JPRN-jRCT2080223986已完成2 期
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
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 740
研究概览
简要总结
A statistically significant improvement was found in the primary endpoint of mean changes in MADRS total scores in the brexpiprazole 2 mg/day group compared with the placebo group, and a statistically significant improvement was also found in the brexpiprazole 1 mg/day group. The results of the secondary endpoints also supported the efficacy of brexpiprazole as adjunctive therapy to antidepressants (SSRI or SNRI). Brexpiprazole 1 and 2 mg/day had no major safety concerns and both doses were well tolerated.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 64age old（—）
- 性别
- All
入选标准
- •1) 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
- •2) Male and female patients 20 - 64 years of age (at the time of informed consent)
- •3) 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
- •4) 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
- •1) Women who are pregnant or breastfeeding or who have positive pregnancy test (urine) results at screening
- •2) 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.
- •5) Patients with a treatment history showing that all antidepressants (including those not used for the current major depressive episode) cannot be tolerated
- •6) Patients with a history of electroconvulsive therapy
- •7) Patients with a diagnosis of any of the following diseases according to DSM-5
- •a) Neurocognitive disorders
- •b) Schizophrenia spectrum and other psychotic disorders
- •c) Bipolar and related disorders
- •d) Feeding and eating disorders
- •e) Obsessive-compulsive disorder
- •f) Panic disorder
- •g) Posttraumatic stress disorder
研究者
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