Clinical Trials List
Protocol Number54135419SUI3001
2017-07-01 - 2019-09-09
Phase III
Terminated4
ICD-10F33.3
Major depressive disorder, recurrent, severe with psychotic symptoms
ICD-10F33
Major depressive disorder, recurrent
ICD-9296.34
Major depressive disorder, recurrent episode, severe specified as with psychotic behavior
A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of Intranasal Esketamine in Addition to Comprehensive Standard of Care for the Rapid Reduction of the Symptoms of Major Depressive Disorder, Including Suicidal Ideation, in Subjects Assessed to be at Imminent Risk for Suicide
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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
2025/08/20
Investigators and Locations
Co-Principal Investigator
- 徐佳福 Division of Psychiatry
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- W. C. LIN Division of Psychiatry
- Mu-Hong Chen Division of Psychiatry
- Ya-Mei Bai Division of Psychiatry
- T.P. SU Division of Psychiatry
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 劉宜釗 Division of Psychiatry
- YAO-TUNG LEE Division of Psychiatry
- 陳永展 Division of Psychiatry
- 林佳霈 Division of Psychiatry
- JIUNN-KAE WANG Division of Psychiatry
The Actual Total Number of Participants Enrolled
3 Stop recruiting
Audit
None
Condition/Disease
Major Depressive Disorder
Objectives
Primary Objective
The primary objective is to evaluate the efficacy of intranasal esketamine 84 mg compared with intranasal placebo in addition to comprehensive standard of care in reducing the symptoms of MDD, including suicidal ideation, in subjects who are assessed to be at imminent risk for suicide, as measured by the change from baseline on the Montgomery-Asberg Depression Rating Scale (MADRS) total score at 24 hours post first dose.
Key Secondary Objective
The key secondary objective is to assess the efficacy of intranasal esketamine compared with intranasal placebo in reducing severity of suicidality as measured by the clinical global impression of severity of suicidality revised version (CGI-SS-R) at 24 hours post first dose.
Test Drug
ESKETAMINE
Active Ingredient
esketamine hydrochloride
Dosage Form
intranasal solution in a nasal spray
Dosage
200 microliter
Endpoints
The primary efficacy endpoint will be the change from baseline (Day 1, predose) to 24 hours post first
dose in depressive symptoms, as measured by the MADRS total score.
The key secondary efficacy endpoint will be the change from baseline (Day 1, predose) at 24 hours post
first dose in severity of suicidality, as measured by the CGI-SS-R.
The other secondary endpoints are:
MADRS
Remission rate (MADRS ≤12) at 4 hours and 24 hours post first dose, and through the end of
the double-blind treatment phase (Day 25)
Change from baseline of MADRS total score at 4 hours post first dose and through the end of
the double-blind treatment phase (Day 25)
CGI-SS-R
Change from baseline at 4 hours post first dose and through the end of the double-blind
treatment phase (Day 25).
Proportion of subjects achieving resolution of suicidality (CGI-SS-R score of 0 or 1) at 4 hours
and 24 hours post first dose, and through the end of the double-blind treatment phase (Day 25)
CGI-SR-I: Change from baseline at 4 hours and 24 hours post first dose, and through the end of the
double-blind treatment phase (Day 25)
BHS: Change from baseline through the end of the double-blind treatment phase (Day 25)
EQ-5D-5L: Change from baseline through the end of the double-blind treatment phase (Day 25)
QLDS: Change from baseline through the end of the double-blind treatment phase (Day 25)
TSQM-9: Scores through the end of the double-blind treatment phase (Day 25)
SIBAT: Change from baseline in Module 3 My Current Thinking and Module 5 My Risk, Question 3
(patient-reported frequency of suicidal thinking), through the end of the double-blind treatment phase
(Day 25)
Pharmacokinetics: Plasma esketamine and noresketamine concentrations will be summarized;
plasma concentrations of esketamine (and noresketamine concentrations, if warranted) will be
included in a population analysis
Safety endpoints will be evaluated throughout the study:
Monitoring of treatment emergent adverse events (TEAEs)
Clinical laboratory tests, physical examination, nasal examination, 12-lead electrocardiogram
(ECG), and vital signs
SIBAT
On dosing days: MOAA/S, CADSS, and pulse oximetry
dose in depressive symptoms, as measured by the MADRS total score.
The key secondary efficacy endpoint will be the change from baseline (Day 1, predose) at 24 hours post
first dose in severity of suicidality, as measured by the CGI-SS-R.
The other secondary endpoints are:
MADRS
Remission rate (MADRS ≤12) at 4 hours and 24 hours post first dose, and through the end of
the double-blind treatment phase (Day 25)
Change from baseline of MADRS total score at 4 hours post first dose and through the end of
the double-blind treatment phase (Day 25)
CGI-SS-R
Change from baseline at 4 hours post first dose and through the end of the double-blind
treatment phase (Day 25).
