EUCTR2015-003578-34-SK进行中（未招募）1 期
An Open-label Long-term Extension Safety Study of Esketamine Nasal Spray in Treatment-resistant Depression - SUSTAIN-3
适应症
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
- •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
- •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:
- 另有 7 项未显示
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
- •has 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 plan and 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
- •barbiturates, 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
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