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A study to assess the safety and effectiveness of GXV813 in hospitalized adults with schizophrenia

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study aims to evaluate the safety and effectiveness of the drug GXV813 in adults experiencing an acute episode of Schizophrenia. Schizophrenia is a mental health disorder that can affect how a person thinks, feels, and behaves, often involving symptoms such as hallucinations or disorganized thinking. Participants in this trial will be treated in a hospital setting and will receive either GXV813, which is provided in a hard capsule to be taken by mouth, or a placebo.

The research involves comparing the effects of the active medication against the placebo to see how it influences both positive and negative symptoms. Positive symptoms refer to behaviors that are added to a person's experience, such as delusions, while negative symptoms involve a loss of normal functions, such as a lack of emotion or motivation. During the study, doctors will monitor various aspects of health, including physical signs, heart activity through an ECG, and changes in movement or behavior.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Participation in the trial

    You will receive either the test medication, known as GXV813, or a placebo, which is an inactive substance that looks like the medication but contains no active ingredients.

    The GXV813 is an oral capsule taken by mouth.

  2. Step 2

    Treatment and monitoring period

    The treatment period lasts for 6 weeks.

    During this time, safety and effectiveness are monitored through various assessments.

    Medical evaluations include checking vital signs (such as blood pressure and heart rate), conducting physical examinations, and performing clinical laboratory tests (such as blood tests).

    Heart activity is monitored using an electrocardiogram, which is a test that records the electrical signals in the heart.

    Specific scales are used to track symptoms and side effects, including the positive and negative symptom scale to measure changes in schizophrenia symptoms, and scales to monitor movement, restlessness, and suicidality (thoughts of self-harm).

    The amount of medication in the blood is also measured to understand how the body processes the substance.

Who can join the trial?

8 criteria

  • You are between 18 and 65 years old at the time of the initial evaluation.
  • You are able to understand the study details and give your informed consent, which means you agree to participate after being fully told about the study.
  • You have been diagnosed with schizophrenia, a mental health condition, using a specific set of professional standards called the DSM-5 and a specialized interview process.
  • You are willing and able to stay in the hospital (an inpatient setting) for the duration of the study and follow all the study rules.
  • You are currently experiencing an acute exacerbation, which means a sudden worsening or flare-up of your symptoms, that started less than 2 months ago.
  • You require hospitalization for this flare-up, or if you are already in the hospital, you have been there for less than 2 weeks for this specific episode.
  • Your score on the Positive and Negative Syndrome Scale, which is a tool used by doctors to measure the severity of symptoms, must be between 80 and 120.
  • You must have a score of 4 or higher on at least two of the following positive symptoms (behaviors that are "added" to a person's experience): delusions (strong beliefs that are not true), conceptual disorganization (disorganized thinking), hallucinatory behavior (seeing or hearing things that are not there), or suspiciousness/persecution (feeling that others intend to harm you).

Who cannot join the trial?

4 criteria

  • If you have been diagnosed with any mental health disorder other than schizophrenia (a condition that affects how a person thinks, feels, and behaves) within the 12 months before joining this study.
  • If you have a history of treatment resistance, which means your previous attempts to treat schizophrenia with two different full courses of medication did not work, or if you have previously taken clozapine (a specific type of medication used for difficult-to-treat cases).
  • If you are taking medications that act as moderate or strong CYP3A4 inhibitors or inducers, which are substances that change how your body processes certain drugs through a specific enzyme in the liver.
  • If you use a long-acting injectable antipsychotic (a medication given by injection that stays in your system for a long time) and it has been less than 12 weeks since your last dose, or less than 24 weeks if you are using INVEGA TRINZA®.
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Investigated drugs

GXV813 is an experimental medication being studied to see if it can help treat the symptoms of schizophrenia in adults who are currently in the hospital.

What is already known about the treatment

  • GXV813

    This medication is an experimental drug taken orally in the form of a hard capsule. Currently being studied in clinical trials, it is being investigated as a potential treatment for schizophrenia. It works at a molecular level by targeting specific brain processes to help balance chemical signals associated with the condition. This substance is classified as an investigational antipsychotic medication.

  • Placebo

    This is an inactive substance administered orally in the form of a hard gelatin capsule. It contains no active medicinal ingredients and is used in clinical studies as a control to compare against the effects of the test drug. It is used to ensure that any observed changes in a patient's condition are due to the medication itself rather than other factors. This substance is classified as a control agent.

Investigated diseases

Schizophrenia - This is a mental health disorder that affects how a person thinks, feels, and behaves. It often involves a disconnection from reality, which can lead to seeing or hearing things that are not there. People may also experience disorganized thinking or unusual beliefs. The condition can progress through different stages, including periods of intense symptoms and periods of stability. Symptoms can be categorized into positive symptoms, such as hallucinations, and negative symptoms, such as a lack of emotion or motivation. Over time, these symptoms may change in frequency or intensity.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-524058-32-00Protocol codeCGXV813B12201Estimated enrolment142 patientsSponsorNovartis Pharma AG

sourced from the EU Clinical Trials Register and site verification

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