A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of the Safety and Efficacy of Fixed-dose Brexpiprazole (OPC-34712) as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder With and Without Anxious Distress
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 837
- 主要终点
- Change in the Montgomery-Asberg Depression
研究概览
简要总结
The purpose of this study is to assess the tolerability, safety, and efficacy of brexpiprazole (2.0 mg/day) as adjunctive therapy in adult subjects with a diagnosis of MDD with and without anxious distress
详细描述
The introduction of atypical antipsychotics has created a renewed interest in adjunctive therapy for MDD, particularly for treatment-resistant MDD. Several atypical antipsychotics have been shown to enhance the response to ADT. This is a phase 3, multicenter, randomized, double-blind, placebo-controlled, fixed-dose trial designed to assess the safety and efficacy of brexpiprazole (2.0 mg/day) as adjunctive therapy to an assigned open-label ADT in depressed subjects with and without anxious distress.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and Female subjects between 18-65 years of age, with diagnosis of major depressive disorder with or without anxious distress
- •Current depressive episode must be at least 8 weeks in duration
排除标准
- •Subjects with a history of Neuroleptic Malignant Syndrome or Serotonin Syndrome
- •Subjects who report an inadequate response to more than 3 antidepressant treatments in the current episode
- •Subjects with a current Axis I diagnosis of: Delirium, dementia, amnestic or other cognitive disorder, Schizophrenia, schizoaffective disorder, or other psychotic disorder, Bipolar I or II disorder
研究组 & 干预措施
Brexpiprazole + ADT
Brexpiprazole + ADT
干预措施: Brexpiprazole +ADT (Drug)
Placebo + ADT
Placebo + ADT
干预措施: Placebo + ADT (Drug)
结局指标
主要结局
Change in the Montgomery-Asberg Depression
时间窗: From baseline (end of Phase A [Week 8]) to week 14
To assess the change in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score from Baseline (End of Phase A \[Week 8\]) to Week 14. The MADRS was utilized as the primary efficacy assessment of the participant's level of depression and was administered utilizing the Structured Interview Guide for the MADRS (SIGMA). The MADRS consisted of 10 items each with 7 defined grades of severity. The rater decided whether the rating lied on predefined scale steps (0, 2, 4, 6) or between them (1, 3, 5). The 10 items were apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, suicidal thoughts. Each item was scored using a scale of 0 to 6 (a higher score indicates increased severity). The maximum total score was 60; 0, no symptom; 60, severely affected.
次要结局
- Change From End of Phase A to End of Phase B in MADRS Total Score for the Subpopulation With <25% Improvement From Baseline of Phase A to End of Phase A in MADRS Total Score(From baseline (end of Phase A [Week 8]) to week 14)
- Change in the Sheehan Disability Scale (SDS) From Baseline to End of Treatment(From baseline (end of Phase A [Week 8]) to week 14)
- Change From End of Phase A to End of Phase B in MADRS Total Score for the Subpopulations With Anxious Distress as Specified in Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V).(From baseline (end of Phase A [Week 8]) to week 14)