Metformin for overweight and obese children and adolescents with bipolar spectrum and related mood disorders treated with second-generation antipsychotics: a randomised, pragmatic trial
Abstract
Background: Second-generation antipsychotics are widely used to treat patients with bipolar spectrum disorders and effectively manage mood symptoms but can often cause substantial weight gain and other metabolic alterations that elevate long-term risks of cardiovascular disease and premature mortality. Metformin has been shown to be safe and efficacious for ameliorating weight gain but has not been evaluated in typical clinical settings or for more than 6 months in this population and is not widely used as standard of care. Therefore, we conducted a pragmatic clinical trial to assess the effect of metformin treatment in young people treated with second-generation antipsychotics who had a bipolar spectrum disorder along with overweight or obesity.
Methods: In this multi-site, open-label, pragmatic parallel group study, we enrolled overweight or obese youth aged 8-19 years, previously or currently diagnosed with a bipolar spectrum disorder, and treated with or starting a second-generation antipsychotic. Participants were recruited and followed at 64 clinical sites (community-based mental health centres or academic health centres) in the USA. Sites were eligible for participation if they projected an enrolment rate of at least three patients per month and a minimum total number of 90 patients. Participants were randomly assigned (1:1) to the healthy eating and physical activity (LIFE) or the metformin plus LIFE (MET plus LIFE) interventions, within eight strata defined by…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 1,299 participants or records.
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