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RECRUITING
NCT06340789
PHASE2

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

Sponsor: National Cheng-Kung University Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

20 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2021-11-18

Completion Date

2028-04-30

Last Updated

2026-06-16

Healthy Volunteers

No

Interventions

DRUG

Sodium Benzoate 2gram/day

the add-on sodium benzoate with conventional pharmacological treatment

DRUG

Placebo

the add-on placebo with conventional pharmacological treatment

Locations (1)

Taichung Veterans General Hospital Chiayi Branch

Chiayi City, Taiwan