Clinical Trials List
2016-12-01 - 2018-06-30
Phase III
Terminated8
ICD-10F32.9
Major depressive disorder, single episode, unspecified
ICD-10F33
Major depressive disorder, recurrent
An Open-label, Long-term, Safety and Efficacy Study of Intranasal Esketamine in Treatment-resistant Depression
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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
- Mu-Hong Chen Division of Psychiatry
- W. C. LIN Division of Psychiatry
- T.P. SU Division of Psychiatry
- Ya-Mei Bai 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
- Yen-Kwuan Yang 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
- 謝明鴻 Division of Psychiatry
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
2 Stop recruiting
Audit
None
Co-Principal Investigator
- 劉宜釗 Division of Psychiatry
- JIUNN-KAE WANG Division of Psychiatry
- 陳永展 Division of Psychiatry
- 林佳霈 Division of Psychiatry
- YAO-TUNG LEE Division of Psychiatry
The Actual Total Number of Participants Enrolled
4 Stop recruiting
Audit
None
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
Occurrence of TEAEs, including TEAEs of special interest
Potential short-term effects observed on the day of intranasal treatment session with special attention
to changes from baseline/predose over time for:
Blood pressure (systolic and diastolic) and heart rate
Blood oxygen saturation
12-lead electrocardiogram
Alertness and sedation using Modified Observer’s Assessment of Alertness/Sedation
(MOAA/S)
Long-term effects, with special attention to changes from baseline over time for:
Computerized cognitive battery and Hopkins Verbal Learning Test-Revised (HVLT-R), to
assess potential effects on cognitive function
Columbia-Suicide Severity Rating Scale (C-SSRS), to assess potential effects on suicidal
ideation and behavior
Changes from baseline over time in clinical laboratory tests, including hematology, serum chemistry,
and urinalysis
Time to discharge readiness, using the Clinical Global Assessment of Discharge Readiness
(CGADR)
Efficacy endpoints include changes from baseline over time for the following:
Depressive symptoms, including response (≥50% improvement from baseline) and remission
(MADRS total score ≤12, PHQ-9 total score <5); using the Montgomery Asberg Depression Rating
scale (MADRS) and 9-item self-reported Patient Health Questionnaire (PHQ-9)
Overall severity of illness, using the Clinical Global Impression Severity (CGI-S)
Functioning and associated disability, using the Sheehan Disability Scale (SDS)
Health related quality of life and health status, using the European Quality of Life (EuroQol) Group,
5-Dimension, 5-Level (EQ-5D-5L)
Health related quality of life using the Quality of Life in Depression Scale (QLDS)
Exploratory endpoints include:
Changes from baseline over time for:
Depression response and remission rates (as defined above) to a second induction phase in
eligible subjects who had relapsed in study ESKETINTRD3003, assessed using the MADRS
and PHQ-9
Subject treatment satisfaction
Depression, assessed using the MAGDA (Magda Avatar Game Depression Implicit
Association)
Subject tradeoff preferences for key benefit and harm outcomes associated with TRD treatment,
using a stated-choice preference survey
Inclution Criteria
˙You must be at least 18 years old.
˙Your doctor has to confirm that you have met certain criteria for your disease (depression).
˙You have taken at least 2 medications for your depression without expected response in the current disease episode and your doctor or pharmacist have records to confirm that.
˙You must be in a good condition based on physical examination and your prior disease history.
˙You must have the blood pressure and pulse rate, airway and heart function as well as laboratory assessments meeting the protocol criteria at screening.
˙If you are a woman you must be prior to screening either being postmenopausal or, if you can get pregnant, you have to use a contraception method as explained by the study doctor during the study and for 6 weeks after the last dose of the intranasal study drug.
˙You must have a negative serum pregnancy test at screening visit and a negative urine pregnancy test on Day 1 of the treatment phase prior to the first intranasal treatment session.
˙If you are a man, and you have a partner who can get pregnant, you or your partner must agree to use a birth control method from Day 1 of the treatment phase through 3 months after the last dose of intranasal study medication.
˙You must be willing to adhere to the prohibitions and restrictions specified in this protocol.
˙You must sign an informed consent form for the study.
Exclusion Criteria
You cannot participate in the study if
˙If, in the past you already took esketamine or ketamine without any improvement of your condition. If in the current episode of depression you already tried all 4 oral medications which are provided during the study without expected improvement of your depression (or these medications are not available in your country).
˙If you have a bipolar disorder or some personality disorders or psychosis, as assessed by the study doctor.
˙If you had thoughts or plans to commit suicide or tried to commit suicide within 6 months prior to the study.
˙If you had problems with alcohol or drug abuse within 6 months before screening (or abuse problem with ketamine any time in your life).
˙If you have significant heart diseases (e.g. stroke, transient ischemic attack, coronary artery disease, with recent infarction or surgical procedure on the heart, heart valve or artery diseases or heart failure – as assessed by your study doctor), uncontrolled hypertension, significant pulmonary disease, epilepsia or AIDS
˙If you have positive test result for drugs of abuse or alcohol. However if the drug is prescribed to you, and you test positively for this drug, you can participate, if you stop taking it before starting the intranasal study drug.
˙If you are at least 65 years old and have cognitive/mental problems, e.g. dementia, Alzheimer disease, Parkinson’s disease
˙If you have some nasal conditions, deviated nasal septum with obstructed nose, frequent nose bleeds or infections, or noisy breathing during sleep.
˙If you have any known allergies to esketamine, ketamine or if you have a condition where esketamine/ketamine is contraindicated, or you are allergic to all of the available oral antidepressant treatments
˙If you take a medication which is not allowed in the study
˙If you are a women who is pregnant, breast-feeding or willing to get pregnant while enrolled in this study or within 6 months after the last dose of intranasal study drug.
˙If you participated in another clinical study and received an investigational drug or used an invasive medical device within 60 days before the start of the screening phase, or if you participated in 2 or more clinical studies investigating a medication for depression or other mental condition in the prior year before the start of the screening phase.
˙If you had a surgery with general anesthesia within 12 weeks before the screening phase, or did not have fully recovered from surgery.
˙If the study doctor assessed it is not in your best interest to participate in the study
The Estimated Number of Participants
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Taiwan
46 participants
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Global
750 participants
