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| Name | Class |
|---|---|
| Neurocrine Biosciences | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Valbenazine | Drug | Selective vesicular monoamine transporter 2 (VMAT2) inhibitor |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sofia Vicenzino, BA | Contact | 773-702-9066 | sofia.vicenzino@bsd.uchicago.edu | |
| Estelle Spira, BS | Contact | 773-834-3778 | estelle.spira@bsd.uchicago.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jon E Grant, MD, JD, MPH | University of Chicago | Principal Investigator |
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| ID | Term |
|---|---|
| D009771 | Obsessive-Compulsive Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C000603978 | valbenazine |
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This study is a randomized, double-blind, placebo-controlled crossover trial.
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| Placebo | Drug | Pill that contains no medicine |
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| Baseline to week 14 |