1. RE-KINECT
- Author
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Caroff, Stanley N, Yeomans, Karen, Lenderking, William R, Cutler, Andrew J, Tanner, Caroline M, Shalhoub, Huda, Pagé, Véronique, Chen, Jun, Franey, Ericha, and Yonan, Chuck
- Subjects
Schizophrenia ,Brain Disorders ,Clinical Research ,Mental Health ,Mental health ,Age Factors ,Antipsychotic Agents ,Case-Control Studies ,Female ,Humans ,Male ,Mental Disorders ,Middle Aged ,Outpatients ,Prospective Studies ,Quality of Life ,Tardive Dyskinesia ,United States ,tardive dyskinesia ,antipsychotics ,movement disorders ,schizophrenia ,mood disorders ,Medical and Health Sciences ,Psychology and Cognitive Sciences ,Psychiatry - Abstract
Purpose/backgroundRE-KINECT (NCT03062033) was designed to assess the presence and impact of possible tardive dyskinesia (TD) in antipsychotic-treated outpatients.Methods/proceduresThe study included adults with 3 or more months of lifetime antipsychotic exposure and 1 or more psychiatric disorder. Based on clinician observation and assessment, patients were assigned to cohort 1 (without involuntary movements or with non-TD involuntary movements) or cohort 2 (with involuntary movements confirmed by clinician as possible TD). Baseline assessments included the following: patient characteristics; location/severity of involuntary movements; and impact of possible TD on health-related quality of life, including the EuroQoL 5-Dimensions 5-Level questionnaire.Findings/resultsOf 739 eligible patients, 204 (27.6%) had clinician-confirmed possible TD (cohort 2). Compared with cohort 1, patients in cohort 2 were significantly older (P < 0.0001), more likely to have schizophrenia or schizoaffective disorder (P < 0.0001) and longer lifetime exposure to antipsychotics (P < 0.0001), and less likely to be working or studying, based on clinician perception (P = 0.0010). Clinician- and patient-rated severity of possible TD movements was significantly correlated in each of 4 body regions (head/face, neck/trunk, upper extremities, lower extremities), for maximum severity in any region, and for total number of affected regions (P < 0.001 for all correlations). For the patient-rated EuroQoL 5-Dimensions 5-Level, the health state visual analog scale score was significantly lower (worse) in cohort 2 versus cohort 1 (66.8 vs 69.7; P = 0.0002), as was the utility index score (0.71 vs 0.76; P < 0.0175).Implications/conclusionsResults from this real-world population indicate that TD occurs frequently and can significantly reduce quality of life in patients with a psychiatric disorder.
- Published
- 2020