GXV813 for adults hospitalized with acute schizophrenia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2, randomized, placebo-controlled study enrolls adults hospitalized for an acute exacerbation of schizophrenia to receive either GXV813 or placebo. Eligible participants are 18–65 years old with DSM-5–confirmed schizophrenia who require inpatient care and can provide informed consent. Participants must be willing to remain confined to the inpatient setting for the treatment period while investigators monitor symptom change, safety, and tolerability. Primary outcomes focus on treatment response during the acute episode and the occurrence of adverse events; dosing details and total study duration are not provided in the public record.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Participant is aged 18 to 65 years, inclusive, at screening
2. Participant is capable of providing informed consent
3. 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)
4. 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
5. Participant is experiencing an acute exacerbation or relapse of psychotic symptoms, with onset less than 2 months before screening

   1. The participant requires hospitalization for this acute exacerbation or relapse of symptoms
   2. If already an inpatient at screening, has been hospitalized for less than 2 weeks for the current exacerbation at the time of screening
6. 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:

   i. Item 1 (P1; delusions)

ii. Item 2 (P2; conceptual disorganization)

iii. Item 3 (P3; hallucinatory behavior)

iv. Item 6 (P6; suspiciousness/persecution)

Exclusion Criteria:

1. 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)
2. 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
3. Participants who need to be treated with drugs that are known to be moderate and strong CYP3A4 inhibitors and inducers will be excluded
4. 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

Other protocol-defined inclusion/exclusion criteria may apply

Where it's running

• Pillar Clinical Research LLC
  Bentonville, Arkansas, United States Recruiting
• CNRI Los Angeles LLC
  Pico Rivera, California, United States Recruiting
• Segal Institute for Clinical Research
  Miami, Florida, United States Recruiting
• CenExel iResearch
  Decatur, Georgia, United States Recruiting
• Uptown Research Institute LLC
  Chicago, Illinois, United States Recruiting
• Pillar Clinical Research LLC
  Chicago, Illinois, United States Recruiting

Study contacts

• Study coordinator: Novartis Pharmaceuticals
• Email: novartis.email@novartis.com
• Phone: 1-888-669-6682

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Using Lumateperone to improve motivation in patients with schizophrenia and psychosis

  This study is testing if Lumateperone can help people with schizophrenia or schizoaffective disorders feel more motivated and less apathetic.

  Recruiting Phase 3 Louisiana State University Health Sciences Center Shreveport · Shreveport, Louisiana · NCT06482554

• Examining the effects of combined therapy for schizophrenia

  This study is testing whether combining two therapies, one for managing thoughts and another for improving cognitive skills, can help people with schizophrenia do better in their daily lives compared to using just one of the therapies.

  Recruiting at 2 sites University of Toronto · Scarborough Village, Ontario and 1 other locations · NCT05731414

• XEP527 in stable schizophrenia: safety and how it behaves in the body

  This small, early-stage study tests the safety and how XEP527 behaves in people with stable schizophrenia who are on a single antipsychotic.

  Recruiting Phase 1 Novartis · Bentonville, Arkansas · NCT07908680

• Theta-Burst Transcranial Magnetic Stimulation for Treatment-Resistant Auditory Hallucinations

  This study tests whether theta-burst transcranial magnetic stimulation can lessen persistent auditory verbal hallucinations in adults with schizophrenia-spectrum or psychotic disorders who have not responded to antipsychotic meds.

  Recruiting Ciusss de L'Est de l'Île de Montréal · Montreal, Quebec · NCT07902518

• Quality of life and safety in quetiapine use for schizophrenia or bipolar disorder

  This study looks at how patients with schizophrenia or bipolar disorder feel and stay safe when treated with quetiapine alone or with other antipsychotics.

  Recruiting Bosnalijek D.D · Sarajevo · NCT07858565

• Neuronavigated rTMS for treatment-resistant auditory hallucinations

  We are testing whether personalized neuronavigated inhibitory rTMS can reduce persistent auditory verbal hallucinations in adults who don’t respond to medication.

  Recruiting Psychiatric University Hospital, Zurich · Zurich · NCT07856368

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.