Actively Recruiting
Study to Assess the Safety, Tolerability, and Treatment Response of GXV813 in Hospitalized Adults With Schizophrenia
Led by Novartis Pharmaceuticals · Updated on 2026-05-14
142
Participants Needed
7
Research Sites
57 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to assess the efficacy, safety, and tolerability of GXV813 in the treatment of an acute episode of schizophrenia
CONDITIONS
Official Title
Study to Assess the Safety, Tolerability, and Treatment Response of GXV813 in Hospitalized Adults With Schizophrenia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 65 years at screening
- Able to provide informed consent
- Primary diagnosis of schizophrenia confirmed by DSM-5 and SCID-5-CT
- Willing and able to stay hospitalized during the study (except follow-up), follow instructions, and comply with protocol
- Experiencing an acute relapse or worsening of psychotic symptoms within 2 months prior to screening
- Requires hospitalization for this acute episode or has been hospitalized less than 2 weeks for the current episode at screening
- Positive and Negative Syndrome Scale (PANSS) total score between 80 and 120 at screening
- PANSS positive scale score of 4 or higher for at least two specified symptoms (delusions, conceptual disorganization, hallucinatory behavior, suspiciousness/persecution)
You will not qualify if you...
- Any DSM-5 disorder other than schizophrenia within 12 months before screening
- History of treatment-resistant schizophrenia, defined as inadequate response to two adequate antipsychotic treatments or previous clozapine use
- Need for treatment with moderate or strong CYP3A4 inhibitors or inducers
- Received long-acting injectable antipsychotic medication within 12 weeks before baseline (24 weeks for INVEGA TRINZA®)
- Other protocol-defined inclusion/exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Pillar Clinical Research LLC
Bentonville, Arkansas, United States, 72712
Actively Recruiting
2
CNRI Los Angeles LLC
Pico Rivera, California, United States, 90660
Actively Recruiting
3
Segal Institute for Clinical Research
Miami, Florida, United States, 33016
Actively Recruiting
4
CenExel iResearch
Decatur, Georgia, United States, 30030
Actively Recruiting
5
Uptown Research Institute LLC
Chicago, Illinois, United States, 60640
Actively Recruiting
6
Pillar Clinical Research LLC
Chicago, Illinois, United States, 60641
Actively Recruiting
7
Arch Clinical Trials LLC
St Louis, Missouri, United States, 63141
Actively Recruiting
Research Team
N
Novartis Pharmaceuticals
CONTACT
N
Novartis Pharmaceuticals
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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