A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-arm Trial to Assess the Efficacy, Safety, and Tolerability of Centanafadine Extended-release Capsules as Monotherapy or as Adjunct to SSRI in Adult Subjects With Major Depressive Disorder
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 337
- 试验地点
- 122
- 主要终点
- Change from baseline to Week 6 in Montgomery-Asberg Depression Rating Scale (MADRS) Total score.
研究概览
简要总结
This is a phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-arm trial to assess the efficacy, safety, and tolerability of centanafadine once-daily (QD) extended-release (XR) capsules for the treatment of adult subjects diagnosed with Major Depressive Disorder (MDD).
The trial will evaluate the efficacy and safety of centanafadine QD XR capsules as monotherapy or as adjunct to the selective serotonin reuptake inhibitor (SSRI), escitalopram.
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
- 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 subjects between 18-65 years of age, with a primary diagnosis of major depressive disorder and in a current major depressive episode.
- •History of an inadequate response to at least 1 and no more than 3 antidepressant treatments in the current major depressive episode.
排除标准
- •Subjects who report an inadequate response to more than 3 antidepressant treatments in the current episode.
- •Subjects with a lifetime history of schizophrenia spectrum or other psychotic disorder, bipolar or related disorder, neurocognitive disorder, or personality disorder.
- •Subjects with a current diagnosis of post-traumatic stress disorder, obsessive compulsive disorder, panic disorder, or eating disorder (including anorexia nervosa or bulimia).
- •Sexually active subjects, who could become pregnant, not agreeing to practice 2 sponsor approved methods of birth control or remain abstinent during the trial and for 30 days (females) or 90 days (males) after last dose of study drug.
研究组 & 干预措施
Placebo + Placebo
干预措施: Placebo (Drug)
Escitalopram + Placebo
干预措施: Placebo (Drug)
Centanafadine + Placebo
干预措施: Placebo (Drug)
Centanafadine + Placebo
干预措施: Centanafadine (Drug)
Centanafadine + Escitalopram
干预措施: Centanafadine (Drug)
Centanafadine + Escitalopram
干预措施: Escitalopram (Drug)
Escitalopram + Placebo
干预措施: Escitalopram (Drug)
结局指标
主要结局
Change from baseline to Week 6 in Montgomery-Asberg Depression Rating Scale (MADRS) Total score.
时间窗: Baseline, Week 6
次要结局
未报告次要终点