RE-KINECT: A Prospective Real-World Dyskinesia Screening Study and Registry in Patients Taking Antipsychotic Agents: Patient Demographics (P4.083)

Objective: To document the presence and impact of involuntary movements (possible TD) in outpatients from psychiatric practices in the United States who are taking antipsychotic medications. Background: Tardive dyskinesia (TD) is associated with prolonged exposure to dopamine receptor blockers, including antipsychotics. Negative effects of TD on treatment outcomes, disease progression (for schizophrenia), and daily functioning have been reported, but the impact of TD on all patients prescribed antipsychotics (i.e., major depressive disorder, bipolar disorder, schizophrenia, schizoaffective disorder) and the burden of TD on caregivers is not well described. Design/Methods: RE-KINECT (NCT03062033) is expected to enroll ~1,000 patients from ≤70 US psychiatric practices. Outpatients (≥18 years) with ≥3 months antipsychotic exposure and ≥1 psychiatric disorder are eligible. Screening involves 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 2 or Cohort 1 (with or without abnormal involuntary movements, respectively). Baseline assessments include: 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 a 12-month retrospective chart review of medical and treatment history. Cohort 2 will also participate in a 12-month longitudinal evaluation. Results: Recruitment is ongoing. Interim baseline results from 3 sites, representing chart review data for 162 patients are: mean age, 50.5 years; male, 35.1%; schizophrenia/schizoaffective disorder, 32.8%; mood disorder, 64.8%; 9.6 years mean cumulative lifetime exposure to antipsychotic(s). 31.5% of subjects had clinically observed TD symptoms. The major health concerns reported by current participants were mental health (69.0%), followed by physical activity and nutrition (33.6%). Updated results will be presented at the meeting. Conclusions: This novel registry aims to evaluate the real-world impact and burden of TD. Preliminary analyses will describe the prevalence and functional impact of possible PD. Study Supported by: Neurocrine Biosciences, Inc. Disclosure: Dr. Tanner has nothing to disclose. Dr. Cutler has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with consulting fees from Acadia, Allergan, Alkermes, AstraZeneca, Forum, Intra-Cellular Therapies, Lundbeck, Neurocrine Biosciences, Inc., Novartis, Noven, Sunovion, Takeda, and Teva. Dr. Cutler has received research support from research grant support from Acadia, Allergan, Alkermes, AstraZeneca, Braeburn, Forum, Intra-Cellular Therapies, Janssen, Eli Lilly, Lundbeck, Novartis, Noven, Otsuka, Pfizer, Reckitt Benckiser, Sunovion, Takeda, and Teva. Dr. Caroff has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Teva Pharmaceuticals, Inc. and Neurocrine Biosciences, Inc. Dr. Caroff has received research support from Neurocrine Biosciences, Inc. Dr. Lenderking has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee, Evidera. Dr. Yeomans has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee, Evidera. Dr. Shalhoub has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee, Evidera. Dr. Ross has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee, PPD. Dr. Yonan has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee, Neurocrine Biosciences, Inc.