Objectives: To evaluate the maintenance of efficacy of risperidone long-acting injectable (RLAI) in stable patients with schizophrenia or schizoaffective disorders. The prevalence of patients who met standardized remission criteria will be also evaluated as well as the predictors factors of remission according to psychopathological, psychosocial and subjective correlates.
Methods: 52-week, open-label prospective trial in 347 stable patients switching directly to RLAI from any previous antipsychotic treatment.
Results: One year of treatment was completed by 70% of patients. Positive and Negative Syndrome Scale (PANSS) total and subscale, Global Assessment of Functioning (GAF) and Clinical Global Impression (CGI) scores improved from baseline at each assessment visit (p < 0.001, p < 0.001 and p < 0.05, respectively). Drug Attitude Inventory 30 (DAI30) scores improved significantly from month 3 onwards. 32% of patients met sustained remission at week 52. In a logistic regression model less severe positive and negative PANSS scores at baseline predicted remission (p < 0.001). RLAI treatment was well tolerated: one-third of patients reported mild to moderate adverse events (AEs). Eleven patients (3.2%) discontinued treatment due to an AE. No significant weight gain (p = 0.093) was reported.
Conclusions: RLAI treatment up to one year improved symptoms and global functioning versus baseline, indicating that an established and accepted antipsychotic therapy can enable patients with schizophrenia to achieve and maintain remission.