None listed
Conditions
Brief summary
The study will be a randomised, placebo-controlled double-blind parallel-group trial; over a 6 week period. The primary objective in this study is to determine the dose of sodium benzoate which maximises the clinical benefits in patients with treatment refractory schizophrenia. Specifically, it is hypothesised those participants allocated to the active arms (1000mg daily or 2000mg daily or 4000mg daily) of Sodium Benzoate treatment will have significant reductions in PANSS total score at week 6 compared to individuals taking placebo.
Interventions
The study will include 52 individuals with treatment refractory schizophrenia who will be randomised to receive 1000mg daily (500mg twice daily) or 2000mg daily (1000mg twice daily) or 4000mg daily (2000mg twice daily) of Sodium Benzoate or placebo for 6 weeks, in addition to their normal routine care.
Participants will be requested to return all unused study medication (i.e. capsules not taken) to the delegated research assistants. All unused supplies of study medication will be accounted for
The study will include 52 individuals with treatment refractory schizophrenia who will be randomised to receive 1000mg daily (500mg twice daily) or 2000mg daily (1000mg twice daily) or 4000mg daily (2000mg twice daily) of Sodium Benzoate or placebo for 6 weeks, in addition to their normal routine care. Participants will be requested to return all unused study medication (i.e. capsules not taken) to the delegated research assistants. All unused supplies of study medication will be accounted for and documented by the designated Research Pharmacist. Compliance with study medication will be calculated at each visit by means of self-report and a capsule count Face to face clinical assessments will be at baseline (week 0) and weeks 2, 4 and 6. Weekly phone contact will occur in between face to face visits.
Sponsors
QIMR Berghofer Medical Institute of Research
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
1.Aged between 18 and 64 years (inclusive). 2.Fulfil the DSM-IV criteria practice for schizophrenia, based on the Diagnostic Interview for Psychosis. 3.Have had the diagnosis of schizophrenia for at least 12 months duration 4.Have a Positive and Negative Syndrome Scale (PANSS) total score greater than or equal to 70 5.Have received antipsychotic medications for a period of at least one continuous month prior to assessment for the study and remained symptomatic despite taking antipsychotic therapy 6.Agree to participate, has capacity to consent and able to follow the study instructions and procedures.
Exclusion criteria
1.Known allergies to sodium benzoate (E211) or any part of the formulation of the investigational product. 2.Suspected allergies or known adverse reactions to food preservatives in general. 3.Comorbid physical illnesses that would impair the participants’ ability to complete the trial. 4.People who are unable to understand or communicate in English. 5.For female participant, those currently pregnant, or planning to become pregnant or lactating during the study period. 6.Inability to follow the study instructions and procedures.
Outcome results
None listed