Adjunctive NaBen treatment of schizophrenia in adults
Research type
Research Study
Full title
An Adaptive Phase IIb/III, multi-center, prospective, randomised, double blind, placebo controlled study of the safety and efficacy of NaBen® (sodium benzoate)a D-amino acid oxidase inhibitor, as an add on treatment for schizophrenia in adults.
IRAS ID
260025
Contact name
Sukhi Shergill
Contact email
Sponsor organisation
SyneuRx International (Taiwan) Corp
Eudract number
2017-001169-26
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Adult schizophrenia presents both negative and positive symptoms and cognitive deficits. Current effective treatments-conventional anti-psychotics and atypical anti-psychotics, target selective neurotransmitters in varying degrees of effectiveness. This also may cause extra-pyramidal side effects to be suffered by the patient. There is also a considerable number of patients resistant to or partially responsive to the available treatments. Most schizophrenic patients suffer a life-long illness with deteriorating function.
There is an urgent need to find a treatment with a better safety and efficacy profile to improve both symptoms and cognitive deficit.
This study proposes to study the safety and efficacy of adjunctive oral sodium benzoate in adult schizophrenic patients. It is proposed that each eligible participant will remain in the study for 68 weeks and will be randomised to receive either NaBen®/placebo in addition to their normal stabilised anti-psychotic medication for 68 weeks.
The study will require each participant to fulfil 13 study visits overall- which will involve provision of a Blood sample for testing and to complete symptom and quality of life questionnaires.
Recruitment of eligible participants will take place at carefully selected hospital sites that have both the clinical expertise and experience to ensure optimal care for the study participants.REC name
HSC REC A
REC reference
19/NI/0049
Date of REC Opinion
2 May 2019
REC opinion
Further Information Favourable Opinion