NCT03141658已完成1 期
A Randomized, Single-blind, Parallel-group Study to Evaluate the Effects of TS-134 on Ketamine-induced BOLD Signals in Resting fMRI in Healthy Adult Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- BOLD fMRI signals in pre-specified ROIs
研究概览
简要总结
The purpose of this study is to evaluate the effects of TS-134 on ketamine-induced BOLD signals in ROIs in resting fMRI in healthy adult subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult male and female subjects between 18 and 55 years of age inclusive (at the time of initial informed consent)
- •Body weight ≥ 45 and ≤ 87 kg
- •Body Mass Index (BMI) ≥ 18 and ≤ 30 kg/m2
排除标准
- •Female subjects who are pregnant, intend to become pregnant, or are breastfeeding
- •History or presence of psychiatric or neurologic disease or condition
- •History of first-degree relative with schizophrenia or mood disorder with psychosis
- •History of alcohol or drug abuse
- •History of recreational ketamine use, recreational PCP use, or an adverse reaction to ketamine
- •History of violence
- •Presence or positive history of significant medical illness, including high blood pressure, low blood pressure or orthostatic hypotension
- •Any subjects who show subthreshold ketamine BOLD response
- •Metal implants, pacemaker, other metal or paramagnetic objects contained within the body
- •Claustrophobia
- •Subject with any history of suicidal behavior or is currently at risk of suicide in the opinion of the investigator
研究组 & 干预措施
TS-134 20 mg
Experimental
干预措施: TS-134 (Drug)
TS-134 20 mg
Experimental
干预措施: Ketamine (Other)
TS-134 60 mg
Experimental
干预措施: TS-134 (Drug)
TS-134 60 mg
Experimental
干预措施: Ketamine (Other)
Placebo
Experimental
干预措施: Placebo (Drug)
Placebo
Experimental
干预措施: Ketamine (Other)
结局指标
主要结局
BOLD fMRI signals in pre-specified ROIs
时间窗: Screening and Day 6
Changes in ketamine-induced BOLD fMRI signals in pre-specified ROIs (anterior cingulate cortex (ACC) and anterior insula) following administrations of TS-134
次要结局
- BOLD fMRI signals in whole brain(Screening and Day 6)
- Brief Psychiatric Rating Scale (BPRS)(Screening and Day 6)
- Clinician Administered Dissociative State Scale (CADSS)(Screening and Day 6)
研究者
研究点 (1)
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