Double-blind randomised controlled trial
The Cadence BZ trial is a randomised controlled trial. This means that participants will be selected to receive either sodium benzoate or a placebo (sugar pill) completely by chance (like flipping a coin). Randomised controlled trials are considered the gold standard in clinical trials, because they produce the most reliable evidence.
The trial is a double-blind study, which means that neither participants nor research staff will know who is receiving sodium benzoate and who is receiving placebo, until the entire study is finished.
Participants will be recruited from mental health services based in 5 Hospital and Health Services in South East Queensland. They must be aged between 15 and 45 years of age, with onset of psychosis in the last 2 years, and have some ongoing problems with psychotic symptoms.
Trial participants will be asked to take 2 capsules per day (one in the morning and one at night with meals) for 12 weeks, in addition to their usual treatment.
Symptoms will be assessed every two weeks using careful and detailed interviews. Each assessment interview will take approximately 1.5 hours to complete.
We also invite participants to provide 2 blood samples (at the beginning and end of the 12 week trial). This blood sample will enable the research team to measure the effects of sodium benzoate more precisely.
In this video Associate Professor James Scott explains the features of the Cadence BZ trial in more depth.