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Seltorexant 作为抗抑郁药辅助治疗的成人和老年抑郁症患者的研究

2026年4月21日更新者：Janssen Research & Development, LLC

一项多中心、双盲、随机、平行组、安慰剂对照的研究，旨在评估 Seltorexant 20 mg 作为抗抑郁药辅助治疗的疗效和安全性，用于对具有失眠症状的严重抑郁症成人和老年患者的疗效和安全性反应不充分抗抑郁治疗和使用 Seltorexant 的开放标签长期安全延长治疗

本研究的目的是评估 seltorexant 与安慰剂相比作为抗抑郁药的辅助治疗在改善患有重度抑郁症伴失眠症状 (MDDIS) 的参与者的抑郁症状方面的疗效，这些参与者对目前的选择性抗抑郁治疗反应不足5-羟色胺再摄取抑制剂 (SSRI) 或 5-羟色胺-去甲肾上腺素再摄取抑制剂 (SNRI) 在双盲治疗阶段评估 seltorexant 作为抗抑郁药辅助治疗的长期安全性和耐受性-标签处理阶段。

研究概览

地位

完全的

条件

抑郁症，主要

干预/治疗

详细说明

重度抑郁症 (MDD) 是一种常见、严重、反复发作的疾病。 Seltorexant (JNJ-42847922) 是一种有效的选择性人食欲素-2 受体 (OX2R) 拮抗剂，正在开发用于辅助治疗伴有失眠症状的重度抑郁症 (MDDIS)。本研究的假设是，根据蒙哥马利阿斯伯格抑郁量表 (MADRS) 总分从基线到第 43 天的变化，在患有 MDDIS 的成年和老年参与者中，使用 seltorexant 的辅助治疗在治疗抑郁症状方面优于安慰剂对 SSRI/SNRI 治疗的反应不足。该研究将分 4 个阶段进行：筛选阶段（最多 30 天）、双盲 (DB) 治疗阶段（43 天）、开放标签 (OL) 治疗阶段（1 年）和后期治疗随访阶段（治疗结束后 7 至 14 天）。每个参与者的总研究持续时间将长达 64 周。将在本研究的特定时间点评估疗效、安全性、药代动力学和生物标志物。

研究类型

介入性

注册 (实际的)

