Metformin for Overweight & OBese ChILdren and Adolescents With BDS Treated With SGAs
Summary
A prospective, large, pragmatic, randomized trial to study the impact of METFORMIN and healthy lifestyle intervention (LIFE) vs. LIFE alone on patient-centered outcomes of body weight, SGA-adherence and satisfaction, psychiatric symptom burden (e.g. mood/anxiety), and Quality of Life.
Timeline
- Start
- 2015-12
- Primary completion
- 2022-12
- Completion
- 2023-06
Outcome
Met primary endpoint
paper After 6 months and 24 months, assignment to the MET plus LIFE group resulted in greater change in BMI Z-score compared with LIFE alone PMID 41233082 ↗
registry analysis (superiority test); MET and LIFE vs Healthy Lifestyle Intervention (LIFE); p <0.001; Mean Difference (Net) 0.08; ANCOVA NCT02515773 ↗
registry analysis (superiority test); MET and LIFE vs Healthy Lifestyle Intervention (LIFE); p = 0.044; Mean Difference (Net) 0.07; ANCOVA NCT02515773 ↗
registry analysis (superiority test); MET and LIFE vs Healthy Lifestyle Intervention (LIFE); p = 0.041; Mean Difference (Net) 0.09; ANCOVA NCT02515773 ↗
Publications
- DelBello MP, Welge JA, Klein CC, Blom TJ, Fornari V, Higdon C, Sorter MT, Kurtz B, Starr C, Smith A, Huang B, Chen C, Modi AC, Crimmins N, Correll CU; MOBILITY Consortium. Metformin for overweight and obese children and adolescents with bipolar spectrum and related mood disorders treated with second-generation antipsychotics: a randomised, pragmatic trial. Lancet Psychiatry. 2025 Dec;12(12):893-905. doi: 10.1016/S2215-0366(25)00273-1.
- Higdon C, Welge JA, Crimmins NA, Klein CC, Fornari VM, Sorter MT, Blom TJ, Kurtz BP, Correll CU, DelBello MP. Metabolic syndrome in youth with bipolar spectrum disorders treated with second-generation antipsychotics: baseline results from the community-based pragmatic MOBILITY Trial. Eur Child Adolesc Psychiatry. 2025 Sep;34(9):2917-2929. doi: 10.1007/s00787-025-02680-2. Epub 2025 Apr 11.
- Welge JA, Correll CU, Sorter MT, Fornari VM, Blom TJ, Carle AC, Huang B, Klein CC, DelBello MP. Metformin for Overweight and Obese Children With Bipolar Spectrum Disorders Treated With Second-Generation Antipsychotics (MOBILITY): Protocol and Methodological Considerations for a Large Pragmatic Randomized Clinical Trial. JAACAP Open. 2023 Mar 13;1(1):60-73. doi: 10.1016/j.jaacop.2023.03.004. eCollection 2023 Jun.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Metformin | Small molecule | 500 mg | Oral |