What is the mechanism of action of this treatment?

Common treatments for schizophrenia include first-generation antipsychotics (FGAs) and second-generation antipsychotics (SGAs), which primarily work by antagonizing dopamine D2 receptors to reduce positive symptoms like hallucinations and delusions. SGAs also affect serotonin receptors, potentially improving negative symptoms and reducing side effects. Sodium benzoate, a D-amino acid oxidase inhibitor, represents a novel approach by modulating glutamate neurotransmission, addressing glutamatergic dysfunction implicated in schizophrenia. This is significant for patients who may not respond adequately to traditional dopamine-targeting therapies, offering a potential alternative treatment pathway.

What side effects are associated with this type of intervention?

Common treatments for schizophrenia, such as antipsychotic medications (e.g., olanzapine, risperidone) and adjunctive treatments like glycine, can cause side effects including weight gain, metabolic changes, sedation, extrapyramidal symptoms (e.g., tremors, rigidity), nausea, vomiting, and headaches. These side effects vary in severity and frequency among individuals.

What prior FDA approvals exist?

The FDA has approved several antipsychotic drugs for the treatment of schizophrenia, including both first-generation (typical) and second-generation (atypical) antipsychotics. Commonly used atypical antipsychotics include risperidone, olanzapine, quetiapine, and aripiprazole. For treatment-resistant schizophrenia, clozapine is often used, sometimes augmented with mood stabilizers, anticonvulsants, or pro-glutamatergic agents. Sodium Benzoate (NaBen®), a D-amino acid oxidase inhibitor, is being studied as an add-on treatment, which aligns with the strategy of using pro-glutamatergic agents to manage persistent symptoms in schizophrenia.

What other types of research exist?

A promising novel alternative to NaBen® for schizophrenia patients in 2024 is the blonanserin patch (BLO-P). Approved in Japan in 2019, it has shown efficacy and safety in double-blind, randomized, placebo-controlled trials.

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NaBen for Schizophrenia

Phase 2 & 3

Waitlist Available

Led By Robert Findling, MD

Research Sponsored by SyneuRx International (Taiwan) Corp

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Summary

This trial is testing NaBen® as an additional treatment for adolescents with schizophrenia. The goal is to see if it can safely and effectively improve their symptoms when added to their usual medication.

Who is the study for?

Adolescents aged 12-17 with schizophrenia, stable on current antipsychotic meds for at least 8 weeks, in good health without serious medical conditions or drug abuse. They must not be pregnant or nursing and agree to birth control measures.

What is being tested?

The trial is testing NaBen®, a potential add-on treatment for schizophrenia against a placebo. Adolescents will receive either the real medication or a dummy pill without knowing which one they are taking.

What are the potential side effects?

While specific side effects of NaBen® aren't listed, common ones may include allergic reactions, changes in mood or behavior, dizziness, headaches, and stomach issues. The study aims to assess its safety profile.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: NaBen®Experimental Treatment1 Intervention

NaBen® is a white oral tablet (500 mg), which will be taken twice daily at a total dose of 1000 mg/day during this study.

Group II: PlaceboPlacebo Group1 Intervention

The control treatment is placebo.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for schizophrenia include first-generation antipsychotics (FGAs) and second-generation antipsychotics (SGAs), which primarily work by antagonizing dopamine D2 receptors to reduce positive symptoms like hallucinations and delusions. SGAs also affect serotonin receptors, potentially improving negative symptoms and reducing side effects. Sodium benzoate, a D-amino acid oxidase inhibitor, represents a novel approach by modulating glutamate neurotransmission, addressing glutamatergic dysfunction implicated in schizophrenia. This is significant for patients who may not respond adequately to traditional dopamine-targeting therapies, offering a potential alternative treatment pathway.

Glutamate agonist activity: implications for antipsychotic drug action and schizophrenia.Efficacy and safety of add-on sodium benzoate, a D-amino acid oxidase inhibitor, in treatment of schizophrenia: A systematic review and meta-analysis.The past and future of novel, non-dopamine-2 receptor therapeutics for schizophrenia: A critical and comprehensive review.