588

阶段

第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

俄罗斯
- - Saint Petersburg、俄罗斯、190013
    - Psychoneurological Dispensary of Frunzensky District
  - Saint Petersburg、俄罗斯、190020
    - SPb SBIH 'City Psychoneurological Dispensary # 7 (With Inpatient Facilities)'
  - Saint Petersburg、俄罗斯、190121
    - City Psychiatric Hospital of St. Nikolay Chudotvorets
  - Saint Petersburg、俄罗斯、192019
    - Bekhterev Psychoneurological Research Institute
  - Saint Petersburg、俄罗斯、192019
    - St-Petersburg Bekhterev Psychoneurological Research Institute
  - Saint Petersburg、俄罗斯、199106
    - Psychoneurological dispensary 1
  - Stavropol、俄罗斯、357034
    - Stavropol Region Psychiatric Hospital #2
  - Yaroslavl、俄罗斯、150003
    - Yaroslavl Region Clinical Psychiatric Hospital
保加利亚
- - Burgas、保加利亚、8001
    - Mental Health Center Prof. Dr. Ivan Temkov
  - Cherven Bryag、保加利亚、5980
    - Ambulatory for Individual Practice for Specialized Medical Care in Psychiatry Dr. Ivo Natsov ET
  - Kardzhali、保加利亚、6600
    - State Psychiatric Hospital Kardzhali
  - Plovdiv、保加利亚、4000
    - UMHAT 'Sv. Georgi' EAD
  - Plovdiv、保加利亚、4000
    - Medical center Spectar - Plovdiv EOOD
  - Slivnitsa、保加利亚、1202
    - MHC - Sofia, EOOD
  - Sofia、保加利亚、1408
    - DCC 'Sv. Vrach and Sv. Sv. Kuzma and Damyan', OOD
  - Sofia、保加利亚、1680
    - Medical Center Intermedica, OOD
  - Sofia、保加利亚、1113
    - Medical Center St. Naum
  - Targovishte、保加利亚、7700
    - Medical center - VAS OOD
  - Vratsa、保加利亚、3000
    - Mental Health Center - Vratsa EOOD
南非
- - Bloemfontein、南非、9301
    - Farmovs Pty Ltd
  - Bloemfontein、南非、9324
    - Iatros International
  - Cape Town、南非、7530
    - Cape Town Clinical Research Centre
  - Cape Town、南非、7530
    - Flexivest 14 Research
  - Krugersdorp、南非、1739
    - DJW Research
  - Mamelodi East、南非、0122
    - Stanza Clinical Research Centre : Mamelodi
  - Pretoria、南非
    - Synexus Watermeyer
  - Strand、南非、7140
    - Somerset West Clinical Research Unit
台湾
- - Keelung、台湾、204
    - Chang-Gung Memorial Hospital-Keelung
  - Taipei、台湾、10002
    - National Taiwan University Hospital
  - Taipei、台湾、110
    - Taipei Medical University
  - Taipei、台湾、10449
    - Mackay Memorial Hospital
  - Taipei、台湾、112
    - Taipei Veterans General Hospital
  - Taipei、台湾、112
    - Cheng Hsin General Hospital
  - Taoyuan County、台湾、33305
    - Chang Gung Memorial Hospital- Linkou
哥伦比亚
- - Barranquilla、哥伦比亚
    - Centro de Investigaciones y Proyectos en Neurociencias CIPNA
  - Bello、哥伦比亚、051053
    - HOMO - ESE Hospital Mental de Antioquia
  - Bogotá、哥伦比亚、111166
    - Centro de Investigaciones del Sistema Nervioso Grupo Cisne Ltda.
  - Medellín、哥伦比亚
    - Fundacion Centro de Investigacion Clinica CIC
  - Pereira、哥伦比亚
    - Psynapsis Salud Mental S.A.
墨西哥
- - Monterrey、墨西哥、64310
    - Iecsi S.C.
  - Nuevo León、墨西哥、64060
    - CRI Centro Regiomontano de Investigacion SC
  - San Luis Potosí City、墨西哥、78213
    - BIND Investigaciones S.C.
巴西
- - Belo Horizonte、巴西、30150-270
    - CPN - Centro de Pesquisa em Neurociências Ltda
  - Brasília、巴西、70200-730
    - CCB Centro Cardiologico de Brasilia Ltda - CCB Cardiologia
  - Curitiba、巴西、81210-310
    - Instituto de Neurologia de Curitiba
  - Fortaleza、巴西、60430-380
    - Universidade Federal do Ceara Hospital Universitario Walter Cantidio
  - Passo Fundo、巴西、99010-120
    - Instituto Méderi de Pesquisa e Saúde
  - Rio de Janeiro、巴西、22270 060
    - Ruschel Medicina e Pesquisa Clínica Ltda
  - São Paulo、巴西、04037-003
    - SPDM - Associacao Paulista para o Desenvolvimento da Medicina - Hospital Sao Paulo
  - São Paulo、巴西、13970-905
    - Instituto Bairral de Psiquiatria
捷克语
- - Kladno、捷克语、27201
    - Brain-Soultherapy s.r.o.
  - Kutná Hora、捷克语、284 01
    - Neuroterapie KH S R O
  - Pilsen、捷克语、31200
    - A Shine S R O
  - Prague、捷克语、16000
    - Medical Services Prague S R O
  - Prague、捷克语、10000
    - Clintrial s r o
瑞典
- - Halmstad、瑞典、SE-30248
    - Affecta Pskyiatrimottagning
  - Helsingborg、瑞典、25220
    - PharmaSite Helsingborg
  - Lund、瑞典、22222
    - ProbarE i Lund AB
  - Malmö、瑞典、21152
    - PharmaSite
  - Skövde、瑞典、54143
    - Läkarmottagningen
  - Stockholm、瑞典、111 37
    - ProbarE i Solna
美国
- California
  - Anaheim、California、美国、92805
