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

Bipolar Disorder Clinical Trial

— MOBILITY  

Official title:

MOBILITY- Metformin for Overweight & OBese ChILdren and Adolescents With BIpolar Spectrum Disorders Treated With Second-Generation AntipsYchotics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02515773
• Other study ID #: DelBello PCORI
• Status: Completed
• Phase: Phase 4
• Start date: December 2015
• Est. completion date: June 2023

Study information

• Verified date: September 2023
• Source: University of Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1565
• Est. completion date: June 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 17 Years

Eligibility

Inclusion Criteria

1. Inpatient or outpatient age 8-19 years inclusive; participants must live with a parent, guardian, or caregiver;

2. Fluent in English;

3. 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);

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, brexpiprazole or cariprazine) that is not prescribed as a PRN medication;

Exclusion Criteria:

1. 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;

2. Patients will be excluded if they could not tolerate MET during the recommended titration schedule outlined in the protocol;

3. 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]);

4. Fasting glucose = 126 mg/dL on 2 occasions during screening indicating need for prompt treatment;

5. 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;

6. Pregnant or breast feeding;

7. Children and caregivers who are unable to complete assessments for any reason;

Related Conditions & MeSH terms

• Bipolar Disorder
• Overweight

Intervention

Drug:
• Metformin
Metformin - to achieves maximum insulin-sensitizing effects

Behavioral:
• healthy lifestyle intervention (LIFE)
Healthy Life style intervention

Locations

Country	Name	City	State
United States	South Oaks	Amityville	New York
United States	Seton Family of Hospitals	Austin	Texas
United States	Maimonides	Brooklyn	New York
United States	NYCCC	Brooklyn	New York
United States	SUNY Downstate/ Kings County Hospital	Brooklyn	New York
United States	Central Clinic	Cincinnati	Ohio
United States	Child Focus	Cincinnati	Ohio
United States	Children's Home	Cincinnati	Ohio
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Lighthouse Youth Services	Cincinnati	Ohio
United States	NECCO	Cincinnati	Ohio
United States	Resident Mood Medication Clinic	Cincinnati	Ohio
United States	St. Aloysius	Cincinnati	Ohio
United States	St. Joseph's Orphanage	Cincinnati	Ohio
United States	Talbert House	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	The Children's Home of Northern Kentucky	Covington	Kentucky
United States	South Community	Dayton	Ohio
United States	Northwell Zucker Long Island Jewish Hospital	Glen Oaks	New York
United States	Butler Behavioral Health Services	Hamilton	Ohio
United States	Jersey Shore Medical Center	Neptune	New Jersey
United States	LIJ Zucker Hillside Hospital	New York	New York
United States	Mount Sinai	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	TCN Family Solutions	Xenia	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Melissa Delbello	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BMI z-score	BMI z-score will be computed from measurement of height and weight. Raw BMI is calculated as (weight(kg)/ height(m)2). Normalized BMI (z-score, adjusted for age and sex), will be calculated using the program provided by the USDA/ARS Children's Nutrition Research Center at Baylor College of Medicine (http://www.bcm.edu/cnrc/bodycomp/bmiz2.html). At each site weight will be measured with a Seca scale, model 882, calibrated to the nearest 0.2 kg per manufacturer instructions at intervals not to exceed 2 months using standard weights.	Screen/Baseline to Visit 24
Secondary	Composite Metabolic Health and Nutrition Measure	As per clinical standards, blood pressure will be measured after 5 minutes of sitting at each patient visit. A minimum of 8-hour fasting total cholesterol, low-density lipoprotein (LDL)-cholesterol, high density lipoprotein (HDL)-cholesterol, triglycerides, glucose, insulin, and glycosylated hemoglobin (HbA1c) will be collected. For HTE analyses the homeostatic model assessment for insulin-resistance (HOMA-IR) will be computed as: (Insulin [IU/mL] x Glucose [mg/dL] /405). Following the modified ATPIII guidelines,130-132 metabolic syndrome is defined when >3 of the following: 1) abdominal obesity (BMI >90%ile, as in NHANES study of metabolic syndrome in youth133; 2) blood pressure >90%ile for height, age, sex; 3) fasting triglycerides >150 mg/dL; 4) low HDL cholesterol (males <40 mg/dL and for females <50 mg/dL); 5) fasting glucose >100 mg/dL Fulfillment of individual criteria and metabolic syndrome will be outcome measures.	Screen/Baseline to Visit 24