A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of OPDC-34712 (1 to 3 mg/Day) as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 773
- 试验地点
- 42
- 主要终点
- Change From the End of Phase A (Week 8 Visit) to the End of Phase B (Week 14 Visit) in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score.
研究概览
简要总结
This is a Double-blind study wherein patients with Major Depressive Disorder (MDD) will receive either from 1 to 3 mg a day of study medication (OPC-34712)or placebo (an inactive substance) in addition to an FDA approved antidepressant in order to determine if the study medication is effective as an add on treatment of MDD.
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
- Triple (Participant, Care Provider, Investigator)
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 or female subjects between 18 and 65 years of age, with diagnosis of major depressive disorder, as defined by DSM-IV-TR criteria
- •The current depressive episode must be equal to or greater than 8 weeks in duration
- •Subjects must report a history for the current depressive episode of an inadequate response to at least one and no more than three adequate antidepressant treatments.
排除标准
- •Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving study drug.
- •Subjects who report an inadequate response to more than three adequate trials of antidepressant treatments during current depressive episode at a therapeutic dose for an adequate duration.
- •Subjects with a current Axis I (DSM-IV-TR) diagnosis of: Delirium, dementia,amnestic or other cognitive disorder Schizophrenia, schizoaffective disorder, or other psychotic disorder Bipolar I or II disorder
- •Subjects with a clinically significant current Axis II (DSM-IV-TR) diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal or histrionic personality disorder.
研究组 & 干预措施
Brexipiprazole + ADT
OPC-34712 Tablets, Oral, 1 - 3 mg OPC-34712 + ADT
干预措施: OPC-34712 (Drug)
Brexipiprazole + ADT
OPC-34712 Tablets, Oral, 1 - 3 mg OPC-34712 + ADT
干预措施: Placebo (Drug)
Brexipiprazole + ADT
OPC-34712 Tablets, Oral, 1 - 3 mg OPC-34712 + ADT
干预措施: ADT (Drug)
Placebo + ADT
Placebo + ADT
干预措施: Placebo (Drug)
Placebo + ADT
Placebo + ADT
干预措施: ADT (Drug)
结局指标
主要结局
Change From the End of Phase A (Week 8 Visit) to the End of Phase B (Week 14 Visit) in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score.
时间窗: Baseline (end of week 8) to Week 14
The MADRS was utilized as the primary efficacy assessment of a participants level of depression. The MADRS consisted of 10 items, all rated on a 0 to 6 scale with 0 being the "best" rating and 6 being the "worst" rating. The MADRS Total Score is the sum of ratings for all 10 items; therefore, possible total scores range from 0 to 60. The MADRS total score were to be unevaluable if less than 8 of the 10 items were recorded. If 8 or 9 of the 10 items were recorded, the MADRS total score was the mean of the recorded items multiplied by 10 and then rounded of to the first decimal place.
次要结局
- Change From End of Phase A (Week 8 Visit) in MADRS Total Score for Every Trial Week Visit in Phase B.(Baseline (end of week 8) to Week 14)
- Change From End of Phase A (Week 8) to Phase B in Sheehan Disability Scale (SDS) Score.(Baseline (end of week 8) to Week 14)
- Change From End of Phase A (Week 8) to End of Phase B (Week 14) in the Hamilton Depression Rating Scale 17-item Version (HAM-D17) Total Score.(Baseline (end of week 8) to Week 14)
- Number of Participants With MADRS Response During Phase B Relative to the End of Phase A (Week 8) Visit.(Baseline (end of week 8) to Week 14)
- Change From End of Phase A (Week 8 Visit) to Phase B by Study Week in Inventory of Depressive Symptomatology (Self-Report) (IDS-SR) Total Score.(Baseline (end of week 8) to Week 14)
- Number of Participants With MADRS Remission During Phase B Relative to the End of Phase A (Week 8) Visit.(Baseline (end of week 8) to Week 14)
- Number of Participants With CGI-Improvement Response During Phase B Relative to the End of Phase A (Week 8).(Baseline (end of week 8) to Week 14)
- Change From End of Phase A (Week 8 Visit) to Phase B by Study Week in Clinical Global Impression- Severity Illness Scale (CGI-S) Score.(Baseline (end of week 8) to Week 14)
- Clinical Global Impression- Improvement Scale (CGI-I) Score by Study Week in Phase B Relative to End of Phase A.(Baseline (end of week 8) to Week 14)