    - Advanced Research Center Inc
  - Cerritos、California、美国、90703
    - SYNEXUS
  - Irvine、California、美国、92614
    - Irvine Clinical Research
  - La Habra、California、美国、90631
    - Omega Clinical Trials LLC
  - Lemon Grove、California、美国、91945
    - Synergy East
  - Los Angeles、California、美国、90048
    - Semel Institute for Neuroscience and Human Behavior
  - Montclair、California、美国、91763
    - Catalina Research Institute
  - Oakland、California、美国、94607
    - Pacific Research Partners
  - Oceanside、California、美国、92056
    - North County Clinical Research
  - Santa Ana、California、美国、92705
    - Syrentis Clinical Research
  - Temecula、California、美国、92591
    - Viking Pharmaceutical Trials Inc. dba Viking Clinical Research
- Connecticut
  - Cromwell、Connecticut、美国、06416
    - Connecticut Clinical Trials LLC
  - Farmington、Connecticut、美国、06030
    - University of Connecticut Health Center
- Florida
  - Gainesville、Florida、美国、32607
    - Sarkis Clinical Trials
  - Jacksonville、Florida、美国、32256
    - Clinical Neuroscience Solutions Inc
  - Miami、Florida、美国、33134
    - Medical Research Center of Miami II Inc
  - Miami、Florida、美国、33126
    - Pharmax Research Clinic Inc
  - Miami、Florida、美国、33165
    - Phoenix Medical Research, Inc.
  - Miami Springs、Florida、美国、33166
    - Galiz Research
  - North Bay Village、Florida、美国、33141
    - Bravo Health Care Center
  - Orlando、Florida、美国、32803
    - APG Research LLC
  - Orlando、Florida、美国、32803
    - Combined Research Orlando
  - Orlando、Florida、美国、32803
    - Nova Psychiatry INC
- Illinois
  - Elgin、Illinois、美国、60123
    - Revive Research Institute
  - Joliet、Illinois、美国、60435
    - Joliet Center For Clinical Research
  - Naperville、Illinois、美国、60563
    - Baber Research Group
  - Oak Brook、Illinois、美国、60523
    - American Medical Research, Inc.
  - Springfield、Illinois、美国、62701
    - Southern Illinois University School of Medicine
- Louisiana
  - Shreveport、Louisiana、美国、71101
    - Louisiana Clinical Research
- Massachusetts
  - Watertown、Massachusetts、美国、02472
    - Adams Clinical
- Michigan
  - Bloomfield Hills、Michigan、美国、48302
    - NeuroBehavioral Medicine Group
- Missouri
  - Saint Charles、Missouri、美国、63301
    - Midwest Research Group - St. Charles Psychiatric Associates
  - St Louis、Missouri、美国、63128
    - PsychCare Consultants Research
  - St Louis、Missouri、美国、63109
    - Mid-America Clinical Research, LLC
- Nebraska
  - Lincoln、Nebraska、美国、68526
    - Premier Psychiatric Research Institute, LLC
- Nevada
  - Las Vegas、Nevada、美国、89102
    - Altea Research Institute
- New Jersey
  - Berlin、New Jersey、美国、08009
    - Hassman Research Institute, LLC.
- New York
  - Jamaica、New York、美国、11432
    - Synexus Clinical Research US Inc
  - Mount Kisco、New York、美国、10549
    - Bioscience Research LLC
- Ohio
  - Avon Lake、Ohio、美国、44012
    - Haidar Almhana Nieding
  - Columbus、Ohio、美国、43221
    - The Ohio State University
  - Mason、Ohio、美国、45040
    - Lindner Center of Hope
- Oklahoma
  - Oklahoma City、Oklahoma、美国、73112
    - Oklahoma Clinical Research Center
- Pennsylvania
  - Allentown、Pennsylvania、美国、18104
    - Lehigh Center For Clinical Research
  - Philadelphia、Pennsylvania、美国、19104
    - University of Pennsylvania - Perelman School of Medicine
- Texas
  - Dallas、Texas、美国、75243
    - Relaro Medical Trials
  - Fort Worth、Texas、美国、76104
    - North Texas Clinical Trials
  - Houston、Texas、美国、77030
    - Baylor College of Medicine
  - Houston、Texas、美国、77090
    - Red Oak Psychiatry Associates
- Utah
  - Clinton、Utah、美国、84015
    - Alpine Research Organization
- Vermont
  - Rutland、Vermont、美国、05701
    - Green Mountain Research Institute
西班牙
- - Barcelona、西班牙、08025
    - Institucion Hosp Hestia Palau
  - Barcelona、西班牙、08035
    - Hosp Univ Vall D Hebron
  - Bilbao、西班牙、48013
    - Hosp. Univ. de Basurto
  - Madrid、西班牙、28034
    - Hosp. Univ. Ramon Y Cajal
  - Madrid、西班牙、28046
    - Hosp. Univ. La Paz
  - Oviedo、西班牙、33011
    - Centro Salud Mental La Corredoria
  - Pamplona、西班牙、31008
    - Clinica Univ. de Navarra
  - Sabadell、西班牙、08208
    - Corporacio Sanitari Parc Tauli
  - Salamanca、西班牙、37005
    - Centro de salud San Juan - IBSAL
  - Zamora、西班牙、49021
    - Hosp. Prov. de Zamora

