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临床试验/EUCTR2014-004587-38-IT
EUCTR2014-004587-38-IT进行中（未招募）1 期

an open-label, long-term, safety and efficacy study of intranasal esketamine in treatment- resistant depression - SUSTAIN-2

JANSSEN CILAG INTERNATIONAL NV0 个研究点目标入组 877 人开始时间: 2018年2月22日最近更新:
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试验速览

阶段
1 期
状态
进行中（未招募）
入组人数
877
研究概览入排标准研究者记录与标识符相似试验

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

  • •A). For Direct-Entry Participants
  • •- At the time of signing the informed consent form (ICF), participant must be a man or woman =18 (or older if the minimum legal age of consent in the country in which the study is taking place is greater than [>]18) - At the start of the screening phase, participant must meet the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnostic
  • •criteria for single-episode major depressive disorder (MDD) (if singleepisode MDD, the duration must be greater than or equal to [>=] 2 years) or recurrent MDD, without psychotic features, based upon clinical assessment and confirmed by the Mini-International Neuropsychiatric Interview (MINI)
  • •- At screening, participant must have a MADRS total score of >=22 - At the start of the screening phase, participants must have had nonresponse to >=2 oral antidepressant treatments taken at adequate
  • •dosage and for adequate duration, as assessed using the Massachusetts General Hospital
  • •B). For Transferred-entry Participants
  • •-All participants who completed the double-blind induction phase of ESKETINTRD3005 study, regardless of their response status, will be eligible to participate in this study, if they meet the study specific eligibility criteria
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range: 1
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range 750
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 127

排除标准

  • •A). For Direct-Entry Participants
  • •- Participant's depressive symptoms have previously not responded to:
  • •1).Esketamine or ketamine in the current major depressive episode per clinical judgment,
  • •2). All of the 4 oral antidepressant treatment options available in the respective country for the open-label induction phase (that is, duloxetine, escitalopram, sertraline, and venlafaxine XR) in the current major depressive episode (based on Massachusetts General Hospital - Antidepressant Treatment Response Questionnaire [ MGH-ATRQ]) -
  • •Participant has a current or prior DSM-5 diagnosis of a psychotic disorder or MDD with psychosis, bipolar or related disorders (confirmed by the MINI), comorbid obsessive compulsive disorder, intellectual disability (DSM-5 diagnostic codes 317, 318.0, 318.1, 318.2, 315.8, and 319), autism spectrum disorder, borderline personality disorder,
  • •antisocial personality disorder, histrionic personality disorder, or narcissistic personality disorder
  • •- Participant has homicidal ideation/intent, per the investigator's clinical judgment, or has suicidal ideation with some intent to act within 6
  • •months prior to the start of the screening phase, per the investigator's clinical judgment or based on the Columbia Suicide Severity Rating Scale (C-SSRS) - Participants with history of moderate or severe substance or alcohol use disorder according to DSM-5 criteria - Participants aged greater than or equal to 65 years: Has a Mini Mental State Examination (MMSE) <25; Has neurodegenerative disorder (example, Alzheimer's disease, vascular dementia, Parkinson's disease),
  • •or evidence of mild cognitive impairment (MCI)
  • •B). Transferred-Entry Participants
  • •- Participant has taken any prohibited therapies that would not permit dosing on Day 1

研究者

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