biostudies-literatureSiskind DRoyal Brisbane and Women’s Hospital Project GrantNational Health and Medical Research CouncilLundbeck Foundatione021000https://www.ebi.ac.uk/biostudies/studies/S-EPMC5855211biostudies-literatureUnknown8(3)<h4>Introduction</h4>Clozapine, 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.<h4>Methods and analysis</h4>A 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 pBMJ openCoMET: a protocol for a randomised controlled trial of co-commencement of METformin as an adjunctive treatment to attenuate weight gain and metabolic syndrome in patients with schizophrenia newly commenced on clozapine.PMC5855211R248-2017-2003Russell AFriend NMcGrath JJStedman TBaker ASardinha SLim CFlaws DSuetani SKisely SPatterson SWinckel KSiskind DMoudgil VfalseCoMET: a protocol for a randomised controlled trial of co-commencement of METformin as an adjunctive treatment to attenuate weight gain and metabolic syndrome in patients with schizophrenia newly commenced on clozapine.<h4>Introduction</h4>Clozapine, 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.<h4>Methods and analysis</h4>A 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 p2018-01-01T00:00:00Z2018 Mar2026-07-15T17:52:07.273Z2019-03-26T22:47:16ZS-EPMC58552112950021710.1136/bmjopen-2017-021000