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Over the last several years, the study of implicit bias has taken the world by storm. Implicit bias was even mentioned by the then candidate, Hillary Clinton, in a presidential debate in 2016. She went on to claim that implicit bias can have deadly consequences when Black men encounter law enforcement (for example, see Correll et al., 2002; Correll et al., 2007; Eberhardt et al., 2004). The controversy over police shootings of Black men and women has only intensified as evidenced by public outcry over the murder of George Floyd on May 25, 2020 and increasing public support for the “Black Lives Matter” movement and its calls for liberty, justice, and freedom (Cohn & Quealy, 2020). These current events are but one reason why the study of implicit bias has so captivated the attention of the larger public: reducing it seems to have the potential to solve real-world problems. One idea is that if police officers were made aware of their implicit bias or participated in training workshops to reduce implicit bias, then perhaps fewer Black people would end up dead, arrested, or disproportionately sentenced to receive the death penalty (Baumgartner et al., 2014; Eberhardt, 2020).
Valbenazine is approved for tardive dyskinesia (TD) in adults based on clinical trials that included patients with mood disorders (e.g., bipolar disorder, major depressive disorder). In two long-termphase 3 trials, KINECT 3 (NCT02274558) and KINECT 4 (NCT02405091), sustained TD improvements were found in participants who received once-daily treatment with valbenazine (40 or 80mg). Data from these studies were analyzed post hoc to evaluate changes in psychiatric status of patients with a primary mood disorder.
Methods
Data were pooled from participants with mood disorders in KINECT 3 (6-week double-blind, placebo-controlled period; 42-week double-blind extension period; 4-week drug-free washout) and KINECT 4 (48week open-label treatment; 4-week drug-free washout). At screening, patients must have had a Brief Psychiatric Rating Scale total score <50. Mood changes were evaluated after long-term treatment (Week 48) and washout (Week 52) 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 (40mg , n=32; 80mg , n=63), 59 (62.1%) were diagnosed with bipolar disorder, 32 (33.7%) with major depressive disorder, and 4 (4.2%) with another mood disorder. A majority of all mood participants received concomitant antidepressants (84.2%) and/or antipsychotics (76.8%) during treatment; other common concomitant medications included antiepileptics (47.4%), anxiolytics (38.9%), and anticholinergics (22.1%). Mean YMRS and MADRS total scores in all mood participants indicated mood symptom stability at baseline (YMRS, 2.7; MADRS, 5.9). This stability was maintained during the studies, as indicated by minimal changes from baseline in mean total scores (YMRS: Week 48, 1.0; Week 52, –1.0; MADRS: Week 48, 0.3; Week52,0.9). Changes in individual items on both scales were also small (<±0.3), indicating no clinically significant changes or worsening in specific mood symptoms or domains.
Conclusions
Mood symptom stability was 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).
Funding Acknowledgements: Neurocrine Biosciences, Inc.