Metformin for Overweight & OBese ChILdren and Adolescents With BDS Treated With SGAs

The investigators propose to recruit 1800 overweight/obese youth with Bipolar Spectrum
Disorder (BSD) who are prescribed second generation anti psychotics (SGAs) from at least 24
public and private mental health practices in the Greater Cincinnati and New York City
regions, (approximately 900 each from ~12 Cincinnati region and ~12 Long Island/New York
mental health treatment sites) to participate in the proposed patient-centered large
pragmatic trial examining the effectiveness of MET and LIFE vs. LIFE alone. Patients will be
eligible if they are ages 8-17 years old, inclusive, overweight or obese (BMI > 85%),
continuing or starting treatment with at least one SGA (i.e., olanzapine, clozapine,
risperidone, quetiapine, aripiprazole, ziprasidone, iloperidone, lurasidone, paliperidone,
or asenapine) and have a clinical diagnosis of BSD (bipolar I or II disorder, cyclothymia,
or bipolar or mood disorder not otherwise specified [or by Diagnostic and Statistical Manual
of Mental Disorders V (DSM-5), other specified bipolar or mood disorder). The enrollment
rate will be 2-3 patients/month/site for a recruitment time of 30 months.

Inclusion Criteria:

1. Inpatient or outpatient age 8-17 years inclusive;

2. Fluent in English;

3. Diagnosed by a clinician with a bipolar spectrum disorder (BSD), i.e., bipolar I,
bipolar II, bipolar or mood disorder not otherwise specified, cyclothymic disorder or
other specified bipolar or mood disorder;

4. Body mass index >85%ile for age and sex by standard growth charts;

5. Received a new or ongoing prescription for at least one SGA (i.e., olanzapine,
clozapine, risperidone, quetiapine, aripiprazole, ziprasidone, iloperidone,
lurasidone, paliperidone, or asenapine)

Exclusion Criteria:

1. Prior intolerance or ineffective exposure to Metformin (MET); No exposure in past 12
month will be permitted;

2. 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]);

3. Fasting glucose > 125 mg/dL on 2 occasions during screening indicating need for
prompt treatment;

4. Serum creatinine ≥1.3 mg/dL on 2 occasions during screening and/or follow-up,
indicating potential impairment of renal functioning;

5. Pregnant or breast feeding;

6. Children with caregivers who are unable to complete assessments of the child for any
reason;