NCT06805565已完成2 期
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., Ltd.27 个研究点 分布在 1 个国家目标入组 115 人开始时间: 2025年1月31日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 115
- 试验地点
- 27
- 主要终点
- Change in L-SAS J(Liebowitz Social Anxiety Scale Japanese version) total score from baseline to Week 12 of the treatment period
研究概览
简要总结
To Evaluate the Efficacy and Safety of ONO-1110 in Patients with Social Anxiety Disorder
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
- •Japanese participants (sex not specified)
- •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
- •Participants diagnosed with social anxiety disorder based on DSM-5-TR (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision) criteria, as determined through an interview using the M.I.N.I. (Mini-international neuropsychiatric interview)
- •Outpatients
- •Participants with a LSAS-J (Liebowitz Social Anxiety Scale Japanese version) total score of 70 or higher and a CGI-S (Clinical global impression-Severity) score of 4 or higher
排除标准
- •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 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision) (assessed using the M.I.N.I. (Mini-international neuropsychiatric interview))
- •Participants with a comorbid or past history of schizophrenia or other psychotic disorders as defined by DSM-5-TR (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision)
- •Participants with neurodevelopmental disorders, neurocognitive disorders, or personality disorders (excluding avoidant personality disorder) as defined by DSM-5-TR
- •Participants who have been primarily diagnosed with a disorder other than social anxiety disorder according to DSM-5-TR (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision) criteria within 24 weeks prior to screening
- •Participants with a MADRS (Montgomery Åsberg Depression Rating Scale) total score of 15 or higher
- •Participants who, in the opinion of the principal (or sub-investigator), have not responded to at least two different SSRIs (Selective serotonin reuptake inhibitor), each administered at an adequate dose for at least 10 weeks, in treating social anxiety disorder
研究组 & 干预措施
ONO-1110
Experimental
干预措施: ONO-1110 (Drug)
ONO-1110
Experimental
干预措施: Placebo (Drug)
Placeo
Placebo Comparator
干预措施: Placebo (Drug)
Placeo
Placebo Comparator
干预措施: ONO-1110 (Drug)
结局指标
主要结局
Change in L-SAS J(Liebowitz Social Anxiety Scale Japanese version) total score from baseline to Week 12 of the treatment period
时间窗: Up to 19 weeks
次要结局
- Transition of CGI-S(Clinical Global Impression of illness Severity) score from baseline to Week 12 of the treatment period(Up to 19 weeks)
- The transition of LSAS-J(Liebowitz Social Anxiety Scale Japanese version) total score from baseline to Week 8 of the treatment period(Up to 19 weeks)
- The transition of LSAS-J(Liebowitz Social Anxiety Scale Japanese version) Fear or Anxiety score from baseline to Week 8 of the treatment period(Up to 19 weeks)
- The transition of LSAS-J(Liebowitz Social Anxiety Scale Japanese version) Avoidance score from baseline to Week 8 of the treatment period(Up to 19 weeks)
- Responder rates of LSAS-J(Liebowitz Social Anxiety Scale Japanese version) total score at 1, 2, 4, 6, 8,10and 2 weeks of the treatment period(Up to 19 weeks)
- Remitted patient rates of LSAS-J(Liebowitz Social Anxiety Scale Japanese version) total score at 1, 2, 4, 6, 8, 10 and 12 weeks of the treatment period(Up to 19 weeks)
- Transition of SDISS(Sheehan Disability Scale) score from baseline to Week 12 of the treatment period(Up to 19 weeks)
- Plasma ONO-1110 concentrations(Up to 19 weeks)
- Adverse Events(Up to 19 weeks)
研究者
研究点 (27)
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