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年至 74年 (成人、年长者)

接受健康志愿者

不

描述

纳入标准：

符合《精神疾病诊断和统计手册》第 5 版 (DSM-5) 的重度抑郁症 (MDD) 诊断标准，无精神病特征，基于临床评估并经 DSM-5 轴 I 障碍临床结构化临床访谈确认试用版 (SCID-CT) 诊断为 60 岁之前首次抑郁发作。当前抑郁发作的长度必须小于或等于（
在当前的抑郁症发作中，对至少 1 种但不超过 2 种以足够剂量和持续时间服用的抗抑郁药反应不足。目前的抗抑郁药不能成为第一次抑郁症发作的第一种抗抑郁药。根据马萨诸塞州综合医院抗抑郁治疗反应问卷 (MGH-ATRQ) 的评估，反应不足被定义为抑郁症状严重程度低于 (] 0%) 且存在除失眠以外的残留症状，并且总体耐受性良好
正在接受并耐受以下任何一种选择性 5-羟色胺再摄取抑制剂 (SSRI) 或 5-羟色胺-去甲肾上腺素再摄取抑制剂 (SNRI) 用于筛选时的抑郁症状，在任何制剂中且在参与国家可用：西酞普兰、度洛西汀、艾司西酞普兰、氟伏沙明、氟西汀、米那普仑、左旋米那普仑、帕罗西汀、舍曲林、文拉法辛、去甲文拉法辛、维拉佐酮或沃替西汀，稳定剂量（治疗剂量水平）至少 6 周，且在当前发作期间不超过 18 个月
体重指数 (BMI) 在每平方米 18 至 40 公斤 (kg/m^2) 之间，包括在内（BMI = 体重/身高^2）
根据筛选时进行的以下检查，参与者的身体状况必须稳定：体格检查（包括简短的神经系统检查）、生命体征（包括血压）以及在筛选和基线时进行的 12 导联心电图 (ECG)

排除标准：

最近（过去 3 个月）有以下病史或目前的体征和症状：a) 严重肾功能不全（肌酐清除率 [CrCl]
在过去 3 个月内有当前或最近的杀人意念或严重自杀意念的历史，对应于第 4 项（主动自杀意念，有某种行为意图，没有具体计划）或第 5 项（主动自杀意念，有特定计划）的积极回应计划和意图）用于构思哥伦比亚自杀严重程度评定量表 (C-SSRS)，或过去 6 个月内的自杀行为史，经 C-SSRS 在筛选或第 1 天验证。之前有自杀行为的参与者应仔细筛选过去一年或过去 6 个月内的严重自杀意念/计划。对于当前的自杀意念，只有具有非严重项目的参与者（C-SSRS 的自杀意念部分的 1-3）可以由研究者自行决定
有治疗抵抗性 MDD 的病史，定义为在当前发作中对 2 种或更多种足够的抗抑郁药治疗缺乏反应，如无或极少（
有精神障碍、双相情感障碍、智力障碍、自闭症谱系障碍、边缘性人格障碍或躯体形式障碍的病史或目前诊断
有任何明显的原发性睡眠障碍，包括但不限于阻塞性睡眠呼吸暂停、不宁腿综合征或异态睡眠。允许失眠症患者参加
根据 DSM-5 标准，筛选前 6 个月内有中度至重度物质使用障碍史，包括酒精使用障碍

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

主要用途：治疗
分配：随机化
介入模型：并行分配
屏蔽：双倍的

手臂数量

武器和干预

参与者组/臂	干预/治疗
实验性的：Seltorexant 在双盲 (DB) 治疗阶段，从第 1 天到第 42 天，参与者每天口服一次 seltorexant 片剂。将进入开放标签 (OL) 治疗阶段的合格参与者将从 OL 基线开始每天接受 seltorexant 片剂，直到阶段结束/提前退出 (EW) 访问（最多 1 年）。	药品：Seltorexant Seltorexant 片剂将每天口服一次。其他名称： JNJ-42847922
安慰剂比较：安慰剂在双盲 (DB) 治疗阶段，从第 1 天到第 42 天，参与者每天口服一次匹配的安慰剂药片。	药品：安慰剂每天口服一次匹配的安慰剂药片。

