Cadence CoMET - Risks and Benefits

Risks and benefitsAll clinical trials, including Cadence CoMET , 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, pregnant women and unborn children.

Benefits

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 metformin is an effective “add-on” treatment to reduce clozapine weight gain. The benefit of metformin cannot be promised, nor can the chance of benefit be accurately predicted. Participants usually find the tasks interesting, and enjoy being able to help advance our knowledge of better treatments.

Risks and disadvantages

Joining a clinical trial involves a commitment – we need to hear how participants are going on a regular basis. We hope that participants can stick to treatment over the entire 24 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.