Clinical trial NCT02515773: Metformin for Overweight & OBese ChILdren and Adolescents With BDS Treated With SGAs
Official title: MOBILITY- Metformin for Overweight & OBese ChILdren and Adolescents With BIpolar Spectrum Disorders Treated With Second-Generation AntipsYchotics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bipolar Disorder
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2015-08-05
Enrollment: 1565
Sex: ALL
Minimum age (years): 8
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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;

Primary outcomes:
measure: Change in BMI Z-score From Baseline to Month 6 in ITT Sample
timeFrame: Baseline to Month 6
measure: Change in BMI Z-score From Baseline to Month 24 in ITT Sample
timeFrame: Baseline to Month 24
measure: Change in BMI Z-score From Baseline to Month 6 in Per Protocol Sample
timeFrame: Baseline to Month 6
measure: Change in BMI Z-score From Baseline to Month 24 in Per Protocol Sample
timeFrame: Baseline to Month 24
Secondary outcomes:
Other outcomes:
Locations:
city: Covington
country: United States
facility: The Children's Home of Northern Kentucky
state: Kentucky
city: Neptune
country: United States
facility: Jersey Shore Medical Center
state: New Jersey
city: Amityville
country: United States
facility: South Oaks
state: New York
city: Brooklyn
country: United States
facility: SUNY Downstate/ Kings County Hospital
state: New York
city: Brooklyn
country: United States
facility: Maimonides
state: New York
city: Brooklyn
country: United States
facility: NYCCC
state: New York
city: Glen Oaks
country: United States
facility: Northwell Zucker Long Island Jewish Hospital
state: New York
city: New York
country: United States
facility: Mount Sinai
state: New York
city: New York
country: United States
facility: LIJ Zucker Hillside Hospital
state: New York
city: Queens
country: United States
facility: Child Center of New York,
state: New York
city: Roslyn Heights
country: United States
facility: NorthShore Child and Family Guidance
state: New York
city: Stony Brook
country: United States
facility: StonyBrook
state: New York
city: Cincinnati
country: United States
facility: Lighthouse Youth Services
state: Ohio
city: Cincinnati
country: United States
facility: Central Clinic
state: Ohio
city: Cincinnati
country: United States
facility: Children's Home
state: Ohio
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Cincinnati
country: United States
facility: Resident Mood Medication Clinic
state: Ohio
city: Cincinnati
country: United States
facility: St. Aloysius
state: Ohio
city: Cincinnati
country: United States
facility: Talbert House
state: Ohio
city: Cincinnati
country: United States
facility: St. Joseph's Orphanage
state: Ohio
city: Cincinnati
country: United States
facility: Child Focus
state: Ohio
city: Cincinnati
country: United States
facility: NECCO
state: Ohio
city: Cleveland
country: United States
facility: University Hospital Medical Center Cleveland
state: Ohio
city: Columbus
country: United States
facility: Nationwide Children's Hospital Columbus
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Dayton
country: United States
facility: South Community
state: Ohio
city: Hamilton
country: United States
facility: Butler Behavioral Health Services
state: Ohio
city: Xenia
country: United States
facility: TCN Family Solutions
state: Ohio
city: Austin
country: United States
facility: Seton Family of Hospitals
state: Texas
Study officials:
affiliation: University of Cincinnati
name: Melissa P DelBello, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: