NCT05600114已完成2 期
A Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study, Evaluating the Efficacy, Safety, and Tolerability of Cannabidiol Oral Solution in Subjects With Social Anxiety Disorder
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 239
- 试验地点
- 3
- 主要终点
- Mean change from baseline to endpoint in the Liebowitz Social Anxiety Scale (LSAS)
研究概览
简要总结
A phase 2, multicenter, double-blind, parallel group, placebo-controlled, randomized clinical study, designed to compare the efficacy, safety, and tolerability of 2 dose levels of CBD and a matching placebo for the treatment of subjects with Social Anxiety Disorder (SAD).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically predominant diagnosis of Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) SAD
- •LSAS score of 70 or higher
- •Females of childbearing potential must test negative for pregnancy and agree to use a reliable birth control method. Male subjects must also agree to use highly effective methods of contraception.
- •Read, understand, and sign the informed consent form.
- •No significant physical health abnormalities based on physical exam, ECG and laboratory tests.
排除标准
- •Other current psychiatric disorder as the clinically predominant diagnosis.
- •Lifetime diagnosis of schizophrenia or any other psychosis, MDD with psychotic features, intellectual disability, autism spectrum disorders, bipolar disorder type 1, and cannabis use disorder
- •Previous 6 months diagnosis of Post-traumatic stress disorder, obsessive compulsive disorder, moderate to severe alcohol use disorder, and substance abuse disorder (except tobacco use disorder or mild alcohol use disorder)
- •Severe MDD
- •Use of oral psychoactive medications or beta adrenergic antagonists in the past 4 weeks, or depot neuroleptics within 12 weeks
- •Electroconvulsive therapy within 6 months, psychotherapy or transcranial magnetic stimulation within 3 months
- •Clinically significant abnormality or clinically significant unstable medical condition
- •Impaired liver function
- •Significant risk of suicide or homicide
- •Pregnancy/lactation
- •Sensitivity to CBD or excipients
- •Current cannabis use; past frequent cannabis use
- •Illegal drug use
研究组 & 干预措施
Cannabidiol (CBD) Oral Solution 300 mg/day
Experimental
干预措施: Cannabidiol oral solution (Drug)
Cannabidiol (CBD) Oral Solution 600 mg/day
Experimental
干预措施: Cannabidiol oral solution (Drug)
Placebo Oral Solution
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Mean change from baseline to endpoint in the Liebowitz Social Anxiety Scale (LSAS)
时间窗: 10 weeks
次要结局
未报告次要终点
研究者
研究点 (3)
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