What side effects are associated with this type of intervention?

Common treatments for schizophrenia, particularly second-generation antipsychotics, are associated with side effects such as weight gain, metabolic syndrome, and sedation. Adjunctive treatments like N-acetylcysteine (NAC) are generally well-tolerated with minimal side effects, whereas minocycline can cause gastrointestinal disturbances and photosensitivity.

What prior FDA approvals exist?

The FDA has approved several second-generation antipsychotics for the treatment of schizophrenia, including aripiprazole, risperidone, quetiapine, and olanzapine. These medications are often used as monotherapy or in combination with other treatments. Aripiprazole, for example, is frequently used due to its relatively favorable side effect profile. Additionally, lumateperone has been approved for schizophrenia and is considered for treatment-resistant cases. NaBen® is being studied as an add-on treatment, similar to how aripiprazole and other second-generation antipsychotics are used to augment existing therapies in patients who do not respond adequately to monotherapy.

What other types of research exist?

Promising novel alternatives to NaBen® for schizophrenia treatment include: 1) Paliperidone palmitate 3-month (PP3M), a long-acting injectable antipsychotic that has shown efficacy and safety in clinical trials. 2) Valproate as an adjunct to antipsychotics, although its overall superiority is inconsistent, it has shown some beneficial effects in certain studies. 3) Aripiprazole, which has been reviewed for its potential in reducing substance use in patients with schizophrenia. These options represent emerging treatments that may be considered in 2024.

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NaBen® for Schizophrenia

Phase 2 & 3

Waitlist Available

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

The subject is outpatient with no hospitalization for worsening of schizophrenia within 3 months of the screening.If the subject is hospitalized during the study for worsening of schizophrenia symptoms the subject will be withdrawn from the study

Physician confirmed DSM-V diagnosis of schizophrenia for the past 2 years based on subject's history and confirmed by psychiatric evaluation and MINI International Neuropsychiatric Interview For Schizophrenia and Psychotic Disorders, version 7.0 (MINI, Version 7.0)

Must not have

Subjects whose illness was resistant to antipsychotics according to prior trials of two different antipsychotics of adequate dose

Subjects who have been previously treated with or are receiving clozapine

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 64 weeks

Summary

This trial tests NaBen®, a medication added to existing treatments, to see if it can improve symptoms in adults with schizophrenia who may not fully respond to their current treatments.

Who is the study for?

Adults aged 18-45 with schizophrenia, stable on current antipsychotic meds for at least 8 weeks, and in good physical health can join. They must not have been hospitalized for worsening symptoms within the last 3 months or have a history of substance abuse. Women must use contraception if not infertile.

What is being tested?

The trial tests NaBen® as an add-on treatment to improve schizophrenia symptoms against a placebo. It's randomized and placebo-controlled, involving screening, run-in, double-blind treatment phases over several weeks, followed by a year-long open-label extension.

What are the potential side effects?

While specific side effects are not listed here, participants will be monitored for any adverse reactions due to NaBen®, which could range from mild to severe depending on individual tolerance and reaction to the drug.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have not been hospitalized for my schizophrenia worsening in the last 3 months.

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I have been diagnosed with schizophrenia for the last 2 years.

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I haven't been hospitalized for worsening schizophrenia in the last 3 months.

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My schizophrenia is stable but I still have some symptoms.

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I am between 18 and 45 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My condition did not improve after trying two different antipsychotics.

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I am currently taking or have taken clozapine.

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I have previously taken NaBen®.

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I am not pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 64 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~64 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 64 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

PANSS sub-scale scores and Marder PANSS factor scores

Personal and Social Performance (PSP) scale

Positive and Negative Syndrome Scale (PANSS)

Other study objectives

Abnormal Involuntary Movement Scale (AIMS)

Barnes Akathisia Rating Scale (BARS)

Clinical Global Impression-Severity (CGI-S) and -improvement (CGI-I)

+10 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: NaBen®Experimental Treatment1 Intervention

NaBen® is a 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.

0 / 9Eligibility criteria met

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

The most common treatments for schizophrenia are antipsychotic medications, which primarily work by blocking dopamine-2 (D2) receptors to reduce psychotic symptoms such as hallucinations and delusions. NaBen® and similar add-on treatments may target different pathways, such as NMDA receptors, to enhance the overall therapeutic effect. Understanding these mechanisms is crucial for patients because it helps tailor treatments to individual needs, potentially improving efficacy and reducing side effects, thereby enhancing quality of life.

The past and future of novel, non-dopamine-2 receptor therapeutics for schizophrenia: A critical and comprehensive review.Statin add-on therapy in the antipsychotic treatment of schizophrenia: A meta-analysis.Treatment of early onset schizophrenia: recent trends, challenges and future considerations.