研究衡量的是什么？

主要结果指标

次要结果测量

结果测量	措施说明	大体时间
DB Treatment Phase: Change From Baseline to Day 43 in the MADRS Without Sleep Item (MADRS-WOSI) Total Score- Estimand 1 大体时间：Baseline (Day 1), Day 43	The MADRS was a clinician-rated scale designed to measure depression severity and detected changes due to antidepressant treatment. MADRS-WOSI was defined as the full MADRS without the sleep item. The MADRS-WOSI scale consisted of 9 items, each of which was scored from 0 (item not present or normal) to 6 (severe or continuous presence of symptoms). MADRS-WOSI total score was the sum of scores from individual question items, which ranged from 0 to 54, higher scores represented a more severe condition. The MADRS-WOSI evaluated apparent sadness, reported sadness, inner tension, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Negative change in MADRS total score indicated improvement.	Baseline (Day 1), Day 43
DB Treatment Phase: Change From Baseline to Day 43 in Sleep Disturbance Using the Patient Reported Outcome Measurement Information System-Sleep Disturbance (PROMIS-SD) Short Form (8a) T-Score: Estimand 1 大体时间：Baseline (Day 1), Day 43	PROMIS-SD Short Form 8a is a static 8-item questionnaire, assessed self-perceptions of sleep initiation (2 items), quality of sleep (3 items), early morning feelings (2 items), worrying about sleep (1 item). Each question has five response options ranging in value from 1 to 5. Direction of responses was not same, sometimes "not at all" represents more sleep disturbance; sometimes "not at all" indicates less sleep disturbance. Total raw score for short form with all questions answered was sum of values of response to each question, total score ranged 8 to 40. Lower scores indicate less sleep disturbance. Total raw score converted into T-score. T-score rescaled the raw score into standardized score with mean: 50; standard deviation: 10. Negative changes in scores indicates improvement. Higher values represent more severe sleep disturbance.	Baseline (Day 1), Day 43
DB Treatment Phase: Change From Baseline to Day 43 in the MADRS-6 Total Score: Estimand 1 大体时间：Baseline (Day 1), Day 43	The 6-item MADRS was a clinician-administered scale designed to measure the core symptoms of depression severity and detected changes due to antidepressant intervention. It is a subset of MADRS (10-item). The MADRS-6 subscale score was the sum of scores for the following MADRS items: apparent sadness, reported sadness, inner tension, lassitude, inability to feel, and pessimistic thoughts. Each item is scored from 0 (item not present or normal) to 6 (most severe or continuous presence of symptoms); the overall score ranges from 0 to 36, higher scores represented a more severe condition. Negative change in score indicates improvement.	Baseline (Day 1), Day 43
DB Treatment Phase: Percentage of Participants With Response on Depressive Symptoms Scale Based on MADRS at Day 43 大体时间：At Day 43	Percentage of participants with response on depressive symptoms scale based on MADRS total score at Day 43 were reported. Responders were defined as participants with a >=50 percent (%) improvement in the MADRS total score from baseline to a given timepoint. The MADRS is a clinician-rated scale designed to measure depression severity and detected changes due to antidepressant intervention. Scale has 10 items(apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts) each of which was scored from 0 (not present or normal) to 6 (severe or continuous presence of symptoms). MADRS total score is sum of scores from individual question items, which ranged from 0 to 60. Higher scores indicates more severe condition. Negative changes in MADRS total score indicates improvement.	At Day 43
DB Treatment Phase: Change From Baseline to Day 43 in Patient Health Questionnaire 9-item (PHQ-9) Total Score 大体时间：Baseline (Day 1), Day 43	The PHQ-9 was a 9-item, participant reported outcome measure to assess depressive symptoms. The scale scores each of the 9 symptom domains of the diagnostic and statistical manual of mental disorders-5th edition (DSM-5) MDD criteria. Each item was rated on a 4 points scale (0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day). The participant's item responses were summed to provide a total score (range of 0 to 27), with higher scores indicating greater severity of depressive symptoms. The severity of the PHQ-9 is categorized as follows: none-minimal (0-4), mild (5-9), moderate (10-14), moderately severe (15-19) and severe (20-27). Negative changes in PHQ-9 total score indicated improvement.	Baseline (Day 1), Day 43
