Valbenazine in Obsessive-compulsive Disorder: A Randomized Double-blind Placebo-controlled Crossover Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)
研究概览
简要总结
The primary aim of the study is to examine the efficacy and safety of valbenazine in adults with moderate to severe obsessive-compulsive disorder (OCD).
详细描述
The primary aim of the study is to examine the efficacy and safety of valbenazine in adults with moderate to severe obsessive-compulsive disorder (OCD). Subjects will either receive double-blind valbenazine or inactive placebo for 6 weeks. This will be followed by a 2-week washout period and then 6 weeks of being assigned to the other agent (valbenazine or placebo). The hypothesis to be tested is that valbenazine will significantly improve symptoms of OCD compared to placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged 18-65 years
- •Primary diagnosis of obsessive compulsive disorder (OCD)
- •Yale Brown Obsessive Compulsive Scale (Y-BOCS) score of at least 21 at baseline (moderate or higher severity)
- •Ability to understand and sign the consent form
排除标准
- •Unstable medical illness based on history or clinically significant abnormalities on baseline physical examination
- •Current pregnancy or lactation, or inadequate contraception in women of childbearing potential
- •Subjects considered an immediate suicide risk based on the Columbia Suicide Severity Rating Scale (C-SSRS) (www.cssrs.columbia.edu/docs)
- •History of psychosis or bipolar disorder based on DSM-5 criteria
- •Alcohol/substance use disorder and/or illegal substance use based on urine toxicology
- •Initiation of psychological interventions within 3 months of screening (those who are continuing with CBT will be included)
- •Use of any new psychotropic medication within 3 months of study entry (stable doses of psychotropics will be allowed)
- •Major cognitive impairment that interferes with the capacity to understand and self-administer medication or provide written informed consent
- •Abnormal liver function tests at baseline (greater than 2x the upper limit of normal)
研究组 & 干预措施
Placebo followed by valbenazine
Following baseline measures, 50% of subjects will receive inactive placebo for 6 weeks. This will be followed by a 2-week washout period and then 6 weeks of being assigned to the other agent (initially 40mg per day for 2 weeks and then 80mg per day for 4 weeks). Participants will be assessed at baseline and every 2 weeks during the remainder of the study period.
干预措施: Placebo (Drug)
Valbenazine followed by placebo
Following baseline measures, 50% of subjects will receive valbenazine (initially 40mg per day for 2 weeks and then 80mg per day for 4 weeks). This will be followed by a 2-week washout period and then 6 weeks of being assigned to the other agent. Participants will be assessed at baseline and every 2 weeks during the remainder of the study period.
干预措施: Valbenazine (Drug)
结局指标
主要结局
Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)
时间窗: Baseline to week 14
A clinician-administered scale assessing OCD severity that will be used at all 8 visits. Total scores range from 0-50. Higher scores indicate worse outcomes.
次要结局
- Cambridge Neuropsychological Test Automated Battery (CANTAB) cognitive testing(Baseline to week 14)