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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

1565 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2023-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Bipolar Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MET and LIFE

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.

Group Type EXPERIMENTAL

Metformin

Intervention Type DRUG

Metformin - to achieves maximum insulin-sensitizing effects

healthy lifestyle intervention (LIFE)

Intervention Type BEHAVIORAL

Healthy Life style intervention

Healthy lifestyle intervention (LIFE)

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).

Group Type EXPERIMENTAL

healthy lifestyle intervention (LIFE)

Intervention Type BEHAVIORAL

Healthy Life style intervention

Interventions

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Metformin

Metformin - to achieves maximum insulin-sensitizing effects

Intervention Type DRUG

healthy lifestyle intervention (LIFE)

Healthy Life style intervention

Intervention Type BEHAVIORAL

Other Intervention Names

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GLUCOPHAGE LIFE

Eligibility Criteria

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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;

Minimum Eligible Age

8 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Melissa Delbello

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Melissa P DelBello, MD, MS

Role: PRINCIPAL_INVESTIGATOR

University of Cincinnati

Locations

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The Children's Home of Northern Kentucky

Covington, Kentucky, United States

Site Status

Jersey Shore Medical Center

Neptune City, New Jersey, United States

Site Status

South Oaks

Amityville, New York, United States

Site Status

SUNY Downstate/ Kings County Hospital

Brooklyn, New York, United States

Site Status

Maimonides

Brooklyn, New York, United States

Site Status

NYCCC

Brooklyn, New York, United States

Site Status

Northwell Zucker Long Island Jewish Hospital

Glen Oaks, New York, United States

Site Status

Mount Sinai

New York, New York, United States

Site Status

LIJ Zucker Hillside Hospital

New York, New York, United States

Site Status

Child Center of New York,

Queens, New York, United States

Site Status

NorthShore Child and Family Guidance

Roslyn Heights, New York, United States

Site Status