Abstract
Effective early detection of impending relapse may offer opportunities for early interventions to prevent full relapse in schizophrenia patients. Previously reported early warning signs were not consistently validated by prospective studies. It remains unclear which symptoms are most predictive of relapse. To prioritize the symptoms to be captured by periodic self-report in technology-enabled remote assessment solutions for monitoring symptoms and detecting relapse early, we analyzed data from three relapse-prevention studies to identify individual items of the Positive and Negative Syndrome Scale (PANSS) that changed the most prior to relapse and to understand exactly when these symptoms manifested. Relapse was defined by a composite endpoint: hospitalization, suicidal/homicidal ideation, violent behavior, a 25% increase in the PANSS total score, or a significant increase in at least one of several pre-specified PANSS items. Longitudinal mixed effect models were applied to model the trajectories of individual PANSS items before relapse. Among 267 relapsed patients, the PANSS items that increased the most at relapse from randomization did not differ much by different relapse reasons or medications. A subset of seven PANSS items, including delusions, suspiciousness, hallucinations, anxiety, excitement, tension, and conceptual disorganization, had on average > 1-point of increase at relapse. The trajectories of these items suggested these items started to increase 7–10 days before relapse and reached on average 1-point of increase 0.3 ~ 1.2 days before relapse. Our results indicated that a subset of PANSS items could be leveraged to develop remote assessment solutions for monitoring symptoms and detecting relapse early in schizophrenia patients.
Highlights
The disease course of schizophrenia is often characterized by frequent relapse of psychotic symptoms for the majority of patients
Demographics and characteristics of patients experienced a relapse during double-blind phase formulations overlapped with the top seven Positive and Negative Syndrome Scale (PANSS) items identified in all relapsed patients (Supplementary Table 3)
These results suggested the PANSS items that had the most increases at relapse did not differ much in patients having different relapse
Summary
The disease course of schizophrenia is often characterized by frequent relapse of psychotic symptoms for the majority of patients. 1234567890():,; clinicians recorded whether the early signs exist during weekly treatment visits prior to decompensation in 47 schizophrenic patients, the most commonly observed symptoms included hallucinations (53%), suspiciousness (43%), change in sleep This is different from the early warning signs identified through retrospective studies where non-psychotic symptoms, such as having trouble sleeping, having trouble concentrating, loss of appetite, and feeling depressed, ranked higher.[26,29,30] A few prospective studies have been performed to assess the predictive validity of the early warning signs but yielded mixed results.[28,31,32,33,34,35,36,37,38,39,40,41]. Our primary objective was to determine: (1) which individual symptoms from the PANSS could be used to predict an impending relapse and (2) the time course of changes in these symptoms prior to relapse The results from these analyses provide basis for developing technology-enabled remote assessment solutions for monitoring symptoms and detecting relapse early in schizophrenia patients. Six out of the top seven PANSS items that had the most increases at relapse in the patients receiving the oral extended-release (ER) formulation of paliperidone and in those receiving one of the two long-acting injectable
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