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

  • STATUS
    Recruiting
  • End date
    Oct 23, 2022
  • participants needed
    1800
  • sponsor
    Melissa Delbello
Updated on 23 January 2021
body mass index
anxiety
olanzapine
ziprasidone
clozapine
aripiprazole
lurasidone
risperidone
psychiatric symptoms
quetiapine
mood disorder
cyclothymic disorder
paliperidone
cariprazine

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.

Details
Condition Bipolar Disorder, Bipolar Disorders (Pediatric), Manic Disorders
Treatment Metformin, healthy lifestyle intervention (LIFE)
Clinical Study IdentifierNCT02515773
SponsorMelissa Delbello
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 8 yrs and 17 yrs?
Gender: Male or Female
Do you have Bipolar Disorder?
Do you have any of these conditions: Bipolar Disorder or Bipolar Disorders (Pediatric) or Manic Disorders?
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

Exclusion Criteria

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
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