Actively Recruiting
Phase 2a Study of Oral GXV813 Compared to Placebo for Treating Hospitalized Adults With Schizophrenia
Led by Novartis Pharmaceuticals · Updated on 2026-07-29
142
Participants Needed
16
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and treatment response of GXV813 in adults hospitalized with schizophrenia who are experiencing an acute episode. This Phase 2a study aims to better understand how GXV813 affects symptoms of schizophrenia compared to a placebo in a controlled hospital setting. Participants will be randomly assigned to receive either GXV813 or a placebo, both given orally. The study uses a parallel-group design with quadruple masking to minimize bias. Treatment and observations will last for up to 6 weeks during hospitalization, focusing on symptom changes and drug pharmacokinetics. During the study, participants will be closely monitored with psychiatric assessments including the Positive and Negative Symptom Scale PANSS and Clinical Global Impression-Severity CGI-S scale. Researchers will also track safety, tolerability, and drug levels in the blood. The total participation time is about 6 weeks, with regular evaluations to measure changes from baseline symptoms and any adverse events.
CONDITIONS
Brief Title
Study to Assess the Safety, Tolerability, and Treatment Response of GXV813 in Hospitalized Adults With Schizophrenia
Research Team
N
Novartis Pharmaceuticals
N
Novartis Pharmaceuticals
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