Department of Economics and Business Economics

CoMET: 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

Research output: Contribution to journal/Conference contribution in journal/Contribution to newspaperJournal articleResearchpeer-review

  • Dan Siskind, The University of Queensland, Metro South Addiction and Mental Health Service, Queensland Centre for Mental Health Research
  • ,
  • Nadia Friend, Sunshine Coast Health and Hospital Service
  • ,
  • Anthony Russell, The University of Queensland, Princess Alexandra Hospital Brisbane
  • ,
  • John J. McGrath
  • Carmen Lim, Queensland Centre for Mental Health Research
  • ,
  • Sue Patterson, Metro North Mental Health Service
  • ,
  • Dylan Flaws, The University of Queensland, Metro North Mental Health Service
  • ,
  • Terry Stedman, West Moreton Health and Hospital Service
  • ,
  • Vikas Moudgil, The University of Queensland, Metro North Mental Health Service
  • ,
  • Savio Sardinha, Gold Coast Health and Hospital Service
  • ,
  • Shuichi Suetani, The University of Queensland, Metro South Addiction and Mental Health Service, Queensland Centre for Mental Health Research
  • ,
  • Steve Kisely, The University of Queensland, Metro South Addiction and Mental Health Service
  • ,
  • Karl Winckel, Princess Alexandra Hospital Brisbane, The University of Queensland
  • ,
  • Andrea Baker, Queensland Centre for Mental Health Research

Introduction 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. Methods and analysis 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 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 dissemination Ethics 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 number ACTRN12617001547336; Pre-results.

Original languageEnglish
Article numbere021000
JournalBMJ Open
Volume8
Issue3
Number of pages10
ISSN2044-6055
DOIs
Publication statusPublished - 2018

    Research areas

  • Antipsychotic Agents/adverse effects, Body Mass Index, Body Weight/drug effects, Clozapine/adverse effects, Diabetes Mellitus, Type 2/prevention & control, Double-Blind Method, Female, Humans, Hypoglycemic Agents/pharmacology, Male, Metabolic Syndrome/prevention & control, Metformin/pharmacology, Obesity/chemically induced, Research Design, Schizophrenia/drug therapy, Secondary Prevention, Treatment Outcome, Weight Gain/drug effects, Weight Loss

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