ACTRN12623001080617招募中2 期
A Phase 2 Open Label Pilot Study of XW10508 Modified Release Tablets Assessing Safety and Efficacy in Patients with Major Depressive Disorder
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 70 Years（—）
- 性别
- All
入选标准
- •Diagnosis of Major Depressive Disorder without psychotic features diagnosed by two Structured Clinical Interview for Axis I Disorders (SCID-I) or Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) with symptoms present for at least 28 days.
- •MADRS total score of greater than or equal to 24 at screening.
- •Patients with an inadequate response to an adequate trial of 1, 2 or 3 antidepressants in the current Major Depressive Episode.
- •Current antidepressant treatment stable for at least 30 days prior to screening and will remain unchanged throughout the study.
- •Female participants of childbearing potential must test negative in a serum pregnancy test at Screening and have a negative urine pregnancy test at the Baseline Visit. Women with childbearing potential must use an acceptable method of contraception during the study and for at least 30 days after completion of dosing.
排除标准
- •Significant medical conditions (e.g., history of bipolar disorder, schizophrenia, cognitive disorder, PTSD, panic disorder).
- •History of suicide attempt or risk of suicide associated with the current episode of MDD.
- •Psychiatric hospitalization during current Major Depressive Disorder episode.
- •Inadequate response to an adequate trial of 4 or more antidepressants in the current Major Depressive Episode.
- •History of substance abuse per DSM-5.
研究者
相似试验
进行中（未招募）
不适用
An Open-Label, Phase II Extension Study of MDX-060 in Patients with Relapsed or Refractory Hodgkin’s Disease Previously Treated in Protocol MDX060-03Relapsed or Refractory Hodgkin’s DiseaseMedDRA version: 5.0Level: LLTClassification code 10020266EUCTR2004-005040-27-GBMedarex, Inc.
进行中（未招募）
不适用
An Open-Label, Phase II Extension Study of MDX-060 in Patients with Relapsed or Refractory Hodgkin’s Disease Treated in Protocol MDX060-03 - not availableRelapsed or Refractory Hodgkin’s DiseaseMedDRA version: 5.0Level: LLTClassification code 10020266EUCTR2004-005040-27-DEBristol-Myers Squibb Company84
进行中（未招募）
不适用
A Phase II Open Label Study of MK-7009 Administered Concomitantlywith Pegylated Interferon Alfa-2a and Ribavirin toPatients with Chronic Hepatitis C Infection After Participation inOther MK-7009 Clinical TrialsEUCTR2009-013053-15-LTMerck & Co., Inc.160
进行中（未招募）
1 期
A Phase II Open Label Study of MK-7009 Administered Concomitantly with Pegylated Interferon Alfa-2a and Ribavirin to Patients with Chronic Hepatitis C Infection after Participation in Other MK-7009 Clinical Trials. - Phase II Open Label Study of MK-7009Hepatitis C VirusMedDRA version: 12.0Level: LLTClassification code 10019751Term: Hepatitis C virusEUCTR2009-013053-15-BEMerck Sharp & Dohme (Europe) Inc.160
进行中（未招募）
不适用
A Phase II Open Label Study of MK-7009 Administered Concomitantly with Pegylated Interferon Alfa and Ribavirin to Patients with Chronic Hepatitis C Infection After Participation in Other MK-7009 Clinical TrialsEUCTR2009-013053-15-PLMerck & Co., Inc.730