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

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Univerzitna nemocnica L. Pasteura Kosice Kosice Slovakia
Spitalul Clinic De Psihiatrie Si Neurologie Brasov Brasov Romania
Vivantes Netzwerk fuer Gesundheit GmbH Berlin Germany
Spitalul Clinic Judetean De Urgenta Bihor Oradea Romania
Clintrial s.r.o. Prague Czechia
Nervenärztliche Praxis Frau Dr. Kirsten HahN Berlin Germany
Virgen del Rocío University Hospital Sevilla Spain
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer Barcelona Spain
Universita Degli Studi Di Brescia Brescia Italy
Mediab S.R.L. Targu Mures Romania
Centru De Evaluare Si Tratament A Toxicodependentelor Pentru Tineri Sf. Stelian Bucharest Romania
Emergency Institute For Cardiovascular Diseases And Transplant Targu Mures Romania
Consorci Mar Parc De Salut De Barcelona Barcelona Spain
Crystal Comfort s.r.o. Vranov Nad Toplou Slovakia
Bona Medic s.r.o. Zlate Moravce Slovakia
Neuropsychiatrie s.r.o. Prague Czechia
A-Shine s.r.o. Plzen Czechia
Institutul De Psihiatrie Socola Lasi Iasi Romania
University Of Frankfurt Frankfurt Germany
Svet Zdravia a.s. Petrzalka Slovakia
Institutul Privat de Cercetari Melchisedec, pentru Boli Autoimune, Ereditare si Rare – IPCM Craiova Romania
Spitalul Clinic De Psihiatrie Prof.Dr.Alexandru Obregia Bucharest Romania
Iywnovtbpet Hgtulocqmgku Hkfkhy Pnwch Barcelona Spain
Palxqebepi sgfpde Rimavska Sobota Slovakia
Ngctinzmm s pxskmcopjhhr Pmiplfioz sw sejugh v Bbnmyngobd Bojnice Slovakia
Doet Ilfanompethxcd sbaky sklijnt Banska Bystrica Slovakia
Harbkiia Dg Lc Smtbu Chfh I Swsh Pax Barcelona Spain

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

Trial status

Country Status Recruitment Start
Czechia Czechia
Not recruiting
02.09.2023
Germany Germany
Not recruiting
02.09.2023
Italy Italy
Not recruiting
02.09.2023
Romania Romania
Not recruiting
02.09.2023
Slovakia Slovakia
Not recruiting
02.09.2023
Spain Spain
Not recruiting
02.09.2023

Trial locations

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.

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 ID:
2022-502233-25-00
Protocol code:
NBI-98854-ATS3020
Trial Phase:
Therapeutic confirmatory (Phase III)

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