Evaluating decision criteria for the choice of pharmacological long-term therapy in risperidone treated patients with schizophrenia

Objectives: To evaluate decision criteria for initiation of pharmacological long-term treatment (LTT) in patients with schizophrenia. Methods: Non-interventional trial in in-patients pretreated with oral risperidone (RIS-SCH-0001). Further treatment strategy was detailed to: monotherapy with (1) long-acting injectable risperidone (LAIR), (2) oral risperidone (oral RIS), (3) no decision taken, (4) other antipsychotics. Study period was limited to 42 days. Results: Decision groups comprised (1) 29.0%, (2) 43.0%, (4) 11.5% and (3)16.5% of the 321 patients who were included (mean age 40.5y). Reasons for taking the decision for LTT included good efficacy of oral RIS (LAIR 17.2%, oral RIS 41.3%, other decision 2.7.%) and previous lack of compliance (LAIR 40.7%, oral RIS 2.2%, other decision 16.2%). Mean observation period was shorter in groups 1/2 compared to groups 3/4. For patients known at the institution odds ratio for being treated with LAIR was 2.8 as opposed to oral RIS. 130 AEs were reported (47 patients), 1 SAE (somnolence) classified as of possible causality to RIS. Conclusion: The trial revealed heterogenous reasons for decision taking into LLT in patients with schizophrenia. LAIR but also other depot formulations have been the favored choice in case of lack of compliance. Patients known at the institution were more likely to be treated with LAIR.

This study was supported by Janssen-Cilag GmbH, Neuss