跳至主要内容
临床试验/jRCT2031240578
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

Ono Pharmaceutical Co.,LTD0 个研究点目标入组 100 人开始时间: 待定最近更新:
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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