Lumateperone Added to Antidepressant Therapy in Adults With Major Depressive Disorder Experiencing Emotional Blunting
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change from baseline to week 8 in Oxford Depression Questionnaire score
研究概览
简要总结
The purpose of this study is to evaluate whether or not adding lumateparone to current antidepressant treatment in adults with major depressive disorder experiencing blunted emotion will reduce or eliminate the blunted emotion as rated by the Oxford Depression Questionnaire.
详细描述
Adults with Major Depressive Disorder who report blunted emotion that is evidenced by responses on the Oxford Depression Questionnaire will add lumateparone to their current treatment once daily for 8 weeks. Primary endpoint will be change fom baseline to week 8 on the Oxford Depression Questionnaire (ODQ). Secondary endpoints will be change from baseline to week 8 on CGI-I and CGI-S as well as change from baseline to week 8 on quality of life as measured by Q-LES-Q-SF.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of major depressive disorder documented in the medical record and confirmed through evaluation by the Principal Investigator using the M.I.N.I., Oxford Depression Questionnaire score of > 50 (substantial emotional blunting), Response of "yes" to the "gold standard" standardized screening question on emotional blunting developed by Price et al(2012): "Emotional effects vary, but may include, for example, feelingemotionally 'numbed' or 'blunted' in some way; lacking positive emotions or negative emotions; feeling detached from the world around you; or 'just not caring' about things you used to care about. Have you experienced such emotional effects during the last 6 weeks?" -
排除标准
- •Concomitant antipsychotics, Concomitant inhibitors of CYP3A4, Concomitant use of cannabis, Moderate to severe hepatic impairment, Primary diagnosis other than major depressive disorder
研究组 & 干预措施
Lumateparone
Investigation of addition of lumateparone for blunted emotion
干预措施: lumateparone 42 mg once daily (Drug)
Lumateparone
Investigation of addition of lumateparone for blunted emotion
干预措施: lumateparone (Drug)
结局指标
主要结局
Change from baseline to week 8 in Oxford Depression Questionnaire score
时间窗: 8 weeks
次要结局
未报告次要终点
研究者
Erin Crown
Owner/Principal Investigator
Future Options Research, LLC