The primary objective for this study is to evaluate the effect of adjunctive valbenazine versus placebo on symptoms of schizophrenia in participants who have inadequate response to antipsychotic treatment.
Phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, and tolerability of valbenazine when administered orally once daily as adjunctive treatment in participants with schizophrenia who have had an inadequate response to antipsychotics. The study will enroll approximately 400 participants with a diagnosis of schizophrenia. The expected duration of study participation for each participant is approximately 16 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
442
Oral capsules
Oral capsules
Change in Positive and Negative Syndrome Scale (PANSS) total score from baseline to Week 10
Time frame: Baseline to week 10
Change in Clinical Global Impression of Severity (CGI-S) score from baseline to Week 10
Time frame: Baseline to week 10
Change in Personal and Social Performance Scale (PSP) score from baseline to Week 10
Time frame: Baseline to week 10
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