasting triglyceride concentration ≥500 mg/dL at screening.
•has positive urine test result(s) for drugs of abuse (including barbiturates, cannabinoids, methadone, opiates, cocaine, PCP, and amphetamine/ methamphetamine) on Day 1 prior to randomization,
OR
if prescribed psychostimulants (eg, amphetamine, methylphenidate) for MDD, the medication must be discontinued at screening and participants must agree not to take during the study. Par-ticipants are excluded if they have a positive urine test result for a prescribed psychostimulant for MDD on Day 1 prior to randomization. However, participants prescribed psychostimulants for indications other than MDD (eg, attention deficit hyperactivity disorder) are permitted to contin-ue taking this medication during the study. Use of psychostimulants for recreational use is exclu-sionary.
Note: intermittent use of cannabinoids prior to the start of the screening phase is not exclusionary as long as the participant does not meet the criteria for substance use disorder or have a positive urine test result for cannabinoids on Day 1 prior to randomization.
See Section 8.2.4, Clinical Safety Laboratory Assessments for additional information on the tim-ing of the urine drug screen at baseline (Day 1) visit.
•has uncontrolled diabetes mellitus, as evidenced by HbA1c >9% in the medical records, rou-tine laboratory test, or history in the 3 months prior to baseline; or diabetic ketoacidosis, hyperglycemic coma, or severe hypoglycemia with loss of consciousness evaluated from medical history.
•has untreated glaucoma, current penetrating or perforating eye injury, brain injury, hyper-tensive encephalopathy, intrathecal therapy with ventricular shunts, or any other condition associated with increased intracranial pressure or increased intraocular pressure or planned eye surgery evaluated from medical history.
•has any anatomical or medical condition that, per the investigator’s clinical judgment based on assessment, may impede delivery or absorption of esketamine nasal spray.
•has a history of malignancy within 5 years before baseline (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that, in the opinion of the investigator, with concurrence with the sponsor’s medical monitor, is considered cured with minimal risk of recurrence).
•has known allergies, hypersensitivity, intolerance, or contraindications to esketamine/ketamine, quetiapine XR, and/or any excipients.
•has taken any prohibited therapies that would not permit dosing on Day 1 as defined in protocol.
•is taking a total daily dose of benzodiazepines greater than the equivalent of 4 mg/day of lo-razepam on Day 1.
•has been included in any esketamine or ketamine clinical study, or has received an investiga-tional drug (including investigational vaccines) or used an invasive investigational medical device within 60 days before the start of the screening phase, or has participated in 2 or more MDD or other psychiatric condition clinical interventional studies (with different in-vestigational medication) in the previous 1 year before baseline, or is currently enrolled in an investigational interventional study.
•any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.
•is a woman who is pregnant, breastfeeding, or planning to become pregnant or a man that plans to father a child while enrolled in this study or within 90 days after the last dose of study intervention.
•received treatment with quetiapine extended- or immediate-release in the current moderate to severe depressive episode of a dose higher than 50 mg/day.
Note: If participants are receiving quetiapine (extended- or immediate-release) of ≤50 mg in the current episode, it needs to be stopped (wash-out period) at least 7 days prior to randomization.
•had depressive symptoms in the current moderate to severe depressive episode that previ-ously did not respond to an adequate course of treatment with electroconvulsive therapy (ECT), defined as at least 7 treatments with unilateral/bilateral ECT.
•has no signs of clinical improvement at all or with a significant improvement on their cur-rent AD treatment that includes an SSRI/SNRI as determined at screening by an experienced clinician during the qualified psychiatric interview.
Note: If a participant does not show signs of minimal clinical improvement at screening
on their current treatment with AD that includes an SSRI/SNRI, they may be rescreened (1 time) on the next consecutive line of treatment with AD (if it includes an SSRI/SNRI) after they have taken it at an adequate dosage for an adequate duration of at least 6 weeks.
•received vagal nerve stimulation or has received deep brain stimulation in the current epi-sode of depression.
•has a current or prior DSM-5 diagnosis of a psychotic disorder or MDD with psychotic fea-tures, bipolar or related disorders (confirmed by the MINI), intellectual disability, autism spectrum disorder, borderline personality disorder, or antisocial personality disorder.
•age at onset of first episode of MDD was 55 years.
•has homicidal ideation or intent, per the investigator’s clinical judgment; or has suicidal ide-ation with some intent to act within 1 month prior to screening, per the investigator’s clini-cal judgment; or based on the C-SSRS, corresponding to a response of “Yes” on Item 4 (ac-tive suicidal ideation with some intent to act, without specific plan) or Item 5 (active suicidal ideation with specific plan and intent) for suicidal ideation, or a history of suicidal behavior within the past year prior to screening. Participants reporting suicidal ideation with intent to act or suicidal behavior prior to the start of the acute phase should also be excluded.
•history of moderate or severe substance use disorder or severe alcohol use disorder accord-ing to DSM-5 criteria, except nicotine or caffeine, within 6 months before the start of the screening or current clinical signs.
•history (lifetime) of ketamine, PCP, lysergic acid diethylamide (LSD), or 3,4-methylenedioxy-methamphetamine (MDMA) hallucinogen-related use disorder.
