#1 Clinical Trials Search in Europe

GXV813

Clinical trials are studying GXV813 in hospitalized adults with schizophrenia. These studies aim to assess safety, tolerability, and treatment response, especially in people with an acute episode. The current trial is in Phase 2 and compares GXV813 with placebo.

Table of Contents

Trial overview

The available clinical trial for GXV813 is a Phase 2 interventional study called STAR-1.[1] It is authorised and includes 142 participants.[1]

The study is designed to assess the safety, tolerability, and treatment response of GXV813 in people with schizophrenia.[1] The trial compares GXV813 with placebo to see whether the study drug improves symptoms.[1]

Who is being studied

This study focuses on hospitalized adults with schizophrenia who are having an acute episode.[1] The trial summary says the participants are adult inpatients diagnosed according to DSM-5 criteria.[1]

In simple terms, this means the study is looking at people who are currently in the hospital and whose symptoms are active enough to need close care.[1]

What is being measured

The main endpoint is the change from baseline in PANSS total score at 6 weeks.[1] Baseline means the starting point before treatment begins.[1]

PANSS stands for Positive and Negative Symptom Scale, which is a rating tool used to measure schizophrenia symptoms.[1] A change in this score helps researchers see whether symptoms improve, worsen, or stay the same over time.[1]

Trial design and treatment groups

The study is interventional, which means researchers assign the treatment rather than just observing what happens.[1] The interventions listed are GXV813 given orally and placebo in hard gelatin capsule form.[1]

Placebo is a comparison treatment that does not contain the active study drug.[1] Using placebo helps researchers judge whether any symptom change is due to GXV813 rather than chance or other factors.[1]

Why this study matters

Schizophrenia can affect both positive symptoms, such as hallucinations or delusions, and negative symptoms, such as low motivation or reduced speech.[1] This trial is important because it focuses on both types of symptoms in a hospital setting where people may need close monitoring.[1]

Because the study is in Phase 2, it is part of the process of learning whether GXV813 may help people with schizophrenia and how it performs in a larger patient group.[1]

Trial ID Phase Condition studied Status Enrollment
2025-524058-32-00 Phase 2 Schizophrenia Authorised 142

FAQ

  • What is GXV813 being studied for? GXV813 is being studied in adults with schizophrenia who are hospitalized and having an acute episode. The trial looks at symptom improvement, safety, and tolerability.
  • Who can take part in the GXV813 trial? The study is for adult inpatients with schizophrenia diagnosed according to DSM-5 criteria. It focuses on people who are currently hospitalized.
  • What phase is the GXV813 study? The trial is a Phase 2 study. Phase 2 studies usually look more closely at whether a treatment may help and how well it is tolerated.
  • What is the main outcome being measured? The main outcome is the change in PANSS total score after 6 weeks. PANSS is a symptom rating scale used to measure positive and negative symptoms of schizophrenia.
  • Is GXV813 compared with another treatment? Yes. The study compares GXV813 with placebo. A placebo is a capsule without the active study drug and helps researchers see whether GXV813 has an effect.

Ongoing Clinical Trials on GXV813

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

    Not yet recruiting

    1
    Investigated diseases:
    Investigated drugs:
    Bulgaria

Glossary

  • Schizophrenia: A mental health condition that can affect how a person thinks, feels, and behaves. It may include symptoms such as hallucinations, delusions, and changes in motivation.
  • Hospitalized adult: An adult who is staying in the hospital for treatment and monitoring.
  • Acute episode: A period when symptoms become suddenly worse or more intense.
  • DSM-5 criteria: Standard rules used by doctors to diagnose mental health conditions. DSM-5 is a widely used diagnostic manual.
  • Phase 2: A stage in clinical research that looks at whether a treatment may work and checks safety in a larger group than early studies.
  • Placebo: A treatment that looks like the study drug but does not contain the active medicine.
  • PANSS: Short for Positive and Negative Symptom Scale. It is a tool used to measure schizophrenia symptoms and how they change over time.
  • Positive symptoms: Symptoms added to normal experience, such as hallucinations or delusions.
  • Negative symptoms: Symptoms that reduce normal function, such as low emotion, low speech, or lack of motivation.
  • Tolerability: How well people can handle a treatment without serious problems.

References

  1. https://clinicaltrials.gov/study/2025-524058-32-00