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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 study about?

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.

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 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 Study?

  • 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 Study?

  • 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®.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Center Za Psihichno Zdrave Veliko Tarnovo EOOD Veliko Tirnovo Bulgaria
University Multiprofile Hospital For Active Treatment Saint Georgi EAD Plovdiv Bulgaria
Diagnostic-consultative center “Aleksandrovska” EOOD Sofia Bulgaria
MBAL Dr. Ivan Seliminski – Sliven AD Sliven Bulgaria
Multiprofile Hospital For Active Treatment Dr. Hristo Stambolski EOOD Kazanlak Bulgaria
Cozoel Fki Mhyehb Hmitan Pmdgt Dtz Ifvs Tdlinr Bchvbs Ektf Burgas Bulgaria
Ceqynm Flh Mdzsxz Hovzqr Vwtvwx Ecmo Vratsa Bulgaria
Cgkrwu faj Mzyolh Hhwyzb “izpgr Ny Suqwufywklkkt Evgm Sofia Bulgaria
Slzzq Pchuhpfbuvl Hjvsiktl &pdvqzm Lgrqah Lovech Bulgaria
Mollxn Hqrmaf Clhklc &kanann Hnawxck Ervx Haskovo Bulgaria

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Bulgaria Bulgaria
Not yet recruiting
25.03.2026

Trial locations

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.

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 ID:
2025-524058-32-00
Protocol code:
CGXV813B12201
Trial Phase:
Therapeutic exploratory (Phase II)

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