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 on individuals with Schizophrenia. Schizophrenia is a mental health disorder that affects a person’s ability to think, feel, and behave clearly. The study aims to evaluate how well Valbenazine works when used alongside other treatments for people who have not had enough improvement with their current antipsychotic medications.

Participants in the study will be randomly assigned to receive either Valbenazine or a placebo, which looks like the medication but does not contain the active ingredient. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo. This helps ensure that the results are not influenced by expectations about the treatment. The study will last for a period of 10 weeks, during which participants will take the medication in capsule form by mouth.

The main goal of the study is to observe any changes in the symptoms of schizophrenia over the course of the treatment. Researchers will monitor participants’ progress and gather data to determine the safety and effectiveness of Valbenazine as an additional treatment option for schizophrenia. The study will also assess how well participants tolerate the medication, looking at any side effects or other issues that may arise during the trial period.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm the diagnosis of schizophrenia and the current treatment regimen. This includes verifying the stability of the antipsychotic medication and ensuring that the symptoms meet the study criteria.

A body mass index (BMI) check is performed, and for female participants, a pregnancy test is conducted to ensure eligibility.

2 baseline evaluation

A baseline evaluation is conducted to record the initial Positive and Negative Syndrome Scale (PANSS) total score and the Clinical Global Impression of Severity (CGI-S) score. These scores help in assessing the severity of symptoms.

The participant’s current antipsychotic medication levels are measured to ensure they are within the required range.

3 randomization and treatment

Participants are randomly assigned to receive either valbenazine or a placebo. The medication is administered in capsule form and taken orally.

The dosage and frequency of administration are determined by the study protocol, and participants are required to adhere to the prescribed regimen for the duration of the study.

4 ongoing monitoring

Throughout the study, participants attend regular visits to monitor their response to the treatment. This includes repeated assessments of the PANSS and CGI-S scores.

Participants are also monitored for any side effects or changes in their condition.

5 final assessment

At the end of the study period, a final assessment is conducted to evaluate changes in the PANSS and CGI-S scores from baseline to Week 10.

The Personal and Social Performance Scale (PSP) score is also assessed to determine any improvements in personal and social functioning.

Who Can Join the Study?

Must have completed a written informed consent form, which is a document that explains the study and confirms your agreement to participate.
Your diagnosis of schizophrenia, current antipsychotic treatment, and symptom severity must be confirmed by the study team before starting the study treatment.
You need to have an adult informant, such as a family member, partner, or caregiver, who can provide information about you.
Your body mass index (BMI), which is a measure of body fat based on height and weight, must be between 18.0 and 40.5.
If you are a female who can become pregnant, you must have a negative pregnancy test before starting the study and agree to use birth control during the study and for 30 days after.
Male participants must agree to use birth control during the study and for 30 days after the last dose of the study treatment.
You must be willing and able to follow all study procedures and restrictions, and the study team must believe you can do so.
You must be at least 18 years old at the time of signing the informed consent form.
You must have a medically confirmed diagnosis of schizophrenia according to specific guidelines and confirmed by a structured interview.
Your initial diagnosis of schizophrenia must have been made at least one year before the screening visit.
You must be receiving a stable dose of antipsychotic medication, other than clozapine, equivalent to 3 mg to 8 mg of risperidone daily.
Your blood levels of at least one antipsychotic medication must be detectable by a test.
You must have a stable treatment plan with antipsychotic medication.
You must meet specific criteria on certain scales that measure symptoms of schizophrenia at both the screening visit and the first day of the study.
You must be an outpatient, meaning you are not currently hospitalized, and your symptoms must be stable.

Who Cannot Join the Study?

Individuals 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.
Participants must be adults, as the study is not open to children or teenagers.
Both men and women can participate, but those who are pregnant or breastfeeding may be excluded for safety reasons.
Individuals who are unable to provide informed consent, meaning they cannot understand the study and agree to participate, are not eligible.
People who have a history of severe allergic reactions to the study medication or similar drugs cannot join the study.
Participants must not have any other serious medical conditions that could interfere with the study or put them at risk.
Individuals who are currently participating in another clinical trial may be excluded to avoid interference with the study results.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Ambulatory For Group Practice For Specialized Psychiatric Help Philipopolis Ltd.	Plovdiv	Bulgaria
Spitalul Clinic De Psihiatrie Prof.Dr.Alexandru Obregia	Bucharest	Romania

