All clinical trials, including Cadence BZ, are rigorously assessed by an independent ethics committee to ensure that the benefits of conducting the trial outweigh the risks to participants.
There are additional safeguards in place to protect people with mental illness, young people under the age of 18, pregnant women and unborn children.
We cannot guarantee that participants will receive any benefits from this clinical trial.
However, participants will be helping the research community and those with psychosis to test if sodium benzoate is an effective “add-on” treatment for psychosis. If the results show that sodium benzoate is better than placebo, and is safe and acceptable to people with early psychosis, this evidence may help improve treatment for people with psychosis in the future. We need better treatments and the best way to advance treatments is to do clinical trials.
Risks and disadvantages
Joining a clinical trial involves a commitment – we need to hear how participants are going on a regular basis. Participants join the extended research team – we hope that participants can stick to treatment over the entire 12 weeks.
While every effort is made to minimise risks to participants, it is still possible that some participants will experience side effects, or will find it upsetting to talk about their illness.
It is important to fully understand these risks in order to give informed consent. The research team will explain the risks in more detail during the informed consent process.