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

Siskind, Dan, Friend, Nadia, Russell, Anthony, McGrath, John J., Lim, Carmen, Patterson, Sue, Flaws, Dylan, Stedman, Terry, Moudgil, Vikas, Sardinha, Savio, Suetani, Shuichi, Kisely, Steve, Winckel, Karl and Baker, Andrea (2018) 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. BMJ Open, 8 3: . doi:10.1136/bmjopen-2017-021000


Author Siskind, Dan
Friend, Nadia
Russell, Anthony
McGrath, John J.
Lim, Carmen
Patterson, Sue
Flaws, Dylan
Stedman, Terry
Moudgil, Vikas
Sardinha, Savio
Suetani, Shuichi
Kisely, Steve
Winckel, Karl
Baker, Andrea
Title 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
Journal name BMJ Open   Check publisher's open access policy
ISSN 2044-6055
Publication date 2018-03-01
Sub-type Article (original research)
DOI 10.1136/bmjopen-2017-021000
Open Access Status DOI
Volume 8
Issue 3
Total pages 10
Place of publication London, United Kingdom
Publisher BMJ Publishing Group
Language eng
Subject 2700 Medicine
Abstract 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.
Keyword clozapine
diabetes
metabolic syndrome
obesity
schizophrenia
Q-Index Code C1
Q-Index Status Provisional Code
Institutional Status UQ

Document type: Journal Article
Sub-type: Article (original research)
Collections: HERDC Pre-Audit
Queensland Brain Institute Publications
Faculty of Medicine
School of Pharmacy Publications
 
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Created: Fri, 16 Mar 2018, 12:18:58 EST