Clinical Trials List
Protocol Number54135419SUI3003
Not yet recruiting
2025-10-15 - 2031-11-14
Phase III
Recruiting5
ICD-10F32.9
Major depressive disorder, single episode, unspecified
ICD-9296.20
Major depressive disorder, single episode, unspecified
A Double-blind, Randomized, Psychoactive Placebo-controlled Study to Evaluate the Efficacy and Safety of Intranasal Esketamine 84 mg in Addition to Comprehensive Standard of Care for the Rapid Reduction of the Symptoms of Major Depressive Disorder in Adolescent Participants with Acute Suicidal Ideation or Behavior
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Trial Applicant
Johnson & Johnson
-
Sponsor
Janssen Research & Development
-
Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 黃郁絜 Division of Psychiatry
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Kuo-Hsuan Chung
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Major Depressive Disorder in Adolescent Participants with Acute Suicidal Ideation or Behavior
Objectives
To assess the efficacy of a single
(first) dose of 84 mg esketamine
compared with psychoactive
placebo (oral midazolam) in
addition to comprehensive SoC in
rapidly reducing the symptoms of
MDD in participants 12 to <18 years
of age with acute suicidal ideation
or behavior
Test Drug
nasal spray
Active Ingredient
Esketamine HCl
Midazolam
Placebo
Midazolam
Placebo
Dosage Form
404
189
189
189
189
Dosage
140 mg/mL
2 mg/mL
30 ml
2 mg/mL
30 ml
Endpoints
Change from baseline (Day 1, predose) at 24 hours post
first dose in depressive symptoms, as measured by the
CDRS-R total score
first dose in depressive symptoms, as measured by the
CDRS-R total score
Inclution Criteria
Age
1. Adolescents: 12 to <18 years
Type of Participant and Disease Characteristic(s)
2. Must meet DSM-5 diagnostic criteria for MDD, without psychotic features, based
upon clinical assessment and confirmed by the MINI-KID (Sheehan 2010).
3. Must have a CGI-SS-R score of “Markedly” or greater (ie, ≥4)at both screening and
baseline (predose) visits.
4. In the physician’s opinion, acute psychiatric hospitalization is clinically warranted
due to subject’s acute suicidality.
5. Must have a CDRS-R total score ≥58 at baseline (predose).
6. As part of SoC treatment, the participant must agree to:
be hospitalized voluntarily (non-compulsory hospitalization) for a
recommended period of 5 days (4 nights) from Day 1, Randomization Day
(may be shorter or longer if clinically warranted in the investigator’s opinion).
take 1 of the following prescribed SoC SSRI antidepressants, in any approved
oral formulation and available in the participating country/territory:
fluoxetine, escitalopram, or sertraline at least during the DB treatment phase.
7. Must be medically stable based on physical examination, medical history, vital signs,
and 12-lead ECG performed at screening. If there are abnormalities, the participant
may be included only if the investigator judges the abnormalities to be not clinically
significant. This determination must be recorded in the participant's source
documents and initialed by the investigator.
Note: Participants recovering from a recent suicide attempt may be eligible provided
they are medically stable.
8. Must be medicallystable based on clinical laboratory tests performed by the local
laboratory at screening. If the results of the serum chemistry panel, hematology, or
urinalysis are outside the normal reference ranges, the participant may be included
only if the investigator judges the abnormalities or deviations from normal to be not
clinically significant. This determination must be recorded in the participant’s source
documents and initialed by the investigator.
Sex and Contraceptive/Barrier Requirements
9. During the DB treatment phase and for at least 6 weeks after the last dose of study
intervention, sexual abstinence (avoiding heterosexual intercourse) is strongly
recommended. However, heterosexually active participants of child-bearing
potential must practice a highly effective method of contraception (failure rate of
<1% per year when used consistently and correctly). If oral contraceptives are used,
a barrier method of contraception must also be used.
