Phase 4
Completed N=1,299
Metformin for Overweight & OBese ChILdren and Adolescents With BDS Treated With SGAs
Source: ClinicalTrials.gov NCT02515773 ↗Enrolled (actual)
1,299
Serious AEs
2.9%
Results posted
Jan 2025
Primary outcomePrimary: Change in BMI Z-score From Baseline to Month 6 in ITT Sample — -0.08; 0.00 Z-score — p=<0.001
◆ Published Evidence
Emerging
6citations · ~2 / year
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.
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.
Linked Publications (3)
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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.
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Metformin for overweight and obese children and adolescents with bipolar spectrum and related mood disorders treated with second-generation antipsychotics: a randomised, pragmatic trial.
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Metabolic syndrome in youth with bipolar spectrum disorders treated with second-generation antipsychotics: baseline results from the community-based pragmatic MOBILITY Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in BMI Z-score From Baseline to Month 6 in ITT Sample |
-0.08; 0.00 | <0.001 sig |
| PRIMARY Change in BMI Z-score From Baseline to Month 24 in ITT Sample |
-0.19; -0.11 | 0.044 sig |
| PRIMARY Change in BMI Z-score From Baseline to Month 6 in Per Protocol Sample |
-0.09; 0.00 | <0.001 sig |
| PRIMARY Change in BMI Z-score From Baseline to Month 24 in Per Protocol Sample |
-0.21; -0.12 | 0.041 sig |
Eligibility Criteria
Inclusion Criteria
- Inpatient or outpatient age 8-19 years inclusive; participants must live with a parent, guardian, or caregiver;
- Fluent in English;
- Diagnosed or told by a clinician that they have any of the following bipolar spectrum disorders (BSD): bipolar I, bipolar II, unspecified bipolar and related disorders, Disruptive Mood Dysregulation Disorder (DMDD), cyclothymic disorder, other specified bipolar and related disorders, as well as mood disorder not otherwise specified (if diagnosed in the past as per DSM-IV);
- Body mass index >85%ile for age and sex by standard growth charts;
- Received a new or ongoing prescription for at least one SGA (i.e., olanzapine, clozapine, risperidone, quetiapine, aripiprazole, ziprasidone, iloperidone, lurasidone, paliperidone, brexpiprazole or cariprazine) that is not prescribed as a PRN medication;
Exclusion Criteria
- Patients will be excluded if they have had exposure to a total daily dose of MET 1000 mg bid for at least 2 weeks in the past 3 months;
- Patients will be excluded if they could not tolerate MET during the recommended titration schedule outlined in the protocol;
- Major neurological or medical illnesses that affect weight gain (e.g., unstable thyroid disease) or require a systemic medication that might impact weight or glucose regulation (e.g., diabetes mellitus [insulin], chronic renal failure [steroids]);
- Fasting glucose ≥ 126 mg/dL on 2 occasions during screening indicating need for prompt treatment;
- If lab results are available in the last 6 months, then a serum creatinine ≥1.3 mg/dL on 2 occasions during screening and/or follow-up, indicating potential impairment of renal functioning;
- Pregnant or breast feeding;
- Children and caregivers who are unable to complete assessments for any reason;
Data sourced from ClinicalTrials.gov (NCT02515773) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.