ABSTRACT
OBJECTIVE: This study aimed to evaluate the clinical efficacy, safety, and tolerability of paliperidone extended release (ER) in patients with schizophrenia by switching previous antipsychotics to paliperidone ER. METHODS: An open-label, 24 weeks, prospective, non-comparative, multi-center study evaluated total 387 patients with schizophrenia requiring a switch in antipsychotic medication due to suboptimal efficacy, intolerability, and non-compliance. Patients were switched to flexible-dose trial of paliperidone ER (3-12 mg/day). Efficacy was measured by Krawiecka Scale, Clinical Global Impression-Schizophrenia-Severity (CGI-SCH-S), Clinical Global Impression-Schizophrenia-Improvement (CGI-SCH-I), sleep visual analog scale (VAS), and Personal and Social Performance Scale (PSP). Safety assessments included adverse events (AEs), evaluation of extrapyramidal symptoms (EPS) using the Drug Induced Extrapyramidal Symptoms Scale (DIEPSS), and laboratory tests. RESULTS: Data from a total of 321 subjects who took the paliperidone ER and had at least one follow-up assessment without a major protocol violation were analyzed. Switching to paliperidone ER led to a significant improvement in the Krawiecka, CGI-SCH-S, CGI-SCH-I, PSP, and DIEPSS scales. However, serum prolactin levels and metabolic parameters including body weight and waist circumference were significantly increased. Insomnia was the most common adverse event. CONCLUSION: This study suggested that patients with schizophrenia who showed insufficient response or intolerance to other previous antipsychotics can be switched to paliperidone ER, with efficacy, safety, and tolerability.
Subject(s)
Humans , Antipsychotic Agents , Body Weight , Follow-Up Studies , Isoxazoles , Prolactin , Prospective Studies , Pyrimidines , Schizophrenia , Sleep Initiation and Maintenance Disorders , Waist Circumference , Weights and MeasuresABSTRACT
OBJECTIVES: Major depressive disorder (MDD) causes patients' distress and makes socioeconomic burden, both directly and indirectly. We used the concept of lost productive time (LPT) to estimate the indirect costs and calculated both absenteeism and presenteeism among workers with MDD. METHODS: Depression group was recruited from workers visiting psychiatric outpatient clinic who had MDD without major physical or mental disorders (N=106). Age and sex matched healthy control group was also recruited through advertisement (M=100). All participants completed a interview using WHO Health and Work Performance Questionnaire (HPQ), Job Stress Measurement Scale for Korean Employees, and Hamilton Rating Scale for Depression. Statistical analysis was performed with independent t-test or Chi2 test as characteristics of values (p=0.05). RESULTS: The number of absence (0.94-day/month vs. 0.10-day/month, p=0.015) and the number of early leaving (2.56-day/month vs. 0.24-day/month, p<0.001) were significantly higher in the depression group. Depression group evaluated their performance level much lower than controls with significant value (5.16 vs. 7.62, p<0.001). In addition, depression group estimated their performance level during the last 4 weeks lower compared to the level of past 1-year (5.16 vs 6.63, p<0.001). The estimated costs of absenteeism in depression group were higher than controls by 2,520,000 Korean Won per year, and those of presenteeism were also higher by 4,880,000 Korean Won per year. The total costs of LPT in depression group were higher than controls by 7,400,000 Korean Won, which corresponds to 26% of mean annual salary. In addition, the level of occupational stress, such as high demand and interpersonal conflict, was higher in the depression group. CONCLUSION: Major depressive disorder costs substantial productivity loss to workers and their company. Presenteeism imposes more time cost than absenteeism. Effectiveness trials are needed to devise cost-effective programs for the early detection and treatment of depression at the workplace.