biostudies-literatureWilson CNational Health &amp; Medical Research Council Emerging Leadership FellowshipLiu McCabe Family ScholarshipNational Health and Medical Research CouncilCaroline Quinn Research Grante064682https://www.ebi.ac.uk/biostudies/studies/S-EPMC9945047biostudies-literatureUnknown13(2)<h4>Introduction</h4>Metformin is a medication likely to improve measures of cardiometabolic disturbance in young people with mental illness. Evidence also suggests metformin may improve depressive symptoms. This 52-week double-blind randomised control trial (RCT) aims to investigate the efficacy of metformin pharmacotherapy as an adjunct to a healthy lifestyle behavioural intervention in improving cardiometabolic outcomes, and depressive, anxiety and psychotic symptoms in youth with clinically diagnosed major mood syndromes.<h4>Methods and analysis</h4>At least 266 young people aged 16-25 presenting for mental healthcare for major mood syndromes who are also at risk for poor cardiometabolic outcomes will be invited to participate in this study. All participants will engage in a 12-week slBMJ openDouble-blind, randomised placebo-controlled clinical trial of metformin as an adjunct to a sleep-wake, activity and metabolically focused behavioural intervention to improve cardiometabolic outcomes and mood symptoms in youth with major mood syndromes: study protocol.PMC9945047awarded to CWawarded to J.J.C511921, awarded to I.B.Hawarded to JSCSong YJCWilson CCrouse JHickie IBScott EMMcHugh CHamilton BCarpenter JSZmicerevska NNichles AKoethe DHockey SfalseDouble-blind, randomised placebo-controlled clinical trial of metformin as an adjunct to a sleep-wake, activity and metabolically focused behavioural intervention to improve cardiometabolic outcomes and mood symptoms in youth with major mood syndromes: study protocol.<h4>Introduction</h4>Metformin is a medication likely to improve measures of cardiometabolic disturbance in young people with mental illness. Evidence also suggests metformin may improve depressive symptoms. This 52-week double-blind randomised control trial (RCT) aims to investigate the efficacy of metformin pharmacotherapy as an adjunct to a healthy lifestyle behavioural intervention in improving cardiometabolic outcomes, and depressive, anxiety and psychotic symptoms in youth with clinically diagnosed major mood syndromes.<h4>Methods and analysis</h4>At least 266 young people aged 16-25 presenting for mental healthcare for major mood syndromes who are also at risk for poor cardiometabolic outcomes will be invited to participate in this study. All participants will engage in a 12-week sl2023-01-01T00:00:00Z2023 Feb2025-04-04T18:59:44.146Z2025-04-04T18:59:44.146ZS-EPMC99450473681017410.1136/bmjopen-2022-064682