Dynamics of Clinical Manifestations and Social Functioning in Schizophrenia: A Non-interventional Observational Study of Paliperidone Palmitat Dosage Forms.

Abstract

Background: Over the past seven years, the use of long-acting forms of antipsychotic medication has significantly increased in Russia. Specifically, in Moscow, from 2016 to 2021, the proportion of prescribed injectable long-acting antipsychotics had increased more than sevenfold (from 3% to 23%). Studies have shown that the correct selection of target groups for such therapy can reduce the frequency of relapses requiring hospitalization, lower the costs of inpatient care, and shift the focus of therapy from multiple drug administrations to psychosocial work.

Aim: This study was aimed at evaluating changes over time in psychosocial functioning, as well as clinical and psychopathological manifestations, in patients with schizophrenia during early remission and while on therapy with different forms of paliperidone: oral paliperidone (OP), paliperidone palmitate administered once monthly (PP1M), and paliperidone palmitate administered once every three months (PP3M).

Methods: The observational study included 155 patients: 54 patients who had been treated with another second-generation antipsychotic received OP, 50 patients who had been treated with another antipsychotic received PP1M injections, and 51 patients who had been in remission for four months after treatment with PP1M received PP3M. The duration of the follow-up period was 12 months. Assessment of personal and social functioning was conducted five times: before the start of treatment, and 3, 6, 9, and 12 months later.

Results: Treatment in all groups led to a statistically significant reduction in the severity of positive symptoms (p <0.001). Hallucinations proved more susceptible to therapy (p <0.001), while persistent delusions showed greater treatment resistance. Significantly more patients in the PP1M and PP3M groups had completed the entire program (n=24; 48.0%, and n=30; 58.8%, respectively) compared to the OP group (n=11; 20.4%). The PP3M group demonstrated the highest treatment adherence, with the largest number of patients completing the study, and a similar rate of exacerbations or inadequate efficacy compared to the other groups.

Conclusion: Treatment with different forms of paliperidone provides a roughly equal pace reduction in the severity of schizophrenia, including positive and negative symptoms. The PP3M group had better adherence and the highest number of patients who fully completed the study.