Objective: In two long-term phase 3 studies, sustained TD improvements were observed in participants who received once-daily treatment with valbenazine (40 or 80 mg). Data from these studies were analyzed post hoc to evaluate changes in psychiatric status in mood disorder patients.
Methods: Data were pooled from mood disorder participants in KINECT 3 (NCT02274558) and KINECT 4 (NCT02405091). At screening, a Brief Psychiatric Rating Scale total score <50 was required. Mood changes were evaluated after long-term treatment (Wk48) and 4-week washout (Wk52) using the Young Mania Rating Scale (YMRS) and Montgomery-Åsberg Depression Rating Scale (MADRS). For each scale, mean changes from baseline in the total score and individual item scores were analyzed descriptively.
Results: Of the 95 participants with a primary mood disorder, 62.1% were diagnosed with bipolar disorder, 33.7% with major depressive disorder, and 4.2% with another mood disorder. During treatment, 84.2% received concomitant antidepressants and 76.8% received antipsychotics. Mean YMRS and MADRS total scores indicated mood symptom stability at baseline (YMRS, 2.7; MADRS, 5.9), which was maintained during the studies as indicated by minimal changes from baseline in mean total scores (YMRS: Wk48, -1.0; Wk52, -1.0; MADRS: Wk48, 0.3; Wk52, 0.9). Changes in individual items on both scales were also small (Data from two long-term phase 3 valbenazine studies were analyzed post hoc to evaluate changes in psychiatric status in mood disorder patients. These results showed that mood symptom stability was generally maintained in patients with TD and a primary mood disorder who received up to 48 weeks of treatment with once-daily valbenazine in addition to their psychiatric medication(s).