Valbenazine in Obsessive Compulsive Disorder
- Sponsor
- University of Chicago
- Study ID
- NCT07111988
- Phase
- PHASE2
- Status
- Not Yet Recruiting
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Conditions
- Obsessive-Compulsive Disorder
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 65 Years
- Healthy Volunteers
- Not accepted
Interventions
- Valbenazine — DRUGSelective vesicular monoamine transporter 2 (VMAT2) inhibitor
- Placebo — DRUGPill that contains no medicine
Study Details
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).
Key Dates
- First listed
- Aug 8, 2025
- Start date
- Jun 30, 2026
- Status verified
- Jun 2026
- Primary completion
- Dec 31, 2027
- Completion
- Dec 31, 2027
Study Design
- Enrollment
- 30 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- CROSSOVER
- Primary purpose
- TREATMENT
Arms
- Other: Valbenazine followed by placeboFollowing 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.
- Other: Placebo followed by valbenazineFollowing 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.
Primary Outcome Measure
Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) [ Time Frame: Baseline to week 14 ]
Central Contacts
- Sofia Vicenzino, BA773-702-9066
- Estelle Spira, BS773-834-3778
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