Valbenazine in Obsessive Compulsive Disorder

NCT07111988 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: IRB25-0568
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Obsessive-Compulsive Disorder

Keywords

OCD

Outcome Measures

Primary Outcomes (1)

• Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)

  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.

  Baseline to week 14

Secondary Outcomes (1)

• Cambridge Neuropsychological Test Automated Battery (CANTAB) cognitive testing

  Baseline to week 14

Study Arms (2)

Valbenazine followed by placebo

OTHER

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.

Drug: Valbenazine

Placebo followed by valbenazine

OTHER

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.

Drug: Placebo

Interventions

Valbenazine DRUG

Selective vesicular monoamine transporter 2 (VMAT2) inhibitor

Also known as: Ingrezza

Valbenazine followed by placebo

Placebo DRUG

Pill that contains no medicine

Also known as: No other names

Placebo followed by valbenazine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Chicago: lead
• Neurocrine Biosciences: collaborator

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

valbenazine

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• Jon E Grant, MD, JD, MPH

  University of Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sophie Boutouis, BS

CONTACT

773-702-9066; sboutouis@bsd.uchicago.edu

Laurie Avila, BA

CONTACT

773-702-5523; laurie.avila@bsd.uchicago.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is a randomized, double-blind, placebo-controlled crossover trial.

Study Record Dates

• First Submitted: August 1, 2025
• First Posted: August 8, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share