A Study Assessing the Efficacy and Safety of HS-10380 in Hospitalized Adults With Acute Schizophrenia
brief summary
This is a Phase 2b, randomized, double-blind, parallel-group, active-controlled and placebo-controlled, multicenter inpatient study to examine the efficacy and safety of HS-10380 in adult Participants who are acutely psychotic with a Diagnostic and Statistical Manual Fifth Edition (DSM-5) diagnosis of schizophrenia. The primary objective of the study is to assess the efficacy of HS-10380 versus placebo in reducing Positive and Negative Syndrome Scale (PANSS) total scores in adult inpatients with a DSM-5 diagnosis of schizophrenia. The secondary objectives of the study are to evaluate the response rate, improvement in disease severity and symptoms, safety and tolerability, and pharmacokinetics.
detailed description
This trial is a Phase 2b, randomized, double-blind, parallel-group, active-controlled and placebo-controlled, multicenter inpatient study, aims to further evaluate the efficacy and safety of HS-10380 in participants with acute schizophrenia, who were randomized (2:2:2:1:2) to receive HS-10380 ( Low Dose), HS-10380 (Medium dose), HS-10380 ( High Dose), Aripiprazole, or placebo, with the primary endpoint as the changes from baseline in PANSS total score on D42.
official title
A Randomized, Double-Blind, Active-Controlled and Placebo-Controlled Phase 2b Clinical Study to Evaluate the Efficacy and Safety of HS-10380 in Chinese Adult Patients With Acute Schizophrenia