PMID- 29500217
OWN - NLM
STAT- MEDLINE
DCOM- 20180906
LR  - 20190202
IS  - 2044-6055 (Electronic)
IS  - 2044-6055 (Linking)
VI  - 8
IP  - 3
DP  - 2018 Mar 2
TI  - 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.
PG  - e021000
LID - 10.1136/bmjopen-2017-021000 [doi]
LID - e021000
AB  - 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.
CI  - (c) Article author(s) (or their employer(s) unless otherwise stated in the text of 
      the article) 2018. All rights reserved. No commercial use is permitted unless 
      otherwise expressly granted.
FAU - Siskind, Dan
AU  - Siskind D
AUID- ORCID: 0000-0002-2072-9216
AD  - University of Queensland School of Medicine, Brisbane, Queensland, Australia.
AD  - Metro South Addiction and Mental Health Service, Brisbane, Queensland, Australia.
AD  - Queensland Centre for Mental Health Research, Brisbane, Queensland, Australia.
FAU - Friend, Nadia
AU  - Friend N
AD  - Sunshine Coast Health and Hospital Service, Brisbane, Queensland, Australia.
FAU - Russell, Anthony
AU  - Russell A
AD  - University of Queensland School of Medicine, Brisbane, Queensland, Australia.
AD  - Department of Endocrinology, Princess Alexandra Hospital, Brisbane, Queensland, 
      Australia.
FAU - McGrath, John J
AU  - McGrath JJ
AD  - Queensland Centre for Mental Health Research, Brisbane, Queensland, Australia.
AD  - Queensland Brain Institute, University of Queensland, St Lucia, Queensland, 
      Australia.
AD  - National Centre for Register-Based Research, Aarhus University, Aarhus, Denmark.
FAU - Lim, Carmen
AU  - Lim C
AD  - Queensland Centre for Mental Health Research, Brisbane, Queensland, Australia.
FAU - Patterson, Sue
AU  - Patterson S
AD  - Metro North Mental Health Service, Brisbane, Queensland, Australia.
FAU - Flaws, Dylan
AU  - Flaws D
AD  - University of Queensland School of Medicine, Brisbane, Queensland, Australia.
AD  - Metro North Mental Health Service, Brisbane, Queensland, Australia.
FAU - Stedman, Terry
AU  - Stedman T
AD  - West Moreton Health and Hospital Service, Brisbane, Queensland, Australia.
FAU - Moudgil, Vikas
AU  - Moudgil V
AD  - University of Queensland School of Medicine, Brisbane, Queensland, Australia.
AD  - Metro North Mental Health Service, Brisbane, Queensland, Australia.
FAU - Sardinha, Savio
AU  - Sardinha S
AD  - Gold Coast Health and Hospital Service, Gold Coast, Queensland, Australia.
FAU - Suetani, Shuichi
AU  - Suetani S
AD  - University of Queensland School of Medicine, Brisbane, Queensland, Australia.
AD  - Metro South Addiction and Mental Health Service, Brisbane, Queensland, Australia.
AD  - Queensland Centre for Mental Health Research, Brisbane, Queensland, Australia.
FAU - Kisely, Steve
AU  - Kisely S
AD  - University of Queensland School of Medicine, Brisbane, Queensland, Australia.
AD  - Metro South Addiction and Mental Health Service, Brisbane, Queensland, Australia.
FAU - Winckel, Karl
AU  - Winckel K
AD  - Pharmacy Department, Princess Alexandra Hospital, Brisbane, Queensland, 
      Australia.
AD  - University of Queensland School of Pharmacy, Brisbane, Queensland, Australia.
FAU - Baker, Andrea
AU  - Baker A
AD  - Queensland Centre for Mental Health Research, Brisbane, Queensland, Australia.
LA  - eng
SI  - ANZCTR/ACTRN12617001547336
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20180302
PL  - England
TA  - BMJ Open
JT  - BMJ open
JID - 101552874
RN  - 0 (Antipsychotic Agents)
RN  - 0 (Hypoglycemic Agents)
RN  - 9100L32L2N (Metformin)
RN  - J60AR2IKIC (Clozapine)
SB  - IM
MH  - Antipsychotic Agents/adverse effects/therapeutic use
MH  - Body Mass Index
MH  - Body Weight/drug effects
MH  - Clozapine/*adverse effects/therapeutic use
MH  - Diabetes Mellitus, Type 2/prevention & control
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Hypoglycemic Agents/pharmacology/*therapeutic use
MH  - Male
MH  - Metabolic Syndrome/*prevention & control
MH  - Metformin/pharmacology/*therapeutic use
MH  - Obesity/chemically induced/*prevention & control
MH  - Research Design
MH  - Schizophrenia/*drug therapy
MH  - Secondary Prevention
MH  - Treatment Outcome
MH  - Weight Gain/*drug effects
MH  - Weight Loss
PMC - PMC5855211
OTO - NOTNLM
OT  - clozapine
OT  - diabetes
OT  - metabolic syndrome
OT  - obesity
OT  - schizophrenia
COIS- Competing interests: AR has received speaker honoraria and travel grants from 
      AstraZeneca, Boehringer Ingelheim, Eli Lilly, MSD, Novo Nordisk and Sanofi and 
      has participated on advisory panels for MSD and Novo Nordisk.
EDAT- 2018/03/04 06:00
MHDA- 2018/09/07 06:00
PMCR- 2018/03/02
CRDT- 2018/03/04 06:00
PHST- 2018/03/04 06:00 [entrez]
PHST- 2018/03/04 06:00 [pubmed]
PHST- 2018/09/07 06:00 [medline]
PHST- 2018/03/02 00:00 [pmc-release]
AID - bmjopen-2017-021000 [pii]
AID - 10.1136/bmjopen-2017-021000 [doi]
PST - epublish
SO  - BMJ Open. 2018 Mar 2;8(3):e021000. doi: 10.1136/bmjopen-2017-021000.