OL Treatment Phase: Change From Baseline Over Time in MADRS Total Score 大体时间：OL Baseline (Day 1 [Day 43 from study baseline]), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52	MADRS was a clinician-administered scale designed to measure depression severity and detected changes due to antidepressant treatment. The MADRS evaluates the following 10 items: apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Each item is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms). MADRS total score was sum of scores from individual question items, which ranged from 0-60. Higher scores represented a more severe condition. Negative change in MADRS total score indicated improvement.	OL Baseline (Day 1 [Day 43 from study baseline]), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
OL Treatment Phase: Change From Baseline Over Time in the Clinical Global Impression-Severity (CGI-S) Score 大体时间：OL Baseline (Day 1 [Day 43 from study baseline]), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52	The CGI-S (depression) provided an overall clinician-determined summary measure of severity of the participant's illness that considers all available information, included knowledge of participant's history, psychosocial circumstances, symptoms, behavior, impact of symptoms on participant's ability to function. CGI-S evaluated severity of psychopathology on a scale of 1 to 7. The CGI-S was 7-point global assessment scale that measures clinician's impression of severity of illness, rating: 1=normal (not at all ill), 2=borderline ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, 7=among the most extremely ill participants, with higher scores indicate worsening. Negative changes in CGI-S score indicate improvement.	OL Baseline (Day 1 [Day 43 from study baseline]), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
OL Treatment Phase: Change From Baseline Over Time in the MADRS-WOSI Total Score 大体时间：OL Baseline (OL Day 1 [Day 43 from study baseline]), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52	The MADRS was a clinician-rated scale designed to measure depression severity and detected changes due to antidepressant treatment. MADRS-WOSI was defined as the full MADRS without the sleep item. The MADRS-WOSI scale consisted of 9 items, each of which was scored from 0 (item not present or normal) to 6 (severe or continuous presence of symptoms). MADRS-WOSI total score was the sum of scores from individual question items, which ranged from 0 to 54, higher scores represented a more severe condition. The MADRS-WOSI evaluated apparent sadness, reported sadness, inner tension, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Negative change in MADRS total score indicated improvement.	OL Baseline (OL Day 1 [Day 43 from study baseline]), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
OL Treatment Phase: Change From Baseline Over Time in Sleep Disturbance Using the PROMIS-SD Short Form 8a T-Score 大体时间：OL Baseline (OL Day 1 [Day 43 from study baseline]), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52	PROMIS-SD Short Form 8a is a static 8-item questionnaire, assessed self-perceptions of sleep initiation (2 items), quality of sleep (3 items), early morning feelings (2 items), worrying about sleep (1 item). Each question has five response options ranging in value from one to five. Direction of responses was not same, sometimes "not at all" represents more sleep disturbance; sometimes "not at all" indicates less sleep disturbance. Total raw score for short form with all questions answered was sum of values of response to each question, total score ranged 8 to 40. Lower scores indicate less sleep disturbance. Total raw score converted into T-score. T-score rescaled the raw score into standardized score with mean:50; standard deviation:10. Negative changes in scores indicates improvement. Higher values represent more severe sleep disturbance.	OL Baseline (OL Day 1 [Day 43 from study baseline]), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Janssen Research & Development, LLC

