CoMET: a randomised controlled trial of co-commencement of metformin versus placebo as an adjunctive treatment to attenuate weight gain in patients with schizophrenia newly commenced on clozapine.
clozapine
metformin
obesity
randomised controlled trial
Journal
Therapeutic advances in psychopharmacology
ISSN: 2045-1253
Titre abrégé: Ther Adv Psychopharmacol
Pays: England
ID NLM: 101555693
Informations de publication
Date de publication:
2021
2021
Historique:
received:
23
06
2021
accepted:
23
08
2021
entrez:
21
10
2021
pubmed:
22
10
2021
medline:
22
10
2021
Statut:
epublish
Résumé
There is limited evidence on interventions to minimise weight gain at clozapine commencement. We compared the effect of adjunctive metformin People with schizophrenia commencing on clozapine were randomised to either metformin or placebo for 24 weeks. The primary outcome was difference in the change of body weight. Secondary outcomes included comparative rates of weight gain of more than 5%, overall weight gain/loss, and differences in metabolic and psychosis outcomes. The study was closed prematurely in March 2020 due to COVID-19 restrictions. Ten participants were randomised to each of the metformin and placebo groups. Eight metformin group and five placebo group participants completed the trial and were included in the analysis. The study was insufficiently powered to detect difference between the metformin and placebo groups for the primary outcome of change in weight (0.09 kg vs 2.88 kg, While limited by the forced premature closure of the trial due to COVID19, the findings from this randomised controlled trial are promising. Clozapine and metformin co-commencement may be a promising treatment to prevent clozapine-associated weight gain, especially given the low rates of ADRs associated with metformin. This supports the consideration of use of metformin to prevent weight gain in people initiated on clozapine; however, further studies are needed to confirm this finding. ACTRN12617001547336.
Sections du résumé
BACKGROUND
BACKGROUND
There is limited evidence on interventions to minimise weight gain at clozapine commencement. We compared the effect of adjunctive metformin
METHODS
METHODS
People with schizophrenia commencing on clozapine were randomised to either metformin or placebo for 24 weeks. The primary outcome was difference in the change of body weight. Secondary outcomes included comparative rates of weight gain of more than 5%, overall weight gain/loss, and differences in metabolic and psychosis outcomes.
RESULTS
RESULTS
The study was closed prematurely in March 2020 due to COVID-19 restrictions. Ten participants were randomised to each of the metformin and placebo groups. Eight metformin group and five placebo group participants completed the trial and were included in the analysis. The study was insufficiently powered to detect difference between the metformin and placebo groups for the primary outcome of change in weight (0.09 kg vs 2.88 kg,
CONCLUSION
CONCLUSIONS
While limited by the forced premature closure of the trial due to COVID19, the findings from this randomised controlled trial are promising. Clozapine and metformin co-commencement may be a promising treatment to prevent clozapine-associated weight gain, especially given the low rates of ADRs associated with metformin. This supports the consideration of use of metformin to prevent weight gain in people initiated on clozapine; however, further studies are needed to confirm this finding.
TRIAL REGISTRATION
BACKGROUND
ACTRN12617001547336.
Identifiants
pubmed: 34671454
doi: 10.1177/20451253211045248
pii: 10.1177_20451253211045248
pmc: PMC8521414
doi:
Types de publication
Journal Article
Langues
eng
Pagination
20451253211045248Informations de copyright
© The Author(s), 2021.
Déclaration de conflit d'intérêts
Conflict of interest statement: The authors declared no potential conflicts of interest with respect to the research, authorship and/or publication of this article.
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