EUCTR2015-003578-34-LT进行中（未招募）1 期
An Open-label Long-term Extension Safety Study of Esketamine NasalSpray in Treatment-resistant Depression - SUSTAIN-3
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 330
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Based on the prior study the subject is entering 54135419TRD3008 from:
- •a. From ESKETINTRD3001 or ESKETINTRD3002 study:
- •i. Subject has completed the induction phase and the 2-week follow up phase visit; or
- •ii. Subject completed the induction phase and was a responder and study ESKETINTRD3003 is terminated.
- •b. From ESKETINTRD3003 study:
- •i. Subject relapsed during the maintenance phase; or ii. Subject was in the induction phase of the ESKETINTRD3003 study when the study was terminated and, after completion of the induction phase, was determined to be a responder; or
- •iii. Subject was in the optimization or maintenance phases at the time the study was terminated; or
- •iv. At Week 16 of Optimization, the subject was not eligible to proceed to the Maintenance phase and sponsor has approved subject's entry into
- •54135419TRD3008; or
- •v. Subject was in the induction phase and after completion of induction phase was determined to not meet response criteria, and sponsor has
- •approved subject's entry into 54135419TRD3008.
- •c. From ESKETINTRD3004 study:
- •i. Subject completed ESKETINTRD3004 study optimization/maintenance phase; or
- •ii. Subject was in the induction phase of the ESKETINTRD3004 study when the study was terminated and, after completion of the induction
- •phase, was determined to be a responder; or
- •iii. Subject was in the optimization/maintenance phase at the time the study was terminated; or
- •iv. Subject was in the induction phase and did not meet criteria for response, and sponsor has approved subject's entry into
- •54135419TRD3008.
- •d. From ESKETINTRD3005 study: Subject was in the induction phase of the ESKETINTRD3005 study at the time enrollment into the
- •ESKETINTRD3004 study was closed and, after completion of the induction phase, was determined to be a responder or did not meet the
- •criteria for response.
- •e. From ESKETINTRD3006 study (US Study sites only):
- •i. Subject completed the induction phase and was a responder; or
- •ii. Subject completed the induction phase and did not meet the response criteria and sponsor has approved subject's entry into
- •54135419TRD3008.
- •2. Subject must be medically stable on the basis of physical examination, vital signs (including blood pressure), pulse oximetry, and 12-lead ECG
- •performed predose on the day of the first intranasal treatment session.
- •If there are any abnormalities that are not specified in the inclusion and exclusion criteria, their clinical significance must be determined by the
- •investigator and recorded in the subject's source documents and initialed by the investigator.
- •3. Subject must be medically stable according to the investigator's judgment and knowledge of the subject's medical stability in the parent
- •study. This determination must be documented.
- •4. Contraceptive use by men or women should be consistent with local regulations regarding the use of contraceptive methods for subjects
- •participating in clinical studies.
- •A woman must be either:
- •a. Not of childbearing potential defined as:
- •-postmenopausal
- •-permanently sterile
- •b. Of childbearing potential and practicing a highly effective method of contraception (failure rate of <1% per year when used consistently and
- •correctly).
- •Examples of highly effective contraceptives include
- •-user-independent methods:
- •implantable progestogen-only hormone contraception associated with inhibition of ovulation; intrauterine device (IUD); intrauterine hormonereleasing
- •system (IUS); vasectomized partner; sexual abstinence (sexual abstinence is considered a highly effec
排除标准
- •1. The evaluation of the benefit versus risk of continued esketamine nasal spray treatment is not favorable for the participant in the opinion
- •of the investigator
- •2. Since the last study visit in the participant's prior study, participant
- •suicidal ideation with intent to act per the investigator's clinical
- •judgment or based on the Columbia Suicide Severity Rating Scale (CSSRS)
- •[corresponding to a response of Yes on Item 4 (active suicidal
- •ideation with some intent to act,
- •without specific plan) or Item 5 (active suicidal ideation with specific
- •intent) in the suicidal ideation module of the C-SSRS] or suicidal
- •behavior per the investigator's clinical judgment or based on the C-SSRS
- •(corresponding to any score higher than 0 in the suicidal behavior
- •module of the C-SSRS)
- •3. Subject has a neurodegenerative disorder (eg, Alzheimer's disease,
- •vascular dementia, Parkinson's disease), or evidence of mild cognitive
- •impairment (MCI).
- •4. Participant has positive test result(s) for drugs of abuse (including
- •arbiturates,
- •methadone, opiates, cocaine, phencyclidine, and
- •amphetamine/methamphetamine) predose on the day of the first
- •intranasal treatment session
- •5. Participant has any anatomical or medical condition that, per the
- •investigator's clinical judgment based on assessment, may impede
- •delivery or
- •absorption of intranasal study drug
- •6. Participant has taken any prohibited therapies that would not permit
- •administration of the first intranasal treatment session
- •Additional Exclusion Criteria can be found in Protocol section 4.2.
研究者
相似试验
进行中（未招募）
1 期
A Long-term Safety Study of Intranasal Esketamine in Treatment-resistant DepressioTreatment-resistant Major DepressionMedDRA version: 19.0Level: PTClassification code 10057840Term: Major depressionSystem Organ Class: 10037175 - Psychiatric disordersEUCTR2015-003578-34-BEJanssen-Cilag International NV330
进行中（未招募）
1 期
A Long-term Safety Study of Intranasal Esketamine in Treatment-resistant DepressioTreatment-resistant Major DepressionMedDRA version: 21.1Level: PTClassification code 10057840Term: Major depressionSystem Organ Class: 10037175 - Psychiatric disordersEUCTR2015-003578-34-FIJanssen-Cilag International NV330
进行中（未招募）
1 期
A Long-term Safety Study of Intranasal Esketamine in Treatment-resistant DepressioTreatment-resistant Major DepressionMedDRA version: 21.1Level: PTClassification code 10057840Term: Major depressionSystem Organ Class: 10037175 - Psychiatric disordersEUCTR2015-003578-34-ITJANSSEN CILAG INTERNATIONAL NV330
进行中（未招募）
1 期
A Long-term Safety Study of Intranasal Esketamine in Treatment-resistant DepressioEUCTR2015-003578-34-ESJanssen-Cilag International NV330
进行中（未招募）
1 期
A Long-term Safety Study of Intranasal Esketamine in Treatment-resistant DepressioTreatment-resistant Major DepressionMedDRA version: 21.1Level: PTClassification code 10057840Term: Major depressionSystem Organ Class: 10037175 - Psychiatric disordersEUCTR2015-003578-34-SKJanssen-Cilag International NV330