•has a neurodegenerative disorder (eg, Alzheimer’s disease, vascular dementia, Parkinson’s disease with clinical evidence of cognitive impairment) or evidence of mild cognitive impair-ment.
•is currently suffering from seizures, has a history of epilepsy, Neuroleptic Malignant Syn-drome, or Tardive Dyskinesia.
•has one of the following cardiovascular-related conditions:
-cerebrovascular disease with a history of stroke or transient ischemic attack.
-aneurysmal vascular disease (including intracranial, thoracic, or abdominal aorta, or pe-ripheral arterial vessels).
-history of intracerebral hemorrhage.
-coronary artery disease with myocardial infarction, unstable angina, or revascularization procedure (eg, coronary angioplasty or bypass graft surgery) within 12 months before baseline (Day 1). Participants who have had a revascularization performed >12 months prior to screening and are clinically stable and symptom-free, per investigator’s clinical judgment, can be included.
-uncontrolled brady- or tachyarrhythmias that lead to hemodynamic instability.
-hemodynamically significant valvular heart disease such as mitral regurgitation, aortic stenosis, or aortic regurgitation.
-New York Heart Association Class III-IV heart failure of any etiology.
•has clinically significant or unstable respiratory conditions, including, but not limited to:
-significant pulmonary insufficiency, including chronic obstructive pulmonary disease.
-sleep apnea with morbid obesity (body mass index ≥35).
•uncontrolled hypertension despite diet, exercise, or antihypertensive therapy on Day 1 or any history of hypertensive crisis or ongoing evidence of uncontrolled hypertension defined as a supine SBP >140 mmHg or DBP >90 mmHg.
Note: On Day 1 (prior to initiation of study intervention) a supine SBP >140 mmHg or DBP >90 mmHg is exclusionary.
Potential participants may have their current antihypertensive medication(s) adjusted during the screening phase and be re-evaluated to assess their blood pressure control prior to randomization.
•history of additional risk factors for torsade des pointes (eg, heart failure, hypokalemia, or family history of long QT syndrome).
•history of, or symptoms and signs suggestive of, liver cirrhosis (eg, esophageal varices, asci-tes, and increased prothrombin time) or alanine aminotransferase (ALT) or aspartate ami-notransferase (AST) values ≧3 × the upper limit of normal in routine laboratory test or medical record or at screening.
•has a fasting triglyceride concentration ≥500 mg/dL at screening.
•has positive urine test result(s) for drugs of abuse (including barbiturates, cannabinoids, methadone, opiates, cocaine, PCP, and amphetamine/ methamphetamine) on Day 1 prior to randomization,
OR
if prescribed psychostimulants (eg, amphetamine, methylphenidate) for MDD, the medication must be discontinued at screening and participants must agree not to take during the study. Par-ticipants are excluded if they have a positive urine test result for a prescribed psychostimulant for MDD on Day 1 prior to randomization. However, participants prescribed psychostimulants for indications other than MDD (eg, attention deficit hyperactivity disorder) are permitted to contin-ue taking this medication during the study. Use of psychostimulants for recreational use is exclu-sionary.
Note: intermittent use of cannabinoids prior to the start of the screening phase is not exclusionary as long as the participant does not meet the criteria for substance use disorder or have a positive urine test result for cannabinoids on Day 1 prior to randomization.
See Section 8.2.4, Clinical Safety Laboratory Assessments for additional information on the tim-ing of the urine drug screen at baseline (Day 1) visit.
•has uncontrolled diabetes mellitus, as evidenced by HbA1c >9% in the medical records, rou-tine laboratory test, or history in the 3 months prior to baseline; or diabetic ketoacidosis, hyperglycemic coma, or severe hypoglycemia with loss of consciousness evaluated from medical history.
•has untreated glaucoma, current penetrating or perforating eye injury, brain injury, hyper-tensive encephalopathy, intrathecal therapy with ventricular shunts, or any other condition associated with increased intracranial pressure or increased intraocular pressure or planned eye surgery evaluated from medical history.
•has any anatomical or medical condition that, per the investigator’s clinical judgment based on assessment, may impede delivery or absorption of esketamine nasal spray.
•has a history of malignancy within 5 years before baseline (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that, in the opinion of the investigator, with concurrence with the sponsor’s medical monitor, is considered cured with minimal risk of recurrence).
•has known allergies, hypersensitivity, intolerance, or contraindications to esketamine/ketamine, quetiapine XR, and/or any excipients.
•has taken any prohibited therapies that would not permit dosing on Day 1 as defined in protocol.
•is taking a total daily dose of benzodiazepines greater than the equivalent of 4 mg/day of lo-razepam on Day 1.
•has been included in any esketamine or ketamine clinical study, or has received an investiga-tional drug (including investigational vaccines) or used an invasive investigational medical device within 60 days before the start of the screening phase, or has participated in 2 or more MDD or other psychiatric condition clinical interventional studies (with different in-vestigational medication) in the previous 1 year before baseline, or is currently enrolled in an investigational interventional study.
•any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.
•is a woman who is pregnant, breastfeeding, or planning to become pregnant or a man that plans to father a child while enrolled in this study or within 90 days after the last dose of study intervention.
The Estimated Number of Participants
-
Taiwan
40 participants
-
Global
participants
