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).
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
30
Selective vesicular monoamine transporter 2 (VMAT2) inhibitor
Pill that contains no medicine
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
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
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