调查人员

研究主任：Janssen Research & Development, LLC Clinical Trial、Janssen Research & Development, LLC

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2020年9月16日

初级完成 (实际的)

2023年4月25日

研究完成 (实际的)

2024年4月30日

研究注册日期

首次提交

2020年8月14日

首先提交符合 QC 标准的

2020年8月28日

首次发布 (实际的)

2020年8月31日

研究记录更新

最后更新发布 (实际的)

2026年5月12日

上次提交的符合 QC 标准的更新

2026年4月21日

最后验证

2026年4月1日

结果测量	措施说明	大体时间
Double Blind (DB) Treatment Phase: Change From Baseline to Day 43 in Montgomery- Asberg Depression Rating Scale (MADRS) Total Score- Estimand 1 大体时间：Baseline (Day 1), Day 43	The MADRS is a clinician-rated scale designed to measure depression severity and detected changes due to antidepressant intervention. Scale has 10 items(apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts) each of which was scored from 0 (not present or normal) to 6 (severe or continuous presence of symptoms). MADRS total score is sum of scores from individual question items, which ranged from 0 to 60. Higher scores indicates more severe condition. Negative changes in MADRS total score indicates improvement.	Baseline (Day 1), Day 43
Open Label (OL) Treatment Phase: Number of Participants With Treatment Emergent Adverse Events (TEAEs) 大体时间：From start of the treatment in OL phase (OL Day 1 [Day 43 from study baseline]) up to 2 days after last dose in OL phase (up to 52.28 weeks)	An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participants administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study drug. Treatment emergent AEs was defined as any AE occurred at or after the initial administration of study intervention through the day of last dose plus 2 days.	From start of the treatment in OL phase (OL Day 1 [Day 43 from study baseline]) up to 2 days after last dose in OL phase (up to 52.28 weeks)
OL Treatment Phase: Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESI) 大体时间：From start of the treatment in OL phase (OL Day 1 [Day 43 from study baseline]) up to 2 days after last dose in OL phase (up to 52.28 weeks)	AE was defined as any untoward medical occurrence in a clinical study participants administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study drug. Treatment emergent AEs was defined as any AE occurred at or after the initial administration of study intervention through the day of last dose plus 2 days. The AEs considered to be of special interest: cataplexy, sleep paralysis, complex, sleep-related behaviors/parasomnias such as confusional arousals, somnambulism, sleep terrors, bruxism, sleep sex, sleep-related eating disorder, and catathrenia, fall, motor vehicle accident.	From start of the treatment in OL phase (OL Day 1 [Day 43 from study baseline]) up to 2 days after last dose in OL phase (up to 52.28 weeks)
OL Treatment Phase: Change From Baseline in Vital Signs: Blood Pressure 大体时间：OL Baseline (OL Day 1 [Day 43 from study baseline]) and Week 52	Change from baseline in vital signs: systolic/diastolic blood pressure were reported. Blood pressure measurements were assessed with the participant in a sitting position using a completely automated device.	OL Baseline (OL Day 1 [Day 43 from study baseline]) and Week 52
OL Treatment Phase: Change From Baseline: Body Mass Index (BMI) 大体时间：OL Baseline (OL Day 1 [Day 43 from study baseline]) and Week 52	Change from baseline in BMI were reported.	OL Baseline (OL Day 1 [Day 43 from study baseline]) and Week 52
OL Treatment Phase: Change From Baseline in Vital Signs: Temperature 大体时间：OL Baseline (OL Day 1 [Day 43 from study baseline]) and Week 52	Change from baseline in vital signs: temperature were reported.	OL Baseline (OL Day 1 [Day 43 from study baseline]) and Week 52
OL Treatment Phase: Change From Baseline in Vital Signs: Pulse Rate 大体时间：OL Baseline (OL Day 1 [Day 43 from study baseline]) and Week 52	Change from baseline in vital signs: pulse rate were reported. Pulse rate measurements were assessed with the participant in a sitting position using a completely automated device.	OL Baseline (OL Day 1 [Day 43 from study baseline]) and Week 52
OL Treatment Phase: Change From Baseline in Weight 大体时间：OL Baseline (OL Day 1 [Day 43 from study baseline]) and Week 52	Change from baseline in weight was reported.	OL Baseline (OL Day 1 [Day 43 from study baseline]) and Week 52
OL Treatment Phase: Change From Baseline in Waist Circumference 大体时间：OL Baseline (OL Day 1 [Day 43 from study baseline]) and Week 52	Change from baseline in waist circumference were reported.	OL Baseline (OL Day 1 [Day 43 from study baseline]) and Week 52
OL Treatment Phase: Number of Participants With Shift From Baseline in Suicidal Ideation and Behavior Using the Columbia Suicide Severity Rating Scale (C-SSRS) 大体时间：From DB Baseline (Day 1) up to Week 52	C-SSRS is a clinician-rated instrument that reports severity and frequency of suicide-related ideation and behaviors. Suicidal ideation was classified on a 5-item scale: 1 (wish to be dead), 2 (non-specific active suicidal thoughts), 3 (suicidal ideation without plan and intent), 4 (suicidal ideation intent to act without plan), and 5 (suicidal ideation with plan and intent), Suicidal behavior is classified on a 5-item scale: 6 (preparatory acts or behavior), 7 (aborted attempt), 8 (interrupted attempt), 9 (actual attempt), and 10 (suicide). Total score from 10 categories was summarized into 3 categories: No suicidal ideation or behavior(0), suicidal ideation (1-5), suicidal behavior (6-10). Total score ranged from 0 to 10, higher total scores indicate more suicidal ideation and/or suicidal behavior. Categories with at least 1 non-zero data values are reported.	From DB Baseline (Day 1) up to Week 52