Note: if the childbearing potential changes after the start of the study (eg, a
premenarchal participant experiences menarche) or the risk of pregnancy changes
(eg, a participant who can become pregnant and who was not heterosexually active
becomes active), the investigator should reassess the need for contraception. As an
approach to prevent pregnancy, the reliability of sexual abstinence or the use of
effective contraception needs to be evaluated in relation to the duration of the study,
and the preferred and usual lifestyle of the participant. Evaluation of the reliability
of abstinence/use of effective contraception should be documented in source notes.
Contraceptive use by participants should be consistent with local regulations
regarding the use of contraceptive methods in adolescents and should be discussed
in detail confidentially with the potential adolescent participant by the study
investigator. The investigator should evaluate the potential for contraceptive method
failure (eg, noncompliance, recently initiated) in relationship to the first dose of study
medication.
See Appendix 4 on Contraceptive and Barrier Guidance for details.
10. During the DB phase (fromDay 1 through dayoflastdose ofstudyintervention)and
for a minimum of 1 spermatogenesis cycle (defined as approximately 90 days)
after receiving the last dose of studyintervention, a participant who is capable of
producing sperm and is heterosexuallyactive:
must practice a highly effective method of contraception with partner of
childbearing potential. See Appendix 4 on Contraceptive and Barrier
Guidance for details.
must use a condom if participant’s partner is pregnant
must agree not to donate gametes (ie, sperm) or freeze for future use for the
purposes of assisted reproduction.
11. Participants of childbearing potential must have a negative highly sensitive
(eg, beta-human chorionic gonadotropin) urine pregnancy test at screening.
12. Participants must agree not to be pregnant, breastfeeding, planning to become
pregnant, or donate gametes (ie, eggs) or freeze for future use for the purposes of
assisted reproduction while enrolled in this study or within 3 months after the last
dose of study intervention.
Informed Consent
13. The parent(s)/LAR (as defined in Section 2, Introduction) and the participant, must
provide informed consent/assent, as described in Section 10.2.3, Informed Consent
and Assent Process.
Other
14. Participant must be comfortable with self-administration of oral and intranasal
medication and able to follow instructions provided.
15. Participant must be willing and able to adhere to the lifestyle restrictions specified in
Section 5.3 of this protocol.
16. A parent(s)/LAR must be available to help the study-site personnel ensure follow-up;
ensure the participants are accompanied to the study site on each outpatient
assessment day according to the SoA; consistently be available to provide
information on the participant.
1. Adolescents: 12 to <18 years
Type of Participant and Disease Characteristic(s)
2. Must meet DSM-5 diagnostic criteria for MDD, without psychotic features, based
upon clinical assessment and confirmed by the MINI-KID (Sheehan 2010).
3. Must have a CGI-SS-R score of “Markedly” or greater (ie, ≥4)at both screening and
baseline (predose) visits.
4. In the physician’s opinion, acute psychiatric hospitalization is clinically warranted
due to subject’s acute suicidality.
5. Must have a CDRS-R total score ≥58 at baseline (predose).
6. As part of SoC treatment, the participant must agree to:
be hospitalized voluntarily (non-compulsory hospitalization) for a
recommended period of 5 days (4 nights) from Day 1, Randomization Day
(may be shorter or longer if clinically warranted in the investigator’s opinion).
take 1 of the following prescribed SoC SSRI antidepressants, in any approved
oral formulation and available in the participating country/territory:
fluoxetine, escitalopram, or sertraline at least during the DB treatment phase.
7. Must be medically stable based on physical examination, medical history, vital signs,
and 12-lead ECG performed at screening. If there are abnormalities, the participant
may be included only if the investigator judges the abnormalities to be not clinically
significant. This determination must be recorded in the participant's source
documents and initialed by the investigator.
Note: Participants recovering from a recent suicide attempt may be eligible provided
they are medically stable.
