Study of the effect of benzoic acid on glutamic acid

JRCT ID: jRCTs031200050

Registered date:12/06/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Schizophrenia
• Date of first enrollment: 12/06/2020
• Target sample size: 25
• Study type: Interventional
• Intervention(s): Administer sodium benzoate (2 g / day) and obs erve for 6 weeks.

Outcome(s)

• Primary Outcome: Change in the brain glutamate and glutathione levels before and after sodium benzoate administration.

Secondary Outcome

1) Correlation between glutamate and glutathion e concentrations in the brain and the total points of "Positive and Negative Syndrome Scale (PANSS)" at the baseline and 6 weeks after administarati on
2) Correlation between glutamate and glutathion e concentrations in the brain at the baseline and t he total points of "Positive and Negative Syndrom e Scale (PANSS)"
3) Changes in the glutamate levels in the blood after 6 weeks of sodium benzoate intake

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 65age 12month old
• Gender: Both

Include criteria

1) DSM-V diagnosis of schizophrenia or schizoaffective disorder.
2) Age 18 to 65 years.
3) History of failure (score of 4 or more on 2 PANSS positive symptom items and CGI-Severity score of 4 or more) to respond to two or more different kinds of antipsychotics, each attaining a chlorpromazine daily dose of 400 mg or more for a duration 4 or more consecutive weeks.
4) On the same antipsychotic in the last 4 weeks before the inclusion.
5) Subject who provided written informed consent for research.

Exclude criteria

1) Substance abuse or dependence (within past six months), excluding nicotine and caffeine.
2) Metal implants or a pace-maker that would preclude the MRI scan.
3) History of head trauma resulting in loss of consciousness > 30 minutes that required medical attention.
4) Unstable physical illness or significant neurological disorder including a seizure disorder.
5) Refusal to give consent to investigator to communicate with physician of record for the entire duration of the study.
6) Psychiatric concerns raised by the physician of record regarding participation in the study.
7) Currently taking clozapine
8) Currently taking medications that may directly impact the glutamatergic system (i.e. lamotrigine, topiramate, memantine)

Related Information

• Primary Sponsor: Iwata Yusuke
• Source(s) of Monetary Support: Japan Society for the Promotion of Science