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Double-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.
Wilson, Chloe; Carpenter, Joanne Sarah; Nichles, Alissa; Zmicerevska, Natalia; Song, Yun Ju Christine; McHugh, Catherine; Hamilton, Blake; Hockey, Samuel; Crouse, Jacob; Koethe, Dagmar; Scott, Elizabeth M; Hickie, Ian B.
Afiliação
  • Wilson C; Brain and Mind Centre, The University of Sydney, Camperdown, New South Wales, Australia chloe.wilson@sydney.edu.au.
  • Carpenter JS; Brain and Mind Centre, The University of Sydney, Camperdown, New South Wales, Australia.
  • Nichles A; Brain and Mind Centre, The University of Sydney, Camperdown, New South Wales, Australia.
  • Zmicerevska N; Brain and Mind Centre, The University of Sydney, Camperdown, New South Wales, Australia.
  • Song YJC; Brain and Mind Centre, The University of Sydney, Camperdown, New South Wales, Australia.
  • McHugh C; Brain and Mind Centre, The University of Sydney, Camperdown, New South Wales, Australia.
  • Hamilton B; Brain and Mind Centre, The University of Sydney, Camperdown, New South Wales, Australia.
  • Hockey S; Brain and Mind Centre, The University of Sydney, Camperdown, New South Wales, Australia.
  • Crouse J; Brain and Mind Centre, The University of Sydney, Camperdown, New South Wales, Australia.
  • Koethe D; Brain and Mind Centre, The University of Sydney, Camperdown, New South Wales, Australia.
  • Scott EM; Brain and Mind Centre, The University of Sydney, Camperdown, New South Wales, Australia.
  • Hickie IB; Brain and Mind Centre, The University of Sydney, Camperdown, New South Wales, Australia.
BMJ Open ; 13(2): e064682, 2023 02 21.
Article em En | MEDLINE | ID: mdl-36810174
INTRODUCTION: 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. METHODS AND ANALYSIS: 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 sleep-wake, activity and metabolically focused behavioural intervention programme. As an adjunctive intervention, participants will receive either metformin (500-1000 mg) or placebo pharmacotherapy for 52 weeks.Participants will undergo a series of assessments including: (1) self-report and clinician-administered assessments; (2) blood tests; (3) anthropometric assessments (height, weight, waist circumference and blood pressure); and (4) actigraphy. Univariate and multivariate tests (generalised mixed-effects models) will be used to examine changes in primary and secondary outcomes (and associations with predetermined predictor variables). ETHICS AND DISSEMINATION: This study has been approved by the Sydney Local Health District Research Ethics and Governance Office (X22-0017). The results of this double-blind RCT will be disseminated into the scientific and broader community through peer-reviewed journals, conference presentations, social media and university websites. TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry (ANZCTR) Number: ACTRN12619001559101p, 12 November 2019.
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Doenças Cardiovasculares / Metformina Tipo de estudo: Clinical_trials / Diagnostic_studies / Guideline / Prognostic_studies Limite: Adolescent / Humans País como assunto: Oceania Idioma: En Ano de publicação: 2023 Tipo de documento: Article

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Doenças Cardiovasculares / Metformina Tipo de estudo: Clinical_trials / Diagnostic_studies / Guideline / Prognostic_studies Limite: Adolescent / Humans País como assunto: Oceania Idioma: En Ano de publicação: 2023 Tipo de documento: Article