8. Must be medicallystable based on clinical laboratory tests performed by the local
laboratory at screening. If the results of the serum chemistry panel, hematology, or
urinalysis are outside the normal reference ranges, the participant may be included
only if the investigator judges the abnormalities or deviations from normal to be not
clinically significant. This determination must be recorded in the participant’s source
documents and initialed by the investigator.
Sex and Contraceptive/Barrier Requirements
9. During the DB treatment phase and for at least 6 weeks after the last dose of study
intervention, sexual abstinence (avoiding heterosexual intercourse) is strongly
recommended. However, heterosexually active participants of child-bearing
potential must practice a highly effective method of contraception (failure rate of
<1% per year when used consistently and correctly). If oral contraceptives are used,
a barrier method of contraception must also be used.
Note: if the childbearing potential changes after the start of the study (eg, a
premenarchal participant experiences menarche) or the risk of pregnancy changes
(eg, a participant who can become pregnant and who was not heterosexually active
becomes active), the investigator should reassess the need for contraception. As an
approach to prevent pregnancy, the reliability of sexual abstinence or the use of
effective contraception needs to be evaluated in relation to the duration of the study,
and the preferred and usual lifestyle of the participant. Evaluation of the reliability
of abstinence/use of effective contraception should be documented in source notes.
Contraceptive use by participants should be consistent with local regulations
regarding the use of contraceptive methods in adolescents and should be discussed
in detail confidentially with the potential adolescent participant by the study
investigator. The investigator should evaluate the potential for contraceptive method
failure (eg, noncompliance, recently initiated) in relationship to the first dose of study
medication.
See Appendix 4 on Contraceptive and Barrier Guidance for details.
10. During the DB phase (fromDay 1 through dayoflastdose ofstudyintervention)and
for a minimum of 1 spermatogenesis cycle (defined as approximately 90 days)
after receiving the last dose of studyintervention, a participant who is capable of
producing sperm and is heterosexuallyactive:
must practice a highly effective method of contraception with partner of
childbearing potential. See Appendix 4 on Contraceptive and Barrier
Guidance for details.
must use a condom if participant’s partner is pregnant
must agree not to donate gametes (ie, sperm) or freeze for future use for the
purposes of assisted reproduction.
11. Participants of childbearing potential must have a negative highly sensitive
(eg, beta-human chorionic gonadotropin) urine pregnancy test at screening.
12. Participants must agree not to be pregnant, breastfeeding, planning to become
pregnant, or donate gametes (ie, eggs) or freeze for future use for the purposes of
assisted reproduction while enrolled in this study or within 3 months after the last
dose of study intervention.
Informed Consent
13. The parent(s)/LAR (as defined in Section 2, Introduction) and the participant, must
provide informed consent/assent, as described in Section 10.2.3, Informed Consent
and Assent Process.
Other
14. Participant must be comfortable with self-administration of oral and intranasal
medication and able to follow instructions provided.
15. Participant must be willing and able to adhere to the lifestyle restrictions specified in
Section 5.3 of this protocol.
16. A parent(s)/LAR must be available to help the study-site personnel ensure follow-up;
ensure the participants are accompanied to the study site on each outpatient
assessment day according to the SoA; consistently be available to provide
information on the participant.
Exclusion Criteria
Medical Conditions
1. Participant has a current DSM-5 diagnosis of bipolar (or related disorders),
intellectual disability, autism spectrum disorder, conduct disorder, oppositional
defiant disorder.
2. Participant currently meets DSM-5 criteria for borderline personality disorder.
3. Participant has a current or prior DSM-5 diagnosis of a psychotic disorder, or MDD
with psychosis.
4. 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
screening. A history (lifetime) of (es) ketamine, phencyclidine, lysergic acid
diethylamide, or 3, 4-methylenedioxy-methamphetamine hallucinogen-related use
disorder is exclusionary.
