Valbenazine in Obsessive Compulsive Disorder

ConditionObsessive-Compulsive Disorder

Trial statusNot yet recruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-65

SponsorUniversity of Chicago

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

Valbenazine
Drug
Selective vesicular monoamine transporter 2 (VMAT2) inhibitor
Placebo
Drug
Pill that contains no medicine

Treatment groups

30 Participants

are divided into 2 treatment groups

Group A: Valbenazine followed by placeboOther 1 intervention

Group B: Placebo followed by valbenazineOther 1 intervention

Trial outcomes

Primary outcomes

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

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

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Chicago

Lead sponsor

Neurocrine Biosciences

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: