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

Completed · Phase 4

Conditions studied: Bipolar Disorder

In brief

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.

Key facts

Study ID

NCT02515773

Run by

Melissa Delbello

People needed

1565

Starts

2015-12-01

Expected to finish

2023-06-01

Last updated by the study team

2025-01-14

Who can join

Age: 8 and older, up to 19. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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;

You may not qualify if…

• 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;

Where it is running

• The Children's Home of Northern Kentucky — Covington, Kentucky, United States
• Jersey Shore Medical Center — Neptune City, New Jersey, United States
• South Oaks — Amityville, New York, United States
• SUNY Downstate/ Kings County Hospital — Brooklyn, New York, United States
• Maimonides — Brooklyn, New York, United States
• NYCCC — Brooklyn, New York, United States
• Northwell Zucker Long Island Jewish Hospital — Glen Oaks, New York, United States
• Mount Sinai — New York, New York, United States
• LIJ Zucker Hillside Hospital — New York, New York, United States
• Child Center of New York, — Queens, New York, United States
• NorthShore Child and Family Guidance — Roslyn Heights, New York, United States
• StonyBrook — Stony Brook, New York, United States
• Lighthouse Youth Services — Cincinnati, Ohio, United States
• Central Clinic — Cincinnati, Ohio, United States
• Children's Home — Cincinnati, Ohio, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Resident Mood Medication Clinic — Cincinnati, Ohio, United States
• St. Aloysius — Cincinnati, Ohio, United States
• Talbert House — Cincinnati, Ohio, United States
• St. Joseph's Orphanage — Cincinnati, Ohio, United States
• Child Focus — Cincinnati, Ohio, United States
• NECCO — Cincinnati, Ohio, United States
• University Hospital Medical Center Cleveland — Cleveland, Ohio, United States
• Nationwide Children's Hospital Columbus — Columbus, Ohio, United States
• Ohio State University — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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