Double-blind randomised controlled trial
The Cadence M trial is a randomised controlled trial. This means that participants will be selected to receive either mangosteen pericarp 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 mangosteen pericarp and who is receiving placebo, until the entire study is finished.
This study will be conducted at several sites, including Barwon Health, Geelong, and several health districts in Brisbane.
Trial participants must be aged 18 years and over, and meet the DSM-5 criteria for schizophrenia or schizoaffective disorder.
Participants will be asked to take 2 capsules at any one time of the day (as long as it is consistently the same time of day) for 24 weeks, in addition to their usual treatment.
Symptoms will be assessed every four weeks using careful and detailed interviews. Each assessment interview will take approximately 40-60 minutes to complete.
Participants will also be asked to provide 2 blood samples (at the beginning and end of the 24 week trial). This blood sample will enable the research team to measure the effects of mangosteen pericarp more precisely.