Objective: Burden is significant for caregivers of patients with schizophrenia. Little is known about the relationship between changes in patient illness severity and functioning and changes in caregiver burden. The objective of this post hoc analysis is to describe the association between changes in patient symptom severity and functioning and changes in caregiver burden.
Methods: Data from a randomized, double-blind, multicenter, phase 3 study (NCT01515423) evaluating noninferiority between paliperidone palmitate 1-month (PP1M) and paliperidone palmitate 3-month (PP3M) formulations in patients with schizophrenia were examined. After screening, patients entered a 17-week flexible-dose, open-label stabilization (OL) phase to receive PP1M (N=1429) and subsequently a 48-week randomized, fixed-dose, double-blind controlled (DB) phase to receive PP1M (N=512) or PP3M (N=504). The Involvement Evaluation Questionnaire (IEQ), Clinical Global Impression–Severity (CGI-S), Positive and Negative Syndrome Scale (PANSS), and Personal and Social Performance scale (PSP) scores were assessed at baseline and at the end points of both OL and DB phases. Effects of changes in CGI-S, PANSS, and PSP scores on the changes in IEQ scores were assessed using multiple regression (models in both OL and combined OL and DB phases).
Results: Multiple regression analyses indicated that changes in CGI-S, PANSS, and PSP scores were significantly associated with changes in IEQ scores (P<0.001, R-squared ranged from 0.262 to 0.321). Further examination of data suggested that improvements in CGI-S, PANSS, and PSP scores lead to reduction in caregiver burden.
Conclusion: Clinical and functional improvements in patients with schizophrenia are associated with reduced caregiver burden.