NCT05504486撤回4 期
A Phase 4, Multicenter, Single-arm, Open-label, Interventional fMRI Trial to Assess the Effect of Brexpiprazole as Adjunctive Therapy on Functional Brain Network Organization in Adults With Major Depressive Disorder and Symptoms of Anxiety
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 主要终点
- Change in fMRI resting-state salience network community structure from baseline to post-treatment
研究概览
简要总结
The purpose of this study is to use fMRI to evaluate the effects of brexpiprazole as add-on therapy to antidepressants on brain connectivity in individuals with MDD and symptoms of anxiety, aged 18 to 65.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
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
- •18 to 65 year of age
- •Major Depressive Disorder (MDD) with symptoms of anxiety
- •Stable treatment with less than 50% improvement
排除标准
- •Contraindicated to perform fMRI scan
- •Previous exposure to brexpiprazole
研究组 & 干预措施
Arm 1
Experimental
Brexpiprazole
干预措施: Brexpiprazole (Drug)
结局指标
主要结局
Change in fMRI resting-state salience network community structure from baseline to post-treatment
时间窗: Week 6
次要结局
- Association between change in resting-state salience network community structure and change in MADRS total score from baseline to post treatment.(Week 6)
- Change in Default Mode Network (DMN) community structure during emotional face viewing from baseline to post-treatment.(Week 6)
- Change in Central Executive Network (CEN) community structure during a working memory task from baseline to post-treatment.(Week 6)
研究者
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