ACTRN12618001381279撤回1 期
A single centre, double blind, randomised, parallel group, single dose signal study of R-107 in particpants with DSM-5 specific phobia, to spiders.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 入组人数
- 12
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
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 40 Years（—）
- 性别
- All
入选标准
- •Able to provide informed consent; able and willing to comply with study requirements including clinic visits; male or female (not pregnant or lactating); aged 18-40 years; BMI 18-35kg/m2; diagnosed with DSM-5 specific phobia to spiders for at least 12 months; able to swallow tablets; score >95 on Fear of Spiders questionnaire (at screening visit)
排除标准
- •Clinically significant medical history or medications; clinically significant illness in last 30 days or febrile illness in last 5 days prior to Day 1; history of schizophrenia or other psychotic illness; currently taking benzodiazepines; prior exposure to ketamine; history of drug or alcohol abuse or dependency, including ketamine or it's excipients; clinically significant abnormal ECG or laboratory test result during screening; pregnant or breastfeeding female, or not using effective contraception; involvement in another clinical drug or device trial or less than 60 days since last participation; not having a GP or do not consent to GP being contacted; not able to understand information provided about the study, or not able to be compliant with required procedures; malignancy in last 5 years; employee/family member of sponsor, or study site.
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