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Study on Valbenazine for Patients with Schizophrenia Not Responding Well to Antipsychotic Treatment

Fast replyInvestigationalNo placebo
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What is this trial about?

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

This clinical trial is focused on studying the effects of a medication called Valbenazine in individuals with Schizophrenia. Schizophrenia is a mental health condition that affects how a person thinks, feels, and behaves. The study aims to evaluate how effective, safe, and tolerable Valbenazine is when used alongside existing antipsychotic treatments for those who have not had a sufficient response to their current medications.

Participants in the study will receive either Valbenazine or a placebo, which is a substance with no active medication. The study will last for a period of 10 weeks, during which participants will take the medication in capsule form by mouth. The goal is to observe any changes in the symptoms of schizophrenia, as well as overall health and social functioning, over this time.

The study is designed to provide valuable information on whether adding Valbenazine to the treatment plan can help improve the symptoms of schizophrenia in those who are already on a stable regimen of antipsychotic medication. This research could potentially lead to better treatment options for individuals living with this condition.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be randomly assigned to receive either the valbenazine capsule or a placebo capsule. A placebo is a substance with no active medication, used to compare effects.

    The study is designed to be double-blind, meaning neither you nor the study staff will know which capsule you are receiving.

  2. Step 2

    Medication administration

    You will take the assigned capsule orally. The specific dosage and frequency will be provided by the study team.

    The duration of the medication administration is planned for 10 weeks.

  3. Step 3

    Regular assessments

    Throughout the study, you will undergo regular assessments to monitor your symptoms and overall health.

    These assessments will include evaluations using the Positive and Negative Syndrome Scale (PANSS), which measures symptom changes, and the Clinical Global Impression of Severity (CGI-S) score, which assesses the severity of your condition.

  4. Step 4

    Personal and social performance evaluation

    Your personal and social performance will be evaluated using the Personal and Social Performance (PSP) score.

    This evaluation will help determine any changes in your ability to function in daily life.

  5. Step 5

    Completion of the study

    At the end of the 10-week period, you will complete the study.

    Final assessments will be conducted to evaluate the overall impact of the treatment on your symptoms and daily functioning.

Who can join the trial?

6 criteria

  • Must have a medically confirmed diagnosis of schizophrenia.
  • Must be receiving a stable regimen of background antipsychotic medication (medication used to manage symptoms of schizophrenia).
  • Plasma levels for at least one of the participant's antipsychotic medications must be detectable by an available test.
  • Must be an outpatient with stable symptomatology (symptoms are not worsening).
  • Must have an adult informant, such as a family member, relative, partner, social worker, caseworker, residential facility staff, or nurse, who can provide information about the participant.
  • Both male and female participants are eligible.

Who cannot join the trial?

5 criteria

  • Patients who do not have a diagnosis of schizophrenia cannot participate. Schizophrenia is a mental health condition that affects how a person thinks, feels, and behaves.
  • Patients who are not experiencing an inadequate response to their current antipsychotic treatment cannot participate. This means that if your current medication is working well for you, you are not eligible.
  • Patients who are not within the specified age range cannot participate. The study is open to certain age groups only.
  • Patients who are not willing or able to follow the study procedures cannot participate. This means you need to be able to attend appointments and follow instructions given by the study team.
  • Patients who are part of a vulnerable population that the study does not include cannot participate. Vulnerable populations may include groups like pregnant women or people with certain health conditions.
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Investigated drugs

Valbenazine is a medication being studied to see if it can help people with schizophrenia who are not getting enough relief from their current antipsychotic treatments. Schizophrenia is a mental health condition that can cause symptoms like hallucinations, delusions, and trouble thinking clearly. Valbenazine is thought to work by affecting certain chemicals in the brain that may be involved in these symptoms. In this trial, researchers are looking at how well valbenazine can improve these symptoms when added to the treatment that patients are already receiving.

What is already known about the treatment

Valbenazine – Valbenazine is administered orally in the form of capsules. It is currently being studied in clinical trials as an additional treatment for schizophrenia, particularly for patients who do not respond well to standard antipsychotic medications. The main therapeutic use of valbenazine in this context is to help manage symptoms of schizophrenia. At the molecular level, valbenazine works by affecting certain chemicals in the brain, specifically by inhibiting the action of a protein called VMAT2, which is involved in the regulation of neurotransmitters. It is classified pharmacologically as a vesicular monoamine transporter 2 (VMAT2) inhibitor.

Investigated diseases

Schizophrenia – Schizophrenia is a chronic mental disorder characterized by disruptions in thought processes, perceptions, emotional responsiveness, and social interactions. It typically manifests with symptoms such as hallucinations, delusions, disorganized thinking, and significant impairments in daily functioning. The progression of schizophrenia can vary, with some individuals experiencing episodes of acute symptoms followed by periods of remission, while others may have a more continuous course. Over time, the disorder can lead to difficulties in maintaining personal relationships and employment. Cognitive impairments, such as problems with memory and attention, are also common and can worsen as the disease progresses. Social withdrawal and reduced motivation are often observed, impacting the individual's ability to engage in everyday activities.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-502233-25-00Protocol codeNBI-98854-ATS3020Estimated enrolment400 patientsSponsorNeurocrine Biosciences Inc.

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).