MethodsPost-hoc analysis of a double-blind (DB), randomised, placebo-controlled, 12-week study conducted in participants with acutely exacerbated schizophrenia (NCT03160521). Data from the Clinical Global Impressions-Severity (CGI-S) rating scale were analysed by sex to reveal potential differences in efficacy versus placebo. The data were analysed within three separate study groups: 75 mg Risp-ISM, 100 mg Risp-ISM and placebo using a mixed effect with repeated measures model (MMRM). Herein, CGI-S scores changes from baseline (the key secondary efficacy endpoint) are shown.
Disclosure of InterestC. Sherifi Employee of: ROVI Biotech Ltd., J. Martínez González Employee of: Laboratorios Farmaceuticos ROVI S.A., L. Anta Carabias Employee of: Laboratorios Farmaceuticos ROVI S.A., M. Almendros Gimenez Employee of: Laboratorios Farmaceuticos ROVI S.A., C. Salazar García Employee of: Laboratorios Farmaceuticos ROVI S.A., C. Correll Shareolder of: Cardio Diagnostics, Kuleon Biosciences, LB Pharma, Mindpax, and Quantic., Grant / Research support from: Janssen and Takeda., Consultant of: AbbVie, Acadia, Alkermes, Allergan, Angelini, Aristo, Biogen, Boehringer-Ingelheim, Cardio Diagnostics, Cerevel, CNX Therapeutics, Compass Pathways, Darnitsa, Denovo, Gedeon Richter, Hikma, Holmusk, IntraCellular Therapies, Jamjoom Pharma, Janssen/J&J, Karuna, LB Pharma, Lundbeck, MedAvante-ProPhase, MedInCell, Merck, Mindpax, Mitsubishi Tanabe Pharma, Mylan, Neurocrine, Neurelis, Newron, Noven, Novo Nordisk, Otsuka, Pharmabrain, PPD Biotech, Recordati, Relmada, Reviva, Rovi, Sage, Seqirus, SK Life Science, Sumitomo Pharma America, Sunovion, Sun Pharma, Supernus, Takeda, Teva, Tolmar, Vertex, and Viatris.