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Not yet recruitingNCT07111988Updated Jun 10, 2026

Valbenazine in Obsessive Compulsive Disorder

A Phase 2 interventional study of Valbenazine and Placebo in Obsessive-Compulsive Disorder, sponsored by University of Chicago. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-06-10.

Sponsored by University of Chicago · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Obsessive-Compulsive Disorder

Keywords

  • OCD
03

In context

Obsessive-Compulsive Disorder

606 studies on the registry are indexed under Obsessive-Compulsive Disorder; 160 are open to participants now.

This study's planned enrollment of 30 is below the median of 45 across 492 interventional studies indexed under Obsessive-Compulsive Disorder.

Browse Obsessive-Compulsive Disorder studies →

Lead sponsor

University of Chicago is the lead sponsor of 907 studies on the registry; 182 are open to participants now.

Of its 99 completed or terminated interventional studies of FDA-regulated products, 68 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
30 participants (estimated)

Study arms

  • Other
    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.

    Drug: Valbenazine

  • Other
    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.

    Drug: Placebo

Interventions

  • DrugValbenazine

    Selective vesicular monoamine transporter 2 (VMAT2) inhibitor

    Also known as: Ingrezza

  • DrugPlacebo

    Pill that contains no medicine

    Also known as: No other names

06

What researchers measure

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.

    Time frame: Baseline to week 14

Secondary outcomes

  1. Cambridge Neuropsychological Test Automated Battery (CANTAB) cognitive testing

    Objective neuropsychological tasks, including the Tower of London Task, the Intra-dimensional/Extra-dimensional Set Shift (IED) task, the Cambridge Gambling Task (CGT), the Spatial Working Memory (SWM) task, and the Rapid Visual Information Processing (RVP) task, that will be administered pre- and post-pharmacological trial.

    Time frame: Baseline to week 14

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07111988
Lead sponsor
University of Chicago
Collaborators
Neurocrine Biosciences
Responsible party
Sponsor
First posted
Aug 8, 2025
Start date
Jun 2026 (estimated)
Primary completion
Dec 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Jun 10, 2026

Study contacts

Sofia Vicenzino, BA
Contact
sofia.vicenzino@bsd.uchicago.edu
773-702-9066
Estelle Spira, BS
Contact
estelle.spira@bsd.uchicago.edu
773-834-3778
Jon E Grant, MD, JD, MPH
principal investigator · University of Chicago

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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