Proportion of subjects achieving resolution of suicidality (CGI-SS-R score of 0 or 1) at 4 hours
and 24 hours post first dose, and through the end of the double-blind treatment phase (Day 25)
CGI-SR-I: Change from baseline at 4 hours and 24 hours post first dose, and through the end of the
double-blind treatment phase (Day 25)
BHS: Change from baseline through the end of the double-blind treatment phase (Day 25)
EQ-5D-5L: Change from baseline through the end of the double-blind treatment phase (Day 25)
QLDS: Change from baseline through the end of the double-blind treatment phase (Day 25)
TSQM-9: Scores through the end of the double-blind treatment phase (Day 25)
SIBAT: Change from baseline in Module 3 My Current Thinking and Module 5 My Risk, Question 3
(patient-reported frequency of suicidal thinking), through the end of the double-blind treatment phase
(Day 25)
Pharmacokinetics: Plasma esketamine and noresketamine concentrations will be summarized;
plasma concentrations of esketamine (and noresketamine concentrations, if warranted) will be
included in a population analysis
Safety endpoints will be evaluated throughout the study:
Monitoring of treatment emergent adverse events (TEAEs)
Clinical laboratory tests, physical examination, nasal examination, 12-lead electrocardiogram
(ECG), and vital signs
SIBAT
On dosing days: MOAA/S, CADSS, and pulse oximetry
Inclution Criteria
1. Subject must be a man or woman, 18 to 64 years of age, inclusive.
2. Subject must meet Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-5) diagnostic criteria for MDD, without psychotic features, based upon clinical assessment and confirmed by the Mini International Psychiatric Interview (MINI).
3. Subjects must have current suicidal ideation with intent, confirmed by a “Yes” response to Question B3 [Think (even momentarily) about harming or of hurting or of injuring yourself: with at least some intent or awareness that you might die as a result; or think about suicide (ie, about killing yourself)?] AND Question B10 [Intend to act on thoughts of killing yourself?] obtained from the MINI. Note: the response to B3 must refer to the present, whereas the response to B10 may reflect the past 24 hours. If the screening period is longer than 24 hours, assessment of B3 and B10 of MINI must be repeated prior to randomization to confirm eligibility.
4. In the physician’s opinion, acute psychiatric hospitalization is clinically warranted due to subject’s imminent risk of suicide.
5. Subject has a MADRS total score of >28 predose on Day 1.
6. As part of standard of care treatment, subject agrees to be hospitalized voluntarily for a recommended period of 5 days after randomization (may be shorter or longer if clinically warranted in the investigator’s opinion) and take prescribed non-investigational antidepressant therapy(ies) for at least the duration of the double-blind treatment phase (Day 25).
2. Subject must meet Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-5) diagnostic criteria for MDD, without psychotic features, based upon clinical assessment and confirmed by the Mini International Psychiatric Interview (MINI).
3. Subjects must have current suicidal ideation with intent, confirmed by a “Yes” response to Question B3 [Think (even momentarily) about harming or of hurting or of injuring yourself: with at least some intent or awareness that you might die as a result; or think about suicide (ie, about killing yourself)?] AND Question B10 [Intend to act on thoughts of killing yourself?] obtained from the MINI. Note: the response to B3 must refer to the present, whereas the response to B10 may reflect the past 24 hours. If the screening period is longer than 24 hours, assessment of B3 and B10 of MINI must be repeated prior to randomization to confirm eligibility.
4. In the physician’s opinion, acute psychiatric hospitalization is clinically warranted due to subject’s imminent risk of suicide.
5. Subject has a MADRS total score of >28 predose on Day 1.
6. As part of standard of care treatment, subject agrees to be hospitalized voluntarily for a recommended period of 5 days after randomization (may be shorter or longer if clinically warranted in the investigator’s opinion) and take prescribed non-investigational antidepressant therapy(ies) for at least the duration of the double-blind treatment phase (Day 25).
Exclusion Criteria
1. Subject has a current DSM-5 diagnosis of bipolar (or related disorders), antisocial personality disorder, or obsessive compulsive disorder.
2. Subject currently meets DSM-5 criteria for borderline personality disorder.
Subjects not meeting full DSM-5 criteria for borderline personality disorder but exhibiting recurrent suicidal gestures, threats, or self-mutilating behaviors should also be excluded.
3. Subject has a current clinical diagnosis of autism, dementia, or intellectual disability
4. Subject has a current or prior DSM-5 diagnosis of a psychotic disorder, or MDD with psychotic features.
5. Subject 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.
6. Subject has a history or current signs and symptoms of liver or renal insufficiency or of clinically significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic (including current or past history of seizures except uncomplicated childhood febrile seizures with no sequelae), hematologic, rheumatologic, or metabolic disease.
7. Subject has uncontrolled hypertension (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) despite diet, exercise or a stable dose of an allowed anti-hypertensive treatment at screening; or any past history of hypertensive crisis.
An abnormal blood pressure value at screening can be repeated once after 5 minutes of relaxation for subject eligibility. On Day 1 of the double-blind phase prior to randomization, a supine or semi-supine systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg is exclusionary.
2. Subject currently meets DSM-5 criteria for borderline personality disorder.
Subjects not meeting full DSM-5 criteria for borderline personality disorder but exhibiting recurrent suicidal gestures, threats, or self-mutilating behaviors should also be excluded.
3. Subject has a current clinical diagnosis of autism, dementia, or intellectual disability
4. Subject has a current or prior DSM-5 diagnosis of a psychotic disorder, or MDD with psychotic features.
5. Subject 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.
6. Subject has a history or current signs and symptoms of liver or renal insufficiency or of clinically significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic (including current or past history of seizures except uncomplicated childhood febrile seizures with no sequelae), hematologic, rheumatologic, or metabolic disease.
7. Subject has uncontrolled hypertension (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) despite diet, exercise or a stable dose of an allowed anti-hypertensive treatment at screening; or any past history of hypertensive crisis.
An abnormal blood pressure value at screening can be repeated once after 5 minutes of relaxation for subject eligibility. On Day 1 of the double-blind phase prior to randomization, a supine or semi-supine systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg is exclusionary.
The Estimated Number of Participants
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Taiwan
15 participants
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Global
224 participants
