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A Study Testing Brexpiprazole Given Once Weekly to Treat Sudden Worsening of Symptoms in Patients with Schizophrenia

Verified siteRegistered drugNo placebo

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What is this trial about?

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

This study is looking at schizophrenia that is in an acute phase, which means the symptoms have become worse recently. The study will test a medication called brexpiprazole that is given once a week. This medication comes in two forms: one is called brexpiprazole fumarate and another is called RXULTI. Some people in the study will receive placebo instead of the active medication. The purpose of this study is to see if brexpiprazole given once a week works better than placebo in treating the acute symptoms of schizophrenia.

People taking part in this study will have schizophrenia with symptoms that have gotten worse and will either be in the hospital or need to be in the hospital because of their condition. Their symptoms must have started getting worse within the past two months. Before joining the study, they must have been treated with other antipsychotic medications that worked for them in the past year. During the study, participants will be randomly assigned to receive either the brexpiprazole medication or placebo, and neither they nor their doctors will know which one they are getting. The treatment will be given by mouth as tablets.

The study will measure how much the symptoms change from the beginning of the study to week six. Doctors will use a standard rating scale to measure the symptoms of schizophrenia throughout the study period. The medication will be given once a week, and the study will track how well it works and whether it is safe for people with acute schizophrenia.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Placebo administration period
Before receiving the study medication, a placebo period will be conducted. During this time, specific assessments will be performed to confirm eligibility for the trial.
The PANSS (Positive and Negative Syndrome Scale) will be used to measure symptoms. This is a questionnaire that evaluates the severity of symptoms such as hallucinations, unusual thoughts, disorganized thinking, and suspiciousness. A total score of at least 70 points is required, with at least 2 of these 4 symptoms rated as moderate or higher.
The CGI-S (Clinical Global Impression - Severity) will also be assessed. This is a rating scale that measures overall illness severity. A score of at least 4, indicating moderately ill, is required to proceed.
Step 2
Treatment period with study medication
After the placebo period, treatment will begin with either brexpiprazole or placebo. The assignment to one of these groups will be random and neither the patient nor the medical staff will know which treatment is being received.
The medication will be administered once weekly. This means one dose will be taken each week.
The medication is available as film-coated tablets taken by mouth (oral use).
The treatment period will last for 6 weeks. During this time, regular assessments will be conducted to monitor symptoms and any potential side effects.
Step 3
Symptom monitoring and assessments
Throughout the 6-week treatment period, the PANSS total score will be measured regularly to evaluate changes in symptoms from the beginning of treatment.
The primary focus will be on measuring the change in symptoms at Week 6, which will help determine the effectiveness of the treatment.
Additional safety assessments will be conducted throughout the trial to monitor for any adverse effects or changes in health status.

Who can join the trial?

12 criteria

You must be at least 18 years old and younger than 75 years old
You must have a diagnosis of schizophrenia, which is a mental health condition that affects how a person thinks, feels, and behaves, confirmed by a specific diagnostic interview
You must be currently hospitalized or need to be hospitalized because of a sudden worsening of schizophrenia symptoms
Your current episode of worsening symptoms must have started within 2 months before joining the study
You must have a sudden increase in symptoms such as seeing or hearing things that are not there, unusual beliefs, confused thinking, or feeling that others want to harm you, and these symptoms must significantly affect your daily activities
You must score at least 70 points on a specific symptom rating scale called PANSS, which measures the severity of schizophrenia symptoms
You must score at least 4 points, meaning moderate severity, on at least 2 out of 4 specific symptoms: hearing or seeing things that are not real, having unusual thoughts or beliefs, having disorganized thinking, or feeling suspicious or persecuted
You must score at least 4 on the CGI-S scale, which means you are at least moderately ill according to a doctor's assessment
You must have been treated with antipsychotic medications, which are medicines used to treat schizophrenia, at proper doses for at least 6 weeks, and these medications must have worked for you at some point within the past 12 months
The antipsychotic medication that worked for you cannot have been clozapine, which is a specific type of antipsychotic medicine
You must have experienced symptoms coming back or getting worse during a time when you were not taking antipsychotic medications
You must be able to understand the study and provide written agreement to participate

Who cannot join the trial?

3 criteria

The source data does not provide specific exclusion criteria, which are the reasons why a patient cannot participate in the study
Without detailed information about medical conditions or situations that would prevent participation, it is not possible to list specific reasons for exclusion from this clinical trial
Generally, clinical trials for schizophrenia, which is a mental health condition affecting how a person thinks, feels, and behaves, may exclude patients based on other health problems, certain medications they are taking, or pregnancy status, but these specific details are not available in the provided information

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Institutul De Psihiatrie Socola Lasi
Iasi, Romania
Verified
Spitalul Clinic De Psihiatrie Prof.Dr.Alexandru Obregia
Bucharest, Romania
Verified
Spitalul Clinic De Psihiatrie Si Neurologie Brasov
Brasov, Romania

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Investigated drugs

Brexpiprazole is a medication used to treat schizophrenia. In this trial, it is given as a once-weekly injection to help reduce acute symptoms of schizophrenia, such as hallucinations, delusions, and disorganized thinking.

What is already known about the treatment

Brexpiprazole – Brexpiprazole is an antipsychotic medication administered orally in tablet form or as a once-weekly injection, designed to treat symptoms of schizophrenia and other mental health conditions. This medication is currently approved and used in clinical practice, with ongoing research studying new formulations such as the once-weekly version to improve convenience for patients. It works by partially activating certain brain receptors for dopamine and serotonin, which helps balance these chemical messengers in the brain to reduce hallucinations, delusions, and other psychotic symptoms. Brexpiprazole belongs to a class of drugs called atypical antipsychotics, which are newer medications that tend to have fewer side effects than older antipsychotic treatments.

Investigated diseases

Acute Schizophrenia – Acute schizophrenia is a severe mental disorder characterized by a sudden onset or worsening of symptoms that affect a person's thoughts, emotions, and behavior. During an acute episode, individuals may experience hallucinations, which are sensory experiences that seem real but are not, such as hearing voices. Delusions, or false beliefs that are firmly held despite evidence to the contrary, are also common during this phase. People may have disorganized thinking and speech, making it difficult for others to understand them. Their behavior can become unpredictable or inappropriate for the situation. The acute phase represents a period of intense symptoms that significantly interfere with daily functioning and typically requires immediate medical attention.