The study was an open-label, flexible-dose, naturalistic observational trial of patients with schizophrenia NLG919 receiving oral risperidone but who required a change in their medication because of persistent symptoms or troublesome side effects. Patients had high scores on the Positive and Negative Syndrome Scale (PANSS), even though they were considered stable. However, these patients could not be considered refractory to antipsychotics. Switching method Subjects Inhibitors,research,lifescience,medical were switched to RLAI from their previous therapeutic medications as follows. They were given an initial dose of RLAI 25 mg in addition to their previous therapeutic

medications, and received gluteal injections at 2-week intervals, alternating from the left to the right side. After 4 weeks, by which point the blood concentration had started to rise, doses Inhibitors,research,lifescience,medical of previous therapeutic medications were reduced so that the subjects would be receiving total doses equivalent to those of their previous therapeutic medications. After 8 weeks, the RLAI dose was increased as necessary to optimize the dose, and all subjects were receiving RLAI

monotherapy. It was therefore possible Inhibitors,research,lifescience,medical to investigate the intrinsic effect of RLAI on cognitive function. Following RLAI optimal dose adjustment, wherever possible, the doses of any concomitant medications, including anti-Parkinson medications, were reduced. When switching to RLAI, the calculation table of Inagaki and Inada was used as a guideline for calculating antipsychotic equivalents [Inagaki and Inada, 2010], and daily doses were calculated in terms of risperidone equivalents. Only patients who had received a full explanation of the purpose and methods of the Inhibitors,research,lifescience,medical study and had provided voluntary informed written consent to participate were enrolled. Inhibitors,research,lifescience,medical Patient confidentiality was afforded all due consideration, as were ethical considerations. Assessment methods Clinical assessments were performed

at baseline and at 24 weeks by the psychiatrist who was providing the therapy. There were no reliability tests for those who applied the PANSS [Kay et al. 1987], the Clinical Global Impression – Severity of Illness scale (CGI-S) [Guy and Rockville, 1976], and the Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) [Inada, 1996; Inada et al. 1996]. However, assessor training was provided to ensure because a certain degree of reliability. The PANSS and the CGI-S were used to investigate efficacy. Meanwhile, the DIEPSS, body weight, body mass index (BMI), and blood biochemistry tests (total cholesterol, triglycerides, prolactin) were used to investigate safety. Injection site reactions were also assessed. Statistical analysis The Wilcoxon signed rank sum test was used to analyze efficacy and safety before and after RLAI switching. This test was also used to analyze differences between the older group and the younger and control groups in terms of efficacy or safety. The significance level was set at p < 0.05.

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