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Study on Sodium Benzoate and Clozapine for Adults with Refractory Schizophrenia Symptoms

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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 NaBen on adults with refractory schizophrenia. Schizophrenia is a mental health condition that affects how a person thinks, feels, and behaves. Refractory schizophrenia refers to cases where symptoms do not improve significantly with standard treatments. The study will test NaBen, which is a type of medication known as a D-amino acid oxidase inhibitor, to see if it can help improve symptoms when used alongside another medication called clozapine.

The purpose of the study is to evaluate the safety and effectiveness of NaBen in reducing the symptoms of schizophrenia that persist despite treatment with clozapine. Participants in the study will receive either NaBen or a placebo, which looks like the medication but does not contain the active ingredient. The study will be conducted in two parts. In the first part, different doses of NaBen will be tested to find the most effective dose. In the second part, the best dose from the first part will be used to further assess its effectiveness compared to the placebo.

Participants will take the medication orally in the form of film-coated tablets for a period of up to eight weeks. Throughout the study, changes in symptoms will be monitored using various scales and assessments to determine the impact of the treatment. The goal is to find out if NaBen can provide additional benefits for those who have not responded well to other treatments for schizophrenia.

The research process

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

Step 1
Initial visit
Upon joining the study, an initial visit is conducted. During this visit, eligibility is confirmed based on specific criteria such as age, body mass index, and medical history.
A caregiver or responsible person is identified to support participation in the study. This person should be reliable and able to assist with study visits and procedures.
Step 2
Baseline assessment
A baseline assessment is performed to evaluate current symptoms using the Positive and Negative Syndrome Scale (PANSS).
The assessment includes a physical examination, neurological exam, and laboratory tests to ensure there are no significant abnormalities.
Step 3
Randomization
Participants are randomly assigned to receive either NaBen or a placebo. This process is double-blind, meaning neither the participant nor the study team knows which treatment is being administered.
The dosage for NaBen is either 1000 mg or 2000 mg per day, taken orally as a film-coated tablet, in addition to the ongoing clozapine treatment.
Step 4
Treatment phase
The treatment phase lasts for 8 weeks. During this time, the assigned medication is taken daily as instructed.
Regular follow-up visits are scheduled to monitor progress and any side effects. These visits include assessments of symptoms and overall health.
Step 5
Final assessment
At the end of the 8-week treatment period, a final assessment is conducted. This includes a repeat of the PANSS evaluation to measure changes in symptoms.
Additional evaluations may include assessments of personal and social performance, quality of life, and overall clinical impression.

Who can join the trial?

13 criteria

Participants must be male or female and between 18 and 55 years old.
Participants must have a Body Mass Index (BMI) between 17 and 38. BMI is a measure of body fat based on height and weight.
Participants must have a negative urine test for illegal drugs such as heroin, amphetamines (including ecstasy), cocaine, cannabis, or PCP.
Participants must have a caregiver or responsible person like a family member or nurse to help with the study requirements.
Participants must not be a danger to themselves or others according to the study doctor's judgment.
Participants must be able to give informed consent or have a legally authorized representative who can consent for them.
If female and not infertile, participants must agree to use effective birth control during the study. Infertile means unable to have children due to surgery or menopause.
Participants must have a doctor-confirmed diagnosis of schizophrenia for at least 2 years, confirmed by a psychiatric evaluation.
Participants must have refractory schizophrenia, meaning they have not responded to at least two different antipsychotic medications, have not had good functioning in the past 2 years, or have moderate to severe symptoms.
Participants must have been taking clozapine for at least 6 months, with a stable dose for at least 3 months before the study.
Participants must be outpatients and have been consistently symptomatic without significant changes, with no hospitalizations for worsening symptoms in the last 3 months.
Participants must have a minimum PANSS score of 70 at the screening and baseline visits. PANSS is a scale used to measure the severity of schizophrenia symptoms.
Participants must not have any clinically significant abnormalities in physical exams, neurological exams, or lab tests that would exclude them from the study, as determined by the study doctor.

Who cannot join the trial?

4 criteria

Patients who are not adults cannot participate. This means you must be 18 years or older.
Patients who are not diagnosed with refractory schizophrenia cannot participate. Refractory schizophrenia is a type of schizophrenia that does not respond well to standard treatments.
Patients who are not currently taking clozapine cannot participate. Clozapine is a medication used to treat schizophrenia.
Patients who are part of a vulnerable population cannot participate. This includes groups who may need special protection or care.

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Verified sites

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

Centrum Badan Klinicznych Pi-House Sp. z o.o.
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Gdansk, Poland
Centrum Medyczne Luxmed Sp. z o.o.
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Lublin, Poland

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Investigated drugs

NaBen®
is a medication being studied for its potential to help people with schizophrenia who still have symptoms despite taking other treatments. It works by affecting certain chemicals in the brain that may be involved in schizophrenia. In this study, NaBen® is used alongside another medication to see if it can improve symptoms that are not fully managed by the current treatment.
Clozapine
is a medication commonly used to treat schizophrenia, especially in cases where other treatments have not been effective. It helps to manage symptoms like hallucinations, delusions, and mood disturbances by balancing certain chemicals in the brain. In this study, clozapine is used as a base treatment, and researchers are testing if adding another medication can help improve the remaining symptoms.

SODIUM BENZOATE

What is already known about the treatment

NaBen® – NaBen® is administered orally in tablet form and is currently being studied as an add-on treatment for adults with refractory schizophrenia, a condition where symptoms persist despite standard treatment. In medical literature, NaBen® is recognized as a D-amino acid oxidase inhibitor, which means it works by blocking an enzyme that breaks down certain amino acids in the brain, potentially helping to improve symptoms of schizophrenia. This medication is classified pharmacologically as an enzyme inhibitor and is being tested in combination with clozapine to determine its effectiveness in reducing residual symptoms of schizophrenia.

Investigated diseases

Schizophrenia – Schizophrenia is a chronic mental disorder characterized by disruptions in thought processes, perceptions, emotional responsiveness, and social interactions. It often manifests through symptoms such as hallucinations, delusions, disorganized thinking, and impaired functioning. The progression of schizophrenia can vary, with some individuals experiencing episodes of acute symptoms followed by periods of remission. Over time, the disorder may lead to a decline in cognitive abilities and social skills. The course of the disease is typically lifelong, with symptoms fluctuating in intensity. Schizophrenia requires ongoing management to help individuals maintain a functional and fulfilling life.