jRCT2031240578招募中不适用
ONO-1110-08:A Phase IIa, Randomized, Double-blind, Placebo Controlled, Parallel Group, Multi-center Trial to Evaluate the Efficacy and Safety of ONO-1110 in Patients with Social Anxiety Disorder
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 18age old over 至 65age old not(—)
- 性别
- All
入选标准
- •1.Japanese participants (sex not specified)
- •2.Participants who, in the opinion of the principal (or sub-investigator), are capable of understanding the content of the clinical trial and complying with its requirements
- •3.Participants diagnosed with social anxiety disorder based on DSM-5-TR criteria, as determined through an interview using the M.I.N.I.
- •4.Outpatients
- •5.Participants with a LSAS-J total score of 70 or higher and a CGI-S score of 4 or higher
排除标准
- •1.Participants with a current or past history of psychiatric or neurological disorders that meet any of the following criteria:
- •Participants with a comorbid psychiatric disorder other than social anxiety disorder as defined by DSM-5-TR (assessed using the M.I.N.I.)
- •Participants with a comorbid or past history of schizophrenia or other psychotic disorders as defined by DSM-5-TR
结局指标
主要结局
-
Efficacy: The change in the total LSAS-J score from baseline
次要结局
未报告次要终点
研究者
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