Other Sites

Site Name	City	Country
KBC Zagreb	Zagreb	Croatia
Medical Center Hera EOOD	Sofia	Bulgaria
Mediab S.R.L.	Targu Mures	Romania
Centru De Evaluare Si Tratament A Toxicodependentelor Pentru Tineri Sf. Stelian	Bucharest	Romania
Penta Hospitals SK a.s.	Rimavska Sobota	Slovakia
Spitalul Clinic De Psihiatrie Si Neurologie Brasov	Brasov	Romania
Medical Center Saint Naum EOOD	Sofia	Bulgaria
Medical Center Mentalcare Ltd.	Plovdiv	Bulgaria
Medical Center Spectar Plovdiv EOOD	Plovdiv	Bulgaria
Crystal Comfort s.r.o.	Vranov Nad Toplou	Slovakia
University Multiprofile Hospital For Active Treatment Saint Georgi EAD	Plovdiv	Bulgaria
Spitalul Clinic Judetean De Urgenta Bihor	Oradea	Romania
A-Shine s.r.o.	Plzen	Czechia
Univerzitna nemocnica L. Pasteura Kosice	Kosice	Slovakia
Center Za Psihichno Zdrave Veliko Tarnovo EOOD	Veliko Tirnovo	Bulgaria
Virgen del Rocío University Hospital	Sevilla	Spain
Poliklinika Solmed d.o.o.	Zagreb	Croatia
Spitalul Clinic Judetean Mures	Targu Mures	Romania
Multi-profile Hospital for Active Treatment Heart and Brain EAD	Pleven	Bulgaria
Diagnostic And Consultation Centre St.Vrach And St.St. Kuzma And Damian OOD	Sofia	Bulgaria
Medical Center Intermedica Ltd.	Sofia	Bulgaria
Institutul De Psihiatrie Socola Lasi	Iasi	Romania
Clinic for psychiatry Sveti Ivan	Zagreb	Croatia
Klinika za psihijatriju Vrapce	Zagreb	Croatia
Clgezp Fjs Mavkib Heyzmx Rtle Ewcc	Ruse	Bulgaria
Mdnu Doq Habvos Shfueesjzy Eger	Kazanlak	Bulgaria
Nwvlrdkiveqyqaoj Porohms smrtpt	Prague	Czechia
Mfhwev slwnno	Stare Mesto	Slovakia
Pocphjfkwj sogbtl	Rimavska Sobota	Slovakia
Dpdo Ihavzjaqqfoegf sgogc svqjjub	Banska Bystrica	Slovakia
Mefapb Hvyklh Cdaogd Sjlyq Empk	Sofia	Bulgaria
Cxtpnx Fmp Meatbh Hzmwpv Vlnbmq Eghx	Vratsa	Bulgaria
Pzpo Tmhpw Hrddetkb Uoynqjevayby	Sabadell	Spain
Inljkwcksw Pycbxz dz Cgubasnqv Mcgqquyglor pbunwh Bcze Aerjepydxc Ezqbgewhi sh Rjus	Craiova	Romania
Hlwuzrfe Dm Ly Szxfk Chcp I Swrn Pny	Barcelona	Spain
Cdrbjb fyh Mwiheu Holund “kwoui Nk Sqizbfuhqagli Eqey	Sofia	Bulgaria
Nynvvtene s plwygqehmftn Puayamogr st ssuqny v Bfstnmsgsp	Bojnice	Slovakia
Myydpha Cwreop Motutppean Pqxkks Ohb	Pleven	Bulgaria
Saqww Pjtwcfbxobf Hutxjukp &unqyqv Loeple	Lovech	Bulgaria

Trial status

Country	Status	Recruitment Start
Bulgaria	Not recruiting	30.09.2022
Croatia	Not recruiting	30.09.2022
Czechia	Not recruiting	30.09.2022
Romania	Not recruiting	30.09.2022
Slovakia	Not recruiting	30.09.2022
Spain	Not recruiting	30.09.2022

Trial locations

Investigated drugs:

Valbenazine Ditosylate

Valbenazine is a medication being studied to see if it can help improve symptoms in people with schizophrenia who are not responding well to their current antipsychotic treatments. It is used as an additional treatment to see if it can provide better control of symptoms when combined with other antipsychotic medications.

Investigated diseases:

Schizophrenia

Schizophrenia – Schizophrenia is a chronic mental health disorder that affects how a person thinks, feels, and behaves. Individuals with schizophrenia may experience symptoms such as hallucinations, delusions, and disorganized thinking. These symptoms can lead to difficulties in distinguishing between what is real and what is not. The disorder often begins in late adolescence or early adulthood and can vary in severity. Over time, individuals may also experience reduced motivation, emotional flatness, and social withdrawal. The progression of symptoms can fluctuate, with periods of worsening and improvement.

Trial ID:

2023-508433-14-00

Protocol code:

NBI-98854-ATS3019

NCT ID:

NCT05110157

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

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