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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 740
- 试验地点
- 1
- 主要终点
- Mean Changes From Baseline (Week 8 of the Antidepressant Treatment Period [Phase A]) in the MADRS Total Scores at Week 6 of the Double-blind Period (Phase B).
研究概览
简要总结
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.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •Neurocognitive disorders
- •Schizophrenia spectrum and other psychotic disorders
- •Bipolar and related disorders
- •Feeding and eating disorders
- •Obsessive-compulsive disorder
- •Panic disorder
- •Posttraumatic stress disorder
研究组 & 干预措施
Brexpiprazole 1mg
Tablets, Oral, 1mg once daily, 14 weeks Other Name: REXULTI
干预措施: Brexpiprazole (Drug)
Brexpiprazole 2mg
Tablets, Oral, 2 mg once daily, 14 weeks Other Name: REXULTI
干预措施: Brexpiprazole (Drug)
Placebo
Tablets, Oral, once daily, 14 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Mean Changes From Baseline (Week 8 of the Antidepressant Treatment Period [Phase A]) in the MADRS Total Scores at Week 6 of the Double-blind Period (Phase B).
时间窗: Baseline (the end of Phase A), at completion of administration (Week 6).
The MADRS was a clinician-rated scale which evaluated the level of depression. The MADRS consisted 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 was scored from 0 to 6, with higher scores indicating worse condition. Summed subscales were combined to compute a total score. Total score ranges from 0 to 60, with higher scores indicating worse condition.The mean changes were compared between antidepressant treatments and brexpiprazole as adjunctive therapy.
次要结局
- CGI-I Improvement Rate at Week 6 of the Double-blind Period (Phase B)(Baseline (the end of Phase A), at completion of administration (Week 6).)