IntroductionClozapine, while effective in treatment refractory schizophrenia, is associated with significant weight gain, heart disease and increased risk of type 2 diabetes mellitus (T2DM). Although there is evidence for weight loss with metformin for people with obesity who are already taking clozapine, there have been no published trials that have investigated the effect of metformin in attenuating weight gain at the time of clozapine initiation.Methods and analysisA 24-week double-blind placebo-controlled trial of concomitant prescription of metformin at clozapine commencement. Eighty-six people being commenced on clozapine will be randomised to placebo or metformin (variable dose, up to 2 g/day). The primary outcome is comparative end point body weight, between the placebo and metformin groups. Secondary outcomes are comparative rates of conversion to T2DM, alteration of metabolic syndrome parameters, proportion gaining >5% body weight and changes in diet and appetite. We will additionally examine biomarkers associated with change in weight among trial participants.Ethics and disseminationEthics approval was granted by the Metro South Human Research Ethics Committee HREC/17/QPAH/538-SSA/17/QPAH/565. We plan to submit a manuscript of the results to a peer-reviewed journal, and present results at conferences, consumer forums and hospital grand rounds.Trial registration numberACTRN12617001547336; Pre-results.

ObjectivesThe aim of this study was to identify current physical health guidelines for severe mental illness (SMI) and appraise them using the Appraisal of Guidelines for Research and Evaluation (AGREE) II Instrument. MethodsRelevant research databases and grey literature were systematically searched to identify physical health guidelines for people with SMI. The grey literature was explored by web searches and targeted searches of the English websites of relevant peak bodies and government health agencies from Organisation for Economic Co-operation and Development countries. Included guidelines were independently appraised by two authors (NF and JH) using the AGREE II Instrument. ResultsOf the 5352 records screened, 33 were assessed for eligibility. Fifteen practice guidelines met the inclusion criteria. The median domain scores as rated by the AGREE II Instrument ranged from 17% to 69%. The World Health Organization guideline, which demonstrated a broad range of clinical recommendations and sound methodological rigour, was rated the best. ConclusionsMost guidelines scored poorly when rated by the AGREE II Instrument. However, these guidelines may still be useful in assisting evidence-based clinical practice. The methodological rigour of future guidelines can be improved by ensuring the AGREE II domains are addressed during the development phase. What is known about the topic?Compared with the general population, people with SMI experience greater chronic disease morbidity and mortality. There is limited evidence from randomised controlled trials to guide physical health care monitoring for people with SMI. Current guidelines and practice are largely based on expert consensus, clinical experience and good intentions. What does this paper add?Using the AGREE II Instrument, this paper appraises the current physical health guidelines for people with SMI. The attributes of the guidelines examined included the evidence base, clarity of presentation, applicability in the real world, the involvement of stakeholders and conflicts of interest of various parties involved in guideline development. What are the implications for practitioners?This review highlights the scarcity of high-quality and evidence-based guidelines for clinicians and researchers to address the physical health of people with SMI.