RecruitingPhase 2NCT06340789

Neurotransmitters in Treatment Resistant Schizophrenia Patients With add-on Sodium Benzoate

Functional Connectivity and Associated Neuropeptides Variations in Treatment Resistant Schizophrenia Patients: Treatment Efficacy of add-on Sodium Benzoate


Sponsor

National Cheng-Kung University Hospital

Enrollment

90 participants

Start Date

Nov 18, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

Although antipsychotic is effective for schizophrenia, however, still certain proportion of patients were not responsive to treatment. Treatment resistant schizophrenia (TRS) is accompanied by function decline and heavy burden. In recent decades, the biological mechanism of schizophrenia extended from dopamine theory to the role of glutamate system. This shift could be an alternative pathway to developing the treatment of TRS. Sodium benzoate (SB) could be an option as a glutamatergic agent for the patients with TRS. However, most evidence of SB is for treating patients with schizophrenia and other mental disorders but the evidence for treating patients with TRS is scarce. To predict the treatment response of SB will be an urgent topic in the future. Little is known about the precise medicine for treating patients with TRS. The present project will extend our pilot randomized clinical trial on SB for TRS. A total of 90 patients with TRS will be enrolled from three centers and will be assigned to 8 weeks of treatment with SB or placebo (2:1). A comprehensive battery of potential markers will be employed, including 1H- magnetic resonance spectroscopy (MRS), brain functional connectivity, genotyping, immune biomarkers, cognitive function, and clinical characteristics. The efficacy of SB on TRS will be confirmed in this project. Predictors for treatment response will be identified. Artificial intelligence algorithms will be used for probing the feasibility of precision medicine.


Eligibility

Min Age: 20 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Placebo and a drug called Sodium Benzoate 2gram/day for people with schizo affective disorder, schizophrenia, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 20 Years to 55 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSodium Benzoate 2gram/day

the add-on sodium benzoate with conventional pharmacological treatment

DRUGPlacebo

the add-on placebo with conventional pharmacological treatment


Locations(1)

Taichung Veterans General Hospital Chiayi Branch

Chiayi City, Taiwan

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NCT06340789


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