Efficacy and safety of once-monthly Risperidone ISM^® in schizophrenic patients with an acute exacerbation.

ABSTRACT: To evaluate the efficacy and safety of Risperidone ISM^® against placebo in patients with acute exacerbation of schizophrenia. A multicenter, randomized, double-blind, placebo-controlled study was conducted between June 2017 and December 2018 (NCT03160521). Eligible patients received once-monthly intramuscular injections of Risperidone ISM^® (75 or 100 mg) or placebo for 12 weeks. The primary efficacy outcome was change in Positive and Negative Syndrome Scale (PANSS) total score from baseline to week 12. The key secondary efficacy outcome was change from baseline in Clinical Global Impressions-Severity of Illness scale (CGI-S) score. Altogether, 438 patients were randomized (1:1:1) and 390 included in the modified ITT efficacy set. The PANSS total score (mean difference

SUBMITTER: Correll CU 

PROVIDER: S-EPMC7688968 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature