Double-blind randomised controlled trial
The Cadence CoMET trial is a randomised controlled trial. This means that participants will be selected to receive either metformin 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 metformin and who is receiving placebo, until the entire study is finished.
Participants will be recruited from mental health services based in four Hospital and Health Services in South East Queensland. They must be aged between 18 and 64 years of age, with a diagnosis of schizophrenia or schizoaffective disorder, and have received oral clozapine for a period of no more than 2 weeks. For further inclusion and exclusion requirements, please contact the research coordinator on 04 3908 8922
Trial participants will be asked to take half a tablet of trial medication per day during the first week of the study, and then gradually increase to a maximum of two tablets per day (as tolerated by individual participants) for the duration of the study, in addition to their usual treatment.
Research staff will assess participants weekly over the first month of the study, and then on a monthly basis for the remainder of the study duration (24 weeks). Each assessment will include physical measures, interview questions, and identification of any reactions related to the trial medication. Participants will also be regularly telephoned during the trial.
We also require participants to provide three blood samples (at the beginning, middle, and end of the trial). This blood sample will enable the research team to assess the effects of metformin more precisely.