5. Participant has a past history of hypertensive crisis. Participants with conditions in
which blood pressure elevation could pose a serious risk (including severe
cardiovascular disease, recent cerebral injury, increased intracranial
pressure/intracranial mass lesion, intracranial bleeding, or acute stroke, primary
developmental or secondary acquired glaucoma or perforating eye injury) are
excluded.
6. Participant has a history or current signs and/or symptoms of liver or renal
insufficiency. Participants with moderate to severe hepatic impairment are
excluded.
7. Participant has a current diagnosis of clinically significant cardiac (eg, congenital
heart disease, cardiomyopathy, or tachyarrhythmias), vascular, pulmonary,
gastrointestinal, endocrine (including uncontrolled hyperthyroidism), neurologic,
hematologic, rheumatologic, or metabolic (including severe
dehydration/hypovolemia) disease based on investigator judgment.
8. Participant has a history of seizure disorder (excluding childhood febrile seizures).
9. Participant has a history of malignancywithin 5 years before screening, with the
exception of a malignancy that, in the opinion of the investigator and in concurrence
with the sponsor's medical monitor, is considered to have minimal risk of
recurrence.
10. Participant has anatomical or medical conditions that may impede delivery or
absorption of intranasal study medication, including but not limited to an abnormal
or deviated nasal septum with any 1 or more of the following symptoms: blockage
of 1 or both nostrils, nasal congestion (especially 1-sided), frequent nosebleeds, and
frequent sinus infections (and at times has facial pain, headaches, and postnasal drip
with the sinus infection).
11. Participant has known allergies, hypersensitivity, intolerance or contraindications to
midazolam, esketamine or ketamine, or their excipients.
1. Participant has a current DSM-5 diagnosis of bipolar (or related disorders),
intellectual disability, autism spectrum disorder, conduct disorder, oppositional
defiant disorder.
2. Participant currently meets DSM-5 criteria for borderline personality disorder.
3. Participant has a current or prior DSM-5 diagnosis of a psychotic disorder, or MDD
with psychosis.
4. 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
screening. A history (lifetime) of (es) ketamine, phencyclidine, lysergic acid
diethylamide, or 3, 4-methylenedioxy-methamphetamine hallucinogen-related use
disorder is exclusionary.
5. Participant has a past history of hypertensive crisis. Participants with conditions in
which blood pressure elevation could pose a serious risk (including severe
cardiovascular disease, recent cerebral injury, increased intracranial
pressure/intracranial mass lesion, intracranial bleeding, or acute stroke, primary
developmental or secondary acquired glaucoma or perforating eye injury) are
excluded.
6. Participant has a history or current signs and/or symptoms of liver or renal
insufficiency. Participants with moderate to severe hepatic impairment are
excluded.
7. Participant has a current diagnosis of clinically significant cardiac (eg, congenital
heart disease, cardiomyopathy, or tachyarrhythmias), vascular, pulmonary,
gastrointestinal, endocrine (including uncontrolled hyperthyroidism), neurologic,
hematologic, rheumatologic, or metabolic (including severe
dehydration/hypovolemia) disease based on investigator judgment.
8. Participant has a history of seizure disorder (excluding childhood febrile seizures).
9. Participant has a history of malignancywithin 5 years before screening, with the
exception of a malignancy that, in the opinion of the investigator and in concurrence
with the sponsor's medical monitor, is considered to have minimal risk of
recurrence.
10. Participant has anatomical or medical conditions that may impede delivery or
absorption of intranasal study medication, including but not limited to an abnormal
or deviated nasal septum with any 1 or more of the following symptoms: blockage
of 1 or both nostrils, nasal congestion (especially 1-sided), frequent nosebleeds, and
frequent sinus infections (and at times has facial pain, headaches, and postnasal drip
with the sinus infection).
11. Participant has known allergies, hypersensitivity, intolerance or contraindications to
midazolam, esketamine or ketamine, or their excipients.
The Estimated Number of Participants
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Taiwan
31 participants
-
Global
258 participants
