Valbenazine in Obsessive Compulsive Disorder

Not Applicable

Not yet recruiting

• Conditions: Obsessive-Compulsive Disorder
• Interventions: Drug: Valbenazine; Drug: Placebo

• Registration Number: NCT07111988
• Lead Sponsor: University of Chicago

Brief Summary

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).

Detailed Description

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.

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-01
• Study First Submitted QC: 2025-08-01
• Last Update Submitted: 2025-08-01
• Study First Posted: 2025-08-08
• Last Update Posted: 2025-08-08
• Study Start: 2025-10-01
• Primary Completion: 2027-10
• Study Completion: 2027-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Men and women aged 18-65 years
2. Primary diagnosis of obsessive compulsive disorder (OCD)
3. Yale Brown Obsessive Compulsive Scale (Y-BOCS) score of at least 21 at baseline (moderate or higher severity)
4. Ability to understand and sign the consent form

Exclusion Criteria

1. Unstable medical illness based on history or clinically significant abnormalities on baseline physical examination
2. Current pregnancy or lactation, or inadequate contraception in women of childbearing potential
3. Subjects considered an immediate suicide risk based on the Columbia Suicide Severity Rating Scale (C-SSRS) (www.cssrs.columbia.edu/docs)
4. History of psychosis or bipolar disorder based on DSM-5 criteria
5. Alcohol/substance use disorder and/or illegal substance use based on urine toxicology
6. Initiation of psychological interventions within 3 months of screening (those who are continuing with CBT will be included)
7. Use of any new psychotropic medication within 3 months of study entry (stable doses of psychotropics will be allowed)
8. Major cognitive impairment that interferes with the capacity to understand and self-administer medication or provide written informed consent
9. Abnormal liver function tests at baseline (greater than 2x the upper limit of normal)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Valbenazine followed by placebo	Valbenazine	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 placebo. Participants will be assessed at baseline and every 2 weeks during the remainder of the study period.
Valbenazine followed by placebo	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 placebo. Participants will be assessed at baseline and every 2 weeks during the remainder of the study period.
Placebo followed by valbenazine	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 valbenazine (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.
Placebo followed by valbenazine	Placebo	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 valbenazine (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.

Primary Outcome Measures

Name	Time	Method
Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)	Baseline to week 14	A clinician-administered scale assessing OCD severity that will be used at all 8 visits.

Secondary Outcome Measures

Name	Time	Method
CANTAB cognitive testing	Baseline to week 14	Objective neuropsychological tasks that will be administered pre- and post-pharmacological trial.