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Clinical Trials List

Protocol Number54135419TRD3008

NCT Number(ClinicalTrials.gov Identfier)NCT02782104

Completed

2017-07-01 - 2022-12-20

Phase III

Recruiting4

Terminated3

ICD-10F33

Major depressive disorder, recurrent

An Open-label Long-term Extension Safety Study of Esketamine Nasal Spray in Treatment-resistant Depression

Trial Applicant

Johnson & Johnson
Sponsor

JOHNSON & JOHNSON TAIWAN LTD.
Trial scale

Multi-Regional Multi-Center
Update

2026/02/01

Investigators and Locations

Principal Investigator 林承儒 Division of Psychiatry

MacKay Memorial Hospital

Co-Principal Investigator

方俊凱 Division of Psychiatry
徐堅棋 Division of Psychiatry

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator Cheng-Ta Li Division of Psychiatry

Taipei Veterans General Hospital

Co-Principal Investigator

W. C. LIN Division of Psychiatry
T.P. SU Division of Psychiatry

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 朱柏全 Division of Psychiatry

Chung Shan Medical University Hospital

Co-Principal Investigator

謝明鴻 Division of Psychiatry
張清綦 Division of Psychiatry
廖尹鐸 Division of Psychiatry

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 洪一永 Division of Psychiatry

Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

洪琪發 Division of Psychiatry
林潔欣 Division of Psychiatry
蔡孟璋 Division of Psychiatry

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chia-Yi Liu Division of Psychiatry

Linkou Chang Gung Medical Foundation

Taiwan National PI

劉嘉逸

Co-Principal Investigator

李晉邦 Division of Psychiatry
林皇利 Division of Psychiatry

The Actual Total Number of Participants Enrolled

2 Stop recruiting

Audit

None

Principal Investigator HSIN-CHIEN LEE Division of Psychiatry

Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

Co-Principal Investigator

YAO-TUNG LEE Division of Psychiatry

The Actual Total Number of Participants Enrolled

2 Recruiting

Audit

None

Principal Investigator 林承儒 Division of Psychiatry

MacKay Memorial Hospital

Co-Principal Investigator

徐堅棋 Division of Psychiatry

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Condition/Disease

Treatment-resistant Depression

Objectives

Primary Objectives The primary objective of this study is to assess the safety and tolerability of esketamine nasal spray in subjects with TRD, with special attention to the following:  Potential long-term effects on cognitive function  Treatment-emergent adverse events (TEAEs), including TEAEs of special interest  Post dose effects on heart rate, blood pressure, respiratory rate and blood oxygen saturation  Potential effects on suicidal ideation/behavior Secondary Objective The secondary objective is to assess long-term efficacy, including effects on:  Depressive symptoms (clinician and self-reported),  Overall severity of depressive illness,  Functioning and associated disability,  Health-related quality of life and health status,

Test Drug

ESKETAMINE

Active Ingredient

Esketamine

Dosage Form

intranasal solution in a nasal spray pump

Dosage

200 microliter

Endpoints

Safety endpoints are listed below:
 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)

Inclution Criteria

•The study population will include adult and elderly men and women who previously participated in studies ESKETINTRD3001, ESKETINTRD3002, ESKETINTRD3003, ESKETINTRD3004, ESKETINTRD3005 or ESKETINTRD3006(US sites only) and will have met the inclusion/exclusion criteria for entry into those studies.
•Medically stable per investigator’s clinical judgment based on physical examination, medical history, vital signs, ECG, labs
•Females must be Not of childbearing potential, Postmenopausal, permanently sterilized, or if of childbearing potential must be practicing highly effective birth control method

Exclusion Criteria

•Potential subjects will be excluded from participating in the study if the evaluation of the risk versus benefit of continued intranasal esketamine treatment is not favorable for the subject in the opinion of the investigator.
•Subjects reporting suicidal ideation with intent to act or suicidal behavior prior to the start of the study will be excluded.
•Subjects with a neurodegenerative disorder or evidence of mild cognitive impairment prior to the first intranasal treatment session will be excluded from participating in the study.
•In addition, any subject with uncontrolled hypertension, or a positive test result(s) for drugs of abuse (including barbiturates, methadone, opiates, cocaine, phencyclidine, and amphetamine/methamphetamine) prior to the first intranasal treatment session will be excluded from participating in the study.

The Estimated Number of Participants

Taiwan

22 participants
Global

1148 participants