NL8440.

Study name	The Metformin‐LIfestyle in Antipsychotic users study (MELIA): optimising the use of metformin in the management of antipsychotic‐induced weight gain
Methods	A randomised, double blind, multicenter, placebo‐controlled, pragmatic study
Participants	Study population: 2 groups of schizophrenia patients who undergo lifestyle interventions: general patients suffering from psychosis and overweight who use a range of antipsychotics; those considered (relatively) treatment‐resistant, therefore are treated with clozapine and suffer from overweight. Patients must have a diagnosis of schizophrenia spectrum disorders according to DSM‐IV‐TR or DSM‐5 criteria. They must have been using the same antipsychotic for at least 3 months. Patients are at least 16 years of age and are overweight (BMI > 25)
Interventions	Metformin or placebo started at 500 mg twice daily and then increased 1000 mg twice daily after 2 weeks
Outcomes	Primary outcome 1. Difference in weight (from treatment inception until 26 weeks of treatment) as a continuous trait Secondary outcomes Subgroup analysis for clozapine versus antipsychotic use only and differences between treatment inception and 26 weeks of treatment in All other elements of metabolic syndrome A measure of response, defined as ≥ 5% body weight loss at 26 weeks relative to treatment inception; Quality of life General psychological and physical health Cost‐effectiveness Safety outcomes include adverse drug reactions
Starting date	1 January 2021
Contact information	Nini de Boer n.m.deboer‐6@umcutrecht.nl 088‐7567412
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