NCT06792136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 Major Depressive Disorder
Ono Pharmaceutical Co., Ltd.30 个研究点 分布在 1 个国家目标入组 103 人开始时间: 2025年1月16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
- 103
- 试验地点
- 30
- 主要终点
- Change in HAM-D17(Hamilton depression rating scale 17 items) total score from baseline to Week 8 of the treatment period
研究概览
简要总结
To Evaluate the Efficacy and Safety of ONO-1110 in Patients with Major Depressive 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 (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 major depressive 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 whose current depressive episode has lasted for at least 2 months but no more than 12 months
- •Participants with a HAM-D17 (Hamilton depression rating scale 17 items) total score of 18 or higher and a CGI-S (Clinical global impression-Improvement) 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 major depressive 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 major depressive disorder with mixed features, psychotic features, or catatonia as defined by DSM-5-TR (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision)
- •Participants with a current 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 or personality disorders as defined by DSM-5-TR (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision)
- •Participants with a current or past history of clinically significant neurological disorders (including epilepsy)
- •Participants with neurodegenerative diseases (such as Alzheimer's disease, Parkinson's disease, multiple sclerosis, etc.)
- •Participants who, in the opinion of the principal (or sub-investigator), have not responded to at least two different antidepressants, each administered at an adequate dose for at least 6 weeks, during the current or past depressive episode.
- •Participants who have used adjunctive treatments such as lithium, triiodothyronine/thyroxine, lamotrigine, valproate, carbamazepine, or atypical antipsychotics, or who have used combination therapy with antidepressants for the current depressive episode.
研究组 & 干预措施
ONO-1110
Experimental
干预措施: ONO-1110 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Placebo
Placebo Comparator
干预措施: ONO-1110 (Drug)
ONO-1110
Experimental
干预措施: Placebo (Drug)
结局指标
主要结局
Change in HAM-D17(Hamilton depression rating scale 17 items) total score from baseline to Week 8 of the treatment period
时间窗: Up to 16 weeks
次要结局
- Remitted patient rates of HAM-D17(Hamilton depression rating scale 17 items) score at 1, 2, 4, 6, and 8 weeks of the treatment period(Up to 16 weeks)
- The transition of HAM-D17(Hamilton depression rating scale 17 items) total score from baseline to Week 8 of the treatment period(Up to 16 weeks)
- Responder rates of HAM-D17(Hamilton depression rating scale 17 items) total score at 1, 2, 4, 6, and 8 weeks of the treatment period(Up to 16 weeks)
- Transition of CGI-I(Clinical Global Impression of Impression Important) score from baseline to Week 8 of the treatment period(Up to 16 weeks)
- Plasma ONO-1110 concentrations(Up to 16 weeks)
- Change in the total MADRS(Montgomery-Åsberg depression rating scale) score from baseline to Week 8 of the treatment period(Up to 16 weeks)
- Transition of HAM-A(Hamilton Anxiety Scale) total score from baseline to Week 8 of the treatment period(Up to 16 weeks)
- Transition of CGI-S(Clinical Global Impression of illness Severity) score from baseline to Week 8 of the treatment period(Up to 16 weeks)
- Transition of QIDS-J(Quick Inventory of Depressive Symptomatology) total score from baseline to Week 8 of the treatment period(Up to 16 weeks)
- Adverse Events(Up to 16 weeks)
研究者
研究点 (30)
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