A Phase 3, Multicenter, Randomized, Double-blind, Placebo and Active Comparator Controlled Trial of Flexible-dose Brexpiprazole (OPC-34712) as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder, the Delphinus Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 2,182
- 主要终点
- Montgomery Asberg Depression Rating Scale (MADRS)
研究概览
简要总结
To compare the efficacy of brexpiprazole (flexible dose) with placebo as adjunctive therapy to an assigned open label antidepressant therapy (ADT) in the proposed subject population with MDD.
详细描述
This is a trial designed to assess the safety and efficacy of brexpiprazole (flexible dose) as adjunctive therapy to an assigned known anti-depressant in depressed subjects. The trial consists of a continuous 18-week double-blind treatment period with a 30-day follow-up. Subjects who complete all trial visits through the Week 18 visit may be offered entry into an optional open-label rollover trial.
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 outpatients 18 to 65 years of age, inclusive, at the time of informed consent.
- •Subjects with both a diagnosis of MDD, and in a current major depressive episode, as defined by DSM-IV-TR criteria
- •Subjects willing to discontinue all prohibited psychotropic medications to meet protocol-required washouts prior to and during the trial period.
排除标准
- •Females who are breast-feeding and/or who have a positive pregnancy test result during screening prior to receiving trial medication
- •Subject has a current Axis I (DSM-IV-TR) diagnosis of: dementia, Schizophrenia, Bipolar, Eating disorder , Obsessive-compulsive disorder, Panic disorder, Posttraumatic stress disorder
- •Subjects experiencing hallucinations, delusions or any psychotic symptomatology in the current major depressive episode.
- •Subjects who have met DSM-IV-TR criteria for substance abuse or dependence within the past 180 days
- •Subjects currently treated with insulin for diabetes.
- •Subjects with uncontrolled hypertension
- •Subjects with known ischemic heart disease or history of myocardial infarction, congestive heart failure, angioplasty, stenting, or coronary artery bypass Surgery
- •Subjects with a positive drug screen for cocaine, marijuana, or other illicit drugs
- •Inability to swallow tablets or tolerate oral medication
- •Abnormal laboratory test results, vital signs and ECG results
- •Subjects who previously participated in any prior brexpiprazole clinical trial.
研究组 & 干预措施
Placebo + ADT
Matching Placebo and assigned ADT
干预措施: Placebo (Drug)
Brexpiprazole + ADT
Brexpiprazole, flexible dose and assigned ADT
干预措施: Brexpiprazole (Drug)
Seroquel XR + ADT
Seroquel XR, flexible dose and assigned ADT
干预措施: Seroquel XR (Drug)
结局指标
主要结局
Montgomery Asberg Depression Rating Scale (MADRS)
时间窗: Randomization Visit (week 8 or week 10) to End of Double-Blind Treatment (week 14 or week 16).
To determine the efficacy of brexpiprazole (flexible dose) with placebo as adjunctive therapy by assessment of MADRS total score. The MADRS depression rating scale was used to assess the subject's level of depression by utilizing the structured interview guide for the MADRS (SIGMA). The MADRS consisted of 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts and suicidal thoughts), each rated 0 to 6. The overall score ranged from 0 (symptoms absent) to 60 (severe depression). Lower score indicated decreased severity of depression.
次要结局
- Sheehan Disability Scale (SDS)(Randomization Visit (week 8 or week 10) to End of Double-Blind Treatment (week 14 or week 16).)
- Number of Participants With MADRS(Phase B week 6 (14/16 weeks after randomization).)
- Sheehan Disability Scale (SDS) Individual Item Scores.(Randomization Visit (week 8 or week 10) to End of Double-Blind Treatment (week 14 or week 16).)
- Change From End of Phase A in MADRS Total Score for Trial Week 2 and Week 4.(Change from baseline to week 2 and week 4 in Phase B (week 10/12 and week 12/14))
- Clinical Global Impression Score(From randomization to Phase B week 6 (14/16 weeks after randomization).)
- MADRS Response at Week 6(Phase B week 6 (14/16 weeks after randomization).)
- CGI-I Response Rate(Phase B week 6 (14/16 weeks after randomization).)
- Number of Participants With Adverse Events(From screening (Day -28 to Day-1) upto post treatment follow-up.)