A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess Efficacy and Safety of NBI-1117568 in Adults With Schizophrenia Requiring Inpatient Hospitalization

What this Trial Is About

Researchers are evaluating the effects of NBI-1117568 on behavioral and psychological symptoms in adults diagnosed with schizophrenia who require inpatient hospitalization. This Phase 3 study compares NBI-1117568 to a placebo to assess its impact on symptom improvement. The trial is led by Neurocrine Biosciences and focuses on adults between 18 and 65 years old experiencing an acute episode or relapse of schizophrenia symptoms. Participants will be randomly assigned to receive either NBI-1117568 or a placebo once daily by mouth for 5 weeks, from Day 1 to Day 35. The study is designed as a double-blind, placebo-controlled trial, meaning neither the participants nor the researchers know which treatment is being given during the study period. During the study, participants will stay in an inpatient setting and be monitored closely. Researchers will measure changes in symptoms using the Positive and Negative Syndrome Scale PANSS total score at the beginning and end of the 5 weeks. They will also assess changes in severity using the Clinical Global Impression - Severity CGI-S score. Safety and tolerability will be tracked throughout the trial, which will continue until October 2027.

NBI-1117568-SCZ3029: Evaluation of NBI-1117568 in Inpatient Adults With Schizophrenia