OBJECTIVES: To assess patient satisfaction with treatment and their social roles with 6-monthly paliperidone palmitate (PP) formulation (PP6M) and 3-monthly formulation (PP3M) in a double-blind (DB), randomised study (NCT03345342) conducted in adult patients with schizophrenia.

METHODS: Following screening, and conditional open-label (OL) transition phase for patients not previously stabilised on once-monthly PP (PP1M)/PP3M, patients entered OL maintenance phase and received 1 injection cycle of PP1M (100/150 mg eq.) or PP3M (350/525 mg eq.). Stable patients were randomised (2:1) to PP6M (700/1000 mg eq., gluteal injections) or PP3M in a 12-month DB-phase (doses corresponded to prescribed doses of PP1M and PP3M). Treatment satisfaction and satisfaction with participation in social roles were measured using the abbreviated Treatment Satisfaction Questionnaire for Medication (TSQM-9) and Satisfaction with Participation in Social Roles (SPSR) scales. The scales were only administered to patients entering on an oral antipsychotic pre-treatment, excluding those who started on a moderate or high dose of PP1M or PP3M.

RESULTS: Overall, 282 patients on PP6M and 124 on PP3M were administered TSQM-9 and SPSR at baseline. At the end of DB-phase, 279 (PP6M) and 121 (PP3M) patients completed TSQM-9; 67 and 146 completed SPSR. From maintenance phase baseline to end of the DB-phase, patients receiving PP6M and PP3M during DB-phase reported 18% and 20% improvement in SPSR; mean (SD) change was 5.0 (8.01) and 4.5 (7.91), respectively. Similarly, at the end of the DB-phase, patients reported 32% and 40% improvement from maintenance phase baseline in TSQM-9; mean (SD) change was 17.2 (27.06) and 21.4 (25.84) in PP6M and PP3M groups.

CONCLUSIONS: Patients switching from oral antipsychotic treatments to long-acting injectables (LAIs) PP6M or PP3M showed improvement in measures of treatment satisfaction and satisfaction with social roles. These findings provide patient-relevant information reinforcing the benefits of LAIs for schizophrenia treatment.