A Long-term, Phase 3, Multicenter, Open-label Trial to Evaluate the Safety and Tolerability of Oral OPC-34712 as Adjunctive Therapy in Adults With Major Depressive Disorder, the Orion Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 2,944
- 试验地点
- 1
- 主要终点
- Adverse Events (AEs) - All Participants
研究概览
简要总结
To assess the long-term safety and tolerability of oral OPC-34712 (brexpiprazole), given in addition to an FDA approved antidepressant (ADT) for the treatment of adults with Major Depressive Disorder (MDD)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 outpatients 18-65 years of age
- •Eligible subjects from Trials 331-10-227, 331-10-228 or 331-12-282:
- •Subjects who completed participation in the Double-blind Randomization Phase (i.e. Week 14 visit) in Trial 331-10-227, Trial 331-10-228, or Trial 331-12-282 or
- •Subjects who met criteria for a response, but did not meet criteria for remission at Week 14 of either trial
- •Eligible subjects from other Phase 3, Double-blind, Brexpiprazole MDD trials:
- •Subjects who completed the last scheduled visit of the prior Double-blind Randomized Phase 3 trial.
排除标准
- •Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving OPC-
- •Subjects with a major protocol violation during the course of their participation in the Double-blind Randomization Phase
研究组 & 干预措施
OPC-34712 and Duloxetine
OPC-34712: Oral tablet; 0.5 to 3 mg/day Duloxetine: Oral delayed-release capsules; 40 or 60 mg/day
干预措施: OPC-34712 (Drug)
OPC-34712 (Brexpiprazole) and Escitalopram
OPC-34712: Oral tablet; 0.5 to 3 mg/day Escitalopram: Oral tablet; 10 or 20 mg/day
干预措施: OPC-34712 (Drug)
OPC-34712 (Brexpiprazole) and Escitalopram
OPC-34712: Oral tablet; 0.5 to 3 mg/day Escitalopram: Oral tablet; 10 or 20 mg/day
干预措施: Escitalopram (Drug)
OPC-34712 and Fluoxetine
OPC-34712: Oral tablet; 0.5 to 3 mg/day Fluoxetine: Oral capsules; 20 or 40 mg/day
干预措施: OPC-34712 (Drug)
OPC-34712 and Fluoxetine
OPC-34712: Oral tablet; 0.5 to 3 mg/day Fluoxetine: Oral capsules; 20 or 40 mg/day
干预措施: Fluoxetine (Drug)
OPC-34712 and Paroxetine CR
OPC-34712: Oral tablet; 0.5 to 3 mg/day Paroxetine CR: Oral controlled-release tablets; 37.5 or 50 mg/day
干预措施: OPC-34712 (Drug)
OPC-34712 and Paroxetine CR
OPC-34712: Oral tablet; 0.5 to 3 mg/day Paroxetine CR: Oral controlled-release tablets; 37.5 or 50 mg/day
干预措施: Paroxetine CR (Drug)
OPC-34712 and Sertraline
OPC-34712: Oral tablet; 0.5 to 3 mg/day Sertraline: Oral tablets; 100, 150, or 200 mg/day
干预措施: OPC-34712 (Drug)
OPC-34712 and Sertraline
OPC-34712: Oral tablet; 0.5 to 3 mg/day Sertraline: Oral tablets; 100, 150, or 200 mg/day
干预措施: Sertraline (Drug)
OPC-34712 and Duloxetine
OPC-34712: Oral tablet; 0.5 to 3 mg/day Duloxetine: Oral delayed-release capsules; 40 or 60 mg/day
干预措施: Duloxetine (Drug)
OPC-34712 and Venlafaxine XR
OPC-34712: Oral tablet; 0.5 to 3 mg/day Venlafaxine XR: Oral extended-release capsules; 75, 150, or 225 mg/day
干预措施: OPC-34712 (Drug)
OPC-34712 and Venlafaxine XR
OPC-34712: Oral tablet; 0.5 to 3 mg/day Venlafaxine XR: Oral extended-release capsules; 75, 150, or 225 mg/day
干预措施: Venlafaxine XR (Drug)
结局指标
主要结局
Adverse Events (AEs) - All Participants
时间窗: From screening to week 52/early termination
To assess the frequency and severity of AEs as the variables of safety and tolerability of brexpiprazole.
次要结局
- Summary of Mean Change From Baseline in Sheehan Disability Scale (SDS) Mean Score(From screening to week 52/early termination)
- Mean Change From Baseline in Clinical Global Impression - Severity (CGI-S) of Illness Score(From screening to week 52/early termination)
- Change From Baseline in Mean Clinical Global Impression - Improvement (CGI-I) Score(From screening to week 52/early termination)
- Change From Baseline in the Inventory of Depressive Symptomatology - Self Report (IDS-SR) Total Score(From screening to week 52/early termination)