Valbenazine in Obsessive Compulsive Disorder

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.

Inclusion criteria

• 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

Exclusion criteria

• 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)