Long term antipsychotic therapy is recognized as being important for preventing relapses and improving outcomes in patients with schizophrenia. In this respect the treatment with RLAI has been shown to be effective and well tolerated in long-term studies lasting up to 12 months1-2.

A 52 weeks open label trial has been performed in 347 stable subjects with schizophrenia or schizoaffective disorders, switching from any previous antipsychotic treatment, in order to evaluate the maintenance of efficacy of RLAI.

70% of subjects completed the study. Mean PANSS total score significantly improved at each assessment visit 4, 12, 26, 38 and 52 weeks (p<0.001). Similar improvements were observed for the PANSS positive, negative and general psychopathology subscales. At 52 weeks, 58% of patients had a > 20% improvement in the PANSS total score compared to baseline. Functionality as measured by GAF improved at each assessment visit till week 52 (p<0.001). Significant improvement was also seen for CGI evaluation (p<0.05). Treatment with RLAI was well tolerated: 30% of subjects experienced at least 1 adverse effect (AE), and 52% of the AEs were mild and 81% did not require treatment change. Only 3% subjects experienced an extrapyramidal symptom related to RLAI. No significant (p=0.09) weight gain was observed.

Direct transition to RLAI in psychotic subjects offers a better, significant and sustained control of symptoms with a good tolerability profile.