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Participant is aged 18 to 65 years, inclusive, at screening\n2. Participant is capable of providing informed consent\n3. Participant has a primary diagnosis of schizophrenia, established by a comprehensive psychiatric evaluation based on the DSM-5 (American Psychiatric Association 2013) criteria and confirmed by Structured Clinical Interview for DSM-5 Clinical Trials version (SCID-5-CT)\n4. Participant is willing and able to be confined to an inpatient setting for the study duration (except for the follow-up period), follow instructions, and comply with the protocol requirements\n5. Participant is experiencing an acute exacerbation or relapse of psychotic symptoms, with onset less than 2 months before screening\n\n   1. The participant requires hospitalization for this acute exacerbation or relapse of symptoms\n   2. If already an inpatient at screening, has been hospitalized for less than 2 weeks for the current exacerbation at the time of screening\n6. Positive and Negative Syndrome Scale total score between 80 and 120, inclusive, at screening a. Score of ≥ 4 (moderate or greater) for ≥ 2 of the following Positive Scale (P) items:\n\n   i. Item 1 (P1; delusions)\n\nii. Item 2 (P2; conceptual disorganization)\n\niii. Item 3 (P3; hallucinatory behavior)\n\niv. Item 6 (P6; suspiciousness\u002Fpersecution)\n\nExclusion Criteria:\n\n1. Any primary DSM-5 disorder other than schizophrenia within 12 months before screening (confirmed using Structured Clinical Interview for DSM-5, Clinical Trials Version (SCID-5-CT) at screening)\n2. History of treatment resistance to antipsychotic medications defined as inadequate response to two adequate courses of pharmacotherapy or previous clozapine treatment for treatment-resistant schizophrenia\n3. Participants who need to be treated with drugs that are known to be moderate and strong CYP3A4 inhibitors and inducers will be excluded\n4. Participants taking a long-acting injectable antipsychotic could not have received a dose of medication in the last 12 weeks (24 weeks for INVEGA TRINZA®) before baseline\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply","ALL","18 Years","65 Years",{"count":181,"type":182},142,"ESTIMATED","INTERVENTIONAL",[185],"PHASE2","The purpose of this study is to assess the efficacy, safety, and tolerability of GXV813 in the treatment of an acute episode of schizophrenia",[188],"Schizophrenia",[188,190],"GVX813","2026-06-25",{"date":193,"type":194},"2026-06-26","ACTUAL",{"date":196,"type":194},"2026-03-16",{"date":198,"type":182},"2027-07-29",{"name":29,"class":6},12]