JPRN-jRCT2080224073终止3 期
A Randomized, Double-blind, Placebo-controlled, Multicenter Study of Rapastinel as Monotherapy in Patients with Major Depressive Disorder
Allergan Japan K.K.0 个研究点目标入组 690 人开始时间: 2018年9月28日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 690
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 <= 75age old（—）
- 性别
- All
入选标准
- •Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition [DSM-5] criteria for MDD
- •- Current major depressive episode of at least 8 weeks and not exceeding 18 months in duration at Visit 1
- •- Treatment naive in the current episode or have inadequate response to 1-3 antidepressant therapies given at adequate dose and duration in the current episode
- •- If female of childbearing potential, have a negative serum beta-human chorionic gonadotropin [beta-hCG] pregnancy test
排除标准
- •- DSM-5-based diagnosis of any disorder other than MDD that was the primary focus of treatment within 6 months before Visit 1
- •- Lifetime history of meeting DSM-5 criteria for:
- •1.Schizophrenia spectrum or other psychotic disorder
- •2.Bipolar or related disorder
- •3.Major neurocognitive disorder
- •4.Neurodevelopmental disorder of greater than mild severity or of a severity that impacts the participant's ability to consent, follow study directions, or otherwise safely participate in the study
- •5.Dissociative disorder
- •6.Posttraumatic stress disorder
- •7.MDD with psychotic features
- •- Significant suicide risk, as judged by the Investigator
研究者
相似试验
进行中（未招募）
1 期
Study of Safety, Tolerability, and Efficacy of Secukinumab in Subjects With Moderate to Severe Palmoplantar PsoriasisEUCTR2012-005412-25-NLovartis Pharma Services AG201
进行中（未招募）
1 期
Rapastinel Versus placebo to prevent relapse of Major depressioMajor depressive disorderMedDRA version: 20.0Level: PTClassification code 10057840Term: Major depressionSystem Organ Class: 10037175 - Psychiatric disordersEUCTR2018-000064-28-SEAllergan Ltd.1,400
进行中（未招募）
1 期
Hidradenitis Suppurativa Phase 3 Study of IzokibepMedDRA version: 20.0Level: LLTClassification code: 10020041Term: Hidradenitis suppurativa Class: 10040785Hidradenitis SuppurativaCTIS2022-503160-33-00Acelyrin Inc.250
进行中（未招募）
不适用
A Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Evaluate theSafety, Tolerability, and Efficacy of AMG 827 in Subjects with Rheumatoid Arthritis and an Inadequate Response to MethotrexateRheumatoid arthritis (RA)MedDRA version: 12.0Level: LLTClassification code 10039073Term: Rheumatoid arthritisEUCTR2009-012566-32-PLAmgen Inc240
进行中（未招募）
1 期
A Study to Evaluate Efficacy and Safety of Zilebesiran Used as Add-on Therapy in Patients With Hypertension Not Adequately Controlled by a Standard of Care Antihypertensive MedicatioHypertensionEUCTR2021-003776-13-LTAlnylam Pharmaceuticals, Inc.1,800