The Efficacy of Sodium Benzoate as an Adjunctive Treatment in Early Psychosis
The University of Queensland
100 participants
Aug 19, 2015
Interventional
Conditions
Summary
The study will be a randomised, placebo-controlled, double-blind parallel-group trial over a 12 week period. The primary objective is to examine the clinical efficacy of the add-on treatment of sodium benzoate for persistent symptoms in patients with early psychosis. Specifically, it is hypothesised, that participants allocated to the active arm (1000mg (500mg twice daily)) Sodium Benzoate treatment will have significant reductions in the Positive and Negative Syndrome Scale (PANSS) total score at week 12 compared to individuals taking placebo.
Eligibility
Inclusion Criteria7
- Aged between 15 and 45 years (inclusive).
- Fulfil the DSM-IV criteria practice for broadly defined early psychosis, based on the Diagnostic Interview for Psychosis. This includes diagnoses such as schizophrenia, schizophreniform psychosis, delusional disorder, bipolar disorder, psychosis not otherwise specified.
- Have had the onset of a psychotic disorder within the last two years
- Have received antipsychotic medications for a period of at least one continuous month within the above two year period.
- Have a Positive and Negative Syndrome Scale (PANSS) total score of at least 55.
- Agree to participate, has capacity to consent and able to follow the study instructions and procedures.
- If under 18 years of age, a parent or legal guardian consents to the young person’s participation.
Exclusion Criteria6
- Known allergies to sodium benzoate (E211) or any part of the formulation of the investigational product.
- Suspected allergies or known adverse reactions to food preservatives in general.
- Comorbid physical illnesses that would impair the participants’ ability to complete the trial.
- People who are unable to understand or communicate in English.
- For female participant, those currently pregnant, or planning to become pregnant or lactating during the study period
- Inability to follow the study instructions and procedures.
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Interventions
The study will include 100 individuals with first episode psychosis who will be randomised to receive either 1g/d (500mg twice daily) of sodium benzoate or placebo (1:1 ratio) for 12 weeks, in addition to their normal routine care. Participants will be requested to return all unused study medication (i.e. unopened blister packs or capsules not taken) and empty blister packs 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, 6, 8, 10 and 12. Weekly phone contact will occur in between face to face visits to monitor medication compliance and discuss any concerns the participant may raise regarding the trial medication. A post-completion visit will be conducted at week 14.
Locations(9)
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ACTRN12615000187549