NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs031200050

Registered date:12/06/2020

Study of the effect of benzoic acid on glutamic acid

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedSchizophrenia
Date of first enrollment12/06/2020
Target sample size25
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Administer sodium benzoate (2 g / day) and obs erve for 6 weeks.

Outcome(s)

Primary OutcomeChange in the brain glutamate and glutathione levels before and after sodium benzoate administration.
Secondary Outcome1) 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
GenderBoth
Include criteria1) 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 criteria1) 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

Contact

Public contact
Name Yusuke Iwata
Address Shimokato1110, Chuo-shi, Yamanashi, 409-3898 Yamanashi Japan 409-3898
Telephone +81-55-273-9847
E-mail yiwata@yamanashi.ac.jp
Affiliation Yamanshi University Hospital
Scientific contact
Name Yusuke Iwata
Address Shimokato1110, Chuo-shi, Yamanashi, 409-3898 Yamanashi Japan 409-3898
Telephone +81-55-273-9847
E-mail yiwata@yamanashi.ac.jp
Affiliation Yamanshi University Hospital