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

NCT02515773 | Completed Phase 4 Results DMC

• 1 other identifier: DelBello PCORI
• Study Type: interventional
• Target: 1,565
• Locations: 1 country
• Sites: 29

Brief 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.

Conditions

Bipolar Disorder

Outcome Measures

Primary Outcomes (4)

• Change in BMI Z-score From Baseline to Month 6 in ITT Sample

  Raw body mass index (BMI) is calculated as (weight(kg)/ height(m)2). This raw BMI value is converted to a normalized BMI z-score, adjusted for age and sex using US Centers for Disease Control and Prevention growth charts. A z-score equal to 0 indicates the population mean and larger z-scores are heavier weights and worse outcomes.

  Baseline to Month 6

• Change in BMI Z-score From Baseline to Month 24 in ITT Sample

  Raw body mass index (BMI) is calculated as (weight(kg)/ height(m)2). This raw BMI value is converted to a normalized BMI z-score, adjusted for age and sex using US Centers for Disease Control and Prevention growth charts. A z-score equal to 0 indicates the population mean and larger z-scores are heavier weights and worse outcomes.

  Baseline to Month 24

• Change in BMI Z-score From Baseline to Month 6 in Per Protocol Sample

  Raw body mass index (BMI) is calculated as (weight(kg)/ height(m)2). This raw BMI value is converted to a normalized BMI z-score, adjusted for age and sex using US Centers for Disease Control and Prevention growth charts. A z-score equal to 0 indicates the population mean and larger z-scores are heavier weights and worse outcomes.

  Baseline to Month 6

• Change in BMI Z-score From Baseline to Month 24 in Per Protocol Sample

  Raw body mass index (BMI) is calculated as (weight(kg)/ height(m)2). This raw BMI value is converted to a normalized BMI z-score, adjusted for age and sex using US Centers for Disease Control and Prevention growth charts. A z-score equal to 0 indicates the population mean and larger z-scores are heavier weights and worse outcomes.

  Baseline to Month 24

Study Arms (2)

MET and LIFE

EXPERIMENTAL

Participants randomized to this group will receive both Metformin and lifestyle intervention.Participants randomized to treatment with MET will start at a dose of 500 mg orally at night and slowly titrated in 2-week intervals to ensure that each patient achieves maximum insulin-sensitizing effects of the drug while minimizing the chance of side effects. Investigators will also recommend that MET be taken with food to minimize side effects. If a participant's BMI percentile \<5% (=underweight) his/her treatment with MET will be discontinued. Although the risk of low vitamin B12 while taking MET is associated with age \> 50 years and having type II diabetes, Investigator will monitor B12 levels and a CBC throughout study participation.

Drug: Metformin; Behavioral: healthy lifestyle intervention (LIFE)

Healthy lifestyle intervention (LIFE)

EXPERIMENTAL

Participants randomized to this group will receive just lifestyle intervention alone.This healthy lifestyle intervention (LIFE) consists of counseling participants and families regarding a healthy eating plan, physical activity and sedentary activities. Prior to study initiation, clinical site staff will participate in a live (or taped) training session from a dietician to lean to administer LIFE. A trained site staff member (e.g. medical assistant or case manager) will meet with participants and their families for a 15-20 minute session at baseline that will focus on nutritional issues using the Traffic Light Plan (TLP).

Behavioral: healthy lifestyle intervention (LIFE)

Interventions

Metformin DRUG

Metformin - to achieves maximum insulin-sensitizing effects

Also known as: GLUCOPHAGE

MET and LIFE

healthy lifestyle intervention (LIFE) BEHAVIORAL

Healthy Life style intervention

Also known as: LIFE

Healthy lifestyle intervention (LIFE); MET and LIFE

Eligibility Criteria

• Age: 8 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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;

Sponsors & Collaborators

• Melissa Delbello: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (29)

The Children's Home of Northern Kentucky

Covington, Kentucky, 41011, United States

Location

Jersey Shore Medical Center

Neptune City, New Jersey, 07753, United States

Location

South Oaks

Amityville, New York, 11701, United States

Location

SUNY Downstate/ Kings County Hospital

Brooklyn, New York, 11203, United States

Location

Maimonides

Brooklyn, New York, 11219, United States

Location

NYCCC

Brooklyn, New York, 11233, United States

Location

Northwell Zucker Long Island Jewish Hospital

Glen Oaks, New York, 11004, United States

Location

Mount Sinai

New York, New York, 10029, United States

Location

LIJ Zucker Hillside Hospital

New York, New York, 11004, United States

Location

Child Center of New York,

Queens, New York, 11373, United States

Location

NorthShore Child and Family Guidance

Roslyn Heights, New York, 11577, United States

Location

StonyBrook

Stony Brook, New York, 11794, United States

Location

Lighthouse Youth Services

Cincinnati, Ohio, 45206, United States

Location

Central Clinic

Cincinnati, Ohio, 45219, United States

Location

Children's Home

Cincinnati, Ohio, 45227, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Resident Mood Medication Clinic

Cincinnati, Ohio, 45229, United States

Location

St. Aloysius

Cincinnati, Ohio, 45237, United States

Location

Talbert House

Cincinnati, Ohio, 45238, United States

Location

St. Joseph's Orphanage

Cincinnati, Ohio, 45239, United States

Location

Child Focus

Cincinnati, Ohio, 45244, United States

Location

NECCO

Cincinnati, Ohio, 45246, United States

Location

University Hospital Medical Center Cleveland

Cleveland, Ohio, 44106, United States

Location

Nationwide Children's Hospital Columbus

Columbus, Ohio, 43205, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

South Community

Dayton, Ohio, United States

Location

Butler Behavioral Health Services

Hamilton, Ohio, 45011, United States

Location

TCN Family Solutions

Xenia, Ohio, 45385, United States

Location

Seton Family of Hospitals

Austin, Texas, 78712, United States

Location

Related Publications (3)

• 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.

  PMID: 41233082 DERIVED

• 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.

  PMID: 40214755 DERIVED

• 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.

  PMID: 39554834 DERIVED

Related Links

• US Centers for Disease Control and Prevention growth charts

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Metformin

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Results Point of Contact

• Title: Casey Moore
• Organization: University of Cincinnati

casey.moore@uc.edu

513-558-6307

Study Officials

• Melissa P DelBello, MD, MS

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 31, 2015
• First Posted: August 5, 2015
• Study Start: December 1, 2015
• Primary Completion: December 1, 2022
• Study Completion: June 1, 2023
• Last Updated: January 14, 2025
• Results First Posted: January 14, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (29)