Valbenazine in Obsessive Compulsive Disorder

NCT ID: NCT07111988

Last Updated: 2026-02-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-28
• Study Completion Date: 2027-12-31

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.

Conditions

Obsessive-Compulsive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: OTHER

Valbenazine

Intervention Type: DRUG

Selective vesicular monoamine transporter 2 (VMAT2) inhibitor

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.

Group Type: OTHER

Placebo

Intervention Type: DRUG

Pill that contains no medicine

Interventions

Valbenazine

Selective vesicular monoamine transporter 2 (VMAT2) inhibitor

Intervention Type: DRUG

Placebo

Pill that contains no medicine

Intervention Type: DRUG

Other Intervention Names

Ingrezza; No other names

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Neurocrine Biosciences

INDUSTRY

Sponsor Role: collaborator

University of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jon E Grant, MD, JD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Central Contacts

Sophie Boutouis, BS

Role: CONTACT

sboutouis@bsd.uchicago.edu

773-702-9066

Laurie Avila, BA

Role: CONTACT

laurie.avila@bsd.uchicago.edu

773-702-5523

Other Identifiers

IRB25-0568

Identifier Type: -

Identifier Source: org_study_id