Real-world paliperidone palmitate data from acute units: The SHADOW study

Introduction There is an increasing interest in understanding how antipsychotic treatments work in a real-world-setting. This is especially important with long-acting-antipsychotics, where explanatory trials may not always represent the real-world-population. Observational studies and pragmatic-clinical trials could provide additional information about new therapies, which could inform decision-making processes. Objectives To assess the effectiveness of Paliperidone-Palmitate(PP) in an acute setting within real-world-conditions. Functionality, satisfaction with treatment and pattern of use were also evaluated. Methods An observational, prospective 6-week follow-up study was performed in acute units including adult patients with acute exacerbation of schizophrenia that started treatment with PP. Data were collected from initiation of PP until week-6 (or patient's discharge if earlier). Clinical-Global Inventory-Severity (CGI-S) was used to assess effectiveness as well as changes in illness severity. Other outcomes included total score on the Personal and Social Performance scale (PSP), patient-satisfaction with medication (MSQ) and tolerability. Student's- t tests were used to assess changes from baseline in CGI-S and PSP. Results Two hundred and eighty patients were included in the analysis (mean age: 40.5 ± 12.2 [SD] years). A significant decrease in mean (SD) CGI-S score between baseline (4.7 [0.9]) and endpoint (3.3 [0.9]) ( P P Conclusions These results support the effectiveness and tolerability of PP in an acute setting under daily-clinical-practice with good acceptance by patients.