Efficacy and safety study of risperidone long-acting injection in the maintenance treatment for schizophrenia

Abstract

Objective To evaluate the efficacy and safety of risperidone long-acting injection (RLAI) in the maintenance treatment for schizophrenia.Methods This was an open label, single arm and multi-center study.Two hundred schizophrenic patients switching from other antipsychotics accepted the treatment of two-week interval injections of RLAI for nine months.The dosages were 25.0 mg, 37.5 mg or 50.0 mg every two weeks.The patients were assessed with the Positive and Negative Syndrome Scale (PANSS), Clinical Global Impression (CGI) rating scale, etc.Safety was assessed with adverse event report, the Extrapyramidal Symptom Rating Scale (ESRS), laboratory test and ECG examination.Results The intend-to-treat (ITT) analysis was included 192 cases and per-protocol (PP) analysis was 169 cases.The PANSS total score were(68.05±22.79), (61.10±21.91), (55.08± 21.29 ), (51.26 ±20.62)and (48.88±19.92)at baseline, 4th, 12th, 24th and 36th week respectively.The reduction of PANSS total score was (19.17±21.50) from baseline to the endpoint.There were significant differences on the scores between at baseline and each of visits after treatment (P<0.01).The improvement and remission rates were 65.6% and 58.9% respectively.According to the CGI-S score, the total patient number of normal,borderline and mild was 135 (70.3%).There were 106 patients (55.2%) reported AE, and the common adverse event were EPS (28.5%), sleep disorder (10.1%), akathisia (7.2%), ECG change (6.3%),weight gain (5.8%) and upper respiratory tract infection (5.3%), etc.Conclusion RLAI is effective and safe in the maintenance treatment of schizophrenia. Key words: Delay-action preparation; Risperidone; Schizophrenia; Treatment outcom