OL Follow Up Phase: Physician Withdrawal Checklist (PWC-20) Total Scores at Start of OL Follow Up 大体时间：Start of OL Follow Up (Week 52)	The PWC-20 was a simple and accurate method used to assess potential withdrawal symptoms following cessation of treatment. The PWC-20 was a reliable and sensitive instrument for the assessment of discontinuation symptoms. The assessment has 20 items (loss of appetite, nausea-vomiting, diarrhea, anxiety-nervousness, irritability, dysphoric mood-depression, insomnia, fatigue, poor coordination, restlessness, diaphoresis, tremor, dizziness, headaches, muscle aches or stiffness, weakness, increased acuity sound smell touch, paresthesia, difficulty concentrating-remember, depersonalization-derealization) evaluated to detect withdrawal symptoms. Symptoms are rated on a scale: 0-3, 0 =not present, 1=mild, 2 =moderate, and 3 =severe. The total PWC-20 score was the sum of 20 item scores and ranged from 0 to 60. The higher score indicates more severe symptoms.	Start of OL Follow Up (Week 52)
OL Follow Up Phase: Physician Withdrawal Checklist (PWC-20) Total Scores at Follow up Visit 1 大体时间：Follow up Visit 1: 1 day after end of OL phase (Week 52.14)	The PWC-20 was a simple and accurate method used to assess potential withdrawal symptoms following cessation of treatment. The PWC-20 was a reliable and sensitive instrument for the assessment of discontinuation symptoms. The assessment has 20 items (loss of appetite, nausea-vomiting, diarrhea, anxiety-nervousness, irritability, dysphoric mood-depression, insomnia, fatigue, poor coordination, restlessness, diaphoresis, tremor, dizziness, headaches, muscle aches or stiffness, weakness, increased acuity sound smell touch, paresthesia, difficulty concentrating-remember, depersonalization-derealization) evaluated to detect withdrawal symptoms. Symptoms are rated on a scale: 0-3, 0 =not present, 1=mild, 2 =moderate, and 3 =severe. The total PWC-20 score was the sum of 20 item scores and ranged from 0 to 60. The higher score indicates more severe symptoms.	Follow up Visit 1: 1 day after end of OL phase (Week 52.14)
OL Follow Up Phase: Physician Withdrawal Checklist (PWC-20) Total Scores at Follow up Visit 2 大体时间：Follow Up Visit 2: 2 weeks after end of OL phase (Week 54)	The PWC-20 was a simple and accurate method used to assess potential withdrawal symptoms following cessation of treatment. The PWC-20 was a reliable and sensitive instrument for the assessment of discontinuation symptoms. The assessment has 20 items (loss of appetite, nausea-vomiting, diarrhea, anxiety-nervousness, irritability, dysphoric mood-depression, insomnia, fatigue, poor coordination, restlessness, diaphoresis, tremor, dizziness, headaches, muscle aches or stiffness, weakness, increased acuity sound smell touch, paresthesia, difficulty concentrating-remember, depersonalization-derealization)evaluated to detect withdrawal symptoms. Symptoms are rated on a scale: 0-3, 0 =not present, 1=mild, 2 =moderate, and 3 =severe. The total PWC-20 score was the sum of 20 item scores and ranged from 0 to 60. The higher score indicates more severe symptoms.	Follow Up Visit 2: 2 weeks after end of OL phase (Week 54)
OL Treatment Phase: Number of Participants With Electrocardiogram (ECG) Abnormalities 大体时间：Week 52	Number of participants with ECG abnormalities during OL treatment phase was reported. ECG abnormalities were assessed as per investigator's discretion.	Week 52
OL Treatment Phase: Number of Participants With Clinically Significant Laboratory Abnormalities 大体时间：From DB Baseline (Day 1) to Week 52	Laboratory parameters: hematology (platelet count, red blood cell [RBC] count, hemoglobin, hematocrit, neutrophils (Segmented/Leukocytes), lymphocytes, monocytes, eosinophils/leukocytes [Eos/Leu], basophils, Reticulocytes/ Erythrocytes [Reti/Ery]); chemistry (sodium, potassium, chloride, bicarbonate, creatinine, Creatine Kinase, glucose, aspartate transaminase [AST], alanine transaminase [ALT], gamma-glutamyl transferase [GGT], alkaline phosphatase, total bilirubin, phosphate, albumin, total protein, total cholesterol, high-density lipoprotein, low-density lipoprotein, Triglycerides); urine (specific gravity, pH, glucose, blood, bilirubin, urobilinogen, RBC). Clinically significant abnormalities (low/high) were determined at the investigator's discretion. Only those categories in which at least one participant had data were reported in this outcome measure.	From DB Baseline (Day 1) to Week 52
OL Treatment Phase: Number of Participants With Sexual Dysfunction as Determined by Arizona Sexual Experiences Scale (ASEX) Score 大体时间：Week 52	ASEX is a five-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm. Each of the 5 items is rated on a 6-point Likert scale, ranging from 1 to 6. The 5 items are summed to create a total score, ranging from 5 to 30, with the higher scores indicating more sexual dysfunction. Sexual dysfunction is defined as an ASEX total score of 19 or greater, or a score of 5 or greater on any item, or a score of 4 or greater on any 3 items.	Week 52

Seltorexant 作为抗抑郁药辅助治疗的成人和老年抑郁症患者的研究

研究概览

地位

条件

干预/治疗

详细说明

研究类型

注册 (实际的)

阶段

联系人和位置

学习地点

参与标准

资格标准

适合学习的年龄

接受健康志愿者

描述

学习计划

研究是如何设计的？

设计细节

手臂数量

武器和干预

参与者组/臂

干预/治疗

研究衡量的是什么？

主要结果指标

结果测量

措施说明

大体时间

次要结果测量

结果测量

措施说明

大体时间

合作者和调查者

赞助

调查人员

研究记录日期

研究主要日期

学习开始 (实际的)

初级完成 (实际的)

研究完成 (实际的)

研究注册日期

首次提交

首先提交符合 QC 标准的

首次发布 (实际的)

研究记录更新

最后更新发布 (实际的)

上次提交的符合 QC 标准的更新

最后验证

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

IPD 计划说明

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

在美国制造并从美国出口的产品