Background: The efficacy and safety of long-acting injectable risperidone have not been compared with those of an oral atypical antipsychotic.
Aims: To compare long-acting risperidone and oral olanzapine in 377 patients with DSM-IV schizophrenia or schizoaffective disorder.
Method: Patients were randomised to receive long-acting risperidone (25 mg or 50 mg every 14 days) or olanzapine (5-20 mg/day).
Results: In the 13-week phase, long-acting risperidone was at least as effective as (not inferior to) oral olanzapine. In the 12-month phase, significant improvements in the Positive and Negative Syndrome Scale (PANSS) total and factor scores from baseline to month 12 and end-point were seen in both groups of patients. Few patients discontinued treatment because of an adverse event.
Conclusions: Both treatments were efficacious and well tolerated.