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117 RE-KINECT: Real-World Dyskinesia Screening Study and Registry in Patients Taking Antipsychotic Agents: Interim Baseline Burden of Illness Results

Published online by Cambridge University Press:  15 June 2018

Andrew Cutler ,
Stanley Caroff ,
Caroline Tanner ,
William R. Lenderking ,
Karen Yeomans ,
Huda Shalhoub ,
Véronique Pagé  and
Chuck Yonan
Andrew Cutler
Affiliation:
Meridien Research, Tampa, FL
Stanley Caroff
Affiliation:
Corporal Michael J. Crescenz Veterans Affairs Medical Center and the Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA
Caroline Tanner
Affiliation:
University of California San Francisco; San Francisco, CA
William R. Lenderking
Affiliation:
Senior Research Leader, Outcomes Research, Evidera, Waltham, MA
Karen Yeomans
Affiliation:
Associate Director, Real-World Evidence, Evidera, Montreal, Canada
Huda Shalhoub
Affiliation:
Senior Research Associate, Outcomes Research, Evidera, Waltham, MA
Véronique Pagé
Affiliation:
Evidera, Montreal, Canada
Chuck Yonan
Affiliation:
Neurocrine Biosciences, Inc., San Diego, CA
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Abstract

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Background

Tardive dyskinesia (TD) is associated with prolonged exposure to dopamine receptor blockers including antipsychotics. This registry describes the prevalence and impact of involuntary movements (possible TD) in a real-world population of patients taking antipsychotics.

Methods

RE-KINECT (NCT03062033) aims to enroll 1,000 patients from 70 US psychiatric practices. Adults with ≥3 months lifetime exposure to antipsychotic(s) and ≥1 psychiatric disorder are eligible for two-tier screening: informal observation, and then clinician observation of abnormal involuntary movements in general body regions (head/face, neck/trunk, upper/lower limbs) and confirmation of possible TD. Based on clinician assessment, patients are assigned to Cohort 1 or Cohort 2 (without or with abnormal involuntary movements, respectively). In both cohorts, the following baseline assessments are included: clinician’s assessment of clinical psychiatric severity, patient perceived health‐related quality of life (EuroQOL 5-Dimensions), social burden/disability questionnaire (Sheehan Disability Scale), and 12-month retrospective chart review ofmedical and treatment history. Cohort 2 also participate in 12-month longitudinal evaluation. Interim baseline data are available from four sites.

Results

Baseline data are currently available for 116 patients—mean age, 49.6 years; female, 60.3%; schizophrenia/schizoaffective disorder, 32.8%; at least 1 mood disorder, 84.5%, and 10.4 years mean cumulative lifetime exposure to antipsychotic(s). The most concerning health condition for both cohorts is their mental health (69.0%), followed by physical activity and nutrition (33.6%). 32.8% of subjects had clinician confirmation of possible TD.

Conclusion

This novel registry aims to evaluate the real-world potential impact/burden of TD. Preliminary analyses suggest that TD is common in patients with schizophrenia and mood disorders taking antipsychotics. Further analyses will explore the burden of illness in this population.

Funding Acknowledgements

This study was funded by Neurocrine Biosciences, Inc.

Type
Abstracts
Information
CNS Spectrums , Volume 23 , Issue 1 , February 2018 , pp. 74
Copyright
© Cambridge University Press 2018