A Study of Brexpiprazole in Patients With Major Depressive Disorder

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追踪信息

首次提交日期 ^ICMJE

July 24, 2018

首次发布日期e ^ICMJE

October 5, 2018

最后更新发布日期

October 5, 2018

预计研究开始日期 ^ICMJE

July 30, 2018

预计主要完成日期

July 2022 (主要结果测量的最终数据收集日期)

目前主要观察指标 ^ICMJE

Mean changes from baseline in Montgomery Åsberg Depression Rating Scale (MADRS) total scores at last visit of the double-blind period[ Time Frame: Baseline and Week 14 ]

The MADRS is a clinician-rated scale which evaluates the level of depression. The MADRS consists of 10 items assessing apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, suicidal thought. Each item is scored from 0 to 6, with higher scores indicating worse condition.

原始主要观察测量 ^ICMJE

与当前相同

目前的二级观察 ^ICMJE

The proportion of subjects who score 1 or 2 on the Clinical Global Impression-Improvement (CGI-I) scale at Week 14[ Time Frame: Baseline and Week 14 ]
The CGI-I Scale is a clinician-rated scale which assesses the total improvement of the patient's condition compared to that at baseline. Scores range from 0 to 7:0 = Not assessed, 1= Very much improved, 2 = Much improved, 3= Minimally improved, 4= No change, 5= Minimally worse, 6= Much worse, 7= Very much worse. Higher scores indicate worse condition.

描述性信息

简略标题 ^ICMJE

A Study of Brexpiprazole in Patients With Major Depressive Disorder

正式标题 ^ICMJE

A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group-comparison Trial to Assess the Efficacy and Safety of Brexpiprazole as Adjunctive Therapy in Patients With Major Depressive Disorder

简要概况

The purpose of this 14 week, randomized, double-blind, placebo controlled study is to assess the safety and efficacy of brexipiprazole to placebo as adjunctive treatment to an assigned open-label marketed antidepressant therapy (ADT) in patients with Major Depressive Disorder.

详细说明

研究类型 ^ICMJE

Interventional

研究阶段

Phase 2/Phase 3

研究设计 ^ICMJE

分配: Randomized
干预模型: Parallel Assignment
干预模型描述:
盲法: Interventional
盲法描述:
主要目的: Treatment

适用条件 ^ICMJE

干预项目 ^ICMJE

Drug: Brexpiprazole
Tablets, Oral, once daily, 14 weeks
Drug: Placebo
Tablets, Oral, once daily, 14 weeks

研究工具

Experimental: Brexpiprazole 1mg
Tablets, Oral, 1mg once daily, 14 weeks Other Name: REXULTI
Experimental: Brexpiprazole 2mg
Tablets, Oral, 2 mg once daily, 14 weeks Other Name: REXULTI
Placebo Comparator: Placebo
Tablets, Oral, once daily, 14 weeks

招募信息

招募状态 ^ICMJE

Recruiting

预计入组 ^ICMJE

720

原始预计入组 ^ICMJE

与当前相同

预计研究完成日期

July 2022

预计主要完成日期

July 2022 (主要结果测量的最终数据收集日期)

合格标准 ^ICMJE

Inclusion Criteria: - Outpatients, or inpatients at the time of informed consent whose treatment status can be successfully shifted to outpatient status before enrollment in the antidepressant treatment period - Male and female patients ≥ 20 to < 65 years of age (at the time of informed consent) - Patients who have a level of comprehension sufficient to allow them to give written informed consent to all of the observation/examination/evaluation items specified in the protocol, and who can understand the contents of the trial - Patients with a DSM-5 classification-based diagnosis of "major depressive disorder, single episode" or "major depressive disorder, recurrent episode," and whose current episode has persisted for at least 8 weeks Exclusion Criteria: - Women who are pregnant or breastfeeding or who have positive pregnancy test (urine) results at screening - Sexually active male subjects or sexually active female subjects of childbearing potential, who will not agree to practice 2 different methods of birth control or to remain abstinent during the trial and for 30 days after the final IMP administration. For birth control, 2 of the following methods must be used: vasectomy, tubal ligation, vaginal diaphragm, intra-uterine contraceptive device (IUD), oral contraceptives, or condom with spermicide. - Patients with a treatment history showing that all antidepressants (including those not used for the current major depressive episode) cannot be tolerated - Patients with a history of electroconvulsive therapy - Patients with a diagnosis of any of the following diseases according to DSM-5 1. Neurocognitive disorders 2. Schizophrenia spectrum and other psychotic disorders 3. Bipolar and related disorders 4. Feeding and eating disorders 5. Obsessive-compulsive disorder 6. Panic disorder 7. Posttraumatic stress disorder

性别

参与研究的性别:

All

年龄

最小年龄：20 Years ，最大年龄：64 Years

接受健康的志愿者

没有

可入组国家 ^ICMJE

Japan

管理信息

数据检测委员会

研究涉及美国FDA监管的产品

研究美国FDA监管的药品: No
研究涉及美国FDA监管的设备产品: No

IPD 共享声明

计划分享 IPD:

责任方

，

研究赞助商 ^ICMJE

Otsuka Pharmaceutical Co., Ltd.

合作者 ^ICMJE

研究员 ^ICMJE

PRS 账户

验证日期

October 2018

^ICMJE 国际医学期刊编辑委员会和世界卫生组织 ICTRP 要求的元素

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