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67 Effects of Long-term Valbenazine on Psychiatric Status in Patients with Tardive Dyskinesia and a Primary Mood Disorder

Published online by Cambridge University Press:  12 March 2019

Roger S. McIntyre ,
Gary Remington ,
Christoph U. Correll ,
Rachel Weber ,
Khodayar Farahmand ,
Leslie Lundt ,
Joshua Burke  and
Scott Siegert
Roger S. McIntyre
Affiliation:
Professor of Psychiatry and Pharmacology, Department of Psychiatry, University of Toronto; Toronto, Canada Senior Scientist in the Campbell Family Mental Health Research Institute and Chief of the Schizophrenia Division, Centre for Addiction and Mental Health; Toronto, Ontario, Canada Medical Director, Recognition and Prevention (RAP) Program, The Zucker Hillside Hospital, Glen Oaks, NY and Professor of Psychiatry and Molecular Medicine, The Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY Medical Communications Specialist, Neurocrine Biosciences, Inc., San Diego, CA Director, Medical Communications, Neurocrine Biosciences, Inc., San Diego, CA Medical Director, Neurocrine Biosciences, Inc., San Diego, CA Director, Biostatistics and Data Management, Neurocrine Biosciences, Inc., San Diego, CA Executive Director, Medical Affairs, Neurocrine Biosciences, Inc., San Diego, CA
Gary Remington
Affiliation:
Senior Scientist in the Campbell Family Mental Health Research Institute and Chief of the Schizophrenia Division, Centre for Addiction and Mental Health; Toronto, Ontario, Canada
Christoph U. Correll
Affiliation:
Medical Director, Recognition and Prevention (RAP) Program, The Zucker Hillside Hospital, Glen Oaks, NY and Professor of Psychiatry and Molecular Medicine, The Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY
Rachel Weber
Affiliation:
Medical Communications Specialist, Neurocrine Biosciences, Inc., San Diego, CA
Khodayar Farahmand
Affiliation:
Director, Medical Communications, Neurocrine Biosciences, Inc., San Diego, CA
Leslie Lundt
Affiliation:
Medical Director, Neurocrine Biosciences, Inc., San Diego, CA
Joshua Burke
Affiliation:
Director, Biostatistics and Data Management, Neurocrine Biosciences, Inc., San Diego, CA
Scott Siegert
Affiliation:
Executive Director, Medical Affairs, Neurocrine Biosciences, Inc., San Diego, CA
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Abstract

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Objective

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.

Type
Abstracts
Information
CNS Spectrums , Volume 24 , Issue 1 , February 2019 , pp. 210 - 211
Copyright
© Cambridge University Press 2019